StemCell Therapy

Identification of key oncogenic drivers and the development of targeted therapies with clinical activity in patients harboring actionable mutations have revolutionized the treatment paradigm in nonsmall cell lung cancer (NSCLC), redirecting attention toward advances in biomarker testing methodologies. This new focus is poised to foster granular refinement of precise, targeted treatment of lung tumors.

Advances in NSCLC research have enabled an understanding of the disease as a collection of molecular subgroups. The proliferation of alteration-matched therapies specific to these subgroups is a prime example of a precision medicine approach. In addition to oncogenic driver mutations, therapeutic response biomarkers have been identified, such as PD-L1 expression as a predictor of immunotherapy efficacy.

Underscoring the importance of biomarker-guided treatment approaches, guidelines for molecular testing in NSCLC include an extensive list of alterations, such as sensitizing EGFR mutations and ALK gene fusions.1,2 The list continues to expand beyond these established canonical markers, with the addition of variants such as MET exon 14 skipping mutations and tumor mutational burden. In fact, the FDA recently approved therapies specific for tumors with these molecular characteristics.3,4

The rapid pace of biomarker discovery, characterization of molecular subtypes of NSCLC, development of matched targeted therapies, and regulatory approval of companion diagnostic tests has accelerated progress in the delivery of optimal care for patients with advanced NSCLC. Areas where continued optimization is particularly emphasized include determining which type of sample(s) should be tested, which biomarkers should be analyzed in different patient subsets, and which assays are most appropriate for specific (sets of) markers, as well as logistical and administrative factors, such as turnaround times and cost/reimbursement considerations.1,5,6

As biomarker testing in NSCLC evolves, investigators continue to evaluate testing approaches with the goal of standardizing the process of oncogenic driver identification.

At the 2020 Molecular Analysis for Precision Oncology (MAP) Virtual Congress, held October 9 to 10, 2020, presentations focused on recent developments in molecular testing, including the results of studies comparing testing methods for aberrations in the MET and NTRK genes.

MET Exon 14 Skipping

Gain-of-function alterations in MET, which encodes a receptor tyrosine kinase, drive oncogenesis. One such alteration with important implications for NSCLC is MET exon 14 skipping, resulting from several types of mutation in either exon 14 itself, the adjacent introns, or the flanking splice sites. Regardless, the effect is the same: a critical ubiquitination site is lost, which leads to MET protein accumulation and activation, enhancing MET pathway signal transduction and culminating in tumorigenesis. Previously, immunohistochemistry was typically performed to detect MET overexpression due to copy number changes. However, next-generation sequencing (NGS) is now the preferred testing method because it can also identify MET exon 14 skipping mutations, the primary driver of oncogenesis.7

MET exon 14 skipping mutations are actionable because the resultant protein is responsive to MET inhibition using tyrosine kinase inhibitors (TKIs) such as capmatinib (Tabrecta),7 which was approved in May 2020 for use in adult patients with metastatic NSCLC harboring a MET exon 14 skipping mutation.3 Compared with their sensitivity to specific TKIs, this subset of patients has exhibited lower rates of response to immunotherapy despite frequent tumor expression of PD-L1,8 suggesting a dual predictive role for the MET exon 14 skipping mutation as a biomarker.

In a study presented at MAP 2020, tumor samples from patients with NSCLC and no other driver mutations were tested for MET exon 14 skipping mutations over a period of 14 months. The investigators compared 2 DNA-based methods: NGS on the Ion Proton platform using AmpliSeq technology and fragment analysis using polymerase chain reaction (PCR) and size-based electrophoretic separation of the amplicons for detection of large deletions.9

Of the 87 patient samples tested, 13 were determined to have a MET exon 14 skipping alteration, with 5 harboring splice variants and 8 carrying deletions affecting the splice site. Two of these deletions were large, spanning 41 and 66 base pairs; they were detected by fragment analysis but not NGS. Although NGS is widely considered superior to single-gene assays, these data indicate that it may have limitations in detecting specific alterations and that complementary methods or large-coverage intron screening could be an alternative for optimal detection of MET alterations to inform selection of first-line treatment, according to lead study author Romain Loyaux, from the Molecular Oncology Department of Georges-Pompidou European HospitalAPHP in Paris, France.

Commenting on the failure of the NGS assay to detect large MET exon 14 deletions, Loyaux stated that fragment analysis is a cheap and robust method to detect large deletions, especially when no RNA is available (FIGURE).9-11 He noted that anchored, multiplex, targeted RNA-based NGS, like the technology developed by the Archer company, may be a good alternative when RNA is available; however, it has a 20% failure rate.12

NTRK Fusion Detection

Fusions involving the NTRK genes, which encode a family of receptor tyrosine kinases, result in a constitutively activated chimeric protein that promotes oncogenesis and therefore, can be therapeutically targeted with TKIs.7 Two FDA-approved TKIs, entrectinib (Rozlytrek) and larotrectinib (Vitrakvi), have activity in NTRK fusionpositive solid tumors.13,14

Broad, hybrid-capture DNA-based NGS, with RNA-based anchored multiplex PCR as an adjunct, are currently the primary methods of detecting NTRK gene fusions in patients with lung cancer.7 The availability of entrectinib and larotrectinib will likely foster further development of NTRK fusion detection methods for use in routine clinical practice.

A recent study presented at MAP 2020 evaluated the analytical performancenamely, sensitivity, specificity, and precisionof 3 commonly available RNA-based NGS assays. The assays examined were TruSight Oncology 500 (TSO500) by Illumina, Oncomine Focus Assay (OFA) by Thermo Fisher Scientific, and Fusion- Plex Lung (AFL) by Archer.15

The limits of sensitivity and precision were assessed using droplet digital PCR with admixtures of both NTRK fusionpositive and negative samples, whereas specificity was evaluated using NTRK fusionnegative clinical samples. The data showed that all 3 NGS assays successfully detected NTRK fusions; however, technical differences between the assays may impact their performance. For instance, although all tested assays demonstrated strong specificity, the sample metrics were variable. Quality control (QC) success rates for OFA and TSO500 were 83% and 77%, respectively, but only 43% of samples on AFL passed all assay QC metrics. Notably, the different assays missed specific NTRK fusions; OFA failed to detect NTRK1-LMNA, NTRK1-TFG, and NTRK2- PAN3, and TSO500 failed to report NTRK3-ETV6 (E5N14) and NTRK3-ETV6 (E5N15).15

Clinical Utility of NGS Panels of Different Sizes

It has been established that multigene panels are superior to single-gene assays for biomarker testing in NSCLC2; however, data to inform clinicians selection of specific NGS gene panels have been lacking.

In a recent study presented at MAP 2020, a literature review was conducted to compare 2 commercially available DNA-based NGS gene panels: the Ion AmpliSeq Cancer Hotspot Panel, covering hotspots in 50 genes (Panel 50); and the FoundationOne panel, covering the complete exons of 315 genes (Panel 315). The clinical utility of each panel was determined based on the number of detectable actionable alterations in various solid tumor types that it contained. The data showed a substantial gain in actionability using the larger gene panel, which matched more actionable genetic mutations to FDA-approved or experimental drugs; the number of actionable alterations in various solid tumor types using Panel 315 was a median 50% higher compared with Panel 50 (t test, P <.001). The authors attributed this gain to the inclusion of more genes related to homologous recombination repair deficiency and microsatellite instability/immunotherapy response in the larger panel.16

In the current era of precision medicine in lung cancer, defined histological subtyping, oncogenic driver testing, and analysis of tumor PD-L1 expression/immunotherapy sensitivity are crucial steps prior to therapeutic decision-making in NSCLC. As additional targeted agents are investigated in clinical trials and the incidence of their molecular targets are characterized in patient populations, expanded molecular testing may become necessary.

Molecular pathologists will continue to play an integral role in the continuum of care in NSCLC, from diagnosis to clinical decision-making based on biomarker detection. Molecular testing is likely to expand rapidly, and additional molecular subtypes will be identified that help match more patients with the optimal targeted therapies, providing highly personalized treatment plans.

Details of analytical procedures and assays will continue to be refined.17 By combining defined sets of biomarkers with appropriate protocols for collecting NSCLC samples and optimized methods for assessing specific changes, clinicians will be able to actualize the promise of precision medicine for patients with this challenging malignancy.

References:

1. Lindeman NI, Cagle PT, Aisner DL, et al. Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors: guideline from the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. Arch Pathol Lab Med. 2018;142(3):321-346. doi:10.5858/arpa.2017-0388-CP

2. NCCN. Clinical Practice Guidelines in Oncology. Non-small cell lung cancer, version 8.2020. Accessed October 26, 2020. https://bit.ly/2TKomAj

3. FDA grants accelerated approval to capmatinib for metastatic nonsmall cell lung cancer. FDA. May 6, 2020. Accessed November 2, 2020. https://bit.ly/360o7Xg

4. FDA approves pembrolizumab for adults and children with TMB-H solid tumors. FDA. June 16, 2020. Accessed November 2, 2020. https://bit.ly/2HWB64q

5. Smeltzer MP, Wynes MW, Lantuejoul S, et al. The International Association for the Study of Lung Cancer global survey on molecular testing in lung cancer. J Thorac Oncol. 2020;15(9):1434-1448. doi:10.1016/j.jtho.2020.05.002

6. Wempe MM, Stewart MD, Glass D, et al. A national assessment of diagnostic test use for patients with advanced NSCLC and factors influencing physician decision-making. Am Health Drug Benefits. 2020;13(3):110-119

7. Sabari JK, Santini F, Bergagnini I, Lai WV, Arbour KC, Drilon A. Changing the therapeutic landscape in non-small cell lung cancers: the evolution of comprehensive molecular profiling improves access to therapy. Curr Oncol Rep. 2017;19(4):24. doi:10.1007/s11912-017-0587-4

8. Sabari JK, Montecalvo J, Chen R, et al. PD-L1 expression and response to immunotherapy in patients with MET exon 14-altered non-small cell lung cancers (NSCLC). J Clin Oncol. 2017;35(suppl 15):8512. doi:10.1200/JCO.2017.35.15_suppl.8512

9. Loyaux R, Blons H, Garinet S, Urban P, Leger C, Bastide M. MET exon 14 screening strategy: how not to miss large deletions. Ann Oncol. 2020;31(suppl 5): S1217-S1239. doi:10.1016/j.annonc.2020.08.2163

10. Pruis MA, Geurts-Giele WRR, von der TJH, et al. Highly accurate DNAbased detection and treatment results of MET exon 14 skipping mutations in lung cancer. Lung Cancer. 2020;140:46-54. doi:10.1016/j.lungcan.2019.11.010

11. Davies KD, Lomboy A, Lawrence CA, et al. DNA-based versus RNAbased detection of MET exon 14 skipping events in lung cancer. J Thorac Oncol. 2019;14(4):737-741. doi:10.1016/j.jtho.2018.12.020

12. Cohen D, Hondelink LM, Solleveld-Westerink N, et al. Optimizing mutation and fusion detection in NSCLC by sequential DNA and RNA sequencing. J Thorac Oncol. 2020;15(6):1000-1014. doi:10.1016/j.jtho.2020.01.019

13. FDA approves entrectinib for NTRK solid tumors and ROS-1 NSCLC. FDA. Published August 15, 2019. Accessed October 28, 2020. https://bit.ly/3mPhUEB

14. FDA approves larotrectinib for solid tumors with NTRK gene fusions. FDA. Published November 26, 2018. Accessed October 28, 2020. https://bit.ly/381dXZe

15. Bormann Chung C, Lee J, Barritault M, et al. Evaluating targeted next-generation sequencing (NGS) assays and reference materials for NTRK fusion detection. Ann Oncol. 2020;31(suppl 5):S1221. doi:10.1016/j.annonc.2020.08.2172

16. zdemir B, Charrier M, Gerard CL, et al. Comparison of the clinical utility of two different size next generation sequencing (NGS) gene panels for solid tumours. Ann Oncol. 2020;31(suppl 5):S1219. doi:10.1016/j.annonc.2020.08.2166

17. Pennell NA, Arcila ME, Gandara DR, West H. Biomarker testing for patients with advanced non-small cell lung cancer: real-world issues and tough choices. Am Soc Clin Oncol Educ Book. 2019;39:531-542. doi:10.1200/EDBK_237863

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Increased Attention on Testing for Oncogenic Drivers in NSCLC Advances the Promise of Precision Medicine - Targeted Oncology

WHIPPANY, N.J. & CHICAGO--(BUSINESS WIRE)--Bayer and Tempus, leaders in precision medicine and artificial intelligence (AI), announced a new collaboration designed to provide broader access to genomic testing and tailored treatment approaches for the oncology community. The collaboration will include an initiative to help facilitate patient identification for precision oncology by providing testing, via the Tempus xT broad-panel genomic sequencing assay, for a subset of patients with metastatic colorectal cancer (mCRC), as well as those with radioactive iodine refractory differentiated metastatic thyroid carcinoma (RAIR thyroid cancers). Looking ahead, Bayer and Tempus will continue to implement data-enriched initiatives dedicated to supporting patients.

Bayer's commitment to precision oncology is currently supported by its approach to research that prioritizes targets and pathways that impact the way cancer is treated. The Tempus xT broad-panel genomic sequencing assay is designed to detect actionable driver alterations, including BRAF, KRAS, RET, and NTRK gene fusions.1 NTRK gene fusions are genomic alterations that drive tumor growth regardless of where they originate in the body.2-4 These genomic alterations typically occur following DNA damage, which results in structural changes to the DNA either through biological changes or from environmental factors (e.g. ultraviolet light damage).2-4 During the DNA damage repair mechanism, the NTRK gene can fuse with an unrelated gene resulting in an altered TRK fusion protein, which causes a constant signaling cascade, driving tumor growth and its metastasis (progression).2-4 Studies suggest NTRK gene fusions are present in approximately 3% of patients with mCRC with prior high microsatellite instability (MSI-H) status and 2.4%-12% of patients with RAIR thyroid cancers.5-7

Testing early and utilizing comprehensive genomic profiling is critical, as it helps physicians understand the underlying driver of DNA alterations for tumor progression (growth).8,9 When actionable alterations are detected, they aid physicians in the treatment decisions appropriate for their patients.10 The Tempus xT broad-panel genomic sequencing assay detects these alterations by sequencing tumor samples with matched normal saliva or blood samples, when available, covering 648 genes.1 The test is used by many oncologists across a diverse set of clinical settings, including leading academic centers, NCI designated cancer centers, hospital networks and community hospitals.

Bayers strong focus in precision medicine combined with Tempus unique testing offering has culminated in this collaboration to bring genomic testing to cancer patients, said Bhavesh Ashar, Senior Vice President, Head of U.S. Oncology at Bayer. "We are excited for the potential of this initiative to identify patients who may benefit from tailored treatment options.

"This strategic collaboration aims to provide eligible colorectal and thyroid cancer patients with broad based access to our genomic test to help their physicians make treatment decisions," said Ryan Fukushima, Chief Operating Officer of Tempus.

Healthcare professionals with eligible patients from the above tumor types can receive additional information by learning more at Tempus.com/bayerprogram and contacting Tempus at support@tempus.com.

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now expands to six marketed products and several other assets in various stages of clinical development. Together, these products reflect the companys approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to http://www.bayer.us.

About Tempus

Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the worlds largest libraries of clinical and molecular data, and an operating system to make that data accessible and useful, Tempus enables physicians to make real-time, data-driven decisions to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.

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2020 Bayer

BAYER and the Bayer Cross are registered trademarks of Bayer.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayers public reports which are available on the Bayer website at http://www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

______________________________________________________________________________

References

PP-PF-ONC-US-1620-1

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Link:
Bayer and Tempus Initiate Collaboration to Advance Patient Access to Genomic Testing and Precision Medicine - Business Wire

Figure 1

Remaining Lifetime Risk for ATM PV Carriers

SALT LAKE CITY, Dec. 11, 2020 (GLOBE NEWSWIRE) -- In a spotlight poster discussion at the 2020 San Antonio Breast Cancer Symposium (SABCS), Myriad Genetics (NASDAQ: MYGN), a global leader in molecular diagnostics and precision medicine, today presented a new study that shows how its myRisk Hereditary Cancer and riskScore tests can better inform individualized clinical screening and prevention strategies for women at risk of developing breast cancer. The new Myriad study highlights how riskScore, a proprietary tool used to evaluate a womans risk of developing breast cancer, can accurately provide breast cancer risk information into a personalized assessment model for women carrying a pathogenic variant (PV) in the ATM gene.

This new study will enable a highly personalized risk calculation for patients who carry mutations in the ATM gene, said Nicole Lambert, president of Myriad Genetic Laboratories. As a result, women carrying gene mutations will be able to make more informed choices about how to manage their risk; if increased surveillance is sufficient or if they would consider surgical options.

Myriads riskScore test combines data from 20 years of genome-wide association studies with a validated algorithm that uses personal and family history. riskScore is performed in conjunction with Myriads myRisk Hereditary Cancer test, where myRisk identifies people who carry specific cancer-linked genetic mutations.

Asummary of the study is below. Follow Myriad on Twitter via @myriadgenetics and keep up to date with SABCS meeting news and updates by using the #SACBS20 hashtag.

riskScore Poster at SABCS Title: Development of a breast cancer risk assessment model for ATM mutation carriers incorporating Tyrer-Cuzick and a polygenic risk score Program Number: PD10-09 Session Title: Spotlight Poster Discussion 10 This study highlights the development of a comprehensive breast cancer risk model for ATM PV carriers incorporating an 86-variant PRS, along with family history and clinical information captured by Tyrer-Cuzick (a tool used to calculate the risk of breast cancer). The study found that with ATM PV carriers (N=216), a comprehensive model allowed for differentiation of carriers into low, moderate, and high breast cancer risk categories (See figure 1 below).

To view Figure 1. Remaining Lifetime Risk for ATM PV Carriers, please visit the following link:https://www.globenewswire.com/NewsRoom/AttachmentNg/d77da35a-714a-41f4-8a8a-dd79a79dc644

AboutriskScore riskScore is a clinically validated personalized medicine tool that enhances Myriads myRisk Hereditary Cancer test. riskScore helps to further predict a womens lifetime risk of developing breast cancer using clinical risk factors and genetic markers throughout the genome. The test incorporates data from more than 80 single nucleotide polymorphisms identified through 20 years of genome wide association studies in breast cancer and was prospectively validated in our laboratory to predict breast cancer risk in women of European descent. This data is then combined with a personal history and family history algorithm, the Tyrer-Cuzick model, to provide an individualized breast cancer risk assessment. Myriad is committed to advancing the validation of risk-assessment tools and making them available to all women, regardless of ancestry.

About Myriad myRisk Hereditary Cancer The Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms to evaluate 35 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma.

About Myriad Genetics Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website:www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice CDx, Vectra, Prequel, Foresight, GeneSight, riskScore and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.

Safe Harbor Statement This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the Company building ATM status into a clinically validated risk assessment tool that will create a more comprehensive, highly personalized report for patients seeking to understand their risk of developing breast cancer; and the Companys strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties associated with COVID-19, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Assn for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Intl, 573 U.S. 208 (2014); risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2020, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

Link:
New Study Provides Personalized Breast Cancer Risk Information for Women with ATM Gene Mutations - GlobeNewswire

SOUTH SAN FRANCISCO, Calif., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Cellworks Group, Inc., a world leader in Personalized Medicine in the key therapeutic areas of Oncology and Immunology, today announced results from the myCare-021-01 clinical trial, which found that the Cellworks Omics Biology Model (CBM) predicted response to Arsenic Trioxide (ATO) and All-trans-retinoic Acid (ATRA) in Acute Promyelocytic Leukemia (APL) patients harboring PML-RARA fusions with 93% accuracy. The study also demonstrated that Cellworks CBM can identify new mechanisms of resistance in APL patients and suggest alternative regimens for non-responders by targeting patient-specific disease biomarkers unique to each.

Results from the myCare-021-01 clinical study will be featured as Oral and Poster Abstract #2784 on Monday, December 7, 2020 during the all-virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition and published online at Blood.

The vast majority (99%) of APL patients have the PML-RARAfusion gene, which is the most critical event involved in the pathogenesis of APL. (Source: PMID: 32182684). The PML-RARAfusion confers a selective sensitivity to the targeted drugs, ATO and ATRA, with response rates over 90% (Source: PMID: 31635329). However, the mechanism of resistance in the minority of APL non-responders is not well understood. This study used the Cellworks Omics Biology Model (CBM) to predict response to the combination of ATO-ATRA in patients harboring the PML-RARA fusion and identify mechanisms of resistance.

The ability of Cellworks CBM to accurately predict non-response to ATO and ATRA in APL patients with PML-RARA fusion up-front could prevent ineffective treatments, avoid unnecessary adverse events and reduce treatment costs, said Dr. Scott Howard, MD, MSc, Professor at University of Tennessee Health Science Center. In addition, we need an understanding of the mechanism of resistance in APL non-responders to prescribe more efficacious therapies and improve patient outcomes. In this study, the Cellworks CBM identified clinically relevant deletions to genes in patients who did not respond to ATO and ATRA and suggested alternative therapies. By taking this personalized approach to treating cancer patients, we can move the needle closer to the ideal 100% response rate.

myCare-021-01 Clinical Study

In this study, outcomes of 30 APL patients treated with ATRA or ATRA plus ATO were compared with outcomes predicted by Cellworks CBM. Genomic data from 6 publications derived from whole exome sequencing (WES), targeted next-generation sequencing (NGS), copy number variation (CNV) and/or karyotype data were used. All data was anonymized, de-identified and exempt from IRB review.

The available genomic data for each profile was entered into the Cellworks CBM which generates a patient-specific disease protein network model using PubMed and other online resources. The CBM predicts the patient-specific biomarker and phenotype response of a personalized diseased cell to drug agents, radiation and cell signaling. Disease biomarkers that are unique to each patient were identified within the protein network models.

ATO and ATRA were simulated on all 30 patient cases. The treatment impact was assessed by quantitatively measuring the drugs effect on a cell growth score which is a composite of the quantified values for cell proliferation, survival, and apoptosis, along with the simulated impact on each patient-specific disease biomarker score. Each patient-specific model was also digitally screened to identify response to ATO and ATRA.

Results of the study demonstrated that Cellworks CBM correctly predicted the response to ATO and ATRA in 28 of 30 cases. The overall prediction accuracy was 93% with a PPV of 100%, NPV of 60%, sensitivity of 93%, and specificity of 100%. In 2 of 30 patients who did not respond to ATO and ATRA, the CBM identified clinically relevant deletions to EZH2, KMT2E, and HIPK2 genes. All three genes are located on chromosome 7 and these non-responders had monosomy 7.

About Cellworks Group

Cellworks Group, Inc. is a world leader in Personalized Medicine in the key therapeutic areas of Oncology and Immunology. Using innovative multi-omics modeling, computational biosimulation and Artificial Intelligence heuristics, Cellworks predicts the most efficacious therapies for patients. The Cellworks unique biosimulation platform is a unified representation of biological knowledge curated from heterogeneous datasets and applied to finding cures. Backed by UnitedHealth Group, Sequoia Capital, Agilent and Artiman, Cellworks has the worlds strongest trans-disciplinary team of molecular biologists, cellular pathway modelers and software technologists working toward a common goal attacking serious diseases to improve the lives of patients. The company is based in South San Francisco, California and has a research and development facility in Bangalore, India. For more information, visit http://www.cellworks.life and follow us on Twitter @cellworkslife.

All trademarks and registered trademarks in this document are the properties of their respective owners.

Media Contacts:

Barbara ReichertReichert Communications, LLCBarbara@reichertcom.com415-225-2991

Michele Macpherson, Chief Business OfficerCellworks Group, Inc.michele.macpherson@cellworksgroup.com

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Cellworks Personalized Biosimulation Clinical Trial Predicted ATO and ATRA Therapy Response in APL Patients with 93% Accuracy - GlobeNewswire

Researchers from the Antimicrobial Resistance (AMR) Interdisciplinary Research Group (IRG) at Singapore-MIT Alliance for Research and Technology (SMART), MITs research enterprise in Singapore, have developed a method to produce customizable engineered lysins that can be used to selectively kill bacteria of interest while leaving others unharmed. The discovery presents a promising alternative to antibiotics for treating existing drug-resistant bacteria and bacterial infections without the risk of causing resistance.

Lysins are enzymes produced by bacteriophages to break open the bacteria cells while treating infections, and have demonstrated potential as a novel class of antimicrobials. A major advantage of lysins is that they allow fast and targeted killing against a specific bacterium of choice without inducing resistance.

The emergence of multidrug-resistant bacteria has left even minor bacterial infections incurable by many existing antibiotics, with at least 700,000 deaths each year due to drug-resistant diseases, according to the World Health Organization.

In a paper titled Engineered Lysins with Customized Lytic Activities Against Enterococci and Staphylococci recently published in the prestigious journal Frontiers in Microbiology, the SMART AMR team demonstrates one of the methods to customize the lytic spectrum of engineered lysins.

The study reveals how the engineered lysins were able to selectively kill bacteria such as staphylococcus Enterococcus faecalis, while leaving the Enterococcus faecium bacteria of the same genus unharmed. This is the first report of a chimeric lysin that can both target bacteria of multiple genera and selectively kill one bacterial species within a genus over another.

The human body contains trillions of bacteria, which form the microbiome, and the majority of the bacteria is either harmless or beneficial to us, says AMR research scientist and corresponding author of the paper Boon Chong Goh. What happens when we are on an antibiotic course is that the antibiotics kill all of the bacteria, leaving us vulnerable to a worse reinfection after we have completed the antibiotic course. Since lysins respect the microbiome and only eliminate the bad pathogenic bacteria, they are a very promising alternative for treating bacterial infections.

Awarded with the Ignition and Innovation Grants from SMART Innovation Center, Gohs team has established the foundation of a technology platform by producing the lysins and testing them in vitro, and are in the process of developing a series of techniques to engineer the lysins.

Since lysins are essentially proteins, they can be engineered and mass produced, says Hana Sakina Bte Muhammad Jai, lead author of the paper and laboratory assistant under Gohs team at SMART. Our study clearly shows how modifying these proteins translates to improvements of their specificity and antibacterial activities.

In the lab, we have observed that once a small amount of lysin is added, it only takes 30 minutes to completely kill the bacteria, making them a very safe and efficient choice for removing unwanted bacteria, says Linh Chi Dam, the co-first author of the paper and laboratory technologist under Gohs team. While developments in the production of customized lysins would greatly impact pharmaceutical industries where lysins can be used to treat bacterial infections, skin-care and consumer care industries would also benefit by using lysins as a targeted agent to remove unwanted bacteria from their products.

The research is carried out by SMART and supported by the National Research Foundation (NRF) Singapore under the Campus for Research Excellence and Technological Enterprise (CREATE). The SMART AMR team was also recently awarded the Intra-CREATE Seed Collaboration Grant to investigate lysins targeting gram-negative bacteria such as Pseudomonas aeruginosa, Acinetobacter baumannii, and Klebsiella pneumoniae.

SMART was established by MIT in partnership with the NRF in 2007. SMART is the first entity in CREATE. SMART serves as an intellectual and innovation hub for research interactions between MIT and Singapore, undertaking cutting-edge research projects in areas of interest to both. SMART currently comprises an Innovation Center and five IRGs: AMR, Critical Analytics for Manufacturing Personalized-Medicine, Disruptive and Sustainable Technologies for Agricultural Precision, Future Urban Mobility, and Low Energy Electronic Systems.

The AMR IRG is a translational research and entrepreneurship program that tackles the growing threat of antimicrobial resistance. By leveraging talent and convergent technologies across Singapore and MIT, they tackle AMR head-on by developing multiple innovative and disruptive approaches to identify, respond to, and treat drug-resistant microbial infections in order to provide transformative, holistic solutions for Singapore and the world.

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SMART researchers use lysins to selectively target bacteria - MIT News

Engaging in regular exercise is typically viewed as a positive activity that results in improved physical and mental health.

But, does regular exercise affect some people more positively than others? And if so, why?

These are questions researchers at Pennington Biomedical Research Center feel compelled to investigate.

So far, they've developed a theory that a person's response to exercise is a direct result of their mitochondria, which are the subcellular structures that help our body by converting sugar into energy.

Armed with their theory, its related questions, and a new $2.5 million award from the National Institutes of Healths National Institute on Aging, Pennington's researchers will investigate the matter by way of a four-year study that will require the assistance of 375 participants.

Dr. Owen Carmichael, Ph.D., Professor and Director of Biomedical Imaging at Pennington Biomedical explained that the four-year study will compare mitochondria responses between younger and older adults who undergo exercise training.

He also expects to identify molecular factors that promote or discourage a positive mitochondrial change in addition to shedding lighton several theories, including that:

-Exercise will not improve mitochondrial function for a certain portion of the population.

-Age will not limit the mitochondrial response to exercise.

-Aerobic training will provide more mitochondrial capacity improvements than resistance training, regardless of age.

Pennington Biomedical Executive Director John Kirwan, Ph.D., said a better understanding of the biology behind the benefits of exercise will advance personalized medicine.

In the long term, we believe the studys findings will help physicians use each individual's unique biological characteristics to precisely tailor exercise training for that person.

In effect, physicians will be able to prescribe an exercise regimen that maximizes the health benefits for each individual patient, Dr. Kirwan said.

As previously mentioned, the study will involve around 375 participants, and Pennington Biomedical plans to begin recruiting volunteers in the Spring of 2021.

Interested individuals should visit http://www.pbrc.edu/clinical-trials/#studylistfor updates.

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Pennington Biomedical to select 375 participants for 2021 research study regarding benefits of exercise - WBRZ

When Mel Mitchell was diagnosed with Parkinsons disease in 2013, he wasnt all that interested in learning what caused the condition.

I have to be honest, he said. I just wanted to figure out how to deal with it.

But after retiring from his human resources job, Mitchell started volunteering with the Minnesota chapter of the Parkinsons Foundation. The work made him more curious about the causes of the disease. When he learned about how researchers were using genetic testing to develop new treatments and therapies, Mitchell, 72, told himself that if the opportunity ever arose to take part in a study, hed gladly step forward.

In 2019, Mitchell learned that the foundation was sponsoring PD GENEration (PD stands for Parkinsons disease), a national initiative offering genetic testing for clinically relevant Parkinsons genes.

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The tests were free of charge at select Parkinsons clinics around the nation, including the Struthers Parkinsons Center in Golden Valley, not far from where Mitchell lives. Researchers plan to one day use the results to help develop improved treatments and personalized medicine to treat Parkinsons.

When the opportunity to get involved in PD GENEration came along, Mitchell said, it struck a chord for several reasons. It piqued my curiosity. It seemed like an easy way to find out more, to help out, to take action.

Mel Mitchell

Nance, who is trained in neurology and genetics, is excited about PD GENErations promise for the treatment of Parkinsons.

Research in this area has been slowed down by the lack of genetic testing, she said. There are about two dozen genes associated with Parkinsons. The study will be testing for seven of the most common.

By identifying people who have specific genetic forms of PD we may find that certain genetic forms of the disease are more common than we think, Nance said, adding with a rueful chuckle: I have been waiting for 20 years for genetics to be relevant to PD.

Even though testing revealed that, rather than having a rarer genetically linked form of the disease, he had just run-of-the-mill Parkinsons, Mitchell said hes glad he took part in the study.

I think I have a responsibility to take part in research, he said. Todays research is tomorrows cure.

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Using genetic information to design medicine targeted to treat specific forms of disease is not a new concept, said James Beck, the Parkinsons Foundation senior vice president and chief scientific officer.

Martha Nance

Advances in genetic research have made it possible to discover specific genes linked to individual diseases, Nance said. We have the tools available right now to look at the genetic aspects of just about anything. The gene genie is out of the bottle, and Parkinsons researchers are starting to take advantage of that.

Of the two dozen genes linked to Parkinsons disease, two specific mutations stand out, Beck said.

One is called LRRK2. The other genetic mutation is in a gene called the GBA gene. These are the two most common in this long list of mutations. Right now pharmaceutical companies are beginning to develop therapies to help treat PD in people who have been found to have those mutations.

Like Mitchell, the majority of people with Parkinsons do not appear to have a specific genetic cause to their disease.

We now think that 10 percent of people with PD have a genetic cause, Nance said. In other people, the cause for their Parkinsons may be environmental, she added. In still others, the disease may be idiopathic or spontaneous, with no known cause.

There are people with clear environmental risks for Parkinsons, like welders, Nance said. The VA has also acknowledged that exposure to Agent Orange is also a risk for developing PD.

Until recent decades, Parkinsons was thought to be a disease that afflicted only older people. The average onset is between 60 and 65, Nance said. But every so often you see a 30-year-old or a 40-year-old with PD. In those cases, she continued, You think, Is this really the same disease?

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The answer, Nance explained, is that there are multiple causes of PD. Now we have the tools available to tease out the genetic forms of Parkinsons. But it is still hard to tease out the environmental forms. She believes that widespread genetic testing of people with the disease might actually hold treatment options for people like Mitchell, as well.

Beck said that its time for a new, large-scale Parkinsons study.

For too long weve been looking at PD in the wrong way, he said. Its been 50-plus years since levodopa, the main drug for treating Parkinsons symptoms, was approved. There has not been a huge change in treatment options since that time.

He hopes that this new genetic research will ultimately unlock information that could forever change treatment options and the long-term outlook for people with Parkinsons disease.

PD GENEration backers like Nance and Beck hope that more people with PD will follow Mitchells lead and sign up for genetic testing. Though the percentage of people with genetically linked forms of Parkinsons is thought to be low, there is a possibility that by gathering information from thousands of participants, researchers may actually be able to learn more about how to best treat individuals with non-genetic forms of the disease.

Maybe by doing a big study like this one, we can start to recognize characteristics that suggest somebody is more likely to have a genetic cause for their disease, Nance said. Maybe in the end we arent going to be testing every 90-year-old who walks in the door with a little bit of a tremor.

And because genetic testing still isnt common in Parkinsons treatment, researchers actually dont have a clear picture of the origins of most cases of the disease, Nance said. By gathering results from thousands of people with the disease, they hope to bring Parkinsons into sharper focus.

It may turn out that this treatment we are proposing for LARRK2 PD may help people with other forms of PD.

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The enrollment goal for the PD GENEration initiative is 15,000, Beck said. So far our study has found that 17 percent of participants have a genetic form of PD. That number might not remain as high as we continue the study. We hope to find 1,500 people with a genetic form of PD.

James Beck

We have had a tremendous interest in this study. In fact, there is a bit of a waiting list at Struthers, Beck said. Parkinsons Foundation officials are working to increase capacity, but the waiting list now stretches into January. Our hope here is that by looking closely at individuals who have genetic mutations for PD we can develop, through the pharmaceutical industry, a cure or a new way to treat PD.

Mitchell is pleased to hear hopeful talk like this. Even if new Parkinsons treatments, or the promise of a cure, are decades away, hes pleased that hes been able to do his part.

PD GENEration is really about applying science to the disease in a way that hasnt been done before, he said. This is an opportunity to get a lot of people involved and discover what our genes say about this disease.

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Research initiative aims to delve into the genetic roots of Parkinson's disease - MinnPost

MADISON, Wis., Dec. 11, 2020 /PRNewswire/ --Exact Sciences Corp. (NASDAQ: EXAS) today announced the presentation of new data at the virtual 2020 San Antonio Breast Cancer Symposium (SABCS) building on the clinical value of the Oncotype DX Breast Recurrence Score test. These data highlight the role of the test in further individualizing treatment decisions in early breast cancer.

"These latest presentations, including data from the RxPONDER trial, further highlight the unique value of the Recurrence Scoreresult in providing critical information to personalize and improve the quality of treatment decisions in node-negative and node-positive early breast cancer," said Rick Baehner, MD, chief medical officer of Precision Oncology at Exact Sciences.

Five-year outcomes from ADAPT study show that not all clinically high-risk patients with node-negative or node-positive disease need chemotherapy

First efficacy results from the ADAPT study (4,691 patients) were presented at SABCS.[i] Patients were all considered candidates for chemotherapy by traditional parameters and were stratified using the Oncotype DX test and changes in the immunohistochemical prognostic marker Ki67 after three weeks of pre-operative anti-hormonal therapy. Patients with clinically high risk node-negative disease, and node-positive disease with up to 3 positive nodes, were treated with anti-hormonal therapy alone if the Recurrence Score result was 011 or if the Recurrence Score result was 12-25 with a Ki67 response. This group of patients had, regardless of their age, favorable outcomes with anti-hormonal therapy alone, with 5-year distant disease-free survival of 96%.

Another analysis from the ADAPT trial also presented at SABCS evaluated 864 breast cancer patients who received neoadjuvant chemotherapy primarily based on their Recurrence Score result.[ii] These results from a large neoadjuvant trial showed that the Recurrence Score result is a strong predictor of response to chemotherapy as assessed by the rate of pathologic complete response (no residual invasive tumor).

ADAPT is one of the largest prospective, randomized studies in early-stage breast cancer and was conducted by the West German Study Group (WSG) in 80 centers across Germany. It utilized a pioneering trial design to assess individualization of (neo)adjuvant decision-making.

"Our study shows the unique value of the complementary biological information provided by the Oncotype DX test and sequential Ki67 testing. Risk stratification using the Recurrence Score result and changes in Ki67 after brief pre-operative anti-hormonal therapy allows us to identify those patients with node-negative or node-positive disease who can be spared the toxicity and side effects of chemotherapy without a negative impact on treatment outcome," said Prof. Nadia Harbeck, Scientific Director of the WSG and Head of the Breast Centre at LMU Klinikum Munich (LMU), Germany. "This is especially important for patients who would be considered at high risk of relapse based on traditional clinical parameters."

New patient-specific meta-analysis provides individualized estimates for both prognosis and absolute chemotherapy benefit in node-negative breast cancer

A new patient-specific meta-analysis of data from more than 10,000 patients with node-negative disease assessed individualized estimates of distant recurrence risk and absolute chemotherapy benefit based on the integration of the Recurrence Score result with clinicopathologic features.[iii] This analysis builds on the practice-changing results from the TAILORx study, which prospectively defined the groups of patients who will and will not benefit from chemotherapy.

The meta-analysis was conducted by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and was presented in an oral session at SABCS by lead author Joseph A. Sparano, M.D., associate director for clinical research at Albert Einstein Cancer Center and associate chair for clinical research in the department of oncology at Montefiore Health System in New York, and leader of the TAILORx study for the ECOG-ACRIN Cancer Research Group. The data was published concurrently in the December 2020 issue of the Journal of Clinical Oncology.

The patient-specific meta-analysis estimates will initially be made available to physicians in the United States, starting in December 2020, as an online educational tool called RSClin. The tool provides a more individualized prediction of absolute chemotherapy benefit that can enhance treatment decisions, particularly for patients whose Recurrence Score result is close to the TAILORx defined cut-off point of 25. By presenting the data in a new, easy-to-understand, visual format, RSClin empowers physicians with information that may be used to facilitate treatment conversations and decision-making with patients.

"As confirmed in TAILORx, for the great majority of patients, treatment based on the Recurrence Score result alone is clear," said Dr. Sparano. "The RSClin tool, which now incorporates data from TAILORx to reflect contemporary treatment outcomes, provides individualized estimates for both risk of distant recurrence and absolute chemotherapy benefit and continues to demonstrate the role of TAILORx in informing early-stage breast cancer treatment."

ECOG-ACRIN conducted the analysis primarily with funding from the National Cancer Institute. Mention of commercial products does not imply endorsement by the U.S. government. Additional support was provided by the Breast Cancer Research Foundation, the Komen Foundation, and the Breast Cancer Research Stamp issued by the United States Postal Service.

About Oncotype DX The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention, and the Oncotype DX AR-V7 Nucleus Detect test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to androgen receptor (AR)-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Exact Sciences. With more than 1 million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit http://www.OncotypeIQ.com, http://www.MyBreastCancerTreatment.orgor http://www.MyProstateCancerTreatment.org.

AboutExact Sciences Corp. A leading provider of cancer screening and diagnostic tests, Exact Sciences relentlessly pursues smarter solutions providing the clarity to take life-changing action, earlier. Building on the success of the Cologuardand Oncotype DX tests, Exact Sciences is investing in its product pipeline to take on some of the deadliest cancers and improve patient care. Exact Sciences unites visionary collaborators to help advance the fight against cancer. For more information, please visit the company's website at http://www.exactsciences.com, follow Exact Sciences on Twitter @ExactSciences, or find Exact Scienceson Facebook.

NOTE: Oncotype, Oncotype DX, Oncotype DX Breast Recurrence Score, Oncotype DX Breast DCIS Score, Oncotype DX Genomic Prostate Score, and Oncotype DX AR-V7 Nucleus Detect are trademarks or registered trademarks of Genomic Health, Inc. Exact Sciences and Cologuard are trademarks or registered trademarks of Exact Sciences Corporation. All other trademarks and service marks are the property of their respective owners.

Forward-Looking Statements This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Risks and uncertainties that may affect our forward-looking statements are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

[i] Harbeck, N. et al. Oral Presentation: GS4-04. San Antonio Breast Cancer Symposium; December 2020. [ii]Kuemmel, S. et al. Oral Presentation: GS4-03. San Antonio Breast Cancer Symposium; December 2020. [iii] Sparano, J. et al. Oral Presentation: GS4-09. San Antonio Breast Cancer Symposium; December 2020.

Investors:Megan Jones+1 608-535-8815[emailprotected]

Media (U.S.):Stephanie Spanos+1 608-556-4380[emailprotected]

Media (Canada, Europe, Asia, Latin America): Federico Maiardi+41 79-138-1326[emailprotected]

SOURCE EXACT SCIENCES CORP

http://www.exactsciences.com

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New Data at SABCS 2020 Highlight the Role of the Oncotype DX Breast Recurrence Score Test in Shaping Clinical Practice - PRNewswire

CHICAGO, Dec. 11, 2020 /PRNewswire/ -- According to the new market research report "Cell Isolation/Cell Separation Market by Product (Reagents, Beads, Centrifuge), Cell Type (Human, Animal), Cell Source (Bone Marrow, Adipose), Technique (Filtration), Application (Cancer, IVD), End-User (Hospitals, Biotechnology) - Global Forecast to 2025", published by MarketsandMarkets, the global Cell Isolation Market size is projected to reach USD 15.0 billion by 2025 from USD 6.9 billion in 2020, at a 16.8% CAGR.

Browse in-depth TOC on "Cell Isolation/ Separation Market"

411 Tables 38 Figures 264 Pages

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The increasing government funding for cell-based research, the increasing number of patients suffering from cancer and infectious diseases, technological advancements, and the growing focus on personalized medicine are the major factors driving the cell isolation markets growth. Emerging economies such as China and Japan are providing lucrative opportunities for the players operating in the market.

The consumables segment accounted for the largest share of the market, by product segment, in 2019

Based on product, the Cell Separation Market is segmented into consumables and instruments. In 2019, consumables segment accounted for the largest share. This can be attributed to the increasing investments by companies to develop technologically advanced products as well as the repetitive use of consumables.

Centrifugation- based segment accounted for the largest share of the cell isolation market, by technique segment, in 2019

Based on technique, the Cell Separation Market is segmented into centrifugation-based cell isolation, surface marker-based cell isolation, and filtration-based cell isolation. primarily due to the wide usage of this technique among end users. This technique is used on a large scale by biotech and biopharmaceutical companies as well as on a small scale by clinical research organizations and academia. The cost-effectiveness of this technique is another major reason for the large share of this segment. The growing demand for centrifugation techniques in biotech and biopharmaceutical companies is a major factor that is expected to drive the growth of this market segment in the coming years.

The biotechnology and biopharmaceutical companies segment accounted for the largest share in the market, by end user segment, in 2019

The cell isolation market is segmented into hospitals and diagnostic laboratories, biotechnology and biopharmaceutical companies, research laboratories and institutes, and other end users based on end users. In 2019, the biotechnology and biopharmaceutical companies segment accounted for the largest share. The widespread adoption of advanced instruments in cell-based experiments and cancer research in biotechnology and biopharmaceutical companies, as well as the increasing number of R&D facilities globally can be attributed for the large share of this end-user segment.

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North America is the largest regional market for cell isolation market

The Cell Separation Market is segmented into four regions, namely, North America, Europe, Asia Pacific and Rest of the world. In 2019, North America accounted for the largest share of the market. The large share of North America can be attributed to technological advancements, growth in the biotechnology and pharmaceutical industries, increasing prevalence of chronic and infectious diseases, and higher investments in cell-based research in the region.

The major players operating in this Cell Separation Market are Thermo Fisher Scientific, Inc. (US), Becton, Dickinson and Company Limited (US), Beckman Coulter Inc. (US).Merck KGaA (Germany), Terumo BCT (Japan), GE Healthcare (US), Bio- Rad Laboratories Inc. (US), Corning Inc. (US), Roche Diagnostics (Switzerland, Alfa Laval (Sweden), Miltenyl Biotech (Germany), pluriSelect Life Science (Germany), STEMCELL Technologies Inc. (Canada), Akadeum Life Sciences, Inc (US), Bio- Techne (US), Bio Legend (US) and Invent Biotechnologies (US).

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https://www.marketsandmarkets.com/Market-Reports/single-cell-analysis-market-171955254.html

Cell Expansion Market by Product (Reagent, Media, Flow Cytometer, Centrifuge, Bioreactor), Cell Type (Human, Animal), Application (Regenerative Medicine & Stem Cell Research, Cancer & Cell-based Research), End-User, and Region - Global Forecast to 2025

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Cell Isolation/ Separation Market worth $15.0 billion by 2025 - Exclusive Report by MarketsandMarkets - PRNewswire

SEATTLE--(BUSINESS WIRE)--Today at AWS re:Invent, Amazon Web Services, Inc. (AWS), an Amazon.com company (NASDAQ: AMZN) announced Amazon HealthLake, a HIPAA-eligible service for healthcare and life sciences organizations. Amazon HealthLake aggregates an organizations complete data across various silos and disparate formats into a centralized AWS data lake and automatically normalizes this information using machine learning. The service identifies each piece of clinical information, tags, and indexes events in a timeline view with standardized labels so it can be easily searched, and structures all of the data into the Fast Healthcare Interoperability Resources (FHIR) industry standard format for a complete view of the health of individual patients and entire populations. As a result, Amazon HealthLake makes it easier for customers to query, perform analytics, and run machine learning to derive meaningful value from the newly normalized data. Organizations such as healthcare systems, pharmaceutical companies, clinical researchers, health insurers, and more can use Amazon HealthLake to help spot trends and anomalies in health data so they can make much more precise predictions about the progression of disease, the efficacy of clinical trials, the accuracy of insurance premiums, and many other applications. To learn more about Amazon HealthLake, visit: https://aws.amazon.com/healthlake.

As machine learning becomes more mainstream, companies across every vertical business are trying to apply it to their data to deliver meaningful business value. Healthcare is applying machine learning to improve operations and patient care, with AWS customers like 3M, Anthem, AstraZeneca, Bristol Myers Squibb, Cerner, the Fred Hutchinson Cancer Research Center, GE Healthcare, Infor, Pfizer, and Philips embracing the cloud and machine learning to get more value out of their vast data troves. From family history and clinical observations to diagnoses and medications, healthcare organizations are creating huge volumes of patient information every day with the goal of getting a full view of a patients health and applying analytics and machine learning to improve care, analyze population health trends, and improve operational efficiency. However, clinical data is complex and renowned for being siloed, incomplete, incompatible, and stored in on-premises systems spread across multiple locations. Getting all this information aggregated and in the FHIR format is a start toward the goal of standardizing structured data, but the majority of data remains unstructured and still needs to be tagged, indexed, and structured in chronological order to make all of the data understandable and able to query. Some healthcare organizations build rule-based tools to automate the process of transforming unstructured data (e.g., medical histories, physician notes, and medical imaging reports) and tagging clinical information (e.g., diagnoses, medications, and procedures), but these solutions often fail because the data needs to be normalized across disparate systems and because the tools cant account for every possible variation in spelling, unintended typos, and grammatical errors. Other organizations use general-purpose optical character recognition (OCR) software to process data sources, but these tools lack the medical expertise to be effective and so organizations resort to manual data entry by medical professionals which adds expense to the digitization process. Even if organizations are able to aggregate and structure their data, they still need to build their own analytics and machine learning applications to uncover relationships in the data, discover trends, and make precise predictions. The cost and operational complexity of doing all this work is prohibitive to most organizations; and as a result, the vast majority of organizations end up missing out on the untapped potential to use their data to improve the health of patients and communities.

Amazon HealthLake offers medical providers, health insurers, and pharmaceutical companies a service that brings together and makes sense of all their patient data, so healthcare organizations can make more precise predictions about the health of patients and populations. The new HIPAA-eligible service enables organizations to store, tag, index, standardize, query, and apply machine learning to analyze data at petabyte scale in the cloud. Amazon HealthLake allows organizations to easily copy health data from on-premises systems to a secure data lake in the cloud and normalize every patient record across disparate formats automatically. Upon ingestion, Amazon HealthLake uses machine learning trained to understand medical terminology to identify and tag each piece of clinical information, index events into a timeline view, and enrich the data with standardized labels (e.g., medications, conditions, diagnoses, procedures, etc.) so all this information can be easily searched. For example, organizations can quickly and accurately find answers to their questions like, How has the use of cholesterol-lowering medications helped our patients with high blood pressure last year? To do this, customers can create a list of patients by selecting High Cholesterol from a standard list of medical conditions, Oral Drugs from a menu of treatments, and blood pressure values from the Blood Pressure structured field and then they can further refine the list by choosing attributes like time frame, gender, and age. Because Amazon HealthLake also automatically structures all of a healthcare organizations data into the FHIR industry format, the information can be easily and securely shared between health systems and with third-party applications, enabling providers to collaborate more effectively and allowing patients unfettered access to their medical information.

There has been an explosion of digitized health data in recent years with the advent of electronic medical records, but organizations are telling us that unlocking the value from this information using technology like machine learning is still challenging and riddled with barriers, said Swami Sivasubramanian, Vice President of Amazon Machine Learning for AWS. With Amazon HealthLake, healthcare organizations can reduce the time it takes to transform health data in the cloud from weeks to minutes so that it can be analyzed securely, even at petabyte scale. This completely reinvents whats possible with healthcare and brings us that much closer to everyones goal of providing patients with more personalized and predictive treatment for individuals and across entire populations.

By aggregating, labeling, indexing, and structuring all their data, Amazon HealthLake makes it easy for customers to query, analyze, and use machine learning to make sense of their data. Customers can use other AWS analytics and machine learning services with Amazon HealthLake like Amazon QuickSight for interactive dashboards and Amazon SageMaker for easily building, training, and deploying custom machine learning models. For example, healthcare organizations can use Jupyter Notebook templates in Amazon SageMaker to quickly and easily run analysis for common tasks like diagnosis predictions, hospital re-admittance probability, and operating room utilization forecasts. Healthcare and life science organizations can use Amazon HealthLake to get a complete view of patient and population health, derive insights using analytics and machine learning, and discover previously obscured relationships and trends.

Cerner Corporation, a global healthcare technology company, is focused on using data to help solve issues at the speed of innovation - evolving healthcare to enhance clinical and operational outcomes, help resolve clinician burnout, and improve health equity. "At Cerner we are committed to transforming the future of healthcare through cloud delivery, machine learning, and AI. Working alongside AWS, we are in a position to accelerate innovation in healthcare. That starts with data. We are excited about the launch of Amazon HealthLake and its potential to quickly ingest patient data from various diverse sources and transform the data to perform advanced analytics to unlock new insights and serve many of our initiatives across population health, said Ryan Hamilton, SVP, Population Health, Cerner.

Ciox Health is a health technology company that is dedicated to improving U.S. health outcomes by transforming clinical data into actionable insights. At Ciox, we work to enable greater health by improving the way health information is managed, said Sasidhar Mukkamala, SVP of Data Management, Ciox Health. Much of the health information that we ingest is unstructured, like notes and handwritten PDFs, and it is a challenge to find solutions that allow us to realize the full analytic value of that data. With 60 percent of the market share in risk adjustments, this is a huge opportunity. We are excited about getting started with Amazon HealthLake and its potential to help us meet this need and deliver better risk adjustments, predictions, billing, and much more, all informed by health data.

Konica Minolta Precision Medicine (KMPM) is a life science company dedicated to the advancement of precision medicine to more accurately predict, detect, treat, and ultimately cure disease. "We are building a multi-modal platform at KMPM to handle a significant amount of health data inclusive of pathology, imaging, and genetic information. Amazon HealthLake will allow us to unlock the real power of this multi-modal approach to find novel associations and signals in our data. It will provide our expert team of data scientists and developers the ability to integrate, label, and structure this data faster, and discover insights that our clinicians and pharmaceutical partners require to truly drive precision medicine," said Kiyotaka Fujii, President of Global Healthcare, Konica Minolta.

Orion Health is a global, award-winning provider of health information technology, advancing population health and precision medicine solutions for the delivery of care across the entire health ecosystem. At Orion Health, we believe that there is significant untapped potential to transform the healthcare sector by improving how technology is used and providing insights into the data being generated. We are pleased to find a like-minded company in AWS who, with Amazon HealthLake, is now taking the next step in using machine learning to help make sense of health data in a secure, complaint, and auditable way, said Anne O'Hanlon, Product Director, Orion Health. Data is frequently messy and incomplete, which is costly and time consuming to clean up. We are excited to work alongside AWS to deliver new ways for patients to interact with the healthcare system, supporting initiatives such as the 21st Century Cures Act designed to make healthcare more accessible and affordable, and Digital Front Door, which aims to improve health outcomes by helping patients receive the perfect care for them from the comfort of their home. Expanding the relationship we enjoy with AWS gives us an opportunity to innovate and explore new ways to deliver patient-centered healthcare and high quality health outcomes that help people live a healthier life.

About Amazon Web Services

For 14 years, Amazon Web Services has been the worlds most comprehensive and broadly adopted cloud platform. AWS offers over 175 fully featured services for compute, storage, databases, networking, analytics, robotics, machine learning and artificial intelligence (AI), Internet of Things (IoT), mobile, security, hybrid, virtual and augmented reality (VR and AR), media, and application development, deployment, and management from 77 Availability Zones (AZs) within 24 geographic regions, with announced plans for 18 more Availability Zones and six more AWS Regions in Australia, India, Indonesia, Japan, Spain, and Switzerland. Millions of customersincluding the fastest-growing startups, largest enterprises, and leading government agenciestrust AWS to power their infrastructure, become more agile, and lower costs. To learn more about AWS, visit aws.amazon.com.

About Amazon

Amazon is guided by four principles: customer obsession rather than competitor focus, passion for invention, commitment to operational excellence, and long-term thinking. Customer reviews, 1-Click shopping, personalized recommendations, Prime, Fulfillment by Amazon, AWS, Kindle Direct Publishing, Kindle, Fire tablets, Fire TV, Amazon Echo, and Alexa are some of the products and services pioneered by Amazon. For more information, visit amazon.com/about and follow @AmazonNews.

Originally posted here:
AWS Announces Amazon HealthLake - Business Wire

As the precision medicine field evolves and the science behind personalized therapies for complex conditions surges ahead, reimbursement models are racing to catch up. Precision medicine treatments, like cell and gene therapies, tend to have high price tags and novel delivery mechanisms. This makes creating effective payment models for these therapies a challenge, but drug developers and payers are working together to create out-of-the-box solutions.

Determining prices for breakthrough cell and gene therapies is a complicated process, said Laura Okpala, director of reimbursement policy at Gilead Sciences, at the MedCity INVEST Precision Medicine conference. Though there is a strong belief that the pricing process needs to be driven by value value means different things to different people. Biopharmaceutical companies, like Gilead Sciences, must consult with various stakeholders, including patients, caregivers and payers, who all have different perspectives on value.

Part of why the pricing is so difficult is because of the inherent complexities in the healthcare system, Okpala said. When we think of traditionally how drugs are paid for, were thinking about chronic treatment, were thinking about treatment over a long, extended period, treatment over and over again, reimbursement every single time, and that adds up.

But when you think about cell and gene therapies, all those costs and all of that treatment happens upfront, she added. And then you get that durable response, up to four years at this point. And that is really a paradigm shift when you think about [a] healthcare system that really isnt set up to deal with that upfront cost and that value delivered over time.

But the upfront payment is just one of many challenges. Mark Trusheim, strategic director of the NEWDIGS initiative at the MIT Center for Biomedical Innovation, said at the virtual conference that there are two more key challenges that arise: the performance uncertainty regarding these therapies, particularly around their durability, and the actuarial uncertainty it causes for payers. Most of these therapies are for rare conditions, so a single high-cost therapy in any given month can have a negative impact on payers income statements.

To combat these challenges, several innovative reimbursement models have been developed.

One is a model based on treatment milestones. Per this model, a certain amount of money is paid upfront, and if the therapy doesnt show the intended effects in certain predetermined timeframes, the drug developer pays back a portion of the initial payment.

[The model allows] some risk sharing between the developer and the payer, so they dont have to argue quite so much up front, Trusheim said. And the actual product performance [resolves] how much [is] finally the net reimbursement or the net price for that therapy.

This model helps manage the different expectations and fears of both parties, he added.

Another is a subscription-based model, which includes a fixed fee for unlimited access to certain therapies, Trusheim explained. Cigna has an insurance product that offers this reimbursement model, where plan members contribute a certain amount each month that is used to pay for therapies as needed. Cigna takes on the risk, guaranteeing that they will provide as much therapy as the members require.

This model is a great example of how payers can manage the actuarial fluctuation that occurs when funding cell and gene therapies, Trusheim said. But it comes with its challenges, because in some cases, its difficult to ascertain the eligible population for a particular therapy especially if there are alternate therapies already available.

But Trusheim is confident that innovation in reimbursement will catch up to clinical innovation in the precision medicine arena.

Were now in an era where innovation in payment structures and approaches are beginning to match the kind of innovation we have in the transformative science for patients, he said. Successfully providing patient access and benefit requires both kinds of innovation, not just scientific innovation. The creativity is there we are going to succeed. Just as the science has succeeded, the payment innovation is also moving forward and having success.

Photo credit: Devrimb, Getty Images

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Innovative payment models to support cell and gene therapies on the rise - MedCity News

Newswise PLYMOUTH MEETING, PA [December 10, 2020] Today, the National Comprehensive Cancer Network (NCCN) hosted an annual patient advocacy summit featuring Senator Chris Van Hollen (D-MD) and Congressman Buddy Carter (R-GA), which was streamed online. Every year, the NCCN Policy department invites people from across the oncology ecosystem to share their perspectives on improving the quality and efficiency of cancer care so that patients can live better lives. This years virtual summit focused on putting the personal into personalized care while exploring how the needs of people with cancer can vary across the lifespan.

We work with patient advocacy organizations year-round to ensure our policy team is advocating for policies that address the most pressing issues for people with cancer and their caregivers, said Alyssa Schatz, MSW, Senior Director of Policy and Advocacy for NCCN and a participant in the roundtable discussion titled Identifying Policy and Practice Solutions for Patients Across the Lifespan. This summit gives us a chance to learn from one another and speak collectively to our audience of providers, payers, and policymakers. A key takeaway from todays conversation is the reminder to treat the personnot the demographicwhile also recognizing that people in some demographics may face additional obstacles to quality cancer care.

Cancer survivors are more than their age, gender, or disease, explained keynote speaker Jan S. White, Cancer Survivor and Patient Advocate. Assumptions around age and gender often figure into care teams expectations for survivorship, but if you have not asked your patients about their goals for how they want to live following treatment, you are missing an important step. Their answers will surprise you.

The idea of recognizing everyones unique set of circumstances was echoed by Danielle Pardue, a panelist who spoke on behalf of caregivers: The best way to support a caregiver is to take the time to understand the individual needs and strengths of each caregiver and patient. No plan of care for any patient can be completely successful without the support of one or more caregivers, especially at home. Providers need to take both the patients preferences and the caregivers abilities into account when determining their treatment recommendations.

Pardue also pointed out: Every problem does not necessarily have a solution; caregivers should be encouraged to share what they need so that solutions can be sought, but shouldnt be discouraged from sharing when solutions are hard to come by. Sharing experiences is in itself a therapeutic experience for overwhelmed caregivers. There is great power and healing in venting because we understand the world through the stories of others.

Speakers also looked at how members of various racial, ethnic, or socioeconomic groups can face some common or recurring barriers to care that must be addressed.

We cannot separate social, racial, and economic inequality from the adult cancer journey, said Darcie Green, Executive Director of Latinas Contra Cancer. The clients we serve face predictable and preventable systemic barriers to cancer care. Navigating cancer can be challenging enough without also having to worry about how you will feed your family, pay rent, absorb income loss, or overcome the obstacles that exist within the healthcare system. The COVID-19 pandemic has only deepened health injustice and the trauma of poverty in this country. This impact is reflected in the experience of cancer patients in the population we serve.

Many of the speakers focused particularly on how a persons age at the time of diagnosis can result in different options or approaches for treatment, for instance older patients, who are more-likely to have additional, unrelated health concerns, or may face implicit bias based on their age.

As we refine our understanding of tumor biology and tailor therapy to the molecular subtype of each tumor, we must remember factors outside of the actual treatment that significantly affect outcomes, observed Efrat Dotan, MD, Fox Chase Cancer Center, Chair of the NCCN Guidelines Panel for Older Adult Oncology. Especially when treating older adults with cancer, evaluating all the domains that affect their careand addressing any deficiencieswill result in truly personalized medicine and improved outcomes.

Cancer is a disease of aging, yet older patients have not shared in the benefits of many modern cancer treatments, and remain woefully underrepresented in clinical trials, said Hyman Muss, MD, FASCO, University of North Carolina Lineberger Comprehensive Cancer Center. It is the obligation of all of us to fix this in order to guarantee that our older cancer patients get the care they need.

We know how important it is to make sure clinical trials enroll a broad representation of patients across age, race, and ethnicity, agreed Maura Dickler, MD, Lilly Oncology. At Lilly, we are committed to reducing the barriers that limit diversity in clinical trial enrollment, including working to ensure our trial sites are closer to patients, utilizing new forms of telehealth when appropriate, and broadening eligibility criteria so we are not excluding patients who have additional health conditions.

There are also unique concerns for cancer survivors who were first diagnosed during childhood or adolescence. Panelists discussed the confusion that can arise over what happens once patients complete active treatment. Thats where survivorship care plans and clinical practice guidelines on preventing or managing recurrence and side effects can play an important role.

Effective transition of care in cancer survivors from oncologists to primary care physicians can make a significant difference in early detection of late effects. You can't find something that you are not looking for, saidAarati Didwania, MD, MSCI, Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

Speakers at the summit also touched on current events impacting cancer care including the upcoming Supreme Court ruling on the Affordable Care Act and the long- and short-term impact of the COVID-19 pandemic on cancer care. The virtual discussions were moderated by Clifford Goodman, PhD, The Lewin Group, and also included Phylicia L. Woods, JD, MSW, from the Cancer Support Community.

Representatives from the Cancer Hope Network, Patient Empowerment Network, and Fight Colorectal Cancer presented information about age-specific resources intended to increase access to recommended screening, improve health literacy, and provide peer-to-peer counseling services. Dottie Shead, MS, from NCCNs patient information department discussed existing NCCN Guidelines for Patients across cancer types and supportive care topics, including symptom management and age-related care for adolescents and young adults. Shead also previewed the soon-to-publish patient and caregiver guidelines focused specifically on survivorship, including guidance on post-treatment wellness recommendations, and monitoring and treating the late and long-term effects that can arise from cancer care.

Visit NCCN.org/patients to learn more about free resources from NCCN. Visit NCCN.org/policy for more on the ongoing work from the NCCN Policy and Advocacy Department and save-the-date for future summits and events. Join the conversation online using the hashtag #NCCNPolicy.

# # #

About the National Comprehensive Cancer Network

The National Comprehensive Cancer Network (NCCN) is a not-for-profit alliance of leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, efficient, and accessible cancer care so patients can live better lives. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) provide transparent, evidence-based, expert consensus recommendations for cancer treatment, prevention, and supportive services; they are the recognized standard for clinical direction and policy in cancer management and the most thorough and frequently-updated clinical practice guidelines available in any area of medicine. The NCCN Guidelines for Patients provide expert cancer treatment information to inform and empower patients and caregivers, through support from the NCCN Foundation. NCCN also advances continuing education, global initiatives, policy, and research collaboration and publication in oncology. Visit NCCN.org for more information and follow NCCN on Facebook @NCCNorg, Instagram @NCCNorg, and Twitter @NCCN.

Original post:
NCCN Patient Advocacy Summit Emphasizes Treating Every Cancer Patient as an Individual - Newswise

DUBLIN--(BUSINESS WIRE)--The "Global Next Generation Sequencing Market: Growth, Trends, Competitive Landscape, and Forecasts" report has been added to ResearchAndMarkets.com's offering.

The global next-generation sequencing market is expected to grow at a CAGR of around 17.5% during 2020-2026.

Next-generation sequencing is also known as high-throughput sequencing. It is the process of determining the sequence of nucleotides in a section of the DNA. It includes procedures such as sequencing by ion semiconductor sequencing, synthesis (SBS), nanopore sequencing and single-molecule real-time (SMRT) sequencing. It is a cost-effective solution that offers precise results with high accuracy and speed. This enables the analysis of millions of DNA molecules simultaneously, which facilitates research in the fields of personalized and genetic medicines, agriculture and animal research, and clinical diagnostics.

The global next-generation sequencing market report elucidates key industry trends, industry dynamics along with the quantitative analysis of the report. The report presents a clear picture of the global next-generation sequencing market by segmenting the market based on sequencing type, product type, technology, application, end user, and region. We believe that this report will aid the professionals and industry stakeholders in making informed decision.

Market Dynamics

Drivers

Challenges

Companies Mentioned

Key Topics Covered:

1. Preface

2. Executive Summary

3. Global Next Generation Sequencing Market

3.1 Introduction

3.2 Market Drivers & Challenges

4. Global Next Generation Sequencing Market Analysis

4.1 Market Portraiture

4.2 Market by Sequencing Type

4.3 Market by Product Type

4.4 Market by Technology

4.5 Market by Application

4.6 Market by End User

4.7 Market by Region

4.8 Impact of COVID-19

5. Global Next Generation Sequencing Market by Sequencing Type

5.1 Market Overview

5.2 Whole Genome Sequencing

5.3 Targeted Resequencing

5.4 Whole Exome Sequencing

5.5 RNA Sequencing

5.6 CHIP Sequencing

5.7 De Novo Sequencing

5.8 Methyl Sequencing

5.9 Others

6. Global Next Generation Sequencing Market by Product Type

6.1 Market Overview

6.2 Instruments

6.3 Reagents and Consumables

6.4 Software and Services

6.5 Others

7. Global Next Generation Sequencing Market by Technology Type

7.1 Market Overview

7.2 Sequencing by Synthesis

7.3 Ion Semiconductor Sequencing

7.4 Single-Molecule Real-Time Sequencing

7.5 Nanopore Sequencing

7.6 Others

8. Global Next Generation Sequencing Market by Application

8.1 Market Overview

8.2 Drug Discovery and Personalized Medicine

8.3 Genetic Screening

8.4 Diagnostics

8.5 Agriculture and Animal Research

8.6 Bioinformatics

8.7 Others

9. Global Next Generation Sequencing Market by End User

9.1 Market Overview

9.2 Academic Institutes & Research Centers

9.3 Hospitals & Clinics

9.4 Pharmaceutical & Biotechnology Companies

9.5 Others

10. Global Next Generation Sequencing Market by Region

10.1 Market Overview

10.2 Europe

10.3 North America

10.4 Asia Pacific

10.5 Latin America

10.6 Middle East & Africa

11. SWOT Analysis

12. Porter's Five Forces

13. Market Value Chain Analysis

14. Competitive Landscape

14.1 Competitive Scenario

14.2 Company Profiles

For more information about this report visit https://www.researchandmarkets.com/r/hjtnq5

Link:
The Worldwide Next Generation Sequencing Industry is Expected to Grow at a CAGR of 17.5% Between 2020 and 2026 - ResearchAndMarkets.com - Business...

DUBLIN--(BUSINESS WIRE)--The "Spectroscopy Equipment and Accessories - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering.

Global Spectroscopy Equipment and Accessories Market to Reach $16.5 Billion by 2027

Amid the COVID-19 crisis, the global market for Spectroscopy Equipment and Accessories estimated at US$14.6 Billion in the year 2020, is projected to reach a revised size of US$16.5 Billion by 2027, growing at a CAGR of 1.8% over the analysis period 2020-2027.

Molecular Spectroscopy, one of the segments analyzed in the report, is projected to record a 2.1% CAGR and reach US$5.8 Billion by the end of the analysis period. After an early analysis of the business implications of the pandemic and its induced economic crisis, growth in the Atomic Spectroscopy segment is readjusted to a revised 1.3% CAGR for the next 7-year period.

The U. S. Market is Estimated at $4 Billion, While China is Forecast to Grow at 3.6% CAGR

The Spectroscopy Equipment and Accessories market in the U. S. is estimated at US$4 Billion in the year 2020. China, the world`s second largest economy, is forecast to reach a projected market size of US$3.2 Billion by the year 2027 trailing a CAGR of 3.6% over the analysis period 2020 to 2027. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at 0.2% and 1.4% respectively over the 2020-2027 period. Within Europe, Germany is forecast to grow at approximately 0.7% CAGR.

Mass Spectrometry Segment to Record 2.1% CAGR

In the global Mass Spectrometry segment, USA, Canada, Japan, China and Europe will drive the 1.8% CAGR estimated for this segment. These regional markets accounting for a combined market size of US$3 Billion in the year 2020 will reach a projected size of US$3.4 Billion by the close of the analysis period. China will remain among the fastest growing in this cluster of regional markets. Led by countries such as Australia, India, and South Korea, the market in Asia-Pacific is forecast to reach US$2.2 Billion by the year 2027, while Latin America will expand at a 2.8% CAGR through the analysis period.

The report presents concise insights into how the pandemic has impacted production and the buy side for 2020 and 2021. A short-term phased recovery by key geography is also addressed.

Key Topics Covered:

I. INTRODUCTION, METHODOLOGY & REPORT SCOPE

II. EXECUTIVE SUMMARY

1. MARKET OVERVIEW

2. FOCUS ON SELECT PLAYERS

3. MARKET TRENDS & DRIVERS

4. GLOBAL MARKET PERSPECTIVE

III. MARKET ANALYSIS

GEOGRAPHIC MARKET ANALYSIS

IV. COMPETITION

For more information about this report visit https://www.researchandmarkets.com/r/hbdoxf

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Global Spectroscopy Equipment and Accessories Market Report 2020-2027: Molecular Spectroscopy to Account for $5.8 Billion of the $16.5 Billion Market...

Medicine has always been personalized what has changed are the tools available that allow us to provide better care for you. The Institute for Personalized Medicine is Penn State Health's commitment to advancing health care for our community through the use of modern technology and more effective tools.

In the past, doctors based treatments on research that studied broad groups of people, finding what is most likely to help a majority of patients. While this approach has been successful, its not always efficient since each of us is different. Our genetics and our biology are unique to us, so treatments that work best for one person may not work best for another.

Personalized medicine is the use of individual characteristics to tailor treatments to the person. For example, one person may respond to a medicine differently than another because of their genetics. By knowing what that genetic difference is, doctors can look for the same in future patients and prescribe medication accordingly helping to recover faster.

Penn State Institute for Personalized Medicine gives scientists the tools to develop research studies seeking this information, and future therapies for patients.

Continue reading here:
Personalized Medicine | Penn State Health

DUBLIN, Nov. 11, 2020 /PRNewswire/ -- The "Personalized Medicine - Scientific & Commercial Aspects" report from Jain PharmaBiotech has been added to ResearchAndMarkets.com's offering.

The concept of personalized medicine described in this report remains remains the best way to integrate new technologies such as nanobiotechnology for improving healthcare.

Increase in efficacy and safety of treatment by individualizing it has benefits in financial terms. Information is presented to show that personalized medicine will be cost-effective in healthcare systems. For the pharmaceutical companies, segmentation of the market may not leave room for conventional blockbusters but smaller and exclusive markets for personalized medicines would be profitable. Marketing opportunities for such a system are described with market estimates from 2019-2029.

Profiles of 298 companies involved in developing technologies for personalized medicines, along with 583 collaborations are included.The aim of personalized medicine or individualized treatment is to match the right drug to the right patient and, in some cases, even to design the appropriate treatment for a patient according to his/her genotype. This report describes the latest concepts of development of personalized medicine based on pharmacogenomics, pharmacogenetics,pharmacoproteomics, and metabolomics.

Basic technologies of molecular diagnostics play an important role, particularly those for single nucleotide polymorphism (SNP) genotyping. Biomarkers play an important role in personalized medicine. Diagnosis is integrated with therapy for selection of treatment as well for monitoring the results. There is emphasis on early detection and prevention of disease in modern medicine. Biochip/microarray technologies and next generation sequencing are also important.

Pharmacogenetics, the study of influence of genetic factors on drug action and metabolism, is used for predicting adverse reactions of drugs. Several enzymes are involved in drug metabolism of which the most important ones are those belonging to the family of cytochrome P450. The knowledge of the effects of polymorphisms of genes for the enzymes is applied in drug discovery and development as well as in clinical use of drugs. Cost-effective methods for genotyping are being developed and it would be desirable to include this information in the patient's record for the guidance of the physician to individualize the treatment.

Pharmacogenomics, a term that overlaps with pharmacogenetics but is distinct, deals with the application of genomics to drug discovery and development. It involves the mechanism of action of drugs on cells as revealed by gene expression patterns. Pharmacoproteomics is an important contribution to personalized medicine as it is a more functional representation of patient-to-patient variation than that provided by genotyping.A 'pharmacometabonomic' approach to personalizing drug treatment is also described.

Story continues

Biological therapies such as those which use patient's own cells are considered to be personalized medicines. Vaccines are prepared from individual patient's tumor cells. Individualized therapeutic strategies using monoclonal bodies can be directed at specific genetic and immunologic targets. Ex vivo gene therapy involves the genetic modification of the patient's cells in vitro, prior to reimplantation of these cells in the patient's body.

Various technologies are integrated to develop personalized therapies for specific therapeutic areas described in the report. Examples of this are genotyping for drug resistance in HIV infection, personalized therapy of cancer, antipsychotics for schizophrenia, antidepressant therapy, antihypertensive therapy and personalized approach to neurological disorders. Although genotyping is not yet a part of clinically accepted routine, it is expected to have this status by the year 2023.

Several players are involved in the development of personalized therapy. Pharmaceutical and biotechnology companies have taken a leading role in this venture in keeping with their future role as healthcare enterprises rather than mere developers of technologies and manufacturers of medicines.

Ethical issues are involved in the development of personalized medicine mainly in the area of genetic testing. These along with social issues and consideration of race in the development of personalized medicine are discussed. Regulatory issues are discussed mainly with reference to the FDA guidelines on pharmacogenomics.

Finally the bibliography contains over 750 selected publications cited in the report. The report is supplemented by 88 tables and 50 figures.

Key Topics Covered:

Part I: Scientific Basis & Technologies

Executive Summary

1. Basic Aspects

2. Molecular Diagnostics in Personalized Medicine

3. Pharmacogenetics

4. Pharmacogenomics

5. Role of Pharmacoproteomics

6. Role of Metabolomics in Personalized Medicine

7. Personalized Biological Therapies

8. Personalized complementary & Alternative Therapies

9. Personalized Medicine in Major Therapeutic Areas

10. Personalized Therapy of Cancer

11. Development of Personalized Medicine

12. Ethical, Legal and Regulatory Aspects of Personalized Medicine

Part II: Markets & Companies

13. Markets for Personalized Medicine

14. Companies Involved in Developing Personalized Medicine

15. References

For more information about this report visit https://www.researchandmarkets.com/r/ty8o34

Source: Jain PharmaBiotech

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Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com

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View original content:http://www.prnewswire.com/news-releases/personalized-medicine-market-2029-301170831.html

SOURCE Research and Markets

Read more here:
Personalized Medicine Market, 2029

LONDON--(BUSINESS WIRE)--The global biochip market size is poised to grow by USD 19.71 billion during 2020-2024, progressing at a CAGR of 22% throughout the forecast period, according to the latest report by Technavio. The report offers an up-to-date analysis regarding the current market scenario, latest trends and drivers, and the overall market environment. The report also provides the market impact and new opportunities created due to the COVID-19 pandemic. Download a Free Sample of REPORT with COVID-19 Crisis and Recovery Analysis.

Personalized medicines growing popularity and demand is expected to drive the growth of the Biochip market. The medicines are personalized as per the patients needs which suits the individual characteristics of the person is a multi-faceted approach. This improves the ability to diagnose and effectively treat the disease as this technique facilitates early diagnosis. These biochips play an important part in the development of these medicines, as it improves the ability to diagnose and effectively treat the disease. It is also expected that during the forecast period the growing incidences of genetic and terminal diseases will influence the demand for personalized medicine for targeted drug development. This will increase the demand for biochips which will result in the growth of this industry.

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Rising Use of Biochips in Safety Detection of Agriculture Products will be a Key Market Trend

The rising use of biochip technology in the agriculture industry is turning out to be one of the major trends in the biochip industry. Biochip helps in the detection of pathogenic microorganisms, biological toxins, pesticide residues, and antibiotics. Microchips help in providing early warning to agricultural products' monitoring with a rapid response system and, thus, enhance the agricultural products' safety detection system. Therefore, significantly helping the agriculture industry from the loss it faces every year.

Technavios sample reports are free of charge and contain multiple sections of the report, such as the market size and forecast, drivers, challenges, trends, and more. Request a free sample report

Biochip Market 2020-2024: Key Highlights

Buy 1 Technavio report and get the second for 50% off. Buy 2 Technavio reports and get the third for free.

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Executive Summary

Market Landscape

Market Sizing

Five Forces Analysis

Market Segmentation by Technology

Customer landscape

Geographic Landscape

Vendor Landscape

Vendor Analysis

Appendix

About Us

Technavio is a leading global technology research and advisory company. Their research and analysis focuses on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavios report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavios comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios.

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Biochip Market | Increased Popularity of Personalized Medicine to Boost the Market Growth | Technavio - Business Wire

THE HAGUE, Netherlands, Dec. 5, 2020 /PRNewswire/ --The HARMONY Alliance announces new analyses demonstrating how Big Data can facilitate personalized medicine in patients with blood cancers, also known as Hematologic Malignancies. Using data from around 12,000 AML and MM patients comprised in the HARMONY Big Data Platform, the researchersobtained fascinating insights into the molecular basis of Acute Myeloid Leukemia (AML) and developed an improved risk stratification model for Multiple Myeloma (MM). These results are presented during the 62nd American Society of Hematology Annual Meeting.

Harmony Alliance Provides Novel Insights into Acute Myeloid Leukemia Based on a Pan-European NGS Data Collection (abstract 1077- Bullinger et al)

Lars Bullinger, HARMONY Partner Charit Berlin, Germany:

"We have analyzed genomic data of 4,986 patients with AML. We could confirm the co-occurrence of certain mutations. In addition, we obtained insight into which mutations occur first and which later in the disease process. We have also investigated the association of mutation patterns with clinical outcomes such as remission, relapse, and survival. For instance, many patients with high-risk mutation patterns benefit only little from an allogeneic stem cell transplantation (alloSCT), but we found specific high-risk genotype combinations that predict a much larger survival benefit."

A New Risk Stratification Model (R2-ISS) in Newly Diagnosed Multiple Myeloma: Analysis of Mature Data from 7,077 Patients Collected By European Myeloma Network within Harmony Big Data Platform (abstract 1329- D'Agostino et al)

Mattia D'Agostino, HARMONY Partner University of Turin, Italy:

"Clinical outcomes for patients with MM vary greatly, with survival ranging from a few months to more than ten years. Investigating data from 7,077 patients with newly diagnosed MM, we discovered that patients who are currently considered as 'intermediate-risk patients' constitute a quite diverse group with varying risk of progression or death. We identified a new prognostic system identifying 4 risk classes. With this model, about half of the patients can be classified as low or low-intermediate risk, and about half of them can be classified as intermediate-high or high risk. Oncologists can use our improved risk stratification model to better estimate patients' prognosis at the time of MM diagnosis. Moreover, this model favors the design of MM treatments tailored according to the individual risk of each patient."

Comprising data from 45,000 patients with blood cancers, makes the HARMONY Big Data Platform one of the largest of its kind in the world. HARMONY scientists use the Platform to characterize the molecular landscape of Hematologic Malignancies, understand their pathophysiology, and identify novel drug targets. Big data analytics has the potential to transform the treatment of patients with blood cancers. The ability to personalize the treatment of a patient based on molecular understanding of a disease or risk stratification will provide treatment strategies in the future to optimize outcomes for the patients.

More information

SOURCE HARMONY Alliance

https://www.harmony-alliance.eu

Original post:
New data from HARMONY demonstrate the power of Big Data analytics to inform personalized medicine in blood cancer - PRNewswire

News Release

Friday, December 4, 2020

Previously unknown genetic connection could be a target for gene therapy.

A study led by researchers at the National Institutes of Health has made a surprising connection between frontotemporal dementia (FTD) and amyotrophic lateral sclerosis (ALS), two disorders of the nervous system, and the genetic mutation normally understood to cause Huntingtons disease.

This large, international project, which included a collaboration between the National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute on Aging (NIA), opens a potentially new avenue for diagnosing and treating some individuals with FTD or ALS.

Several neurological disorders have been linked to repeat expansions, a type of mutation that results in abnormal repetition of certain DNA building blocks. For example, Huntingtons disease occurs when a sequence of three DNA building blocks that make up the gene for a protein called huntingtin repeats many more times than normal. These repeats can be used to predict whether someone will develop the illness and even when their symptoms are likely to appear, because the more repeats in the gene, the earlier the onset of disease.

It has been recognized for some time that repeat expansion mutations can give rise to neurological disorders, said Sonja Scholz, M.D., Ph.D., investigator, NINDS Intramural Research Program. But screening for these mutations throughout the entire genome has traditionally been cost-prohibitive and technically challenging.

Taking advantage of technology available at NIH, the researchers screened the entire genomes from large cohorts of FTD/ALS patients and compared them to those of age-matched healthy individuals. While several patients had a well-established genetic marker for FTD/ALS, a small subset surprisingly had the same huntingtin mutation normally associated with Huntingtons disease. Remarkably, these individuals did not show the classical symptoms of Huntingtons but rather those of ALS or FTD.

None of these patients symptoms would have clued their physicians into thinking that the underlying genetic cause was related to the repeat expansion we see in Huntingtons disease, said Dr. Scholz.

She continued by explaining that whole genome sequencing is changing how neurological patients can be diagnosed. Traditionally, this has been based on which disease best fit the overall symptoms with treatment aimed at managing those symptoms as best as possible. Now, clinicians can generate genetically defined diagnoses for individual patients, and these do not always align with established symptom-based neurological conditions.

Our patients simply dont match a textbook definition of disease when it comes to which mutation produces which symptoms. Here we have patients carrying a pathogenic huntingtin mutation but who present with FTD or ALS symptoms, said Dr. Scholz.

One implication of these findings is that, if successful, these therapies could be applied to the small subset of FTD and ALS patients with that mutation as well. The researchers note that, while the number of FTD/ALS patients seen with the Huntingtons-linked mutation is small (roughly 0.12-0.14%), adding genetic screening for the mutation to the standard diagnostic procedure for patients showing symptoms of FTD or ALS should be considered.

Because gene therapy targeting this mutation is already in advanced clinical trials, our work offers real hope to the small number of FTD and ALS patients who carry this mutation, said Bryan Traynor, M.D., Ph.D., senior investigator, NIA Intramural Research Program. This type of large-scale international effort showcases the power of genomics in identifying the molecular causes of neurodegenerative diseases and paves the way for personalized medicine.

This research was supported by the Intramural Research Program of the National Institutes of Health (National Institute on Aging and National Institute of Neurological Disorders and Stroke; project numbers 1ZIAAG000935, 1ZIANS003154, 1ZIANS003033, 1ZIANS003034), the Intramural Research Program of the National

NINDSis the nations leading funder of research on the brain and nervous system.The mission of NINDS is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease.

About the National Institute on Aging (NIA): NIA leads the U.S. federal government effort to conduct and support research on aging and the health and well-being of older people. Learn more about age-related cognitive change and neurodegenerative diseases via NIAs Alzheimer's and related Dementias Education and Referral (ADEAR) Center website. For information about a broad range of aging topics, visit the main NIA website and stay connected.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

Dewan R. et al. Pathogenic Huntingtin Repeat Expansions in Patients with Frontotemporal Dementia and Amyotrophic Lateral Sclerosis. Neuron. November 25, 2020. DOI:10.1016/j.neuron.2020.11.005

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NIH researchers link cases of ALS and FTD to a mutation associated with Huntington's disease - National Institutes of Health

NEW YORK, Dec. 02, 2020 (GLOBE NEWSWIRE) -- Predictive Oncology (NASDAQ: POAI), a knowledge-driven company focused on applying artificial intelligence (AI) to personalized medicine and drug discovery, today announced that its virtual Special Meeting of Stockholders, scheduled for December 1, 2020, was convened and adjourned without any business being conducted due to the fact that quorum was not achieved. The Special Meeting will be reconvened December 30, 2020 at 3 p.m. CST and will be conducted via live audio webcast at http://www.virtualshareholdermeeting.com/POAI2020SM, so as to allow more opportunity for stockholders to vote on all proposals described in the Companys definitive proxy statement filed with the Securities and Exchange Commission (SEC) on November 3, 2020.

The record date for the Special Meeting remains October 28, 2020. Stockholders of record may vote at the reconvened Special Meeting, vote by proxy using the proxy card enclosed with the Companys definitive proxy statement, vote by proxy via facsimile, email or on the Internet. Whether or not stockholders of record plan to attend the reconvened Special Meeting, the Companys Board of Directors and management urge them to vote by proxy to ensure their vote is counted. Stockholders who have previously submitted their proxy or otherwise voted and who do not want to change their vote need not take any action.

A copy of the Companys proxy statement as previously filed with the SEC is available at no charge on the SEC website at http://www.sec.gov. In addition, copies of the proxy statement and other documents may be obtained free of charge by accessing the Companys website at https://investors.predictive-oncology.com/ or by contacting the Companys Corporate Secretary at (651) 389-4806 or by mail to Corporate Secretary, Predictive Oncology Inc., 2915 Commers Drive, Suite 900, Eagan, MN 55121.

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About Predictive Oncology Inc.

Predictive Oncology (NASDAQ: POAI) operates through three segments (Skyline, Helomics and Soluble Biotech), which contain four subsidiaries: Helomics, TumorGenesis, Skyline Medical and Soluble Biotech.

Helomics applies artificial intelligence to its rich data gathered from patient tumors to both personalize cancer therapies for patients and drive the development of new targeted therapies in collaborations with pharmaceutical companies. TumorGenesis Inc. specializes in media that help cancer cells grow and retain their DNA/RNA and proteomic signatures, providing researchers with a tool to expand and study cancer cell types found in tumors of the blood and organ systems of all mammals, including humans. Skyline Medical markets its patented and FDA cleared STREAMWAY System, which automates the collection, measurement and disposal of waste fluid, including blood, irrigation fluid and others, within a medical facility, through both domestic and international divisions. Soluble Biotech is a provider of soluble and stable formulations for proteins including vaccines, antibodies, large and small proteins and protein complexes.

Forward-Looking Statements

Certain matters discussed in this release contain forward-looking statements. These forward-looking statements reflect our current expectations and projections about future events and are subject to substantial risks, uncertainties and assumptions about our operations and the investments we make. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue and financial performance, projected costs, prospects, plans and objectives of management are forward-looking statements. The words anticipate, believe, estimate, expect, intend, may, plan, would, target and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our actual future performance may materially differ from that contemplated by the forward-looking statements as a result of a variety of factors including, among other things, factors discussed under the heading Risk Factors in our filings with the SEC. Except as expressly required by law, the Company disclaims any intent or obligation to update these forward-looking statements.

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