StemCell Therapy

New Jersey, United States: The report titled Personalized Medicine Market is one of the most comprehensive and important additions to Verified Market Researchs archive of market research studies. It offers detailed research and analysis of key aspects of the Personalized Medicine market. The market analysts authoring this report have provided in-depth information on leading growth drivers, restraints, challenges, trends, and opportunities to offer a complete analysis of the Personalized Medicine market. Market participants can use the analysis on market dynamics to plan effective growth strategies and prepare for future challenges beforehand. Each trend of the Personalized Medicine market is carefully analyzed and researched about by the market analysts.

Global Personalized Medicine Market was valued at USD 96.97 Billion in 2018 and is expected to witness a growth of 10.67% from 2019-2026 and reach USD 217.90 Billion by 2026.

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Personalized Medicine Market Outlook, Growth by Top Company, Region, Application, Driver, Trends and Forecasts By 2026| Verified Market Research -...

A two-day workshop on healthy aging hosted by UCLA is kicking off a five-year partnership between the University of California system and Nanyang Technological University, Singapore.

The workshop is being held at Mong Auditorium in Engineering VI from Dec. 9-10 with several experts from NTU and the majority of UC campuses participating.

The first day focuses on technologies for healthy aging and includes talks on the role of brain-computer interfaces in brain health and on molecular mechanisms of aging and precision medicine. The neurobiology of aging and the impact of lifestyle, prevention and policy is the topic for the second day of the workshop.

UCLA Samueli participants include Jacob Rosen, a professor of mechanical and aerospace engineering, who is presenting on technology for rewiring the brain for stroke patients, and Sam Emaminejad, an assistant professor in electrical and computer engineering, whose main focus is wearable sensors and personalized medicine.

The joint effort between the two organizations fosters an exchange of faculty and students and expands academic and research opportunities in areas including health, technology, innovation and climate change.

NTU President Professor Subra Suresh and UC President Janet Napolitano signed the memorandum of understanding on behalf of their respective institutions earlier this year in February, and the health workshop is one of the initial outcomes of the partnership.

The workshop is organized by a team led by Hal Monbouquette, a UCLA Samueli professor of chemical and biomolecular engineering; NTU Graduate College Associate Dean Sierin Lim; and NTU Graduate College Dean K. Jimmy Hsia.

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Healthy Aging Workshop Launches UC Partnership with Nanyang Technological University, Singapore - UCLA Samueli School of Engineering Newsroom

REDWOOD CITY, Calif., Dec. 11, 2019 (GLOBE NEWSWIRE) -- Despite longstanding medical guidelines recommending biomarker testing for all patients with metastatic colon cancer, a new study published in JCO Precision Oncology shows that only 40 percent of patients are tested according to guidelines.1 These findings are consistent with the rates seen in late-stage lung cancer, where clinical adoption of genomic profiling remains below the recommended standard-of-care guidelines.2 The result is that many patients are potentially being treated with less effective drugs, some having serious side-effects; while others are not being offered highly effective personalized treatment options.

The multi-center retrospective study also found that certain subgroups of patients were less likely to be tested than others. Suboptimal genotyping occurred more often if the patient was male, older than 65, progressed from early stage disease, or treated in a community cancer center. Furthermore, only 28 percent of patients on anti-EGFR treatments received the necessary testing to determine eligibility. This study also showed that using a comprehensive panel, as opposed to single-gene testing, could possibly result in a 50 percent increase in guideline-recommended testing rates.

For over a decade, medical guidelines have recommended multigene mutation testing for metastatic colon and rectal cancer patients to ensure patients receive the optimal treatment available. While the study shows that testing has improved slightly, the disappointing reality is that the majority of patients, including those receiving targeted treatments, are not being comprehensively tested, said Stuart Goldberg, MD, a lead study investigator who served as chief scientific officer at COTA, Inc. during the project. Personalized medicine holds great promise for achieving better outcomes, but we will not see the benefits until genomic testing is routinely adopted into clinical practice.

Newly available therapies routinely help some people with metastatic colorectal cancer gain a year or two of life, but these novel treatments cannot be applied unless comprehensive genotyping is routinely performed, said Richard Lanman, MD, Guardant Health Global Chief Medical Officer. Just as concerning was that 28 percent of patients received targeted treatments without being tested, and for some we would have known in advance that the treatment was not going to work. At Guardant we are committed to helping reverse this trend by helping to educate oncologists and offering a non-invasive and comprehensive genomic testing solution that overcomes the limitations of tissue biopsies with our Guardant360 blood test.

The American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN) guidelines recommend biomarker testing for all patients with metastatic colon cancer to screen for genomic alterations in KRAS, NRAS, BRAF, ERBB2 (HER2), NTRK and microsatellite instability (MSI) to help guide more effective treatment decisions. Targeted therapies and immunotherapies have been shown to improve clinical outcomes. For example, anti-EGFR therapies are commonly used in treating metastatic colon cancer but are not efficacious in patients whose tumors harbor KRAS, NRAS, or BRAF V600E mutations.3 Additionally, immunotherapy is effective in patients with MSI and anti-HER2 treatment is effective in patients with ERBB2 (HER2) amplifications.4,5 Professional guidelines continue to be updated as new therapies come to market such as the recent recommendation to test patients for NTRK fusions because they may benefit from treatment with tumor-agnostic NTRK inhibitors.

Study details can be found here.

About Guardant HealthGuardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360 and GuardantOMNI tests for advanced stage cancer patients and LUNAR assay for research use and for use in prospective clinical trials. In parallel, Guardant Health is actively exploring the performance of the LUNAR assay in initial studies related to screening and early detection in asymptomatic individuals.

Forward Looking StatementsThis press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the adoption of Guardant Healths products, which involve risks and uncertainties that could cause Guardant Healths actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Healths financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the caption Risk Factors in Guardant Healths Annual Report on Form 10-K for the year ended December 31, 2018, and in its other reports filed by Guardant Health with the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Healths views as of any date subsequent to the date of this press release.

In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Guardant Health.

Investor Contact:Lynn Lewis or Carrie Mendivilinvestors@guardanthealth.com

Media Contact:Anna Czene or Ian Stonepress@guardanthealth.com

References1. Gutierrez ME, Price KS, Lanman RB, et al. Genomic Profiling for KRAS, NRAS, BRAF, Microsatellite Instability (MSI) and Mismatch Repair Deficiency (dMMR) among Patients with Metastatic Colon Cancer. JCO Precision Oncol. December 20192. Leighl NB, Page RD, Raymond VM, et al. Clinical Utility of Comprehensive Cell-Free DNA Analysis to Identify Genomic Biomarkers in Patients with Newly Diagnosed Metastatic Non-Small Cell Lung Cancer. Clin Cancer Res. April 20193. Van Cutsem E, Khne CH, Lng I, et al. Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-line treatment for metastatic colorectal cancer: updated analysis of overall survival according to tumor KRAS and BRAF mutation status. J Clin Oncol. May 20114. Overman MJ, Lonardi S, Wong KYM, et al. Durable clinical benefit with nivolumab plus ipilimumab in DNA mismatch repair-deficient/microsatellite instability-high metastatic colorectal cancer. J Clin Oncol. March 20185. Sartore-Bianchi A, Trusolino L, Martino C, et al. Dual-targeted therapy with trastuzumab and lapatinib in treatment-refractory, KRAS codon 12/13 wild-type, HER2-positive metastatic colorectal cancer (HERACLES): a proof-of-concept, multicentre, open-label, phase 2 trial. Lancet Oncol. April 2016

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Study Shows Only 40 Percent of Patients with Metastatic Colon Cancer Receive Guideline-Recommended Biomarker Testing - GlobeNewswire

On March 8, 2019, the US Food and Drug Administration (FDA) approved the PD-L1 inhibitor atezolizumab for first-line treatment of metastatic triple-negative breast cancer in combination with nab-paclitaxel chemotherapy for patients who are ineligible for surgery and whose tumors express PD-L1. This marks the first time a regimen approved for breast cancer includes an immunomodulator, and represents the first targeted agent approval in triple-negative breast cancer a disease that, historically, has only had chemotherapy as a treatment option.

Triple-negative breast cancer is an especially aggressive subtype of breast cancer that is identified by the absence of expression of estrogen, progesterone, or HER2 protein receptors on the cancers surface. These proteins, when present in other subsets of breast cancer, allow us to target and take advantage of the protein to kill the cancer cell. For patients with triple-negative metastatic cancer, the average survival is only slightly more than a year, meaning that half of women diagnosed with this disease will not live beyond that benchmark.

This groundbreaking approval was based on results of the IMpassion130 trial (ClinicalTrials.gov Identifier: NCT02425891), for which Sarah Cannon, the Cancer Institute of HCA Healthcare in Nashville, Tennessee, participated. The IMpassion130 trial treated 902 women with either nab-paclitaxel alone or nab-paclitaxel in combination with atezolizumab.

A post-hoc update of long-term progression-free survival revealed that in the PD-L1 immune cell-positive population, the updated median progression-free survival was 7.5 months

(95% CI, 6.79.2) with atezolizumab plus nab-paclitaxel and 5.3 months (95% CI, 3.85.6) for nab-paclitaxel alone (stratified hazard ratio [HR], 0.63; 95% CI, 0.500.80; P <.0001).1

In patients with PD-L1positive tumours, median overall survival was 25 months (95% CI, 19.630.7) with atezolizumab and 18 months (13.620.1) with placebo. The stratified hazard ratio for overall survival was 0.71 (95% CI, 0.540.94).1

Immunotherapy treatments help a patients immune system recognize cancer as foreign and attack it. In contrast to chemotherapy, which can be thought of as poison for cancer cells, immunotherapy is essentially a way to boost ones own immune cells to fight cancer. Chemotherapy has known side effects, such as hair loss, nausea, and fatigue; however, the side-effect profile for immunotherapy treatment is different. Patients receiving immunotherapy treatment may experience low thyroid hormone levels or inflammation in the lungs or gastrointestinal system. When treating patients with immunotherapy, it is important to closely monitor patients for these rare side effects and treat them with steroids when appropriate.

The approval of atezolizumab not only represents a win for some patients with triple-negative breast cancer characterized by PD-L1 expression, it also more broadly represents a win for personalized medicine. In the past decade, we have gotten smarter about knowing that every persons cancer may be driven by individual mutations and alterations. We have had access to tests to examine the expression of estrogen receptors, progesterone receptors, and HER2 receptors for some time, but only now do we know to test for PD-L1, which allows us break this broad disease down into smaller subsets using the markers the cancer possesses, and, prescribe more targeted treatments. We have also started looking at a broader profile of the alterations in a cancer through molecular profiling, where hundreds of genes are examined for mistakes and abnormal copy numbers in an attempt to personalize care. Tailoring treatment to each person and their individual cancer characteristics at the cell level will become even more common in the coming years.

IMpassion130 also highlights the benefit of clinical trials not just for future patients, but also for those who are currently enrolled. I treated patients enrolled in this trial, and in fact, we still have patients who are receiving this therapy years after their diagnosis. This trial and this agent highlight the advances we make in cancer treatment every day through the power of clinical trials. Unfortunately, only about 2% to 5% of adults with cancer participate in clinical trials in the US and more than 50% say they are not even aware of the existence of trials.2,3 These studies show us that we need to continue to work toward making clinical trials a well-understood concept through patient education, dispelling misconceptions, and celebrating the big advances, such as the approval ofatezolizumab in this patient group.

Erika Hamilton, MD, is the Director of the Breast Cancer and Gynecologic Cancer Research Program at Sarah Cannon Research Institute in Nashville, Tennessee.

References

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Triple-Negative Breast Cancer Now Has a Targeted Agent - Cancer Therapy Advisor

FREMONT, CA: Diagnostics and treatment have undergone sea changes in recent years. The field which was dominated by traditional medical technologies is now on the cusp of artificial intelligence-driven changes. The area of radiology has also come under the influence of advancement, leading to the emergence of radiomics. The development has been helping the medical industry in dealing with the imminent shortage of qualified radiologists. Innovators have put their brains together and taken diagnostic scanning to the next level with radiomics. Radiomics is still in a developmental phase, but it has already contributed to the healthcare industry. Some ways in which the technology is helping medical fraternity is mentioned in the list below.

Immunohistochemical Evaluations

Patients can be checked for immunohistochemical (IHC) characteristics with the help of radiomics-based imaging. Medical researchers have successfully created unique machine learning models that can detect thyroid nodules in patients with high degrees of accuracy. The development makes the process non-invasive and enables the prediction of hormonal presence in patients. Computer topography imaging techniques cannot present ICH related information. According to experts, these capabilities make a timely diagnosis of thyroid cancers possible and feasible.

Brain Tumor Detection and Treatment

Current technologies for detection and classification of malignant brain tumors are good enough, but with radiomics, the amounts of data that can be extracted increases substantially. Subsequently, radiomic analysis can generate insightful data which are helpful for diagnosis, evaluation, and treatments. The advanced imaging also enables practitioners to adhere to recently announced protocols which vary significantly from the standard ones. One of the significant advantages of using radiomics in brain tumor assessment is that it allows the determination of molecular characteristics which help categorize molecular subtypes.

Diagnosis of Cancers in Breast, Lungs and Neck

Radiomics has been widely adopted by medical fraternity for the neck, lungs, and breast cancer diagnosis, treatment, and prognosis. Predicting the stage of cancer in cancer-afflicted patients with minimum or no invasive procedures is a significant step forward. Radiomics has shown excellent results in projecting the differences which help in classifying the stage of cancer. Even reoccurrence predictions have been benefitted with radiomic signature-based investigations. The ability of radiomics to take into consideration a higher number of factors and features by combining recorded clinical information makes it useful in early detection of breast, lungs, and neck cancers. In the case of breast cancer patients, radiomics is predicting response to therapy with high accuracy and thus optimizing treatment.

Precision Medicine

High sensitivity and high specificity are the remarkable features of radiomics. As the medical industry adopts precision medicine, radiomics is all set to play a very crucial role. Radiomics is powerful because it applies artificial intelligence and deep learning characteristics to radiology, thus helping define tissues with much more accuracy. Every patient can undergo a radiomics-based diagnosis and come up with personalized reports. These reports can relay detailed information which enables doctors to prescribe personalized medication or treatment models. Thus, radiomics is helping extract qualitative and quantitative data which make precision medicine possible.

Reading and interpreting medical data is challenging. However, radiomics is transforming decision-making by bettering identification and characterization. One can expect the diagnosis to become faster and error-free as computerization becomes central to the process. Subsequently, patient care will also improve as doctors gain access to deeper health insights.

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How is Radiomics the Next Wave in Medtech? - Medical Tech Outlook

GMI Research has recently published a report on Global Precision Medicine market, the report highlights the key ongoing market trend, market growth, drivers and restraints of Global Precision Medicine market. The report provides the forecast data for the period of 2019 to 2026. GMI Research analysts have a thorough understanding of the market as they are on top of any market trends and developments, which help them to understand current market dynamics, market competitive landscape and future trends of Global Precision Medicine in a couple of years.According to the report, the Global Precision Medicine Market is projected to grow at a CAGR growth of ~XX% through the forecast period from 2019 to 2026 owing to various key factors such as Precision medicine is being eyed upon as lucrative business investment opportunity by the major pharmaceutical companies owing to the rising patient preference for personalized treatment, advancements in wireless technologies and big data analytics, and tremendous increase in genetic diseases such as cancer. Our analyst knows the importance of data and are also aware of the significance of providing accurate data. The analyst deploys various approaches from primary research to credible secondary research sources and validates the data from multiple sources to make sure that our client gets the accurate picture of the Global Precision Medicine and the market size, market projections, competitive landscape etc.The reports also profile the major market players. The major players are Illumina, Inc., GE Healthcare, Roche Group, bioMerieux SA, IBM Corporation, Novartis AG, and Abbott Laboratories among others.Request Sample Report Now at Link https://www.gmiresearch.com/report/global-precision-medicine-market/sample-requestKey areas the report on Global Precision Medicine market addresses are: What are the major market drivers influence the growth of Global Precision Medicine? Which region provides the maximum growth opportunities? What makes one product more attractive over another and ranking of all the products and the market opportunity they provide? What are the key developments and how they are impacting the Global Precision Medicine market? What are the current key trends of Global Precision Medicine? How the competitive landscape looks like and what strategies companies are adopting to increase their market share?How the insights on Global Precision Medicine will help our clients in critical decision making? Help our client to know all the segments and sub-segments in detail Assessment of competitive landscape of Global Precision Medicine Details of new product launch trend, innovations, market expansions and other strategies adopted by major players Regional market trends and opportunities available in each region North America, Europe, Asia Pacific and RoWSpeak to Research Analyst to Understand more About Research at Link https://www.gmiresearch.com/report/global-precision-medicine-market/Competitive Landscape key players main strategies and their product offerings Major players products strength on each segment and vertical Product Benchmarking analysis of key players Key Players Recent Developments and strategic directionRequest for Customization at Link https://www.gmiresearch.com/report/global-precision-medicine-market/request-for-customizationAbout GMI ResearchGMI Research provides research and consulting solutions to our clients. We help our global clients through independent fact-based insights, ensuring their business achieve success by beating the competition. We provide syndicated research, customized market and competitive intelligence research, sales enablement support and data analytics services.Contact UsGMI ResearchLevel 1, The Chase Carmanhall Road, Sandyford Industrial Estate,Dublin D18 Y3X2, IrelandPh. No: +353 1 442 8820Email: [emailprotected]Web: https://www.gmiresearch.com

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Global Precision Medicine Market Key Insights And Growth Scenario Coverage of Top Key Players 2019-2026 - Market Research Sheets

Aspen Neuroscience, a new San Diego biotech company working on stem cell treatment for Parkinsons disease, has come out of stealth mode and raised $6.5 million to pursue clinical testing for its therapy.

Co-founded by well-known stem cell scientist Jeanne Loring, Aspen Neuroscience proposes creating stem cells from modified skin cells of Parkinsons patents via genetic engineering.

The stem cells, which can become any type of cell in the body, then would undergo a process that makes them specialize into dopamine-releasing neurons.

People with Parkinsons lose a large number up to 50 percent at diagnosis of specific brain cells that make the chemical dopamine.

Without dopamine, nerve cells cannot communicate with muscles and people are left with debilitating motor problems.

Once these modified skin cells have been engineered to specialize in producing dopamine, they can be transplanted into the Parkinsons patient to restore the types of neurons lost to the disease.

The reason we called it Aspen is because l was raised in the Rocky Mountain states, said Loring. When there is a forest fire in the Rockies, the evergreens are wiped out but the aspens are the fist that regenerate after the burn. So it is a metaphor for regeneration.

Aspen still has a long way to go before its proposed therapy would be available to Parkinsons patients. It has been meeting with the U.S. Food and Drug Administration to provide animal trial data and other information in hopes of getting permission to start human clinical trials.

But the company expects the earliest it would get the go-ahead from FDA to start human trials would be 2021.

Loring has been working on the therapy for eight years. She is professor emeritus and founding director of the Center for Regenerative Medicine at the Scripps Research Institute.

Loring co-founded the 20-employee company with Andres Bratt-Leal, a former post-doctoral researcher in Lorings lab at Scripps.

Joining them as Aspens Chief Executive is Dr. Howard Federoff, former vice chancellor for health affairs and chief executive of the University of California Irvine Health System.

Federoff said the company is the only one pursuing the use of Parkinsons patients own cells as part of neuron replacement therapy.

Aspens proprietary approach does not require the use of immuno-suppression drugs, which can be given when transplanted cells come from another person and perhaps limit the effectiveness of the treatment.

Aspens approach is a therapy that is likely to benefit from the fact that your own cells know how to make the best connections with their own target cells in the brain, even in the setting of Parkinsons disease, said Federoff. So when transplanted it is able to set back the clock on Parkinsons.

In addition to Aspens main therapy, it is researching a gene-editing treatment for forms of Parkinsons common in certain families.

Aspens research work up to now has been supported by Summit for Stem Cell, a non-profit on which provides a variety of services for people with Parkinsons disease.

The new seed funding round was led by Domain Associates and Axon Ventures, with additional participation from Alexandria Venture Investments, Arch Venture Partners, OrbiMed and Section 32.

Aspens financial backing, combined with its experienced and proven leadership team, positions it well for future success, said Kim Kamdar, a partner at Domain Associates. Domain prides itself on investing in companies that can translate scientific research into innovative medicines and therapies that make a difference in peoples lives. We clearly see Aspen as fitting into that category, as it is the only company using a patients own cells for replacement therapy in Parkinsons disease.

See the article here:
Aspen Neuroscience gets funding to pursue personalized cell therapy for Parkinsons disease - The San Diego Union-Tribune

ViewRay has inked respective agreements with Elekta AB and Medtronic that aim to increase understanding into and practices of MR-guided radiation therapy.

The partnerships will each include the establishment of clinical studies to assess the impact and benefits provided by the treatment, as well as probes into additional therapeutic areas in which the technology could prove beneficial.

"We are pleased to announce these important collaborations and investments in ViewRay, said ViewRays president and CEO Scott Drake in a statement. Our goal is to concurrently prove the value of MR-guided radiation therapy and strengthen our balance sheet.

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Elekta will also invest in ViewRay, taking on a minority interest with the potential to rise to 9.9 percent.

Elekta believes that competition is crucial to drive the adoption of any new technology, and that is why we are committed to continuing to develop and offer customers our high-field Elekta Unity and promoting this technology to benefit patients worldwide, said Elekta's president and CEO Richard Hausmann in a statement. By investing in ViewRay, we ensure that the two inventors of MR-guided radiation therapy continue to drive the paradigm shift forward.

The deal between Medtronic and ViewRay is a similar clinical collaboration, that will make use of the MRIdian MR-guided radiation therapy system in studies. Medtronic has also committed to investing in a minority share of ViewRay as part of the deal.

"We are well-positioned to drive MRIdian to standard of care, noted Drake, adding that, the ability to see clearly during the procedure, track tumors and soft tissues, and auto-gate the beam is integral to delivering highly precise, personalized medicine."

The agreements with Elekta and Medtronic follow a rough period for ViewRay, which was,hit with an investor lawsuit in September, filed over allegedly false or misleading statements made regarding negative operational and financial issues reported in August.

Specific allegations included failure to disclose that demand for ViewRay systems dropped due, in part, to changes around Medicare reimbursement; overstating reported backlog; and damages suffered by investors because of materially false and misleading statements made by ViewRay at all relevant times. Upon disclosing these challenges, the companys stock price fell by more than 50 percent. It also slashed its previously issued full fiscal year 2019 financial guidance.

In addition to the deals with Elekta and Medtronic, ViewRay's biggest shareholder, Fosun International Limited will be putting in more money in order to keep its ownership percentage at present levels.

The investments from Elekta and Medtronic, however, will only take place if at least $75 million is raised. Elekta's investment will also require an aggregate cap of $36 million.

The deals are non-binding, subject to various terms and conditions.

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ViewRay teams with Elekta and Medtronic on MR-guided radiation therapy - DOTmed HealthCare Business News

Washington, DC (UroToday.com) On the final day of the Society of Urologic Oncology Meeting (SUO 2019), the six best abstracts submitted were selected for presentation. One of these highlighted studies from Memorial Sloan Kettering Cancer Center (MSKCC) evaluated the differential response of high grade non-muscle invasive bladder cancer to Bacillus Calmette-Guerin (BCG) on the basis of FGFR3 alterations. Dr. Timothy Clinton, a urologic oncology fellow at MSKCC, presented the groups findings.

Recently, the FDA approved Erdafitinib, a fibroblast growth factor receptor (FGFR)3 kinase inhibitor, for use in metastatic urothelial carcinoma on the basis of phase II results published this summer in NEJM. In that publication, Loriot et al. demonstrated a 59% response rate in patients with unresectable or metastatic urothelial carcinoma.1 These results have driven interest in expanding the use of FGFR3 kinase inhibitors and looking to FGFR3 alterations for prognostication. Specifically, FGFR3 mutations have been previously associated with lower response rates to immune checkpoint inhibition, are more commonly identified in non-muscle invasive bladder cancer which is specifically less likely to progress. For these reasons, Dr. Clinton postulated that FGFR3 alterations may be able to predict BCG response.

To that end, Dr. Clinton and colleagues identified treatment nave patients with high-grade nonmuscle invasive bladder cancer (NMIBC) enrolled in a prospective protocol that captured targeted exon sequencing on pretreatment tumor DNA and matched germline DNA. Within the MSKCC cohort there were over 1,400 bladder specimens with a quarter demonstrating genomic alterations in FGFR3. Of these patients, 119 patients with high-grade NMIBC underwent BCG treatment with 51containing aFGFR3alteration (43%); 39 patients (76%) were cTaHG and 12 (24%) were cT1HG at diagnosis. Interestingly, no patients with CIS had alterations in FGFR3.

Dr. Clinton proceeding by highlight the differential response to BCG between those who were FGFR3 wild-type and those with alterations. Overall, the median follow up was 60 months (IQR 32-75). At that time 39% of the entire cohort was free from high-grade recurrence with a significant difference between the two groups. 65% of wild-type patients were free from high-grade recurrence, were as only 39% of the FGFR3 alteration group was similarly recurrence-free(p<0.05). There was no difference in progression, however, the rate was very low in both groups. Looking more in depth into the FGFR3 altered tumors, the group looked for additional mutations that corresponded to BCG response, identifying significant co-occurrence ofFGFR3mutations with cell cycle genes includingCDKN2A(p=0.03) andMDM2(p=0.03) and noFGFR3mutated tumor contained anERBB2mutation.

Overall, Dr. Clinton concluded that while FGFR3 has been historically associated with favorable prognosis, FGFR3altered tumors are associated with high recurrence rates following BCG. Given these findings and the recent BCG shortages, patients with these alterations may benefit from alternative therapy with FGFR3 kinase inhibitors. The study represents a major step in predicting BCG response rates and FGFR3 profiling could represent a novel path for personalized medicine in the future. Clinical trials for FGFR3 in NMIBC are currently underway with results pending.

Presented by:TimothyClinton, MD, Urologic Oncology Fellow at Memorial Sloan Kettering Cancer Center

Written by: Adrien Bernstein, MD, Society of Urologic Oncology Fellow, Fox Chase Cancer Center, Fox Chase Cancer Center, Philadelphia, PAat the 20th Annual Meeting of the Society of Urologic Oncology (SUO), December 4 - 6, 2019, Washington, DC

References:1.Loriot, Y., Necchi, A., Park, S., Garcia-Donas, J., Huddart, R., & Burgess, E. et al. (2019). Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma.New England Journal Of Medicine,381(4), 338-348. doi: 10.1056/nejmoa1817323

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SUO 2019: Response of FGFR3 Alterations In High-Grade Non-Muscle Invasive Bladder Cancer Treated with Intravesical BCG Therapy - UroToday

In this video from SC19, Jaan Mannik from One Stop Systems describes how the company delivers AI on the Fly.

AI on the Fly puts computing and storage resources for the entire AI workflow, not in the datacenter, but on the edge near the sources of data. Applications are emerging for this new AI paradigm in diverse areas including autonomous vehicles, predictive personalized medicine, battlefield command and control, and industrial automation. The common elements of these solutions are high data rate acquisition, high speed low latency storage and efficient high performance AI training and inference computing. All of these building block elements are connected seamlessly with memory mapped PCI Express system, interconnected and customized as appropriate, to meet the specific environmental requirements of in the field installations.

AI on the Fly solutions are different than traditional datacenter centric AI infrastructure, as they must deploy in harsh and rugged environments. The solutions must meet unique criteria for shock and vibration, redundancy, large operating temperature, altitude ranges and uninterrupted power sources. Few companies have the expertise across all the technologies required for designing and delivering tightly integrated AI on the Fly platforms.

OSS is a custom manufacturer of specialized high performance computing systems for industries that are showing the largest proliferation of use cases for AI on the Fly systems. These industries include:

These edge applications have unique requirements over traditional embedded computing. There is no compromise possible in delivering high performance while maintaining efficient space, weight and power. Delivering the high performance required in edge applications necessitates PCIe interconnectivity providing the fast data highway between high speed processors, NVMe storage and compute accelerators using GPUs or application specific FPGAs. AI on the Fly high performance applications will naturally demand this capability on the edge. Additionally, these solutions often require unique space and power saving form factors and specialized rugged enclosures.

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One Stop Systems does AI on the Fly at SC19 - insideHPC

BETHESDA, Md., Dec. 4, 2019 /PRNewswire/ --The American College of Medical Genetics and Genomics (ACMG) heads to a new destination in sunny San Antonio, Texas in 2020. Named one of the fastest growing meetings in the USA by Trade Show Executive Magazine, the ACMG Annual Clinical Genetics Meeting continues to provide groundbreaking research and news about the latest advances in genetics, genomics and personalized medicine. To be held March 17-21, the 2020 ACMG Annual Meeting will feature more than 40 scientific sessions, 3 Short Courses, workshops, TED-Style talks and satellite symposia, and over 800 poster presentations on emerging areas of genetic and genomic medicine.

Interview those at the forefront in medical genetics and genomics, connect in person with new sources and get story ideas on the clinical practice of genetics and genomics in healthcare today and for the future. Learn how genetics and genomics research is being integrated and applied into medical practice.

Topics include gene editing, cancer genetics, molecular genomics, exome sequencing, pre- and perinatal genetics, biochemical/metabolic genetics, genetic counseling, health services and implementation, legal and ethical issues, therapeutics and more.

Credentialed media representatives on assignment are invited to attend and cover the ACMG Annual Meeting on a complimentary basis. Contact Kathy Moran, MBA at kmoran@acmg.net for the Press Registration Invitation Code, which will be needed to register at http://www.acmgmeeting.net.

Abstracts of presentations will be available online in January 2020. A few 2020 ACMG Annual Meeting highlights include:

Program Highlights:

Cutting Edge Scientific Concurrent Sessions:

Three half-day Genetics Short Courses on Monday, March 16 and Tuesday, March 17:

Photo/TV Opportunity: The ACMG Foundation for Genetic and Genomic Medicine will present bicycles to local children with rare genetic diseases at the Annual ACMG Foundation Day of Caring on Friday, March 20 from 10:30 AM 11:00 AM at the Henry B. Gonzlez Convention Center.

Social Media for the 2020 ACMG Annual Meeting: As the ACMG Annual Meeting approaches, journalists can stay up to date on new sessions and information by following the ACMG social media pages on Facebook,Twitter and Instagram and by usingthe hashtag #ACMGMtg20 for meeting-related tweets and posts.

Note be sure to book your hotel reservations early.

The ACMG Annual Meeting website has extensive information at http://www.acmgmeeting.net.

About the American College of Medical Genetics and Genomics (ACMG) and the ACMG Foundation for Genetic and Genomic Medicine (ACMGF)

Founded in 1991, the American College of Medical Genetics and Genomics (ACMG) is the only nationally recognized medical society dedicated to improving health through the clinical practice of medical genetics and genomics and the only medical specialty society in the US that represents the full spectrum of medical genetics disciplines in a single organization. The ACMG is the largest membership organization specifically for medical geneticists, providing education, resources and a voice for more than 2,300 clinical and laboratory geneticists, genetic counselors and other healthcare professionals, nearly 80% of whom are board certified in the medical genetics specialties. ACMG's mission is to improve health through the clinical and laboratory practice of medical genetics as well as through advocacy, education and clinical research, and to guide the safe and effective integration of genetics and genomics into all of medicine and healthcare, resulting in improved personal and public health. Four overarching strategies guide ACMG's work: 1) to reinforce and expand ACMG's position as the leader and prominent authority in the field of medical genetics and genomics, including clinical research, while educating the medical community on the significant role that genetics and genomics will continue to play in understanding, preventing, treating and curing disease; 2) to secure and expand the professional workforce for medical genetics and genomics; 3) to advocate for the specialty; and 4) to provide best-in-class education to members and nonmembers. Genetics in Medicine, published monthly, is the official ACMG peer-reviewed journal. ACMG's website (www.acmg.net) offers resources including policy statements, practice guidelines, educational programs and a 'Find a Genetic Service' tool. The educational and public health programs of the ACMG are dependent upon charitable gifts from corporations, foundations and individuals through the ACMG Foundation for Genetic and Genomic Medicine.

Kathy Moran, MBAkmoran@acmg.net

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Press Registration for the 2020 ACMG Annual Clinical Genetics Meeting Is Now Open - Herald-Mail Media

An international team of scientists has developed artificial neurons on silicon chips that behave just like neurons in the body. The first-of-its-kind achievement could lead to the development of medical devices for treating chronic diseases, such as heart failure, Alzheimers disease, or other neurodegenerative disorders. Critically, the artificial neurons not only behave just like biological neurons, but require just one-billionth the power of a microprocessor, making them ideally suited for use in medical implants and other bio-electronic devices.

Until now neurons have been like black boxes, but we have managed to open the black box and peer inside, stated research lead Alain Nogaret, PhD, professor from the University of Bath department of physics. Our work is paradigm-changing because it provides a robust method to reproduce the electrical properties of real neurons in minute detail. But its wider than that because our neurons only need 140 nanoWatts of power. Thats a billionth of the power requirement of a microprocessor, which other attempts to make synthetic neurons have used. This makes the neurons well suited for bio-electronic implants to treat chronic diseases.

The researchers, led by the University of Bath team, and including collaborators at the Universities of Bristol, Zurich, and Auckland, describe the artificial neurons in a study published in Nature Communications, titled, Optimal solid-state neurons.

Designing artificial neurons that respond to electrical signals from the nervous system in the same way that real neurons would has been a major goal in medicine for decades, as it would open up the possibility of curing conditions in which neurons dont work properly, have had their processes severed, as in spinal cord injury, or have died. Artificial neurons could repair diseased biocircuits by replicating their healthy function and responding adequately to biological feedback to restore body functions.

However, developing artificial neurons comes with immense challenges associated with the complex biology and hard-to-predict neuronal responses. The difficulty of measuring microscopic parameters that control the dynamics of ionic currents and the nonlinearity of ionic conductances has hampered so far theoretical efforts to build quantitative computational models and subsequently neuromorphic devices replicating the exact response of a biological neuron, the authors wrote.

Silicon neurons, synapses, and brain-inspired networks have all been proposed, but these designs werent meant to recapitulate the behavior of biological cells in detail, rather, they were intended to help identify the organizing principles of biology that could be applied to practical devices. The increasing focus on implantable bioelectronics to treat chronic disease is however changing this paradigm and is instilling new urgency in the need for low-power analog solid-state devices that accurately mimic biocircuits.

For their research to design artificial neurons, the researchers successfully modeled and derived equations to explain how neurons respond to electrical stimuli from other nerves. This is a hugely complicated task, as responses are non-linear, such that a doubling of signal strength may not elicit a reaction doubling. The response may be more, or less than double.

The team then designed silicon chips that accurately modeled biological ion channels, and confirmed that their silicon neurons precisely mimicked real, living neurons responding to a range of stimulations. To demonstrate their models the researchers accurately replicated the complete dynamics of hippocampal neurons and respiratory neurons from rats, under a wide range of stimuli. we built six-channel silicon devicesthat faithfully model CA1 hippocampal and respiratory neurons, they stated. The completed models predict the membrane voltage of biological neurons in excellent agreement (9497%) with the membrane voltage oscillations observed in response to 60 different current protocols.

The potential applications are manifold, the researchers believe. For example, were developing smart pacemakers that wont just stimulate the heart to pump at a steady rate but use these neurons to respond in real-time to demands placed on the heartwhich is what happens naturally in a healthy heart, Nogaret stated.

In heart failure for example, neurons in the base of the brain do not respond properly to nervous system feedback, they in turn do not send the right signals to the heart, which then does not pump as hard as it should. For example, the respiratory neurons which we have modeled couple the respiratory and cardiac rhythms and are responsible for respiratory sinus arrhythmia, the authors commented. Loss of this coupling through age or disease is a prognosis for sleep apnoea and heart failure. Therefore, a device that adapts to biofeedback in the same way as respiratory neurons may offer a much needed therapy for heart failure. Our accurate description of the neurobiology within a model derived from silicon physics answers this need.

Other possible applications could be in the treatment of conditions like Alzheimers and neuronal degenerative diseases more generally, Nogaret suggested. Our approach combines several breakthroughs. We can very accurately estimate the precise parameters that control any neurons behavior with high certainty. We have created physical models of the hardware and demonstrated its ability to successfully mimic the behavior of real living neurons. Our third breakthrough is the versatility of our model which allows for the inclusion of different types and functions of a range of complex mammalian neurons.

Study co-author Giacomo Indiveri, PhD, from the University of Zurich and ETF Zurich, commented, This work opens new horizons for neuromorphic chip design thanks to its unique approach to identifying crucial analog circuit parameters.

Added co-author, Julian Paton, PhD, a physiologist at the University of Auckland and the University of Bristol, said, Replicating the response of respiratory neurons in bioelectronics that can be miniaturized and implanted is very exciting and opens up enormous opportunities for smarter medical devices that drive towards personalized medicine approaches to a range of diseases and disabilities.

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Artificial Neurons on a Chip Developed to Treat Chronic Diseases - Genetic Engineering & Biotechnology News

DUBLIN, Dec. 6, 2019 /PRNewswire/ -- The "The State of Personalized/ Precision Medicine" report has been added to ResearchAndMarkets.com's offering.

This report covers current and future challenges for the development and launch of these medicines, focusing on challenges with transitioning these therapies from bench to bedside and demonstrating efficacy in order to secure reimbursement.

Report ScopeDefinition of Personalized/Precision Medicine - Key attributes of personalized/precision medicine, examining and contrasting definitions by regulatory bodies and KOL respondents.

Personalized Medicine-Impact on Healthcare - Key factors to impacting healthcare for patients and stakeholders providing respondent mix by region and organization size.

Marketed Products - Detailed information is provided for key personalized/precision medicines, including case studies for marketed oncology and rare disease therapeutics.

Pipeline Products - The diverse Phase III pipeline is presented, including detailed information on key candidate's mechanism of action and clinical trial parameters.

Investment in Personalized Medicine - Investment in personalized medicine by indication and clinical trial design and approaches are presented, with case studies for three ongoing oncology trials being considered.

Market Opportunities and Challenges - Key areas of opportunity and roadblocks in developing, launching, and gaining reimbursement are analyzed by geography, company size, and seniority level.

Emerging Trends - Critical new trends, including the use of advanced digital technologies, are examined.Key Topics Covered

1. Preface

2. Executive Summary

3. Overview of Personalized/Precision Medicine3.1 Definition3.2 Definition of Personalized/Precision Medicine3.3 KOL and Payer Perspecive3.4 Key Attributes of Personalized Medicine Therapy3.5 Types of Biomarkers and Diagnostics

4. Impact of Personalized Medicine on Healthcare4.1 Personalized Medicine - Impact on Healthcare - Patients4.2 Advantages of Personalized Medicine - Patients4.3 Role of Personalized Medicine in Clinical Unmet Needs4.4 Personalized Medicine - Impact on Healthcare - Drug Developers' Perspective4.5 Advantages of Personalized Medicine to Drug Developers4.6 Personalized Medicine - Impact on Healthcare - Health System

5. Key Marketed Products

6. Pipeline Products

7. Investment in Personalized Medicine

8. Deal-Making Landscape

9. Market Opportunities and Challenges

10. Pricing, Reimbursement, and Regulatory Strategy

11. Personalized Medicine - Emerging Trends

12. Summary of Key Findings

13. Appendix

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/v886fo

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Media Contact:

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

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The State of Personalized/Precision Medicine in 2019: Impact on Healthcare, Marketed Products, Pipeline Products, Investments, Market Opportunities &...

Ritu Jha-

Prasun Mishra, founding President and CEO of the American Association for Precision Medicine (AAPM) says the demise of his elder sister to pancreatic cancer led him to this work to create awareness about precision (or personalized) medicine.

It was a kind of a calling for me, Mishra told indica at the AAPM annual meeting 2019 held this past month at the Santa Clara Convention Center. Initially I was very sad for my personal loss but eventually I realized it was not just me. Everybody is facing the same thing and has the same story and I am just one of them.

The daylong meeting was based on the theme Accelerating Precision Medicine and Transforming Patient Health. It was attended by both national and international professors, experts, and thought leaders in the fields of precision medicine, life science, biotech, MedTech and pharma.

Mishra, a serial entrepreneur is the Founder and CEO of Agility Pharmaceuticals, founded by AAPM in 2017 with a mission to save lives by accelerating the field of precision medicine through research, education, communication, and collaboration.

Mishra says it was not easy to build a precision medicine community and there was no non-profit voice before them. There were for profit activists out there but the real community message is hard to create. It was also hard to have a meaningful dialogue about precision medicine to create resources and funds.

In our community we have medical doctors, pharma executives, investors, entrepreneurs, and scientists and are pulling our heads together to solve the toughest problem, he added.

A lot of work was done in the previous decade in the field of precision medicine at the universities, even pharma companies and precision medicine come under health care but it is still in the burgeoning stage.

When asked if lifestyle is a part of precision medicine, Mishra said, It includes lifestyle and yes, lifestyle plays a big role. We are monitoring the patients health and behavior [to see] how it impacts their life [] and trying to see how we could through technology and resources predict, based on lifestyle what outcome [the patient] would have.

When asked about President Barack Obamas launch of the Precision Medicine Initiative in 2015 and the $215 million investment in the Presidents 2016 Budget Mishra gave the example said even private companies like Verily, a Google company, they are working on it and have been profiling patients lifestyle, including sleep pattern and genomics data. They have recently acquired Fitbit for $2.1 billion.

So the question is what led to the awareness of precision medicine? Technology or the growing Cancer killer disease? Mishra believes its both. Its a combination and of course there is frustration for not able to make a difference in the life of loved ones and that is the main cause.

During his presentation, Mishra also highlighted another move by Google that might help boost this growing demand, said, I think Google Quantum computers will be very good [at performing] certain tasks in the future and Quantum computers is much needed as it works much faster than regular computers.

But there are challenges, when it comes to data, Mishra stated that the problem is there are a lot of manual facts in the healthcare system and its on paper in the medical records.

Now we are trying to work together as a community and as a consortium on how can we solve that issue. So that manual data needs to be digitized or you can say the whole health care system needs big a U-Haul, and there are many hurdles and we have to move forward and solve each one at a time.

There are many hurdles still. We have a lot of unstructured data and we need defined data sets. We have to make an innovation to collect that data, Mishra said.

When asked if there is awareness of personalized medicine among the South Asian community, he said that precision medicines goal is to define the community, whether its the Indian or American community.

Based on how you respond to disease we are prone to certain things and diet and our lifestyle, and it would be good to have a community to have genomics data, some companies are working on but still we be are far behind in terms of collecting massive data. In India certain organizations are working. We could come together as a community.

Adding further he said as a community [coming] together would generate a pool of data and would help [figure out] what kind of medicine would respond to them.

Precision medicine is also about growing people, individual groups of ethnicity, community and similar genetic group and then treating and doing research. What are the common genetic factors that are missing and gained and use that knowledge to deliver the promise of precision medicine, said Mishra and added that the next 10 years, are going to be very exciting.

I have predicted that in 5 years and as technology is moving forward exponentially we could do so many things and with AI intervention, we could even detect diabetic retinopathy, Radiology, Mishra said and that would even help rural areas where there are no physicians.

The future is very bright and as a community, if we are passionate about making a difference, we will make the progress that is needed in 10 years or earlier.

Another speaker at the conference Pritmohinder Gill, PhD, Associate Professor at the Arkansas Childrens Research Institute, UAMS said the demand grew because of the growing cancer.

Cancer is the area where more therapeutic value from precision medicine has gone. It is the main beneficiary because we are able to target those particular genes in a particular individual, said Professor Gill.

But he sees a long way to go as its expansive and needs more research and both medicine and technology are very expensive.

He said a single medicine could cost $3000 per sample. Some companies commercialize and can do that for 1500 dollars and many places of academia has fewer resources and infrastructure to support new AI-based technology.

UAMS has no money, and without the growth of technology and AI and if you dont have support its very hard to say which gene is impacting you and your condition. Certainly many of the psychiatric disorders are multi-gene.

Without research, there is no understanding of what is happening. The key is research and only after research, you can take these findings to that side.

Pointing to the recent drugs approved by the FDA he said that in 2018, 42 percent of drugs approved by the FDA were personalized medicine drugs.

When asked how to reduce the cost, Professor Gill said that in Norway they have a population of 6 million and all the inhabitants in Norway have their whole genome sequencing done.

The UK is planning now and its in their database and physicians can access it for writing a prescription.

Thats basically where healthcare will move.

But Prof. Gill believes it would take 50 years because its all money and needs regulation and it depends on how the FDA is doing.

Meanwhile, Dr. Sanjeev Jain, CEO of The Columbia Asthma & Allergy Clinic who spoke at the panel, Role of Physicians Transforming Precision Health says precision is useful in helping to customize the treatment plan for each individual when doing allergy immune therapy.

He said he had lots of data but not enough resources, so he is looking forward to collaborating with Stanford University to build a joint database.

Currently the database is going to be focused on food allergies. Hopefully in future we can do it for other diseases, said Dr. Jain.

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Is Precision Medicine the Future of Healthcare? - indica News

December 06, 2019 -In recent years, genomics and genetic data have emerged as an innovative area of research that could potentially transform healthcare. This information could accelerate precision medicine, paving the way for individualized therapies tailored to each person.

Studies have examined how genomics could improve care for Alzheimers, heart failure, and a number of other diseases, leading to a more personalized standard of treatment.

However, this new source of information could also come with unprecedented challenges. Organizations will need new ways of storing this data, and providers and patients will need to be prepared to handle the answers genomic information could hold.

What are some of the benefits of using genomics in healthcare, and how can the industry overcome the possible challenges that can accompany this information?

Proactive, not reactive, care delivery

READ MORE: Big Data Analytics, Precision Medicine Top Priorities in 2020

Using genomic data, providers can identify patients who are at high risk of developing certain conditions and better plan for treatments. This approach could be particularly helpful in proactively treating cognitive or behavioral disorders before people show signs of disease.

Recently, researchers from The Hospital for Sick Children (SickKids) and the University of Alberta found that testing the DNA of siblings of individuals with autism spectrum disorder (ASD) may be predictive of a future diagnosis even if symptoms arent yet apparent.

Genetic factors are the most likely reason we see a clustering of ASD related traits in families, said Dr. Stephen Scherer, Senior Scientist and Director of The Centre for Applied Genomics (TCAG) at SickKids, Director of the McLaughlin Centre at the University of Toronto and principal investigator of the study.

We wanted to investigate the possible benefits of genetic testing for infants whose older sibling had already been diagnosed with ASD. If we can identify those children early, we may be able to enroll them earlier in therapies.

In a separate study published in the American Journal of Psychiatry, a team from the University of North Carolina (UNC) at Chapel Hill used polygenic risk scores (PRS) based on genome-wide association studies to improve psychosis risk prediction in patients meeting high-risk criteria.

READ MORE: How Real-World Data Could Advance Clinical Trials, Precision Medicine

Previous studies reported the PRS discriminates persons with established schizophrenia from unaffected persons. Our study is the first to indicate the PRS predicts future psychosis suggesting a PRS may facilitate the development and eventual targeting of preemptive interventions, said Diana O. Perkins, MD, MPH, a professor of psychiatry in the UNC School of Medicine.

Individualized care that goes beyond the individual

One of the most exciting benefits of genomics and precision medicine is the promise of therapies that are tailored to meet each patients specific needs. Providers can access an individuals genetic code and better determine what sort of treatment is right for him or her, leading to better outcomes and lower costs.

However, genomics also has the potential to improve treatment beyond the level of the individual, boosting health and well-being for entire patient populations.

If the population health community and the precision medicine community would talk to each other more, I suspect they would find that they have a great deal in common, Jonathan Sheldon, former Global Vice President of Healthcare at Oracle Health Sciences, said in a 2017 interview with HealthITAnalytics.com.

READ MORE: How Precision Medicine Could Boost Chronic Disease Management

Precision medicine gives us the molecular tools to phenotype diseases, which you can then predict and manage at the population level.Genomics gives you that level of precision that is often lacking in risk stratification algorithms.They really enhance one another.Theyre not competitive in any way.

Healthcare organizations have recognized the complementary nature of genomics and population health management. In March 2018, the Healthy Nevada Project, a population health study combining genomic data with socioeconomic, environmental, and clinical information, entered its second collection phase.

The project aims to gather insights about how lifestyle interacts with genetics, improving population health for people in Nevada and around the world.

Genomics could also help researchers and providers uncover why particular conditions impact certain races or ethnicities more than others. A recent study published in the journal Nature showed that a genetic mutation linked to blood sugar levels occurs in one percent of Hispanic/Latino people and about six percent of African Americans, but very rare in people of European descent.

Our study confirmed that the apparent effects of the same genetic variant often vary across populations,saidSteve Buyske, a senior author and an associate professor in theDepartment of Statisticsat RutgersNew Brunswick. A genetic variant with a big effect in people of European descent may have a smaller effect in other populations, and vice versa.

These findings could help advance precision medicine treatments for entire populations, many of which may be underrepresented in studies and clinical trials.

More data, more problems

Although genomics and genetic data could give providers a more comprehensive picture of patient health, the industry still has significant data challenges to overcome before this information can be used at the point of care.

A March 2018 survey from Oracle and GenomeWeb showed that data management and storage were ranked among the top obstacles organizations currently face when trying to achieve their precision medicine goals.

Additionally, many survey participants who said they had no plans to pursue a precision medicine initiative cited insufficient technical infrastructure as their most significant barrier. Health systems will need to implement innovative data storage and management tools to realize the benefits of precision medicine and genomics.

The science is changing rapidly every day. Today, there are literally thousands of variants of unknown significance in every patient, and tomorrow some of those variants will be associated with a syndrome, Joel Diamond, MD, adjunct associate professor of biomedical informatics at the University of Pittsburgh, told HealthITAnalytics.com.

The industry needs an enterprise technology solution that can keep up with new advancements, as well as recognize when changes occur in a patient's clinical condition.

Diamond said that organizations should adopt system-wide standards and strategies that make genomics part of a comprehensive solution, as well as adopt advanced technologies like FHIR.

Even without genetic data standards, organizations should have a genetic data strategy in place, said Diamond.Instead of storing this data in PDFs, genetic information can be stored in various files that the organization has right now, in a standard way that allows the data to be usable down the line.

Patient, provider education

As advanced genetic testing becomes more affordable and accessible, more people will be looking to better understand their health risks. While this could help accelerate precision medicine, providers will need to be sure theyre ready to discuss the results of these tests with their patients.

In 2017, Wamberg Genomic Advisors showed that 16 percent of patients are confused by their genetic testing results, and an additional six percent experienced mild depression or anxiety after reviewing their personal data.

Providers, on their part, may not feel totally prepared to talk with their patients about these results. A recent survey of 130 primary care physicians showed that just 23 percent said they would feel comfortable discussing genetics as a risk factor for common diseases.

Geisinger Health System has recently integrated genomics with routine clinical care, and the organization has made patient and provider education a top priority.

One of the challenges we've tried to address up front is the education aspect what the results mean, both on the patient side and the clinician side, she said.

We've developed what we call Just in Time documents that doctors can give to their patients, which say, This is the information that we learned about you. This is what you need to do now given this information. This is what you need to monitor over time, and this is what you need to do long term. Anticipating the needs of patients and providers as they get this new type of information is important.

While there are challenges to leveraging genomics and genetics in healthcare, the potential benefits the information could provide outweigh the barriers. With innovative data storage tools and strategies to educate patients and providers about this new data, health systems could accelerate precision medicine and personalized treatments.

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Evaluating the Benefits and Challenges of Genomics in Healthcare - HealthITAnalytics.com

Here, we deep dive into five of the key trends in precision medicine and personalised healthcare to explore how the healthcare industry is changing and how pharmaceutical and biotech companies can position themselves as leaders at the forefront of these exciting innovations.

Personalised and precision medicines represent an evolution in healthcare, in which traditional clinical information and new data points including genetic data, and healthcare technology come together to match the right patient with the right treatment at the right time.

In short, it means moving away from the one-size-fits-all approach, in which many patients are treated with the same therapy, to targeted treatments that are often based on the patients DNA and the DNA of their disease.

In November 2019, Blue Latitude Health sponsored the 15th Annual Personalized Medicine Conference hosted by thePersonalized Medicine Coalition. Healthcare professionals, patients, payers, providers and pharmaceutical executives joined together to discuss the challenges and opportunities for those operating in this space.

Here, we deep dive into five of the key trends discussed to explore how the healthcare industry is changing and how pharmaceutical and biotech companies can position themselves as leaders at the forefront of innovation.

Download the article to uncover our analysis of the following trends, including real-life case studies:

* Innovative pricing models in precision and personalised healthcare

* Novel approaches in tracking patient data in the long term

* The importance of taking an individualised approach to clinical trials

* A new regulatory landscape for laboratory-developed tests

* Why the behaviour of healthcare professionals will need to change in this new era.

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Five key trends in precision and personalised healthcare - PMLiVE

MINNEAPOLIS, Dec. 05, 2019 (GLOBE NEWSWIRE) -- Predictive Oncology Inc.(POAI) (Predictive Oncology or the Company), focused on applying artificial intelligence (AI) to personalized medicine and drug discovery, today announced that it has received indications of interest from several parties for the possible acquisition of its Skyline Medical division, which produces and sells the STREAMWAY System for disposal of fluids in medical applications. As previously announced, Predictive Oncology has determined that it will focus its resources on its primary mission of applying artificial intelligence to precision medicine and drug discovery.

Skyline Medicals patented, FDA-approved STREAMWAY System is the first truly continuous, direct-to-drain fluid disposal system designed specifically for medical applications. The division has expanded sales globally and made significant inroads in U.S. markets.

Dr. Carl Schwartz, Predictive Oncologys Chief Executive Officer commented, I am exceptionally pleased with the rapid growth and development of our Helomics and Tumor Genesis divisions, as well as the multiple indications of interest for our Skyline Medical division. If this results in the sale of Skyline Medical, it would not only provide additional working capital, it would also allow Predictive Oncology to focus on the further development and commercialization of our two divisions focused on precision medicine.

The Company believes it will have updates on the future of its Skyline Medical business by early in 2020. The Company will evaluate its alternatives for the Skyline Medical business in order to maximize value for its stockholders. There is no assurance that the Company will ultimately receive offers for the division that it deems acceptable. Further, there is no assurance that the Company will enter into a definitive agreement or ultimately complete a sale of the division.

About Predictive Oncology Inc.

Predictive Oncology (POAI) operates through five segments (Domestic, International, Clinical, CRO and DCHIP), which contain four subsidiaries; Helomics, TumorGenesis, Skyline Medical and Skyline Europe. 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. Helomics CLIA-certified lab provides clinical testing that assists oncologists in individualizing patient treatment decisions, by providing an evidence-based roadmap for therapy. In addition to its proprietary precision oncology platform, Helomics offers boutique CRO services that leverage its TruTumor, patient-derived tumor models coupled to a wide range of multi-omics assays (genomics, proteomics and biochemical), and an AI-powered proprietary bioinformatics platform (D- CHIP) to provide a tailored solution to its clients specific needs. Predictive Oncologys TumorGenesis subsidiary is developing a new rapid approach to growing tumors in the laboratory, which essentially fools cancer cells into thinking they are still growing inside a patient. Its proprietary Oncology Discovery Technology Platform kits will assist researchers and clinicians to identify which cancer cells bind to specific biomarkers. Once the biomarkers are identified they can be used in TumorGenesis Oncology Capture Technology Platforms which isolate and help categorize an individual patients heterogeneous tumor samples to enable the development of patient specific treatment options. Helomics and TumorGenesis are focused on ovarian cancer. Predictive Oncologys Skyline Medical division 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. The company has achieved sales in five of the seven continents through both direct sales and distributor partners. For more information, please visit http://www.predictive-oncology.com.

Forward-looking Statements

Certain of the matters discussed in the press release contain forward-looking statements that involve material risks to and uncertainties in the Companys business that may cause actual results to differ materially from those anticipated by the statements made herein. Such risks and uncertainties include (i) risks related to the recent merger with Helomics, including the fact that the combined company will not be able to continue operating without additional financing; possible failure to realize anticipated benefits of the merger; costs associated with the merger may be higher than expected; the merger may result in disruption of the Companys and Helomics existing businesses, distraction of management and diversion of resources; and the market price of the Companys common stock may decline as a result of the merger; (ii) risks related to our partnerships with other companies, including the need to negotiate the definitive agreements; possible failure to realize anticipated benefits of these partnerships; and costs of providing funding to our partner companies, which may never be repaid or provide anticipated returns; and (iii) other risks and uncertainties relating to the Company that include, among other things, current negative operating cash flows and a need for additional funding to finance our operating plan; the terms of any further financing, which may be highly dilutive and may include onerous terms; unexpected costs and operating deficits, and lower than expected sales and revenues; sales cycles that can be longer than expected, resulting in delays in projected sales or failure to make such sales; uncertain willingness and ability of customers to adopt new technologies and other factors that may affect further market acceptance, if our product is not accepted by our potential customers, it is unlikely that we will ever become profitable; adverse economic conditions; adverse results of any legal proceedings; the volatility of our operating results and financial condition; inability to attract or retain qualified senior management personnel, including sales and marketing personnel; our ability to establish and maintain the proprietary nature of our technology through the patent process, as well as our ability to possibly license from others patents and patent applications necessary to develop products; Predictives ability to implement its long range business plan for various applications of its technology; Predictives ability to enter into agreements with any necessary marketing and/or distribution partners and with any strategic or joint venture partners; the impact of competition, the obtaining and maintenance of any necessary regulatory clearances applicable to applications of Predictives technology; and management of growth and other risks and uncertainties that may be detailed from time to time in the Companys reports filed with the SEC, which are available for review at http://www.sec.gov. This is not a solicitation to buy or sell securities and does not purport to be an analysis of Predictives financial position. See Predictives most recent Annual Report on Form 10-K, and subsequent reports and other filings at http://www.sec.gov.

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The GenomeAsia 100K consortium analyzed the genomes of 1,739 people, which represents the widest coverage of genetic diversity in Asia to date.

The study covers 64 different countries and provides what the authors call the first comprehensive genetic map for Asia that will guide scientists in studying diseases unique to Asians, improve precision medicine and identify drugs that may carry higher risk of adverse reactions for certain ethnic groups.

Despite forming over 40 per cent of the worlds population, Asian people have previously accounted for only six per cent of the worlds recorded genome sequences.

The goal of GenomeAsia 100K, which launched in 2016, is to better understand the genome diversity of Asian ethnicities by sequencing 100,000 genomes of people living in Asia. It is a non-profit consortium hosted by Nanyang Technological University, Singapore (NTU Singapore), the only academic member. Its three other members are Macrogen based in South Korea, Genentech, a member of the Roche Group in United States, and MedGenome from India/US.

NTU Professor Stephan C. Schuster, the consortiums scientific chairman and a co-leader of the study, explained the significance of GenomeAsia 100Ks initial findings on the vast genomic diversity in Asia: To put it into context, imagine we looked at all people of European and based on the level of their genetic diversity, observed that they could all be grouped into just one ancestral lineage or population. Now, if we took that same approach with our new data from people of Asian, then based on the much higher levels of genetic diversity observed we would say that there are 10 different ancestral groups or lineages in Asia.

Schuster added, GenomeAsia 100K is a significant and far-reaching project that will affect the well-being and health of Asians worldwide, and it is a great honour for Singapore and NTU to be hosting it.

Executive Chairman of GenomeAsia 100K, Mahesh Pratapneni said, The publication of this pilot study is a first milestone for GenomeAsia 100K, which is an unprecedented collaboration between academia and industry leaders in the field of genomics. We are certain more partners will join GenomeAsia 100K to accelerate medical breakthroughs for people of Asian heritage.

Chairman and CEO of MedGenome, the largest genomics and molecular diagnostics provider in South Asia with facilities in the US, Singapore and across India, Sam Santhosh, said, "We are excited that over 1000 whole genome sequence data from the Indian sub-continent will now be available to researchers; this is an initial step in covering the underrepresented geographies."

Prof Jeong-Sun Seo, at Seoul National University Bundang Hospital Consortium scientific co-chair and Chairman of Macrogen, said, I hope this Asian-focused study serves as a stepping stone for the democratization of health care and precision medicine in Asia.

How the database of Asian genomes was formed

Over the course of the last three decades prior to the pilot project, thousands of blood and saliva samples have already been collected by scientists and anthropologists from donors across Asia in hopes that one day, a deeper analysis to gain insights into the Asian community can be done.

Of particular interest were participants from remote and isolated communities, who have long been the subjects of study by anthropologists but have not yet undergone genomic analysis, until the GenomeAsia 100K project was kickstarted.

The pilot study included 598 genomes from India, 156 from Malaysia, 152 from South Korea, 113 from Pakistan, 100 from Mongolia, 70 from China, 70 from Papua New Guinea, 68 from Indonesia, 52 from the Philippines, 35 from Japan, and 32 from Russia.

Genomic DNA extracted from the blood and saliva samples was then sequenced in laboratories of the four consortium members in the US, India, South Korea and Singapore. The digital sequencing data were subsequently sent to Singapore for processing and storage.

Singapore was selected by the consortium as the host, as the country offered good travel connections for collaborating scientists, strong supercomputing facilities to crunch the data, and the required cybersecurity standards in its data centre for handling sensitive genetic data.

The combined data was compiled and analyzed by NTU scientists, including Assistant Professor Hie Lim Kim, a population genomics expert at the Asian School of The Environment, with the help of the National Supercomputing Centre Singapore (NSCC) and international collaborators.

Different Asian ethnic groups respond differently to mainstream drugs

Every person has approximately 3.2 billion different nucleotides, or building blocks, in their genome, which form their DNA code.

Its estimated that for the genomes of any two people, 99.9 per cent of this code is the same and on average, 0.1 per cent or three million nucleotides, are different between them.

This genetic variance help humankind colonize the most diverse environments on the planet and make it resilient to disease, but it also results in differential response to many medicines.

Genetic variance is the reason we are distinctively different from each other including differences in the diseases that each of us suffer from during our lifetimes. Understanding these differences is the most important source of clues that we have for driving the discovery of innovative new medicines, said Dr Andrew Peterson, an author of the paper and an expert in the use of genetics to drive drug discovery.

Peterson was head of Molecular Biology at Genentech while this work was being carried out, is now Chief Scientific Officer at MedGenome, where he leads drug discovery efforts at MedGenomes Seven Rivers Genomic Medicines division.

The frequencies of known genetic variants related to adverse drug response were analyzed for the genomes collected in this study.

For example, warfarin, a common anticoagulant drug prescribed to treat cardiovascular diseases, likely has a higher than usual risk of adverse drug response for people carrying a certain genetic variant. This particular genetic variant has a higher frequency to appear in those with North Asian ancestry, such as Japanese, Korean, Mongolian or Chinese.

Using data analysis, scientists can now screen populations to identify groups that are more likely to have a negative predisposition to a specific drug.

Knowing a persons population group and their predisposition to drugs is extremely important if personalized medicine is to work, stressed Prof Schuster: For precision medicine to be precise, you need to know precisely who you are.

Hie Lim Kim, who leads the projects efforts in population genetics, added: Only by sequencing the entire genome of an individual can a persons ancestry and genetic background be known. Their genome explains why some people are afflicted by certain diseases while others arent. Scientists know that there is no single drug that works well for everybody and our latest findings not only reinforce this, but suggest how specific groups could be harmed by specific medicines.

Moving forward, the GenomeAsia 100K will continue to collect and analyze up to 100,000 genomes from all of Asias geographic regions, in order to fill in the gaps on the worlds genetic map and to account for Asias unexpected genetic diversity.

Reference

GenomeAsia100K Consortium. (2019) The GenomeAsia 100K Project enables genetic discoveries across Asia. Nature. DOI: https://doi.org/10.1038/s41586-019-1793-z

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BETHESDA, Md., Dec. 4, 2019 /PRNewswire/ --The American College of Medical Genetics and Genomics (ACMG) heads to a new destination in sunny San Antonio, Texas in 2020. Named one of the fastest growing meetings in the USA by Trade Show Executive Magazine, the ACMG Annual Clinical Genetics Meeting continues to provide groundbreaking research and news about the latest advances in genetics, genomics and personalized medicine. To be held March 17-21, the 2020 ACMG Annual Meeting will feature more than 40 scientific sessions, 3 Short Courses, workshops, TED-Style talks and satellite symposia, and over 800 poster presentations on emerging areas of genetic and genomic medicine.

Interview those at the forefront in medical genetics and genomics, connect in person with new sources and get story ideas on the clinical practice of genetics and genomics in healthcare today and for the future. Learn how genetics and genomics research is being integrated and applied into medical practice.

Topics include gene editing, cancer genetics, molecular genomics, exome sequencing, pre- and perinatal genetics, biochemical/metabolic genetics, genetic counseling, health services and implementation, legal and ethical issues, therapeutics and more.

Credentialed media representatives on assignment are invited to attend and cover the ACMG Annual Meeting on a complimentary basis. Contact Kathy Moran, MBA at kmoran@acmg.net for the Press Registration Invitation Code, which will be needed to register at http://www.acmgmeeting.net.

Abstracts of presentations will be available online in January 2020. A few 2020 ACMG Annual Meeting highlights include:

Program Highlights:

Cutting Edge Scientific Concurrent Sessions:

Three half-day Genetics Short Courses on Monday, March 16 and Tuesday, March 17:

Photo/TV Opportunity: The ACMG Foundation for Genetic and Genomic Medicine will present bicycles to local children with rare genetic diseases at the Annual ACMG Foundation Day of Caring on Friday, March 20 from 10:30 AM 11:00 AM at the Henry B. Gonzlez Convention Center.

Social Media for the 2020 ACMG Annual Meeting: As the ACMG Annual Meeting approaches, journalists can stay up to date on new sessions and information by following the ACMG social media pages on Facebook,Twitter and Instagram and by usingthe hashtag #ACMGMtg20 for meeting-related tweets and posts.

Note be sure to book your hotel reservations early.

The ACMG Annual Meeting website has extensive information at http://www.acmgmeeting.net.

About the American College of Medical Genetics and Genomics (ACMG) and the ACMG Foundation for Genetic and Genomic Medicine (ACMGF)

Founded in 1991, the American College of Medical Genetics and Genomics (ACMG) is the only nationally recognized medical society dedicated to improving health through the clinical practice of medical genetics and genomics and the only medical specialty society in the US that represents the full spectrum of medical genetics disciplines in a single organization. The ACMG is the largest membership organization specifically for medical geneticists, providing education, resources and a voice for more than 2,300 clinical and laboratory geneticists, genetic counselors and other healthcare professionals, nearly 80% of whom are board certified in the medical genetics specialties. ACMG's mission is to improve health through the clinical and laboratory practice of medical genetics as well as through advocacy, education and clinical research, and to guide the safe and effective integration of genetics and genomics into all of medicine and healthcare, resulting in improved personal and public health. Four overarching strategies guide ACMG's work: 1) to reinforce and expand ACMG's position as the leader and prominent authority in the field of medical genetics and genomics, including clinical research, while educating the medical community on the significant role that genetics and genomics will continue to play in understanding, preventing, treating and curing disease; 2) to secure and expand the professional workforce for medical genetics and genomics; 3) to advocate for the specialty; and 4) to provide best-in-class education to members and nonmembers. Genetics in Medicine, published monthly, is the official ACMG peer-reviewed journal. ACMG's website (www.acmg.net) offers resources including policy statements, practice guidelines, educational programs and a 'Find a Genetic Service' tool. The educational and public health programs of the ACMG are dependent upon charitable gifts from corporations, foundations and individuals through the ACMG Foundation for Genetic and Genomic Medicine.

Kathy Moran, MBAkmoran@acmg.net

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LAGUNA HILLS, Calif., Dec. 5, 2019 /PRNewswire/ --Prelude Corporation (PreludeDx), a leader in molecular diagnostics and precision medicine for early stage breast cancer, announced today the official appointment of David J. Dabbs, MD, a world renowned expert in breast pathology, to its medical team to provide pathology leadership for both currently marketed tests and services and others in development.

Dr. Dabbs joins PreludeDx with over 30 years of experience in direct patient care and clinical research at university-based pathology practices. He has educated hundreds of pathologists globally through his previous academic appointments including most recently as Professor and Chief of Pathology at Magee-Women's Hospital of UPMC, Pittsburgh, PA. He has ledpresentations at key international medical meetings and co-authored textbooks which have become the diagnostic standard in pathology, Breast PathologyandDiagnostic Immunohistochemistry (Elsevier, New York). Dr. Dabbs has advanced the field of breast pathology and the cancer community's understanding of ductal carcinoma in situ (DCIS) and breast cancer by publishing over 200 papers in peer-reviewed medical journals.

In addition to providing pathology guidance for the company's DCISionRTtest and future developments, Dr. Dabbs will lead Prelude's newly launched second opinion service, BREAST SOS, a consultation service designed for patients and the breast care team. "I am first and foremost a fierce patient advocate. My role with PreludeDx will be to help patients through the work we do today and by guiding the on-going development and validation of new approaches for women diagnosed with DCIS and early stage breast cancer," Dabbs said. "I believe precision medicine requires precision information. Both DCISionRT and BREAST SOS add clarification and needed information to help clinicians and patients make the right decisions about individual patient care."

Daniel Forche, President and CEO of PreludeDx, stated, "We are honored to have David join us to apply his mastery and experience in breast cancer diagnosis, biomarker development and patient care. His addition to the team further supports the principles upon which we were founded; Patient Focus, Quality First and Driving Innovation. Every patient should have access to an expert second opinion, and with Dr. Dabbs at the helm of BREAST SOS, we can help make this a reality for women around the world by providing expertise and clarification during their time of need."

About David J. Dabbs, MD

David J. Dabbs, MD is a thought leader in breast pathology. He has published over 200 papers and has several editorial board appointments and responsibility for peer review of pathology journals. He completed his medical degree at Medical College of Ohio, and his residency and fellowship at University of Washington and Affiliated Hospitals. Dr. Dabbs served as Director of Anatomic Pathology, and Chief of Pathology, Magee-Women's Hospital of UPMC, Pittsburgh, PA for over 15 years. Most recently, he was Professor of Pathology, University of Hawaii Cancer Center, John A. Burns School of Medicine. He is certified by the American Board of Pathology for Anatomic Pathology and Cytopathology.

About DCISionRT for Breast DCIS

DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. In the US, over 60,000 women are newly diagnosed with DCIS each year. The test was developed by PreludeDx and built on research that began with funding from the National Cancer Institute to better understand the biology of DCIS. DCISionRT assesses a woman's individual tumor biology along with other risk factors to provide a personalized recurrence risk. The test provides a Decision Scorethat identifies a woman's risk as low or elevated. DCISionRT's intelligent reporting provides a woman's recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed treatment decisions.

About PreludeDx

PreludeDx is a leading personalized breast cancer diagnostics company dedicated to serving breast cancer patients and physicians worldwide. Founded in 2009 with technology licensed from University of California San Francisco, PreludeDx has focused on developing precision breast cancer tools that will impact a patient's treatment decision. Our mission is to provide patients and physicians with innovative technologies that improve patient outcomes and reduce the overall cost burden to the healthcare system. Before making a treatment decision, Know Your Risk.

For more information on how PreludeDx is making a difference for patients, please visit the Company's website: http://www.preludedx.com

PreludeDx, the PreludeDx logo, DCISionRT, the DCISionRT logo, Decision Score, The DCIS Test, Know Your Risk and Your Biology, Your Decision are trademarks of Prelude Corporation or its wholly owned subsidiaries in the United States and foreign countries.

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PreludeDx Announces David J. Dabbs, MD as Chief of Pathology and Director of BREAST SOS (Second Opinion Service) - PRNewswire