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Archive for the ‘Personalized Medicine’ Category

Oncology Precision Medicine Market Research, Industry Trends and Global Forecasts, 2035 – Rising Partnership and … – PR Newswire

Monday, March 18th, 2024

Oncology Precision Medicine Market Research, Industry Trends and Global Forecasts, 2035 - Rising Partnership and ...  PR Newswire

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3 Precision Medicine Stocks That Could Benefit From the Industry’s Rise – InvestorPlace

Monday, March 18th, 2024

3 Precision Medicine Stocks That Could Benefit From the Industry's Rise  InvestorPlace

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Prime Editing Approach Provides a Faster, More Effective Way to Screen for Cancer Mutations – Inside Precision Medicine

Monday, March 18th, 2024

Prime Editing Approach Provides a Faster, More Effective Way to Screen for Cancer Mutations  Inside Precision Medicine

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Global Genomics Industry Research 2024-2031: Rising Adoption of Personalized Medicines and Gene Therapies … – PR Newswire

Monday, March 18th, 2024

Global Genomics Industry Research 2024-2031: Rising Adoption of Personalized Medicines and Gene Therapies ...  PR Newswire

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CAR T-Cell Therapy Successfully Used to Treat Brain Tumors – Inside Precision Medicine

Monday, March 18th, 2024

CAR T-Cell Therapy Successfully Used to Treat Brain Tumors  Inside Precision Medicine

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Revolutionizing Wellness: The Power of Personalised Health Tech – AutoGPT

Monday, March 18th, 2024

Revolutionizing Wellness: The Power of Personalised Health Tech  AutoGPT

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Personalized medicine is coming, but who will have access to it?

Sunday, March 10th, 2024

Editors Note: This is the second article in a two-part series exploring the promise and limitations of the field of personalized medicine. The first part focused on advances and innovation in the field.

In the mid-1990s, researchers identified two gene mutations that are key to predicting genetic susceptibility to breast cancer: BRCA1 and BRCA2. In 1996, the BRCA1/2 mutation screening became the first genetic test for cancer risk available as a clinical service.

This genetic screening was an early innovation in a field that has come to be known as personalized medicine, which can be applied across a variety of medical specialties. Its defining characteristic is that a patients health care team takes into consideration a wide range of factors such as genetics, lifestyle, diet, specifics of disease presentation, and living environment when deciding on an individualized prevention or treatment plan.

With the advent of personalized medicine, including genetic screening as well as more targeted cancer drugs and therapies, the death rate for breast cancer in the United States declined by 43% from 1989 to 2020, according to the American Cancer Society (ACS). But even as mortality from breast cancer has decreased overall, there are statistics that highlight inequities in outcomes. Despite Black women having a lower incidence of breast cancer than non-Hispanic White women, Black women of all ages die from breast cancer at a 40% higher rate than non-Hispanic White women, and Black women under 50 years old die of breast cancer at twice the rate of non-Hispanic White women in the same age category.

Research shows that Black women get the BRCA1/2 screening less often than White women, at least in part because it is offered to them less frequently. One 2017 study found that, of women under 50 years old diagnosed with invasive breast cancer in Florida, 85.7% of the White women in the study were referred for genetic testing, while only 37% of the Black women were.

This is just one example of the inequities that some medical researchers and health equity advocates say severely limit the benefits of personalized medicine, even as technology advances.

[Personalized medicine] products are informative and are having an impact in certain communities, but its not equitable across all communities, says Rick Kittles, PhD, senior vice president for research at Morehouse School of Medicine, a historically Black medical college (HBCU) in Atlanta.

In the United States, people who are Black, Hispanic or Latino, American Indian or Alaska Native, people with low incomes, people who are uninsured or underinsured, and those who live in rural areas, as well as others who have been marginalized, face multiple barriers to personalized medicine. These barriers include a lack of inclusion of diverse genetics in research, the high cost of genetic testing and technology used in personalized medicine, and a lack of awareness of and education about personalized medicine among health care providers outside of urban medical centers. Some sociologists hypothesize that advances in medical innovation may, in fact, exacerbate existing inequities because people with economic and educational advantage are more likely to access care that improves lives and reduces mortality, while those from marginalized communities are left behind.

Its a problem that several academic medical centers are seeking to address with a range of strategies, from expanding personalized medicine research at HBCU medical schools to engaging community partners for research recruitment.

The field of human genetics has grown exponentially since the 2003 completion of the Human Genome Project, an international research effort that mapped the gene pairs that make up human DNA. The endeavor found that all humans share 99.9% of the same genome, with the other 0.1% accounting for all genetic diversity among individuals. Within that 0.1% are the wide variety of heritable traits, from physical characteristics to genetic mutations that cause or increase risk for certain diseases.

And yet, in the more than 6,000 genome-wide association studies (when researchers scan the genomes of large populations to try to identify genetic variations associated with diseases) that have been published internationally over the last two decades, 90% of all people analyzed were of European descent, according to a 2023 article in the Human Molecular Genetics journal.

This means that researchers have very little understanding of heritable disease risk for the vast majority of the worlds population when it differs from the variations seen in people of European descent.

Kittles, who is a genetic epidemiologist by trade, joined Morehouse in 2022 to lead the medical schools expanding efforts to advance medical research focusing on the inclusion of people from groups that have historically been excluded from clinical research and underserved in health care.

Among his faculty recruits is Melissa B. Davis, PhD, a genetics researcher focused on racial disparities in cancer who will lead the schools new Institute of Genomic Medicine. Davis previous work includes identifying two genes found in women of African ancestry that may increase their likelihood of developing an aggressive form of breast cancer, much like the BRCA1/2 gene.

For women of color who get tested [for BRCA 1/2], the benefit of that test is not equitable and in many cases the tests come back unknown, Kittles says. Thats because those variants [that are found in people of African descent] are not in databases Its a glaring, prime example of where we are in precision medicine right now.

The research expansion at Morehouse is funded by an $11.5 million grant from the Chan Zuckerberg Initiative (CZI, created by Facebook founder Mark Zuckerberg and his wife, Priscilla Chan) and is part of the charitable foundations larger Accelerate Precision Health program. CZI has granted equal funds to each of the nations three other HBCU medical schools: Charles Drew University College of Medicine in Los Angeles; Howard University College of Medicine in Washington, D.C.; and Meharry Medical College in Nashville.

When we think about the science we want to support, [we ask,] Who does the science? What science is being done? Who does the science serve? says Bil Clemons, PhD, science program officer for Diversity, Equity, and Inclusion in Science for CZI. Fundamentally, Is the science that were doing inclusive of everyone?

Most of the funding from CZI has gone to hiring faculty at HBCU medical schools to bolster their capacity to expand their research footprint over time, but its also funded the creation of new programs to train genetic counselors at Charles Drew University College of Medicine.

Kittles says that CZIs funding is instrumental to advancing research into genetic diversity and health disparities at HBCU medical schools, particularly because these institutions have often been overlooked for federal and philanthropic funding in the past.

That creates a disparity that not only limits the research impact of those institutions, but also the health of the communities that they serve, says Kittles. So much so that while all HBCUs have strong teaching experience, the development of research has been hampered because of the lack of funding and the ability to bring in talent who want to do research. The sustainability of research is limited because of that history.

In turn, thats set back progress in reducing health disparities, especially in Black communities and other communities of color, Kittles says, because HBCU medical schools tend to have more trust and access to those communities than many other medical centers.

Many academic medical centers historically have had a very strong disconnect with disparate communities, Kittles explains. The bulk of their research and the bulk of their patients are not diverse And so, when they do research, theyre limited in terms of their touch.

In addition to the efforts at the HBCU medical schools, dozens of medical centers are participating in the National Institutes of Health (NIH) All of Us research program, the goal of which is to build one of the largest and most diverse health databases in the world.

The All of Us program is studying patients social determinants of health, a phrase that refers to the various factors such as environment, socioeconomic status, access to healthy food, and access to health care that can affect health.

The NIH has funded and partnered with more than a dozen organizations to expand their reach into the communities that are historically underrepresented in biomedical research, including the American Association on Health and Disability; the National Alliance for Hispanic Health; and the National Baptist Convention, USA Inc.; among others. These organizations use their connections within marginalized communities to enroll and retain participants in the program. As of September 2021, the partners had helped enroll more than 400,000 participants, 80% of whom are from communities that are historically underrepresented in research. The study aims to provide a holistic picture of health by collecting samples of blood, urine, and saliva; physical measurements; electronic health records; health and family medical histories; information about lifestyles and communities; and data from wearable technologies, such as smartwatches, according to the NIH.

And while this and other endeavors are a step forward, Kittles says that all academic medical centers have a responsibility to resolve inequities in their own communities in order to truly make progress in advancing accessibility to personalized medicine.

In my career, Ive been at resource-rich [institutions], and resource-poor [institutions], and what I call community-rich and community-poor. Some had strong relationships with the community, and others had no trust from communities around them, says Kittles. When we talk about health equity, there has to be a commitment that goes beyond the window dressings and the social media tags that you see Part of that is bringing individuals into the institution that represent the communities that you want to benefit.

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Personalized medicine | Definition, Origins, Examples, & Ethical …

Sunday, March 10th, 2024

Also called: precision medicine or individualized medicine(Showmore)

personalized medicine, field of medicine in which decisions concerning disease prevention, diagnosis, and treatment are tailored to individual patients based on information derived from genetic and genomic data. Personalized medicine centres on the concept that information about a patients genes and genome allows physicians to make more informed and effective decisions about a patients care.This idea essentially is an extension of conventional medicine, in which one strategy is applied across all patients, without tailoring to personal genetic and genomic information.

The concept of personalized medicine, although not novel at the time, materialized in the 1990s, following advances in DNA sequencing technology, including automation and increased throughput. Out of those advances came efforts such as the Human Genome Project (HGP; 19902003), in which sequences of more than three billion base pairs of the human genome were elucidated and made available to researchers worldwide. Likewise, the International HapMap Project (200210), which identified genetic variations that contribute tohuman disease, provided researchers with the information needed to associate gene variants with specific diseases and disorders.

Those advances cast light on phenomena in medicine that had been observed for yearsfor example, that certain drugs are more effective in some patients and that, in response to certain medications, some patients experience unusually severe side effects. Progress in understanding the molecular factors underlying the influence of individual genetic constitution on disease and therapeutics was greatly aided by developments in pharmacogenetics and pharmacogenomicsthe study of genetic causes behind differences in how individuals respond to drugs and the study of how multiple variations within the genome affect responses to drug treatments, respectively. Using data derived from pharmacogenetics and pharmacogenomics, researchers were able to develop more objective and accurate tests fordisease diagnosis and for predicting how patients would respond to therapeutic agents. In some cases, researchers found, using genetic and other molecular data to inform diagnosis and treatment, that the development or outcome of certain diseases could be modified.

The emergence of personalized medicine was further facilitated by developments in the area of health information technology, which entails electronic processing and storage of patient data, and in the clinical uptake of personalized medicine, particularly through translational and clinical research. Advances in those areasespecially the implementation of electronic health records (EHRs), which store data on patient history, medications, test results, anddemographicswere critical to the integration of data derived from genetics and genomics research and clinical settings.

Personalized medicine is used in various ways to facilitate the prevention, diagnosis, and treatment of disease. For example, physicians can use information on family history of disease to assess a patients risk for a disease. In certain instances, family history can be used to determine whether a patient should undergo genetic testing and, based on that information, whether the individual would benefit from specific preventive measures. In the case of individuals with a family history of Lynch syndrome (a cause of hereditary colorectal cancer), for instance, detection of the causative mutation through genetic testing can be used to inform decisions about screening. For persons who carry the mutation, frequent and routine screening for evidence of precancerous lesions in the colon allows for early disease detection, which can be a lifesaving measure. Similarly, tests capable of detecting mutations in multiple genes at one time can assist in the early diagnosis of hereditary forms of breast cancer, ovarian cancer, and prostate cancer.

The term personalized medicine is sometimes considered to be synonymous with targeted therapy, a form of treatment centred on the use of drugs that target specific molecules involved in regulating the growth and spread of cancer.Among the first successful targeted therapies was the anticancerdrug imatinib, which istailored to patients with chronic myelogenousleukemia(CML) who carry anenzymecalled BCR-ABLtyrosinekinase, a protein produced by a cytogenetic abnormality known as the Philadelphiachromosome. Imatinib blocks the proliferation of CML cells that possess themutated kinase, effectively reversing the abnoramalitys cancerous effects.

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Another example of personalized medicine applied to therapeutics is the use of genotyping to identify variations in enzymes that alter a patients sensitivity to the commonly prescribed anticoagulant drug warfarin. Information about variations in warfarin-metabolizing enzymes can be used to help guide decisions about the amount of the drug that a patient needs to receive in order to achieve the desired effect.

Personalized medicine faces significant challenges. For example, compared with the HGP reference sequence of the human genome, each individual persons genome houses roughly three to five million variations. Thus, attributing disease causation or therapeutic response to a given genetic variant requires careful analysis and interpretation across multiple disciplines. Moreover, genomes vary across geographic and ethnic populations and are influenced by environmental factors; thus, an individual variation identified within a given population may have very different impacts on disease in another population, based on ethnic or geographic factors.

Technological issues also continue to challenge advances in personalized medicine. The structure of EHR data, for example, can impact its utility. Access to and analysis of genomic data in EHRs may be limited by the presentation of genomic test results as a summary that includes relevant observations but excludes raw data and by the lack of information on details such as patient lifestyle and behaviour, which are essential to the accurateinterpretation of genomic information.

Various ethical issues are associated with personalized medicine. Of particular concern is that the majority of genomic studies historically have focused on populations of European descent, with significant underrepresentation of racial and ethnic minorities. This unevenness in representation can impact algorithms used to guide decisions about drug selection and dosing regimens, potentially resulting in ineffective treatment and poorer outcomes for patients whose genetic backgrounds and lifestyles differ from more thoroughly studied groups.

Other ethical issues surround privacy and security concerns, mainly involving the use of EHRs. For example, a breachin an EHR system could result in the release of personal information and health data as well as information about health care providers.Personalized medicine also carries high costs and therefore is potentially inaccessible for patients who lack health insurance and financially out of reach for less-developed countries with limited health resources.

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Innovating for Individual Care: The Impact of USP on Personalized Medicine

Sunday, March 10th, 2024

In 2022, personalized medicines (PM) made up more than 34% of new therapeutics approved by the Food and Drug Administration (FDA). PM is defined by the Personalized Medicines Coalition as the use of diagnostic tests to determine which medical treatments will work best for each patient or [the] use [of] medical interventions to alter molecular mechanisms that impact health. This emerging approach to healthcare is growing rapidly and having an important impact on patients, practitioners, and health systems. While many healthcare providers have already discovered the value of PM for their patients, others may remain unsure or unconvinced. The primary rationale for using PM is that the standard-of-care therapy may work well for some patients, but for others, it may have lower efficacy or higher risk for side effects due to patients biological differences. , This is the subset of patients who could benefit the most from PM.

At USP, the Healthcare Quality & Safety (HQS) Center of Excellence has developed a science-based roadmap for personalized medicine that considers how USP can evolve standards to address new modalities of medicine and close important gaps in these treatments that help ensure quality patient care. Waypoints on this roadmap include examining established standards, building collaborations with key stakeholders, identifying volunteers for future DTx standards work at USP, holding roundtable discussions, drafting Stimuli articles, and developing workplan focus areas for the HQS Expert Committees. USP has a long-standing history of healthcare standards including those for compounding preparations that are tailored to meet the unique needs of patients who may not otherwise have access to their medications. Currently, USP is exploring other specialized areas within PM, including pharmacogenomics, digital therapeutics, and 3D-printed medications to name a few.

Pharmacogenomics

Pharmacogenomics (PGx) is the study of how a patients genes can affect drug therapy. From a sample of saliva, cheek cells, or blood, scientists can extract a patients DNA and sequence it to understand how that individuals genes are similar to or different from genes of other patients. The individuals genetic results are then considered by healthcare providers, in combination with other data about the patient and their medical condition, to select the most appropriate drug therapy for them.

Based on decades of research with populations around the globe, healthcare providers can now use PGx to make predictions of an individuals personalized response to medications. For example, PGx can help predict the amount of drug available in the patients body, which can determine both its therapeutic effect(s) and likelihood to cause side effects. This is based on the observation that multiple people who take the same dose of the same medication may metabolize, transport, bind, or otherwise interact with drugs differently, leading to different amounts of drug in their bodies.

PGx presents opportunities for USP to collaborate with key stakeholders who are already developing PGx standards and guidelines and to apply its standards-setting process to establish alignment and consistency in PGx standards. Specifically, some of the standards and guidelines that USP could help develop are the 1) naming of genetic biomarkers and PGx terminology, 2) labeling of medicines to incorporate PGx information, 3) incorporation of PGx into healthcare information technology such as electronic health records and clinical decision support, and 4) diversification of clinical trials so that PGx information is not limited to patients of common ancestries, such as those of European ancestry. USP is well-positioned to engage a wide audience while increasing the reliability of and confidence in the utilization of PGx. This will help support PGx implementation, including payment and reimbursement, both nationally and globally.

Digital Therapeutics

Digital therapeutics (DTx) are defined by the International Organization for Standardization as health software intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patients health. The DTx landscape is evolving rapidly, with more than 40 prescription digital therapeutics already available in the U.S. DTx is projected to have a cumulative annual growth rate of up to 25.4% in the U.S. market by 2030, and this growth is not limited to the U.S., as the global DTx market is expected to expand by 31.6% by 2027. Due to this burgeoning expansion, DTx products are increasingly in need of robust standards to underpin the creation of high-quality products and the delivery of comprehensive care on a large scale.

USP is actively engaged in researching the landscape of DTx and has started an investigation into opportunities for DTx standards to improve the quality of care provided to patients. USP has identified areas for potential standards that include establishing, or supporting the establishment of, global DTx definitions including outcomes used in clinical studies of DTx products. These potential standards may also include key aspects such as security and privacy, promoting awareness and education among healthcare providers and patients, adopting consistent labeling practices, setting standard technology proficiency requirements, addressing issues related to data integrity and code authenticity to deter counterfeit DTx products, facilitating interoperability among the various clinical systems used in healthcare around the world, and integrating DTx into healthcare delivery systems such as existing software and devices.

These elements would create a comprehensive framework for seamlessly integrating DTx within the healthcare industry, as well as for its development and regulation. USP is also maintaining awareness of the current position of DTx, understanding the potential role of standards in DTx product growth, identifying factors that can expedite progress, recognizing and addressing barriers, and determining the competencies needed to navigate the ever-changing, technology-driven market.

What comes next

USP is currently engaging with stakeholder leaders to develop Stimuli Articles related to its research involving potential standards for PGx and DTx. These future articles will feature in the USP-PF and will solicit public comment to promote stakeholder engagement. In the meantime, USP encourages interested parties to reach out for more information as USP approaches its new 2025-2030 cycle.

For further information about USPs work on personalized medicine, visit our webpage, sign up for the HQS newsletter, or contact:

Blaine GroatEmail: blaine.groat@usp.org

Yasmin HaidarbaigiEmail: Yasmin.haidarbaigi@usp.org

__________________________________

i Personalized Medicine Coalition. Personalized Medicine at FDA: the Scope & Significance of Progress in 2022.report.pdf (personalizedmedicinecoalition.org) Accessed November 10, 2023. Personalized Medicine Coalition.ii Personalized Medicine 101.https://www.personalizedmedicinecoalition.org/personalized-medicine-101/. Accessed November 6, 2023.iii Schork, N. Personalized medicine: Time for one-person trials. Nature 520, 609611 (2015).https://doi.org/10.1038/520609a.iv US Department of Health and Human Services. National Action Plan for Adverse Drug Event Prevention.Washington (DC): 2014; pharmacogenomics working group whose mission is to develop a 56.v International Organization for Standardization. "Health Informatics Personalized Digital Health DigitalTherapeutics Health Software Systems." ISO/TR 11147:Edition 1, 2023, https://www.iso.org/obp/ui/#iso:std:iso:tr:11147:ed-1:v1:en.vi Liesch J, Murphy D, Singh V. Under Pressure: Prescription Digital Therapeutics - How an analysis of the U.S. PDTlandscape indicates mounting pressure for a make-or-break next 3 years. Blue Matter. 2022.vii Digital Therapeutics Market Size, Share, and Analysis Report. Grand View Research, 2023. Accessed viahttps://www.grandviewresearch.com/industry-analysis/digital-therapeutics-market on Sep 05, 2023.viii Digital Therapeutics Market Revenue Forecast: Latest Industry Updates. Markets and Markets, 2023. Accessed via https://www.marketsandmarkets.com/Market-Reports/digital-therapeutics-market-51646724.html on Sep 05, 2023.

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AI and predictive medicine: Recent advances – News-Medical.Net

Sunday, March 10th, 2024

AI and predictive medicine: Recent advances  News-Medical.Net

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Personalized medicine is coming, but who will have access to it? – AAMC

Sunday, March 10th, 2024

Personalized medicine is coming, but who will have access to it?  AAMC

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Why personalized medicine is a business trend to watch in 2024 – HealthLeaders Media

Sunday, March 10th, 2024

Why personalized medicine is a business trend to watch in 2024  HealthLeaders Media

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AI helps cardiologists deliver personalized healthcarebut there is still plenty of work to do – Cardiovascular Business

Sunday, March 10th, 2024

AI helps cardiologists deliver personalized healthcarebut there is still plenty of work to do  Cardiovascular Business

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Q&A: How AI and wearable technologies are transforming medicine – EMS1.com

Sunday, March 10th, 2024

Q&A: How AI and wearable technologies are transforming medicine  EMS1.com

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HealthTech Revolution: Wearables, AI, and the Personalized Future of Healthcare – GearBrain

Sunday, March 10th, 2024

HealthTech Revolution: Wearables, AI, and the Personalized Future of Healthcare  GearBrain

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Redefining Healthcare: The Rise of Personalized Medicine and the Shift from Conventional Care – Medriva

Sunday, March 10th, 2024

Redefining Healthcare: The Rise of Personalized Medicine and the Shift from Conventional Care  Medriva

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Dr Kalinsky on Unanswered Questions Regarding Genomic Testing in HR+ Breast Cancer – OncLive

Sunday, March 10th, 2024

Dr Kalinsky on Unanswered Questions Regarding Genomic Testing in HR+ Breast Cancer  OncLive

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Chemotherapy Plus High Doses of Radiation Effective for Treating Non-Small Cell Lung Cancer – Inside Precision Medicine

Wednesday, January 17th, 2024

Chemotherapy Plus High Doses of Radiation Effective for Treating Non-Small Cell Lung Cancer  Inside Precision Medicine

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It’s Time to Fully Embrace Precision Medicine’s Promise in Pediatrics – Healthcare Innovation

Wednesday, January 17th, 2024

It's Time to Fully Embrace Precision Medicine's Promise in Pediatrics  Healthcare Innovation

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Special Report: Radiation Oncology Takeaways from RSNA23 – Imaging Technology News

Wednesday, January 17th, 2024

Special Report: Radiation Oncology Takeaways from RSNA23  Imaging Technology News

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