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Personalized Medicine Food and Drug Administration (FDA) Diagnostic Tests

Foley & Lardner LLP

Personalized Medicine at FDA: The Scope & Significance of Progress in 2022

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The Personalized Medicine Coalition (PMC) recently released its annual report on the progress of precision medicine as measured by precision medicine FDA approvals in 2022 (“Report”). As summarized in the Report, 2022...more

Womble Bond Dickinson

New blood test to guide personalized cancer treatment

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On August 26, 2020, the U.S. Food and Drug Administration approved Foundation Medicine, Inc.’s Foundation One® Liquid CDx, a quantitative next-generation sequencing (NGS) test that can detect mutations using circulating...more

Foley & Lardner LLP

2019 FDA Precision Medicine Approvals: Progress At FDA

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On February 21, 2020, the Personalized Medicine Coalition (PMC) released its annual “Personalized Medicine At FDA: The Scope and Significance of Progress in 2019” (Report) that monitors FDA approvals of precision medicine...more

Baker Donelson

Precision Medicine Advances: Medicare Coverage of Next Generation Sequencing Testing

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Medicare recently released a new national coverage determination (NCD) that addresses certain diagnostic laboratory tests using Next Generation Sequencing (NGS) for patients with advanced cancer. NGS technology has made it...more

Akin Gump Strauss Hauer & Feld LLP

New CMS National Coverage Determination and FDA Regulatory Approach: the Next Generation for NGS Testing Policy?

• The new national Medicare coverage determination covers only FDA-authorized NGS tests with companion diagnostic indications, leaving NGS cancer tests without that specific indication to seek coverage from local Medicare...more

Foley & Lardner LLP

FDA Approves Companion Dx for PD-1 Inhibitor

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According to the American Cancer Society (“ACS”), lung cancer (both small cell and non-small cell) is the second most common cancer in both men and women (not counting skin cancer). About 14% of all new cancers are lung...more

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Three Pressing Challenges for Personalized Medicine

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Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

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Navigating the Diagnostic Commercialization Process

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Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more

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FDA Oversight of Diagnostic Medicine – A Trap for the Unwary

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Diagnostic medicine is experiencing new challenges at the USPTO and the U.S. Food and Drug Administration (FDA). Under a new FDA proposal, laboratory developed test providers, previously exempt from FDA oversight, must now...more

Foley & Lardner LLP

AmerisourceBergen Guest Post: Solutions to Overcome Reimbursement Challenges in Personalized Medicine

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The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report - Spring 2015

In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more

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Is Next Generation Sequencing Ready for Personalized Medicine?

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Next generation sequencing (NGS) promises to transform the delivery of health care by providing in one test diagnostic and prognostic information that had previously only been available in multiple analyses. One application...more

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FDA Regulation of Laboratory Developed Tests: Benefit or Unnecessary Burden?

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The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the...more

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