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Medical Devices › Genetic Testing

ArentFox Schiff

Investigations Newsletter: DOJ Announces Charges Against 138 Defendants for Alleged Health Care Fraud Schemes Resulting in $1.4...

ArentFox Schiff on

DOJ Announces Charges Against 138 Defendants for Alleged Health Care Fraud Schemes Resulting in $1.4 Billion in Losses, with Focus on Telemedicine - On September 17, 2021, the Department of Justice (DOJ) announced criminal...more

Rivkin Radler LLP

HHS, DOJ Release Fraud and Abuse Report

Rivkin Radler LLP on

The U.S. Department of Health and Human Services (HHS) and Department of Justice (DOJ) have released the 2019 annual report for their Health Care Fraud and Abuse Control Program. The government recovered almost $3.6 billion,...more

Fenwick & West Life Sciences Group

Biotech & Life Sciences Trends to Consider Following JPM 2020: M&A, Venture Capital and More

Fenwick & West Life Sciences Group on

The annual gathering of life sciences executives and investors in San Francisco that many now call “JPM Week” recently concluded, marking the J.P. Morgan Healthcare Conference’s 38th year....more

Holland & Knight LLP

Sequence of Events: Genetic Testing Offers Significant Promise, But Coverage and Access Limited

Holland & Knight LLP on

In the world of rare diseases, patient testimonies about the extreme difficulties of receiving an accurate diagnosis for an illness are numerous. For instance, one woman, sick for most of her young life, was not properly...more

Akin Gump Strauss Hauer & Feld LLP

Checking In On FDA’s Enforcement Discretion Policy for Laboratory Developed Tests

Akin Gump Strauss Hauer & Feld LLP on

• In a recent warning letter, the Food and Drug Administration (FDA) advised a laboratory to seek marketing authorization for its genetic tests that qualified as laboratory developed tests (LDTs)—which have largely benefited...more

Hogan Lovells

FDA finalizes guidances for NGS-based tests

Hogan Lovells on

On April 12, 2018, the U.S. Food and Drug Administration (FDA or the Agency) finalized two guidances on the oversight of next generation sequencing (NGS)-based in vitro diagnostic tests. Unlike most IVDs that typically detect...more

Hogan Lovells

FDA Cleared First DTC Genetic Tests for Health Risks

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe’s Personal Genome Service (PGS) Test for 10 diseases or conditions. This was the first FDA authorization for a...more

Mintz - Health Care Viewpoints

Cures Act Developments: FDA Proposes Class II Device Exemptions

Mintz - Health Care Viewpoints on

Since the 21st Century Cures Act became law on December 13, 2016, we have been blogging on regulatory and clinical areas affected by its provisions. On March 14, 2017, FDA made further progress on its Cures Act obligations by...more

McDonnell Boehnen Hulbert & Berghoff LLP

23andMe Receives FDA Approval for Genetic Diagnostic Test

McDonnell Boehnen Hulbert & Berghoff LLP on

Last Thursday the genetic diagnostic and DNA analysis company 23andMe announced that the FDA had granted the company approval to market a genetic diagnostic test for Bloom's Syndrome, the first such approval for this rare...more

Foley & Lardner LLP

Direct-to-Consumer Genetic Test Authorized by FDA

Foley & Lardner LLP on

23andMe is not a traditional diagnostics company. Rather than seeking to directly sell its services to health care professionals, 23andMe went straight to the consumer, offering genetic screening and analysis in a mail-order...more

McDonnell Boehnen Hulbert & Berghoff LLP

Patients Push Back on FDA Threats to 23andMe Genetic Testing Products

McDonnell Boehnen Hulbert & Berghoff LLP on

In a petition published on the "We the People" portion of the White House website, a group of self-titled healthcare consumers call for the Obama Administration to overrule the FDA and permit genetic testing company 23andMe...more

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