23andMe Has Accelerated The Consumer Genomics Debate

23andMe’s battle with FDA is another reminder that genomics is rapidly becoming incorporated not only into the clinic, but also into everyday life. It is forcing FDA and other agencies to take a stand on critical technical, legal, and ethical issues, which will influence the strategies of medical diagnostics and pharmaceutical companies as well as labs performing tests directly for the consumer.

Since mid-January, commentaries have run in Nature, The New England Journal of Medicine (NEJM), and The Journal of the American Medical Association discussing consumer genomics company 23andMe Inc.’s tug of war with the US Food and Drug Administration, which in December resulted in 23andMe halting new consumer access to health-related data from its Personal Genome Service (PGS). (See Also see "FDA Comes Down Hard On 23andMe, Putting Consumer-Directed Genetic Testing On Notice" - Medtech Insight, 16 December, 2013..) The rapid appearance of these articles, along with a timely report from a presidential bioethics advisory committee, has heightened awareness that genomics is rapidly becoming incorporated not only into the clinic, but into everyday life.

The consumer genomics horse is out of the barn. Demand for the technology is forcing FDA and other agencies to...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from United States

Somnee AI-Powered Sleep Wearable Raises $10M Seed Round

 

The $10m seed extension funding round will be used to launch the second-generation wearable headband with the added SmartSleep AI operating system.

‘Small Business’ Applications For Waiver Of Device User Fees To Be Streamlined By US FDA

 

FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.

Ultrahuman Launches Home Health Monitoring

 

Ultrahuman seeks to “create an environment that aligns with our bodies" by linking environmental parameters collected by Ultrahuman Home to health physiology, measured by the Ultrahuman Ring Air.

FDA Outlines Responsibilities For Owners Of Transferred 510(k)s

 
• By 

The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.

More from North America

US House Budget Sets FDA FY26 Funding At $3.2B

 

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

Panel: FDA’s Home Healthcare Initiative Holds Promise, But Challenges Remain

 
• By 

During a recent FDLI panel, experts discussed the FDA's Home Healthcare initiative, highlighting its potential benefits and challenges. Key issues include usability testing, reimbursement, labeling for home use, and the need for innovation while ensuring patient safety.

J&J MedTech Launches KINCISE 2 Surgical Automated System In US

 

The KINCISE 2 Surgical Automated System aims to “reduce the physical burden on surgeons compared to manual impaction in primary and revision hip and revision knee replacement procedures,” said J&J MedTech.