1. Medtech Insight
  2. >>Device Area
  3. >>Diagnostics
  4. >>In Vitro Diagnostics

23andMe Opens Up FDA Pathway For DTC Genetic Predisposition Tests

23andMe has made it full circle with at least 10 direct-to-consumer genetic predisposition tests gaining FDA go-ahead for testing services to provide information on an individual's risk for developing Alzheimer's, Parkinson's, and celiac disease, among others. The de novo classification comes three-and-half years after the firm's DTC genetic testing service was forced off the market by FDA, and two years after it was able to relaunch carrier-screening test services.

FDA cleared the way for 23andMe Inc.to launch the first FDA-validated direct-to-consumer intended to alert people of genetic predispositions to certain conditions with a de novo classification that allows marketing of DTC tests for 10 conditions, including Alzheimer's and Parkinson's, and establishes a pathway for the Mountain View, Calif., firm to launch new risk-predisposition tests without needing FDA review.

With the April 6 decision, 23andMe is preparing to launch its Personal Genome Service Genetic Health Risk tests for the...

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
Start Free Trial

Already a subscriber?

More from In Vitro Diagnostics

FDA Ends Effort To Regulate LDTs By Rescinding Final Rule

 
• By Brian Bossetta

Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.

Exact Sciences Reveals Thinking On CRC Liquid Biopsy After Freenome Deal

 
• By Natasha Barrow

Exact Sciences has entered into an exclusive licensing agreement with Freenome, stipulating clinical benchmarks and a first-line rating in the USPSTF guidelines. Medtech Insight interviewed screening CMO Paul Limburg about CRC screening and Exact’s strategy on liquid biopsy.

SpotitEarly Sets Up US HQ, Launches Trials For Dog- And AI-Powered Early Cancer Detection Test

 
• By Marion Webb

Among early cancer screening tests, SpotitEarly stands out by combining dogs’ superior sense of smell with machine learning. SpotitEarly plans two US clinical trials for breast and lung cancer aiming to seek FDA clearance, but needs more funding to support clinical development and commercialization.

Abbott Lowers Outlook But Headwinds Are Temporary

 
• By Natasha Barrow

Despite headwinds, executives remain optimistic about growth in Abbott’s medical devices and diabetes divisions and plan several product rollouts, including the Volt PFA catheter for electrophysiology and the dual glucose-ketone sensor CGM.

More from Diagnostics

SpotitEarly Sets Up US HQ, Launches Trials For Dog- And AI-Powered Early Cancer Detection Test

 
• By Marion Webb

Among early cancer screening tests, SpotitEarly stands out by combining dogs’ superior sense of smell with machine learning. SpotitEarly plans two US clinical trials for breast and lung cancer aiming to seek FDA clearance, but needs more funding to support clinical development and commercialization.

Ultromics Wins $55M, The Key To Success: Diagnosing Diseases With Available Treatment

 
• By Natasha Barrow

Ultromics has secured $55m in Series C funding to advance its AI tool, EchoGo, which detects undiagnosed heart failure. The company's focus on diseases with available treatments resonated with investors.

Siemens Healthineers Mitigates Headwinds With ‘Value-Add Structural Changes’

 
• By Natasha Barrow

Siemens Healthineers anticipates €400m-€500m tariff impact by 2026 but says it will mitigate losses through structural changes and pricing. Despite a revenue decline in diagnostics due to China’s VBP, diagnostics transformation activities, including cutting product, were “successful."