1. Medtech Insight
  2. >>Device Area
  3. >>Diagnostics

US FDA's Next-Gen Sequencing Guidances: One Stop On A Pathway

Two recent next-generation sequencing draft guidances have been positively received so far by industry and clinical research groups. But for FDA's ideas to play out, more databases will need to be populated and more standards developed, agency officials say. There are also more guidances to come on different types of NGS tests. Read our coverage below, and also listen to our podcast interview with FDA's Elizabeth Mansfield.

DNA

US FDA hopes its two recent draft-guidance documents for companies developing next-generation sequencing diagnostics will spur development of new NGS databases and standards – the very tools that the guidance documents rely on to outline a new regulatory paradigm for these assay types.

The agency issued a draft guideline earlier this month addressing how to employ standards to support regulatory approval...

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 Diagnostics

Philips Deals Itself A Strong Hand In POCUS Stakes

 
• By Ashley Yeo

Point of care ultrasound technology that can be used by non-sonographers will plug gaps in workforce coverage and bring new critical care capabilities to the frontline of care, said Royal Philips.

Liquid Biopsy Startup Mursla Bio Launches AI Precision Medicine Platform

 
• By Natasha Barrow

The new AI Precision Medicine platform supports the company’s flagship product, EvoLiver, which received US FDA breakthrough device designation in April.

Harbinger Health Showcases Two-Tiered MCED Test With Strong Specificity And Per-Cancer Accuracy

 
• By Shubham Singh

With a test platform designed to mirror the biological diversity of cancer, Harbinger Health is moving beyond traditional performance measures to introduce cancer-specific sensitivity and “intrinsic accuracy” as cornerstones of its clinical narrative.

Veterinary Heart Health Goes High-Tech: Eko And Boehringer Use AI To Spot Heart Murmurs In Dogs

 
• By Marion Webb

Eko hopes its new partnership with Boehringer Ingelheim to develop algorithms for accurately detecting heart murmurs in dogs will pave the way for more collaborations with medical and pharmaceutical companies to advance early detection in humans as well as animals.

More from Device Area

Harbinger Health Showcases Two-Tiered MCED Test With Strong Specificity And Per-Cancer Accuracy

 
• By Shubham Singh

With a test platform designed to mirror the biological diversity of cancer, Harbinger Health is moving beyond traditional performance measures to introduce cancer-specific sensitivity and “intrinsic accuracy” as cornerstones of its clinical narrative.

Veterinary Heart Health Goes High-Tech: Eko And Boehringer Use AI To Spot Heart Murmurs In Dogs

 
• By Marion Webb

Eko hopes its new partnership with Boehringer Ingelheim to develop algorithms for accurately detecting heart murmurs in dogs will pave the way for more collaborations with medical and pharmaceutical companies to advance early detection in humans as well as animals.

Prix Galien Spotlights Mental Health ‘Renaissance’ But Systemic Hurdles Persist

 
• By Natasha Barrow

Experts at the Prix Galien UK Forum discussed the future of mental health innovation, emphasizing the important roles of digital solutions, diagnostic biomarkers and community involvement.