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

FDA Finalizes Guidelines To Promote Next-Gen Sequencing Technology

The promise of next-generation sequencing technology to help patients understand risk and target treatment for disease is high. US FDA is hoping to help accelerate practical advancements with the release of two final guidances addressing NGS technology and databases that aggregate genomic information.

DNA & RNA

US FDA has finalized a pair of guidances that the agency hopes will spur development of databases that aggregate genomic data and advance the promising new diagnostics field of next-generation sequencing (NGS). The complementary guidances outline the agency's thinking on what sponsors need to consider when submitting pre-market applications for NGS tests and the databases that could be used to support the submissions.

FDA hopes the guidances could help revolutionize how patients are diagnosed with hereditary diseases or considered to be at higher...

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

More from Diagnostics

First AI Breast Cancer Prediction Platform Receives FDA Authorization

 
• By Natasha Barrow

Clairity’s "first-in-class" mammography-based AI screening tool, Clairity Breast, provides "equitable risk assessments," expanding access to lifesaving early detection for breast cancer, said company founder Connie Lehman.

Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 
• By Brian Bossetta

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

SAGA Diagnostics Launches Early Breast Cancer MRD Detection Test In US

 
• By Natasha Barrow

SAGA Diagnostics has launched its breast cancer residual and recurrence detection test – Pathlight – in the US. The test’s ultrahigh sensitivity and specificity is rare to see in oncology, the company claimed.