1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Regulation

Myriad Enters Companion Diagnostics Field With An FDA First

Myriad Genetics' BRCA1/2 gene testing service has been approved as a companion diagnostic to AstraZeneca's new ovarian cancer drug, an important step in the company's diversification plan and a significant milestone in FDA's oversight of laboratory-developed tests.

Myriad Genetics Inc.'s strategy to remake the growth prospects for its BRACAnalysis gene testing service took a step in the right direction with the Dec. 19 FDA approval of its BRACAnalysis CDx assay as a companion diagnostic to AstraZeneca PLC’s ovarian cancer drug Lynparza (olaparib). The approval is also an important milestone in FDA's oversight of laboratory developed tests.

It is Myriad's first companion diagnostic approval for the BRCA1/2 genetic assay, resulting from an ongoing collaboration with AstraZeneca.

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 Regulation

UK MHRA Joins New Global Network For Safe Use Of AI In Healthcare

 
• By Natasha Barrow

The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.

MHRA Opens Second AI Airlock Program For Applications

 
• By Natasha Barrow

"The AI Airlock program creates a supervised testing ground where novel technologies and challenge areas can be safely investigated," said James Pound, MHRA interim executive director of innovation and compliance.

MHRA’s Tallon Hails PMS Regulation As Start Of UK Device Framework Transformation

 
• By Ashley Yeo

16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
• By Elizabeth Orr

With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.

More from Policy & Regulation

Home-Testing Added To UK National Cervical Cancer Screening Program

 
• By Natasha Barrow

NHS England will offer at-home cervical cancer self-testing kits to people who are overdue for routine screening by six months. The Department of Health and Social Care identified four HPV collection and testing combinations with highest accuracy.

FDA’s AI Tool Won’t Make Regulatory Decisions, Official Says

 
• By Cathy Kelly

Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.

MHRA Opens Second AI Airlock Program For Applications

 
• By Natasha Barrow

"The AI Airlock program creates a supervised testing ground where novel technologies and challenge areas can be safely investigated," said James Pound, MHRA interim executive director of innovation and compliance.