Quest Enters Market For BRCA Gene Testing

With the Oct. 15 launch of the BRCAvantage genetic test, Quest Diagnostics Inc. became the latest entrant into the now-competitive marketplace for BRCA diagnostic testing for the likelihood of inheriting breast or ovarian cancer.

Quest Diagnostics Inc. has joined the competitive field of BRCA diagnostic testing for the risk of inherited breast or ovarian cancer with the BRCAvantage genetic test, launched Oct. 15.

Quest’s said it planned to launch a BRCA diagnostic test soon after the Supreme Court ruled in June that Myriad Genetics Inc. patents on the BRCA1 and BRCA2 genes...

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

Zika Virus Test Among 4 New FDA Device Classifications

 
• By 

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.

Industry Execs Talk Tariff Turbulence During MD&M East

 

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

Bone Surgery Startup Surgify Medical Raises $7.9m

 

Surgify Medical’s selective drill tip, Surgify Halo, is “an obvious choice for surgeons,” said Boris Hofmann, head of ZEISS Ventures and lead investor in the company’s series A funding round.

More from North America

German Bionic Launches ‘Strongest Exoskeleton To Date’

 

German Bionic’s new exoskeleton Exia helps healthcare practitioners, nurses, and other caregivers to lift and move patients by supporting muscle movement and reducing the risk of injury.

FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
• By 

The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.

TRiCares Tricuspid Valve Replacement System Reduces Regurgitation In First-In-Human Study

 

TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.