First Blood-Based Lung Cancer EGFR Test Gets Green Light

FDA has approved the first liquid biopsy test to detect genetic mutations linked to drug response in patients with non-small cell lung cancer. Roche's cobas EGFR Mutation Test v2 could be a game-changer in helping to diagnose certain NSCLC patients without requiring a tumor biopsy, the agency suggests.

FDA has approved Roche Diagnostics Corp.'s cobas EGFR Mutation Test v2 as a companion diagnostic to Tarceva (erlotinib), a Roche/Astellas Pharma Inc. drug to treat non-small cell lung cancer (NSCLC). The test is the first blood-based genetic test approved by FDA to detect epidermal growth factor receptors genetic mutations that are associated with treatment response to Tarceva.

Roche first gained approval for a companion diagnostic to Tarceva in 2013, but that was for evaluating tumor biopsy rather than blood samples. (See Also see "New Products In...

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 Clinical Trials

Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
• By 

Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.

Cardiosense Advances Noninvasive Heart Monitoring With Final Validation Study

 
• By 

Cardiosense has launched a nationwide clinical study, SEISMIC-HF II, to validate its non-invasive, AI-powered technology for monitoring heart failure. The data will be used to file for US regulatory clearance of the Cardiosense heart failure monitoring platform.

Roche Diagnostics Day 2025: ‘We Need To Become A Leader In Decentralized Testing’

 

Roche aims to grow its diagnostics sales by mid to high single digits, said CEO of Roche Diagnostics Matt Sause. The company unveiled the Axelios synthesis and sequencing solution and discussed its “long-term commitment” to China, as well as its business strategy for the next five years.

Salvia Bioelectronics Secures $60M In Series B To Advance Chronic Migraine Implant, Eyes US Trials

 
• By 

Medtech Insight spoke with Hubert Martens, CEO of Netherlands-based neuromodulation company Salvia Bioelectronics, about the company’s innovative implant for treating chronic migraines, ongoing clinical trials and plans for US clinical trials and commercialization.

More from R&D

ConcertAI Launches Generative AI-Powered Precision Suite

 

Valued at over $1.9bn, ConcertAI is building on its pre-existing multi-agentic AI SaaS solution CARAai to bring life science customers the new Precision suite of applications: Precision Explorer, Precision Trials, Precision GTM and Precision360.

Handheld Diagnostics: A Resurging Category That is Here to Stay

 

Handheld diagnostics are more powerful, accessible and clinically relevant than ever. Medtech Insight spoke to companies behind such technologies to learn how they work and discuss their commercial models.

Roche Diagnostics Day 2025: ‘We Need To Become A Leader In Decentralized Testing’

 

Roche aims to grow its diagnostics sales by mid to high single digits, said CEO of Roche Diagnostics Matt Sause. The company unveiled the Axelios synthesis and sequencing solution and discussed its “long-term commitment” to China, as well as its business strategy for the next five years.