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FDA Grants Breakthrough Device Designations for MRD Test

The FDA has granted two Breakthrough Device Designations (BDD) for a molecular residual disease (MRD) test. 

The designations will help the test’s use through phase 3 clinical trials to help diagnose two cancer therapies. 

The test is currently available for clinical and research purposes and has already been granted BDD for multiple cancer types and indications, according to a release from the manufacturer.

It is designed to “detect and quantify how much cancer is left in the body, to detect recurrence earlier, and to help optimize treatment decisions” and is validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. 

The FDA has not approved the test, but the release noted that the BDD “helps accelerate the approval” for devices that can improve the treatment or diagnosis of serious diseases.

“We are committed to working with the FDA and with our biopharma partners to validate the use of the Signatera MRD test across a broad range of solid tumor indications. These two new Breakthrough Device Designations will help us accelerate our mission to bring life-saving diagnosis and treatment to cancer patients as early as possible,” said Fayyaz Memon, Vice President of Regulatory Affairs at Natera, in the release.


By Adam Hochron
 

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