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FDA Grants Two New Breakthrough Device Designations for Molecular Residual Disease Test


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The U.S. Food and Drug Administration (FDA) granted two breakthrough device designations covering new intended uses of the Signatera molecular residual disease (MRD) test. These new designations will support the development of Signatera through phase III clinical trials as a companion diagnostic to two different cancer therapies.

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and MRD assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use and has been granted a total of three breakthrough device designations by the FDA for multiple cancer types and indications.

The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Signatera is intended to detect and quantify how much cancer is left in the body to detect disease recurrence earlier and to help optimize treatment decisions. Its performance has been clinically validated in multiple cancer types, including colorectal, non–small cell lung, breast, and bladder cancers.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
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