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Medical Devices / Submissions and Approvals

Natera Earns Breakthrough Device Designation for Tumor DNA Test

May 9, 2019

The FDA granted Natera breakthrough device designation for its Signatera product, a post-surgical test used for detecting and quantifying circulating tumor DNA (ctDNA) in a patient’s blood.

The test is tailored individually to patients previously diagnosed with certain cancers based on the unique mutations found in their tumors. It is meant to be used in combination with certain drugs.

Clinical studies showed that the test can identify residual disease in non-small cell lung, bladder, breast and colorectal cancer patients up to two years earlier than standard imaging.

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