Natera Earns CE Mark for Molecular Residual Disease Test

Natera has earned a CE mark certification for its Signatera test, a circulating tumor DNA (ctDNA) assay used for disease assessment and treatment monitoring in cancer patients.

The customized blood test looks for the unique signatures of mutations found in patients’  tumors, allowing it to accurately detect residual disease in their blood samples.

The test received a Breakthrough Device designation from the FDA in 2019, but it has not yet been cleared by the agency.