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OCTOBER 4, 2023

FDA Approves DNA Test to Assess Predisposition for Dozens of Cancer Types

The FDA granted De Novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test that can detect hundreds of genetic variants associated with an elevated risk for developing certain cancers. The test can also identify potentially cancer-associated hereditary variants in individuals with already-diagnosed cancer. The test, which is the first of its kind to be granted FDA marketing authorization, evaluates DNA extracted from a blood sample to identify