Research & Development

DNA test for predisposition to certain cancers granted marketing authorisation by FDA

The US Food and Drug Administration (FDA) has granted de novo marketing authorisation to the Invitae Common Hereditary Cancers Panel, which is an in vitro diagnostic test to detect hundreds of genetic variations associated with risk of developing certain cancers.
The test not only detects genetic variants that suggest cancers, but can also identify potentially cancer-associated hereditary variants in patients with already diagnosed cancers. DNA extracted from blood samples is tested to identify variants in 47 genes that are known to be associated with an elevated risk of developing some cancers.
The Invitae Common Hereditary Cancers Panel can be used to identify inherited causes of various cancer types, but it is recommended that patients speak to a healthcare professional to discuss any personal or family history of cancer prior to use as this information can be used in understanding results.
Jeff Shuren MD JD, director of the FDA’s Center for Devices and Radiological Health, commented: “This test can assess multiple genes in a single test by using next-generation sequencing, which has proven helpful in providing insight into genetic variants with sensitivity and speed. Today’s action can provide an important public health tool that offers individuals more information about their health, including possible predisposition for certain cancers, which can help guide physicians to provide appropriate monitoring and potential therapy, based on discovered variants.”
The test has already demonstrated a ≥99.0% accuracy for all tested variant types, with the main risks associated with the test being the possibility of false positives and false negatives.