FDA Grants Marketing Authorization for Invitae Hereditary Cancer DNA Sequencing Test

The US Food and Drug Administration said late last Friday that it has granted de novo marketing authorization for Invitae’s Common Hereditary Cancers Panel, a DNA sequencing test that identifies variants in 47 genes associated with an elevated risk of various cancer types.

The authorization, which the agency said is the first for this type of test, provides “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,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

Source: https://www.genomeweb.com/molecular-diagnostics/fda-grants-marketing-authorization-invitae-hereditary-cancer-dna-sequencing