In an announcement straight from the FDA itself, the agency announces de novo marketing authorization for a multi-cancer hereditary risk test from Invitae.
The test assesses 47 genes. Of interest, this past summer, AMA has held public workshops about creating a code for pan-cancer hereditary testing. The FDA clearance, I believe, will allow Invitae to apply for ADLT status. I believe earns automatic coverage under the NGS NCD 90.2, which was expanded a few years ago to include NGS germline tests, particularly those for breast and ovarian cancer.
There is a quote from the head of CDRH, Jeff Shuren:
“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,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “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.”