Invitae has collected a de novo clearance from the FDA for a blood test designed to detect hundreds of potential genetic markers to help evaluate whether a person carries an increased risk of developing a range of certain cancers.
While the act of parsing DNA for an inherited, cancer-linked mutation is nothing new for the diagnostic industry, the scale offered by Invitae’s test has defined a new product category going forward, the agency said in its announcement.
“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., 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,” Shuren added.
The company’s Common Hereditary Cancers Panel searches for variants in 47 genes—including BRCA1 and BRCA2, which have been associated with hereditary breast and ovarian cancer, as well as genes connected with Lynch syndrome, which can trigger many types of tumors, including colorectal cancer. Other conditions include particular cancers of the digestive system, such as diffuse gastric cancer and tumors associated with Peutz-Jeghers Syndrome.
The FDA noted that the prescription-only test does not evaluate all known genes that are connected to a predisposition to cancer and advised patients to discuss their results with a genetic counselor or other healthcare professional.
The agency said that Invitae tested more than 9,000 clinical samples and found greater than 99% accuracy in validating the panel’s performance. The test can also help identify potentially hereditary variants in patients who have already been diagnosed with cancer.