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FDA Grants Marketing Authorization for Invitae Hereditary Cancer DNA Sequencing Test

NEW YORK – 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.

The Invitae test, which requires a prescription, analyzes germline mutations in genes associated with breast, ovarian, endometrial, prostate, stomach, colon, rectal, small bowel, and pancreatic cancer using blood, saliva, or buccal swabs. According to the firm's website, it is "designed to maximize diagnostic yield for individuals with a personal or family history of mixed cancers affecting these organ systems" and may help guide treatment and management decisions.

Among the genes the test analyzes are BRCA1 and BRCA2, which are associated with breast and ovarian cancer; MLH1, MSH2, MSH6, PMS2, and EPCAM, which are associated with Lynch syndrome; CDH1, which has been linked to diffuse gastric cancer and lobular breast cancer; and STK11, associated with Peutz-Jeghers syndrome.

In order to validate the assay's performance, Invitae tested more than 9,000 clinical samples and achieved greater than 99 percent accuracy for all tested variant types.

The FDA said that along with the authorization, it established special controls that define the requirements for labeling and performance testing. The accuracy for reporting base substitutions, indels, and copy number variants, for example, must be greater than 99 percent for positive agreement and greater than 99.9 percent for negative agreement with a validated orthogonal method.

The authorization of Invitae's test also creates a new regulatory classification, the FDA said, meaning that future tests of the same type and with the same intended use may use the agency's 510(k) premarket process, where test makers can obtain marketing authorization by demonstrating substantial equivalence to the Invitae test, thus potentially saving time and money.

In morning trading on the New York Stock Exchange, Invitae's shares were up 13 percent to $.68.