Invitae test for hereditary cancers gains FDA de novo nod

Dive Brief:

Genetic testing company Invitae has received de novo authorization from the Food and Drug Administration for an in vitro diagnostic test that can help detect hundreds of genetic variants linked with a greater risk of developing certain types of cancer, the agency said.
The test has the potential to be an important public health tool by informing people about possible genetic predispositions for certain cancers, Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement Friday.
The genetic test, the first of its kind to gain FDA marketing authorization, analyzes DNA from a blood sample to identify variants in 47 genes known to be associated with hereditary breast, ovarian, uterine, colorectal, gastric, prostate, melanoma and pancreatic cancers.

Dive Insight:

As many as 10% of patients diagnosed with cancer have a germline variant in a gene that increases susceptibility to cancer, according to research from the Dana Farber Cancer Institute and Memorial Sloan-Kettering Cancer Center. Genetic testing can enable patients diagnosed with cancer to get more targeted treatment and identify relatives who may benefit from personalized cancer screening.

The Invitae Common Hereditary Cancers Panel “can help guide physicians to provide appropriate monitoring and potential therapy,” Shuren said. “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.”

The Invitae test achieved greater than or equal to 99% accuracy across all variant types in more than 9,000 clinical samples, the FDA said.

Genes it can identify include BRCA1 and BRCA2, which are associated with hereditary breast and ovarian cancer syndrome; MLH1, MSH2, MSH6, PMS2 and EPCAM, associated with Lynch syndrome; CDH1, associated with hereditary diffuse gastric cancer and lobular breast cancer; and STK11, associated with Peutz-Jeghers syndrome.

Increasing access to cancer screenings is a priority of the Biden administration's Cancer Moonshot initiative, which has identified testing for hereditary cancer syndromes as an underused prevention strategy.

Invitae is on a mission to expand adoption of genetic testing into widespread clinical practice. But the San Francisco-based company has struggled to reach profitability. It has taken steps to reduce its cash burn rate, including a restructuring last year under new CEO Ken Knight that eliminated more than 1,000 jobs.

In August, the company said that while its hereditary cancer testing volumes increased in the second quarter, and it is pushing to improve insurance payment rates, overdue payments from several commercial insurers resulted in a revenue shortfall, prompting the company to lower its full-year forecast.

Investors have soured on the stock, which once traded above $55 a share. In September, the company received a notice from the New York Stock Exchange that its shares, which currently trade below $1, are in danger of being delisted.