FDA Clears Genetic Cancer Risk Detection Test

(DennisM2, Flickr. https://flic.kr/p/SjHYyM)

2 Oct. 2023. The Food and Drug Administration authorized marketing of a genetic test for detecting hundreds of gene variants associated with a higher risk of developing certain cancers. The agency announced its authorization on Friday of the Common Hereditary Cancers Panel, a test provided by Invitae Corp. in San Francisco.

The Common Hereditary Cancers Panel assesses blood or other sample specimens for variations in 47 genes in the human genome. The specimen sample is taken by a clinician, then sent to a lab for high-throughput sequencing to identify inherited alterations in those genes associated with higher risk of certain cancers. Results of the test are intended to be interpreted by professionals for discussion with patients, bringing in factors such as family and personal history. It is not designed for direct-to-consumer reporting, nor does the test detect predisposition to all known cancer risks.

Among the variants detected by the Common Hereditary Cancers Panel are BRCA1 and BRCA2, associated with breast and ovarian cancer. Also reported are several genes associated with risk of Lynch syndrome, an inherited form of colorectal cancer and other solid tumor cancers. Invitae says, in addition, the genetic alterations revealed by the test indicate risk of developing certain forms of uterine, prostate, stomach, and pancreatic cancer.

99 percent or higher accuracy

The company says physicians can also use the Common Hereditary Cancers Panel determine if patients already diagnosed with cancer harbor any of the 47 inherited gene variants. FDA notes, however, that this and other tests of its kind run risks of false positive or negative results, leading to inappropriate medical decision-making or a false sense of assurance. Nonetheless, says FDA, Invitae tested the panel with more than 9,000 clinical samples, achieving 99 percent or higher accuracy on all of the variant types assessed.

“Today’s action can provide an important public health tool,” says Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health in an agency statement, “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 adds, “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.”

FDA says the Common Hereditary Cancers Panel is the first test of its kind to receive marketing clearance. FDA also issued special controls for labeling and performance testing of the test. The agency says it authorized the test under the agency’s De Novo marketing pathway, a mechanism for completely new types of medical devices rated low or moderate risk. As a new form of medical device, the Common Hereditary Cancers Panel can serve as a so-called predicate device that future genetic tests of its type can compare for pre-market authorization from FDA.

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