FDA grants marketing authorization for Invitae DNA test

FDA grants marketing authorization for Invitae DNA test

Time Stamp: October 2, 2023 9:46 AM
Source Node: 2305380

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The FDA cautioned that the prescription test is “not intended to identify or evaluate all known genes that can provide insight into predisposition for cancer,” and that the test can report false positive and false negative test results. Image Credit: StockSmartStart / Shutterstock.

The US Food and Drug Administration (FDA) has granted de novo marketing authorization for the InVitae Common Hereditary Cancers Panel to identify genetic predisposition for multiple cancers.

The cancer panel is an in vitro diagnostic test that analyses 47 genes associated with cancers of the breast, ovary, uterus, prostate, and gastrointestinal system. It can also help individuals with already-diagnosed cancer by identifying potentially cancer-associated hereditary variants.

At-home genetic testing is becoming more common, with the US FDA clearing these tests for varied purposes. Last month, FDA cleared 23andMe to report 41 additional genetic variants of BRCA1 and BRCA2 genes. The agency also granted the company the first-ever Predetermined Change Control Plan (PCCP), which outlines the protocols and acceptance criteria to validate BRCA1 and BRCA2 variants.

Genetic testing is a growing area of research. There are over 500 products in development for genetic testing, according to GlobalData.

“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, director of the FDA’s Centre for Devices and Radiological Health.

“Today’s [29 September] 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.”

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The FDA cautioned that the prescription test is “not intended to identify or evaluate all known genes that can provide insight into predisposition for cancer,” and that the test can report false positive and false negative test results.

Unlike at-home testing kits, the specimen for Invitae’s test is collected at a point of care centre, such as a doctor’s office. Following testing, the results are interpreted using criteria consistent with those established by appropriate professional organisations or accredited boards.

The genes included in testing include hereditary breast and ovarian cancer syndrome (BRCA1 and BRCA2), Lynch syndrome associated genes (MLH1, MSH2, MSH6, PMS2 and EPCAM), CDH1 (mainly associated with hereditary diffuse gastric cancer and lobular breast cancer) and STK11 (associated with Peutz-Jeghers Syndrome).

In addition to the clearance, the FDA also created a new regulatory classification that similar products can use to obtain 510(k) clearance by demonstrating equivalence.

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