Medicine

23andMe gets FDA green light for cancer risk test

23andMe gets FDA green light for cancer risk test

This test analyzes a sample of saliva and screens for three mutations of the BRCA1 and BRCA2 genes.

It's called 23andMe, and tests for three of the more than 1,000 genetic mutations linked to breast cancer.

Federal regulators have approved the first direct-to-consumer genetic test for breast, ovarian and prostate cancer risks.

The test should also not be used by consumers or health care providers to decide on any treatments, including anti-hormone therapies and preventive removal of breasts or ovaries.

Erica Ramos, the organization's president, said, "Anyone who has a strong personal or family history of breast or ovarian cancer and is interested in finding out more about their individualized risk should consult with a genetic counselor to discuss their genetic testing options, or to discuss their results". The test should not be used as a substitute for regular cancer screenings, he said. However, even prescription-ordered genetic testing is not 100% conclusive that a person will develop cancer or not.

The three hereditary mutations detected by the test occur in about 2% of Ashkenazi Jewish women but are far more rare in the general population (0-0.1%).

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However, this does not find all genes that cause cancer, the FDA cautioned.

The FDA today granted authorization for a direct-to-consumer test for a highly selected group of cancer-associated BRCA mutations.

The FDA reviewed data for the test through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device.

The agency also set a condition known as special controls, clarifying its expectations for assuring test accuracy and reliability.

Robert C. Green, a medical geneticist at Brigham and Women's Hospital, said the FDA's decision was somewhat surprising, but gratifying - and a step forward in democratizing genomic information.

"I don't want to trivialize the potential for serious psychological burden that this risk information might provide; however, it is risk information that we know can lead to life saving interventions", Green said.


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