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FDA approves another home genetic testing service

23andMe’s kit will check for an increased risk of certain cancers developing


The US Food and Drug Administration (FDA) has authorised another one of 23andMe’s home genetic kits, and this one tests if certain women are at an increased risk of developing breast and ovarian cancer.

Known as a genetic health risk (GHR) report, the kit analyses DNA collected from a saliva sample, and through this the company can detect if a woman carries any BRCA1 or BRCA 2 mutations.

However, the test only identifies three out of more than 1,000 known BRCA mutations, and while these specific mutations are the most common in those of an Eastern European Jewish descent, they aren’t the most common mutations in the general population.

Additionally, the test can also analyse if a man is at an increased risk of developing breast or prostate cancer.

Donald St Pierre, acting director of the office of In Vitro Diagnostics and Radiological Health in the FDA’s Center of Device and Radiological Health, said: “This test provides information to certain individuals who may be at increased breast, ovarian or prostate cancer risk and who might not otherwise get genetic screening, and is a step forward in the availability of DTC genetic tests.”

Although the test does emphasise that a negative result does not rule out the possibility that the individual can carry other BRCA mutations and that it should not be used as a substitute for attending cancer screenings.

The FDA also said that most cases of cancer are not caused by hereditary gene mutations but are thought to be triggered by a wide variety of factors, including smoking, obesity, hormone use and other lifestyle choices.

St Pierre added: “While the detection of a BRCA mutation on this test does indicate an increased risk, only a small percentage of Americans carry one of these three mutations and most BRCA mutations that increase an individual’s risk are not detected by this test.”

The approval is welcomed news for the online genetics firm, particularly because of the FDA’s initial rejection of the service back in 2013, with the US regulator claiming that the kits could potentially confuse consumers.

However, the FDA changed its mind last year, allowing the production of 23andMe’s first genetic kit, which tests for gene sequences linked to diseases or conditions such as Alzheimer’s and Parkinson’s.

Article by
Gemma Jones

16th March 2018

From: Regulatory



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