7 March 2018 - Deborah Wilkes
The US Food and Drug Administration (FDA) has authorised 23andMe's direct-to-consumer (DTC) genetic test for the risk of breast, ovarian and prostate cancer.
The FDA says the Personal Genome Service Genetic Health Risk Report from genetics testing company 23andMe is a "step forward in the availability of DTC genetic tests".
A lot of caveats
However, the regulatory agency adds that there are a "lot of caveats". "The test only reports three out of more than 1,000 known BRCA mutations," says the FDA, stressing that a "negative result doesn't rule out increased cancer risk".
Anne Wojcicki, 23andMe's chief executive officer and co-founder, said: “Being the first and only direct-to-consumer genetics company to receive FDA authorisation to test for cancer risk without a prescription is a major milestone for 23andMe and for the consumer."
"We believe it is important for consumers to have direct and affordable access to this potentially life-saving information," added Wojcicki. "We will continue pioneering a path for greater access to health information, and promoting a more consumer-driven, preventative approach to healthcare.”
23andMe's test analyses DNA taken from a self-collected saliva sample. The company's report describes if a woman is at increased risk of developing breast and ovarian cancer, and if a man is at increased risk of developing breast cancer or might be at increased risk of developing prostate cancer.
The FDA says the test reports on three specific BRCA1/BRCA2 breast cancer gene mutations that are most common in people of Ashkenazi Jewish descent. However, it adds that these three mutations are not the most common BRCA1/BRCA2 mutations in the general population.
Not a substitute for screenings and counselling
"The test should not be used as a substitute for seeing a doctor for cancer screenings or counselling on genetic and lifestyle factors that can increase or decrease cancer risk," cautions the FDA.
The FDA stresses that consumers and healthcare professionals should not use the test results to determine any treatments, including anti-hormone therapies and prophylactic removal of the breasts or ovaries. "Such decisions require confirmatory testing and genetic counselling," it says.
Furthermore, the agency says the test does not provide information on a person’s overall risk of developing any type of cancer. "The use of the test carries significant risks if individuals use the test results without consulting a physician or genetic counsellor," warns the FDA.
Founded in 2006, 23andMe is a privately-held consumer genetics and research company based in the US. It provides genetic tests that allow people to find out more about their health and ancestry.
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