Boston-based clinical screening company receives European seal of approval for breast and ovarian cancer test.

Direct-to-consumer genetic testing is a divisive issue. Supporters of the technology often consider it empowering to be able to explore their own genomes, while detractors remain concerned that such tests can create false alarm or even false hope in consumers. Thus far Veritas Genetics, manufacturers of the myBRCA test that launched in May this year, have worked hard to establish their reliability and sound ethical credentials. This includes partnerships with the scientific community, and donating free tests to women who need them for every test purchased. This week it seems that Europe sat up and took notice, by granting Veritas its first European CE mark.

“Working closely with European oncology researchers, we validated myBRCA across ethnicities, making this a very comprehensive test especially for European population,” says Veritas CEO Mirza Cifric. “With the CE mark approval, we can now offer myBRCA across Europe, starting with a select group of 15 countries.”

Like many consumer tests, myBRCA customers send in a saliva sample that is then sequenced in a clinical lab. The test identifies mutations in the BRCA1 and BRCA2 genes that are associated with higher rates of breast and ovarian cancer in women. As part of the process, Veritas will send the test results to your doctor, and will provide additional genetic counselling if needed. Clinical validation has shown that the test is over 99% accurate.

“We believe knowledge is power,” says Preston Estep III, founder and Chief Scientific Officer of Veritas and Director of Gerontology of the Personal Genome Project at Harvard Medical School. “We are dedicated to making genetic information accessible globally so everyone can make informed decisions about disease prevention and early detection.”

A BRCA mutation diagnosis is a frightening reality for many woman, and Veritas clearly take that concern and their responsibility to their consumers seriously.