Boston's Veritas Genetics received a CE mark to conduct BRCA gene testing for the likelihood of inheriting breast and ovarian cancer.
Its myBRCA test sequences the BRCA1 and BRCA2 genes to detect deleterious variants with next-generation sequencing technology. Veritas launched myBRCA in North America in May. It offers the test for $199 in the U.S.
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| Veritas CEO Mirza Cifric |
"Working closely with European oncology researchers, we validated myBRCA across ethnicities, making this a very comprehensive test especially for European population," said Veritas CEO Mirza Cifric in a statement. "With the CE mark approval, we can now offer myBRCA across Europe, starting with a select group of 15 countries.
The company says the saliva-based test has an accuracy greater than 99.99%, and bases its results on a database of more than half a million patients and 8,000 known mutations.
Having a deleterious mutation increases a subject's lifetime risk of developing breast cancer by as much as 80% and ovarian cancer by as much as 40%, the company says.
The market for BRCA testing opened up following a Supreme Court ruling in June 2013 that found Myriad Genetics' ($MYGN) patent on testing the BRCA genes to be invalid. Veritas is just one of a plethora of companies that have joined the market, most notably including Invitae ($NVTA) and Quest Diagnostics ($DGX).
The newcomers have undercut the incumbent's prices. Myriad justifies its higher prices in part based on a proprietary dataset, derived from its years of testing, that enables the company to classify variants of the BRCA gene as either deleterious or benign based on the cancer history of previous customers and their families.
Competitors are banding together by using public and shared data to catch up with Myriad.
The goal of Big Data in this context is to drive down the rate of "variants of unknown significance," or sequences of the BRCA gene whose correlation with cancer is unknown. In a May study, Veritas determined the myBCRA test's all-important VUS rate to be 2.3%.
- read the release