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Veritas' myBRCA Test Gets CE Mark

NEW YORK (GenomeWeb) – Veritas Genetics today said that its myBRCA screening test for hereditary breast and ovarian cancer has received CE marking in Europe.  

As a result, the Boston-based firm plans to make the test available in a select group of 15 countries, it said, though it did not disclose which 15 countries. The saliva-based test identifies mutations in the BRCA1 and BRCA2 genes with 99.99 percent accuracy, according to Veritas, and results are compared with a database representing more than 500,000 patients and 8,000 known mutations. 

"Working closely with European oncology researchers, we validated myBRCA across ethnicities, making this a very comprehensive test especially for [the] European population," Veritas CEO Mirza Cifric said. 

The company is a new entrant into BRCA testing, having launched myBRCA about two-and-a-half months ago. The cost of the test is $199 and does not need insurance approval, though a doctor requisition is needed. For every paid myBRCA test performed, Veritas will donate another test to a patient.

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