Veritas Genetics Receives European CE Mark Approval for myBRCA Genetic Test for Hereditary Breast and Ovarian Cancer

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Aug 24, 2015, 02:30 ET

BOSTON, Aug. 24, 2015 /PRNewswire/ -- Boston-based Veritas Genetics, a pioneer in accessible genetic screening for disease prevention and early detection, received its first European CE mark approval for the company's hereditary breast and ovarian cancer genetic screening test, myBRCA. Veritas introduced myBRCA, which sequences BRCA1 and BRCA2 genes using proprietary gene-targeting technology and Next Generation Sequencing, in North America in May 2015.

"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."

myBRCA is a simple, affordable, saliva-based test performed in a clinical lab. The test identifies mutations in BRCA1 and BRCA2, is over 99.99% accurate, and uses a database representing over half a million patients and 8,000 known mutations.¹

Breast and ovarian cancer risk is high in individuals with a known family history of these cancers. However, studies show that some 50% of women with BRCA1 and BRCA2 mutations have no substantial family history of breast and ovarian cancer.² Over 20 years of experience and clinical evidence show that harmful mutations in these genes represent a lifetime risk of up to 80% for breast cancer and up to 40% for ovarian cancer.³

"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."

Veritas was founded by leaders in genomics from Harvard Medical School, Dr. George Church and Dr. Preston Estep, and Massachusetts General Hospital, Joseph Thakuria M.D., and life sciences entrepreneurs Mirza Cifric and Jonathan Zhao. Veritas has operations in the U.S., Asia, and Europe.

¹ Veritas Genetics myBRCA Validation Summary, May 11, 2015.Link
² King M-C, Levy-Lahad E, Lahad A. Population-Based Screening for BRCA1 and BRCA2. JAMA. 2014;312(11):1091-1092.NCBI
³ Petrucelli N, Daly MB, Feldman GL. BRCA1 and BRCA2 Hereditary Breast and Ovarian Cancer. 1998 Sep 4 [Updated 2013 Sep 26]. In: Pagon RA, Adam MP, Ardinger HH, et al., editors. GeneReviews^® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2015.NCBI