US-based Veritas Genetics has obtained CE mark approval for its hereditary breast and ovarian cancer genetic screening test, myBRCA.
Using proprietary gene-targeting technology, myBRCA sequences BRCA1 and BRCA2 genes. It was introduced in North America in May this year.
Veritas Genetics CEO Mirza Cifric said: "Working closely with European oncology researchers, we validated myBRCA across ethnicities, making this a very comprehensive test especially for European population.
"With the CE mark approval, we can now offer myBRCA across Europe, starting with a select group of 15 countries."
Performed in a clinical lab, the saliva-based test is said to identify mutations in BRCA1 and BRCA2. It uses a database representing over half a million patients and 8,000 known mutations.
According to the firm, breast and ovarian cancer risk is high in individuals with a known family history of these cancers and around 50% of women with BRCA1 and BRCA2 mutations have no substantial family history of breast and ovarian cancer.
Veritas Genetics founder and chief scientific officer Preston Estep III said: "We are dedicated to making genetic information accessible globally so everyone can make informed decisions about disease prevention and early detection."