New multi-gene test for predicting breast cancer probability

The United Press International posted a news article today stating that a U.S. biotech firm has launched "the first genetic-based, breast-cancer-risk test to the global market.

According to the news release,

The test, to be sold as OncoVue, uses a patient's personal history and gene-based information to determine future breast-cancer risk.

"OncoVue has undergone over seven years of research, and the genetic information for this test came from the testing of over 8,000 women with and without breast cancer from five geographic regions of the United States, giving us the support to introduce the test to an international market." said Craig Shimasaki, InterGenetics' chief executive officer and president.

InterGenetics said U.K. genetic clinic chain Opaldia will release OncoVue in the United Kingdom and Ireland under an exclusive agreement.

The test, which could be a rival for Myriad Genetics test for BRCA1 and BRCA2 genes, involves a medical history questionnaire, followed by use of a mouthwash, which collects cheek cells form the patient for DNA analysis. The OncoVue test analyzes combinations of genes, rather than any single gene alone.

The cancer risk supposedly detected by the test is for "sporadic breast cancer" which, according to the news release, accounts for 90 percent to 95 percent of all breast cancer cases. Myriad's test, on the other hand, examines the genes believed to be responsible for about 5% of all breast cancers.

Let's be cautious until we learn more about the test. Remember that genetic tests do not need FDA approval so this possible layer of quality control is not in place. I, for one, will need to learn more about the basis for the test and its success rate.

Marie Godfrey, PhD

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