FDA greenlights 23andMe's direct-to-consumer cancer risk test

The FDA announced it will allow the genetic testing company 23and Me to market directly its breast cancer test that will help assess 3 mutations in a common form of breast cancer gene

Experts say the three genetic mutations found in the 23andMe test are most commonly found in Jewish people. These mutations are not the most common of the BRCA mutations in the general population, the agency said.

It is also estimated that only between 10 to 15 percent of women diagnosed with breast cancer have a mutation in either BRCA1 or BRCA2 gene, according to the American Society of Clinical Oncology. The regulator said it reviewed data for the company's test under a pathway for low-to-moderate risk devices that are not equivalent to an already marketed device. Additionally, the FDA says that this test should not substitute for a doctor visit because it doesn't account for every possible outcome. It is important to note that the test only detects 3 out of the more than 1,000 known breast cancer mutations.

In its statement 23andMe referenced that a genetic test initially done for ancestry might make an individual aware for the first time of their link to a certain ethnic population with an increase risk for certain cancers associated with an inherited mutation.

USA consumers soon will be able to test themselves at home for some genetic mutations that increase the risk of breast, ovarian and prostate cancer - but you might want to think before you spit. When they carry mistakes themselves, the fix isn't made, or it's made improperly. About 45 percent of women with faulty BRCA2 genes will.

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"Some of the uses for which PGS is intended are particularly concerning", the FDA writes, "such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these".

"People are going to have a false sense of security because they tested for something very small but the consumer doesn't know they only tested for a small area".

The newly approved 23andMe test will not find all of these mutations. Those decisions should be based on confirmatory tests and genetic counselling.

And the FDA said no doctor or patient should use the test as a basis for deciding treatment, "including anti-hormone therapies and prophylactic removal of the breasts or ovaries". The agency also outlined special controls created to assure test's accuracy and reliability.

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