FDA OKs home breast cancer DNA test, with warning


But the U.S. Food and Drug Administration said Tuesday it will require warnings about the limitations of the genetic information from California-based 23andMe.

The authorisation allows 23andMe to provide customers with information on three genetic variants known to be associated with a risk for breast, ovarian, and prostate cancer.

This approval is expected to raise concerns over whether or not people should ask for professional medical help, as this information may not be appropriately handled by everyone, cancer experts said.

However, this does not find all genes that cause cancer, the FDA cautioned. "This means a negative result does not rule out the possibility that an individual carries other BRCA mutations that increase cancer risk". And FDA warned that the tests, which work by analyzing saliva samples, carry significant risks for individuals if they are used without consulting a doctor or genetic counselor. It can not determine a person's overall risk of developing cancer.

Around one in 400 people have BRCA mutations that can cause cancer, and is more common among those with eastern European or Jewish descent.

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"These three mutations, however, are not the most common BRCA1/BRCA2 mutations in the general population", the FDA said in a statement.

The test should also not be used by consumers or health care providers to decide on any treatments, including anti-hormone therapies and preventive removal of breasts or ovaries.

These variants are most prevalent in those of Ashkenazi Jewish descent, and have been observed at much lower rates in other ethnicities.

The FDA today granted authorization for a direct-to-consumer test for a highly selected group of cancer-associated BRCA mutations. "Together, BRCA1 and BRCA2 mutations account for about 20 to 25 percent of hereditary breast cancers and about 5 to 10 percent of all breast cancers", the National Cancer Institute says. Along with this authorization, the FDA is establishing criteria, called special controls, which set forth the agency's expectations in assuring the test's accuracy, reproducibility, clinical performance and labeling.