Update, 9:20 a.m.: This story has been updated with 23andMe’s response. A recent study found that 23andMe’s direct-to-consumer BRCA test misses almost 90% of mutation carriers, GenomeWeb ...

The Food and Drug Administration (FDA) authorized the first direct-to-consumer test designed to report on three specific BRCA1/BRCA2 gene mutations. The Personal Genome Service Genetic Health Risk ...

Well, it doesn’t. The FDA did not approve the test. Rather, the FDA classified the 23andMe Personal Genome Service (PGS) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) into Medical ...

There are several players though the market mover of note is 23andMe. The report also looks at both the direct-to-consumer and consumer initiated, physician coordinated test products as well.

Overall, BRCA testing increased 80-fold during those 11 years, with a large spike in testing occurring in 2013.

Francis Collins, the director of the Human Genome Project, agreed in U.S. Senate testimony in 1996 that the BRCA1 test should not be commercially available to women.

In its report, the task force outlined the risks faced by women who have the dangerous mutations. In the general population, 12.8% of women are expected to develop breast cancer and 2.8% will die ...

“The test found I did not have a BRCA mutation which meant my family and I could breathe a small sigh of relief about that aspect of our family risk of developing cancer. I hope more people can access ...