FDA OKs Direct-to-Consumer Cancer Mutation Test

Officials with the FDA authorized the Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/2 (selected variants), which evaluates an individual’s risk of developing multiple cancer types, according to a press release.

The newly-approved test is the first direct-to-consumer (DTC) product to examine 3 specific BRCA1/2 mutations that are common among patients of Ashkenazi Jewish descent; however, the mutations are not the most common variants among the general population, according to the FDA.

The GHR Report examines DNA from a self-collected saliva sample to determine a woman’s risk for breast and ovarian cancers. Notably, the test also examines whether a man is at risk of developing breast and prostate cancers.

The FDA cautions that the test only detects 3 out of more than 1000 BRCA mutations, meaning that a negative result may not necessarily indicate whether or not a patient carries another variant that increases the risk of cancer.

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