In a reversal of fortune for 23andMe, the US Food and Drug Administration (FDA) has granted the company the first-ever authorization for direct-to-consumer genetic testing for cancer risk without a prescription.
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.
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"The test should not be used as a substitute for seeing your doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk", said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, in an FDA press release.
Erica Ramos, the organization's president, said, "Anyone who has a strong personal or family history of breast or ovarian cancer and is interested in finding out more about their individualized risk should consult with a genetic counselor to discuss their genetic testing options, or to discuss their results".
These three mutations, however, are not the most common BRCA1/BRCA2 mutations in the general population.
Of course, the test shouldn't be taken as the be all, end all of cancer risk - nor is it meant as a replacement for a proper screening.
These variants are most prevalent in those of Ashkenazi Jewish descent and have been observed at much lower rates in other ethnicities.
However, this does not find all genes that cause cancer, the FDA cautioned.
The three variants of the gene are found most often in people of Ashkenazi Jewish descent, with one in 40 people of that background carrying one. 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.
Critics say this groundbreaking test likely will spark huge debate, saying anything regarding a serious disease needs to be left up to medical professionals.