Research & Development
23andMe wins first-ever US FDA authorisation for direct-to-consumer genetic test for cancer risk
7 March 2018 -

Healthcare economics and market research firm Kalorama Information stated on Tuesday that personal genetics company 23andMe Inc has passed the first-ever US FDA authorisation for a direct-to-consumer genetic test for cancer risk.

According to Kalorama Information, this US FDA approval enables the company to provide customers information on three genetic variants found on the BRCA1 and BRCA2 genes known to be associated with higher risk for breast, ovarian and prostate cancer, without a prescription. The US FDA has cited need for greater cancer detection as a key reason for the approval.

Kalorama Information added that it has estimated the direct-to-consumer genetic health tests market at USD99m. The DTC genetic health market will grow to USD310m in 2022.

Several trends are continuing to shape the direct to consumer laboratory testing market including the demand for early disease detection and diagnosis, personalised medicine, importance of disease monitoring and expanded technologies, concluded the company.



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