Research & Development
FDA Approval of BRCA Test Boosts Direct-to-Consumer Genetic Testing Market
9 March 2018 - - Rockville, Maryland-based healthcare economics and market research firm Kalorama Information finds the FDA authorization of Mountain View, CA-based personal genetics company 23andMe, Inc.'s direct-to-consumer genetic test for cancer risk to be a sign of growth of the market for, and popularity of, genetic tests, the company said.
Kalorama Information estimated the market for direct-to-consumer genetic health tests at USD99 m. The firm's latest report, Direct to Consumer Genetic Health Testing, used interviews, annual report findings and economic data to make its analysis, and factored likely future approvals in its analysis.
The authorization allows 23andMe to provide customers, without a prescription, 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.
The FDA cited a need for greater cancer detection as a key reason for approval. The agency also stated its concern that tests are not the be-all and end-all of detecting cancer risk.
Several trends are continuing to shape the direct to consumer laboratory testing market including the growing demand for early disease detection and diagnosis, personalized medicine, importance of disease monitoring, and expanded technologies.
Kalorama Information, a division of, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services.


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