HIT Consultant June 9, 2020
Joel Diamond, MD, FAAFP, Chief Medical Officer at 2bPrecise

Direct-to-consumer (DTC) genetic tests have been on the scene for some time now. The Federal Drug Administration (FDA) approved the first DTC test on three specific BRCA1/BRCA2 breast cancer gene mutations more than two years ago. Six months after that, the agency similarly green-lighted a DTC pharmacogenomic (PGx) test to examine 33 variants for eight different genes that indicate how effectively patients metabolize specific medications.

Like many such advances, availability of DTC tests is a double-edged sword. On the one hand, it has been a boon to patient awareness and engagement around genetic susceptibility and the value of injecting greater precision into the care process. On the other hand, it has introduced an “end-around” channel that bypasses the provider who...

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Topics: FDA, Govt Agencies, Patient / Consumer, Pharma / Biotech, Precision Medicine, Provider
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