Summary
Comments made by regulatory agencies during a recent American Association for Clinical Chemistry (AACC) online conference indicate continued monitoring and compliance of companies offering direct-to-consumer (DTC) genetic testing. According to CMS, there are over 117 "entities" involved in DTC genetic testing. In addition to CMS and the FDA, several other government agencies such as the Federal Trade Commission (FTC) are involved in regulatory oversight.
Analysis
Comments made by regulatory agencies during a recent American Association for Clinical Chemistry (AACC) online conference indicate continued monitoring and compliance of companies offering direct-to-consumer (DTC) genetic testing. According to CMS, there are over 117 "entities" involved in DTC genetic testing. In addition to CMS and the FDA, several other government agencies such as the Federal Trade Commission (FTC) are involved in regulatory oversight.
The State of New York's decision to regulate direct to consumer (DTC) companies that provide genetic testing services is yet another example of increased in regulatory genetic test oversight. State of New York regulations of companies offering DTC genetic testing adds to a growing list of public and private agencies calling for regulation of genetic testing, Laboratory Developed Tests (LDTs), and In Vitro Diagnostic Multivariant Assays (IVDMIAs). There is also growing concern regarding LDTs from public and private groups. These include Genentech(NYSE:DNA) (NYSE:DNA), HHS's Secretary’s Advisory Committee on Genetic Testing (SACGT), the Genetics and Public Policy Center, Advanced Medical Technology Association (AdvaMed) and others.
New regulations could impact the market potential for DTC genetic testing firms such as 23andMe, deCode Genetics, Navigenics and many others.
For more information on the evolving regulation of the high growth, molecular diagnostics/genetic testing markets and companies, please contact your GLG representative and schedule an individual consult.
