REGULATORS, LAWMAKERS SEEK MORE OVERSIGHT OF GENETIC TEST SALES
Genetic test makers marketing their products for direct-to-consumer sale can expect to find themselves under a regulatory microscope after a government report found some manufacturers are testing the limits of advertising claims.
The Government Accountability Office (GAO) said in a recent report that genetic tests marketed by Suracell, Genelex, Sciona and Market America give consumers "medically unproven" health-related predictions based on unscientific test results.
Sen. Gordon Smith (R-Ore.) commissioned the GAO report in an effort to increase regulatory scrutiny of these genetic tests. In a July 27 Senate Special Committee on Aging hearing, Smith, who chairs the committee, compared the sales tactics of the firms cited in the report to "modern-day snake oil."
On the same day, the FDA's Office of In Vitro Diagnostic Devices Evaluation and Safety issued a joint statement with the FTC and Centers for Disease Control and Prevention advising consumers that genetic tests should only be performed "in a specialized laboratory" and the results interpreted by a healthcare professional.
The laboratories producing and promoting these tests operate in the "regulatory abyss" of the FTC, FDA and Centers for Medicare & Medicaid Services jurisdiction, said Smith.