A report just issued by the Government Accountability Office (GAO) that specifically focused on four companies’ marketing of direct-to-consumer <"https://www.yourlawyer.com/practice_areas/defective_medical_devices">gene test kits says such testss may have provided “contradictory and misleading results,†according to the Wall Street Journal.
23andMe Inc., deCODE genetics, Navigenics Inc., and Pathway Genomics Corp. promised to help consumers with their gene testing kits; however, government investigators claim the results were not what was promised, wrote the Journal. The GAO’s report was just released at a Congressional hearing this week.
The Investigators sent DNA samples to the four companies for testing that cost between $299 and $999 and were hyped to offer genetic risk results for medical issues such as breast cancer and Alzheimer’s diseases, explained the Journal. The results were differing and, in some cases, conflicted. One woman’s sample came back with an “above average,” “below average,” and “average” risk of leukemia by the different firms, reported the Journal. In another case, a man implanted with pacemaker for atrial fibrillation was told by 23andMe and deCODE that he actually tested with a below-average risk, according to the Journal.
Sign On San Diego recently reported that a Congressional committee initiated an investigation into the “consumer-direct genetic testing industry†when another firm, Pathway, began its plans to sell its kit at Walgreens. Members of the House Committee on Energy and Commerce requested significant company records from Pathway, Navigenics, and 23andMe, with lawmakers requesting, in part, documents on how samples are collected, how results are analyzed, and the accuracy of the firms’ interpretations. The companies had until June 4th to respond, said Sign On San Diego.
Not surprisingly, all the testing companies questioned defended their results, claiming different firms use different standards, noted the Journal.
In light of the House Energy and Commerce subcommittee hearing, which included two days of meetings held by the U.S. Food and Drug Administration (FDA), the agency is now considering wider regulatory oversight of these tests to be administered by one lab, which is beyond the realm of consumer-marketed test kits, explained the Journal. Most testing occurs in hospitals.
Meanwhile, the GAO report found that the results were “misleading and of little or no practical use to consumers†and found that industry over-touted their tests’ results, said the Journal. “We have uncovered questionable marketing claims, serious quality control and privacy concerns, and questions about the accuracy of information provided to consumers,” said Representative Henry Waxman, the California Democrat who chairs the Energy and Commerce Committee, quoted the Journal.
We previously wrote that the FDA told five genetic test kit makers that they had to receive federal approval prior to marketing specific devices to consumers. The FDA’s letters point to the agency’s move to step up its handling of companies that market products alleging to predict diseases via DNA samples, specifically inheritable diseases.
The letters told each firm their specific products are considered medical devices and, because they are so designated, must receive federal approval for safety and efficacy; none of the firms—23andMe Inc., deCODE Genetics, Illumina, Navigenics, and Knome Inc.—have sought approval, said the FDA.
