The FDA may tighten regulations on at-home genetic tests and will ask an outside panel of experts to weigh in on the pros and cons of gene-based tests that consumers can order from their own home.
Though the FDA believes the biggest risks of direct-to-consumer tests are false positive or false negative results, the watchdog agency said the “DTC model has created public health and social quandaries” because the general public can have tests for serious medical issues delivered to their doorstep without consulting a physician.
“While this may enable the consumer to learn more about themselves, it also raises important questions of whether there is sufficient information available to assure that associations are real and meaningful,” the FDA wrote in an executive summary (PDF) ahead of this week’s panel.
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The watchdog agency cited numerous studies that raise questions on how DTC tests might “alter consumers perceptions and behaviors about their own health and medical care … whether the availability of these tests directly to a general public of varying health literacy, without the involvement of a healthcare provider, has appropriate informational content.”
The panel, which is meeting today and tomorrow, is considering whether consumers might take actions such a changing or discontinuing prescribed medications after taking DTC test, and whether doctors would rely on such test results to for without full knowledge of the test’s reliability.
The FDA considers such diagnostics tests medical devices and has approved home both “collection kits,” where the test subject mails a specimen to a lab, and “test kits,” such as pregnancy tests, but believes DTC genetic tests “effectively create a third type of home use tests,” the agency wrote.
According to FDA standards, a genetic tests involve “the analysis of human DNA, RNA, chromosomes, protein, or certain metabolites in order to detect alterations related to a heritable disorder,” and cover a wide range of medical issues as disparate as cancer and Parkinson’s risk to whether a patient will respond to Hepatitis C treatment.
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The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
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