The industry behind direct-to-consumer gene tests needs to establish guidelines for its wares.
The burgeoning, but virtually unregulated, direct-to-consumer (DTC) genetic-testing industry faces some serious changes in the United States. In a series of hearings last month, the US Food and Drug Administration (FDA) hinted that it will impose new regulations on companies selling such tests. The agency has also sent letters to test makers, as well as to one maker of the gene chips on which many such tests rely, saying that the firms are not in compliance with its rules.
In addition, the Government Accountability Office (GAO) last month unveiled the findings of its year-long investigation into the scientific validity, safety and utility of the gene tests used by the industry. The report called some of the tests misleading, pointing out inconsistencies in the results they provided, as well as some companies' shady marketing practices. Although industry supporters have protested that the GAO's report lacked transparency and wrongly lumped good companies in with bad, it did bring the need for regulation into political and public view. Similar hearings held four years ago — also paired with a damning GAO report — led to a tempest that quietly petered out. That is unlikely to happen this time, if only because more genetic-testing companies now exist, making the market harder to ignore.
It remains unclear exactly what the FDA's new regulations might look like or when they might arrive (see page 816), which leaves the industry in a high state of uncertainty. Rather than just waiting for the FDA's edict, the DTC companies should start working together on their own industry-wide standards for the tests. This would not only show that the industry cares about quality of service and the integrity of its own members, but would provide regulators with concrete information about how various standards work in the real world.
Although there have been attempts to create such industry standards before, consensus has been elusive — in part because competitive interests have kept companies from agreeing on what constitutes a well-validated genetic test. That is an indulgence that the industry can no longer afford. Leading firms should guide the industry towards a set of universally accepted and scientifically informed guidelines to ensure that tests from different companies provide comparable results — or at least, transparently explaining why they might not — and a set of best practices for marketing.
Such a move would not and should not take the place of formal FDA regulation. But it would give FDA officials something to work with in crafting their regulations. That would make it more likely that the rules they develop will help foster and encourage innovation, rather than being more restrictive than is warranted.