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The last few years have seen the rise in consumer-based genetics testing. Original players included 23andMe, Navigenics, and deCode Genetics.Pathway Genomics, all of which entered the game in early 2009. The companies offered genetic results for over 90 disease traits as well as an extensive analysis of an individual’s DNA for risks of diabetes, Alzheimer’s and several other serious diseases along with ancestry tracing, counseling, education and networking. What used to cost thousands of dollars became available for under $500—in some cases less than $200—without the need for a visit to the doctor.

However, not long after Pathway partnered with CVS/Walgreens to offer the saliva tests on pharmacy shelves across the country, the FDA stepped in and called a halt to the direct testing due to concern over reliability and how people might interpret them. Then a House panel was convened to investigate genetic tests, not just from Pathway but also from 23andMe Inc. and Navigenics. While these saliva tests are not FDA-approved, the companies maintain that this was not a necessary step to bringing the product to market.

The FDA then requested that five companies provide data that their diagnostic tests present scientific evidence that a test result, either positive or negative, is linked to a disease or the risk of one. They also wanted the companies to seek regulatory approval for the tests, although they stopped short of requiring that the companies pull their tests from the market, at least for now. In fact the letter itself is rather tame, “appreciating a response within 15 days,” but again not “requiring” it.

Now an FDA has convened an outside panel of experts to help them decide on whether consumer-based home genetics testing should be available directly to the public, or made available only through a medical professional. Meeting this week, the panel will review the tests efficacy, the information the tests provide, and the impact on the consumer.

Among the concerns are that consumers might change or discontinue prescribed medications based on the results of a test; that consumers might misinterpret results; and that a serious condition could be revealed without attendant explanation and counseling.

The panels findings will have a direct impact on whether the FDA approves use of the current tests or introduces tougher restrictions on them.