Last week, the FDA raised concerns about Pathway Genomics’ genetic test kits they had planned to sell in Walgreens across the country. Now, the House Energy and Commerce Committee is investigating Pathway’s tests as well as those sold online from 23andMe Inc. and Navigenics, all of which analyze saliva to determine a person’s risk of developing certain genetic diseases, according to the Wall Street Journal. Rep. Henry Waxman, D-Calif., the chairman of the Energy and Commerce Committee, and the rest of the panel
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Very interesting.
I liked the comment attributed to Pathway Genomics about how they “didn’t think it needed FDA approval”. Other companies in the retail genetic tests market either make sure they have it, or alternatively work with the FDA ahead of commercialization to ensure that they are exempt.
Regarding Navigenics and 23andme, I believe those companies have integrated genetic counseling teams which sets them apart. The kind of “drugstore” approach being proposed here doesn’t, on the face of it, seem to provide that level of support to the end-user.
Regarding the question of deriving ancestry information – there was at one time a Florida-based company retailing such a product (DNAPrint Genomics as I recall). They went bust a few years ago. There are probably others. I see the “disease risk” approach as different – very similar in a way to the retailing of nutritional supplements, which also escape pharmaceutical regulatory oversight as long as they don’t claim to treat or remedy any specific medical conditions (at least here in Canada; I believe in the US the situation is similar). A DTC genetic test that provides risk assessment for at least one medical condition would seem to me to be in a very gray area indeed, and I’m unsurprised that it’s caught the attention of the US federal government.
I am answering this as a private consumer. I am a member of 23andme and find it to have a varied group of medical results broken down by traits, carrier, diseases, etc. The risks are clearly laid-out and the results list information on how they got their results and what the results are based on. There are a few companies out there that are of this level. I also belong to another but since 23andme was targeted, I am using them in this response. I think any person that wants a good quality of life for a longer time is doing preventative measures for their health, from early diagnosis, nutrition, supplements, exercise and even hormones. My parents were old and acted old by 55. I am not sure what career path will interest me next at 55 but the possibilities are endless.
Though I feel like any business, there needs to be some checks and balances, but the possibility of the government with what could be a potential halt to a client have direct access to the information on their heath is a concern.
I will again use the example at 23andme with stating we have a lot of people in the medical field on the forums from all areas. There is constant dialog about the test, what the group wants as far as additional risks, diseases, etc. There are many experts in all areas as clients. There are many disclaimers in place and resources listed of people to get genetic info in your area for each person. There are checks on the types tests by each person and I doubt if anyone would object to a quality control on the testing. I do object to a witch hunt and a possible prohibiting of affordable genetic testing by a reputable company to help with mine and others early information of what can be an increased risk in a certain area of health. That allows me to find a Dr in that area of expertise and research what possible advances in that disease or condition is available if the possibility turns out to be an actual concern. A proclivity is not a guarantee you will get it. As someone that had a medical issue come up that I did not have time to find a good specialist to treat me, I ended up with a botched eye surgery and it took two additional surgeries to fix it.
Lastly, I really do not want this type of information only made available to me from a genetic counselor who will have to log in all tests ordered and all results if they even agree to test. At that point a possibility is documented and the insurance company has the information. Does that make it a preexisting condition so you can’t get coverage if it occurs?
I think that, except the case of monogenic pathologies, genetic tests that can reliably assess a genetic risk to develop a complex disease are far from being developed. I think that talking about complex diseases is misleading since what is normally called a complex disease is a set of many different alterations of networks of biochemical paths, mostly completly unknown, that lead to a similar phenotype. For this reason most of the tests that now are produced to assess genetic risks for complex diseases have very low statistical power and are usefull for a small subset of patients.
I believe that eventually will be possible to produce reliable genetic tests but we need time, even some decades, before to have them in the chemist’s desk.
Thanks for that interesting perspective, Jamy.
sppiras – I tend to take the view that “real” reliable genetic tests should *never* be available over the chemist’s (drugstore for North Americans) desk. Genetic tests require genetic counseling. Even a simple blood pressure (which you can get by sitting in a chair at the chemist/drugstore) or blood sugar level (which millions of diabetics test multiple times per day) requires information to interpret. Perhaps the greatest strength of genetic tests as they are applied now in the hospital environment (or, I suppose, the managed healthcare environment in the US) is the availability of well-trained, well-informed genetic counsellors to assist the patient (“client”?) in interpretation.
Providing these tests DTC without such information is simply asking for the level of disinformation provided to the general public to reach the same kind of epidemic levels that currently surround, say, nutritional supplements, or homeopathy.