If all it took was $99 and some spit in a cup to learn certain key factors about your health, would you do it?
A Google-backed company called 23andMe is under some heat from the FDA for their at-home genetic testing kits known as a Personal Genome Service or PGS.
The kit tests for more than a million genetic factors, including specific data points that may indicate an increased risk for breast cancer, blood clots, celiac disease, heart disease and other major health risks.
The kit can be ordered online and is sent to your home address where you spit in a tube and send your saliva back to the genetic testing company where your DNA will be extracted and tested, according to co-founder Anne Wojcicki. Though the service provides you with genetic information that may indicate risk factors for chronic conditions, it is not a predictive or diagnostic test (aka you're not going to get a result that says "You have breast cancer.") However, its founders hope the results may motivate you to see your doctor or change poor health habits.
Unfortunately for Wojcicki, the FDA recently sent 23andMe a strongly worded letter requesting that the company cease all marketing efforts within 15 days as a result of weak scientific scope and a potential risk for users to get -- or not get -- appropriate medical attention based on the results provided.
The FDA’s response has sparked a heated debate in the medical and health community. Is this just the FDA doing its job as a government entity and protecting American citizens from the harm of potentially faulty genetic information? Or is this an example of bureaucracy stealing our basic rights?
This isn't the first time the FDA has stepped in to make big changes. They recently instated a ban on trans fats in our foods, even though it’s been common knowledge since 2006 that trans fats are estimated to cause roughly 7,000 American deaths per year. The FDA has also recently administered new guidelines for statins based on very loose scientific studies funded by major pharmaceutical companies.
So, the question becomes, if the FDA is so concerned for the well-being of their citizens, where have they been on these separate occasions?
Wojcicki told CNBC in an interview that the PGS kits are intended to “empower people to be able to get valuable access to themselves and actually have a road map for how they could be as healthy as possible.” She gives the example of someone who may be predisposed to getting a blood clot taking an aspirin before getting on a plane.
That's not to say that 23andMe's product is perfect. In 2009, Craig Venter, the founder of the J. Craig Venter Institute, a leader in genetic research, and collaborators from that institute and from Scripps Translational Science Institute in La Jolla, CA put 23andMe's DNA testing methods, and rival Navigenetics', to the test. They found that the raw genetic sequencing data, what determines genetic markers for various diseases, that the companies came up with was consistent with Venter's data.
What was different, though, was how the information was analyzed. Seven diseases were analyzed by both companies, yet about half of the risk factors were the same. For example, three of five of the subject had different results for lupus and type 2 diabetes. Individual risk factors were also different. 23andme showed a risk factor of 4.02 (four times greater) for psoriasis for one individual, while Navigenics reported only a 1.25 risk factor (25 percent greater). Venter determined that standards were needed to make results more consistent and helpful for the average user, and in the past few years, the tests have become more accurate.
What are your thoughts? Would you use 23andMe’s Personal Genome Service?
By: Jen Wolfe
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