DNA Test Kits Face More Scrutiny

DNA Test Kits Face More Scrutiny

Earlier this year in our print magazine, Whole Health, we noted the re-emergence of DNA-based tests designed to predict future health conditions like diabetes. The thinking is that if a person knows they are pre-disposed to a certain condition, they can take preventative steps now to prevent that from becoming a reality.

It’s a noble idea, and — with the advances DNA testing has made in a few short years — perfectly feasible that one day soon we will have the ability to analyze biological markers in each and every one of us to predict our future health.

pathway_box3.jpgAs of this week, federal regulators apparently remain unconvinced: After a letter from the Food & Drug Administration was made public, Walgreen’s announced it was pulling back from offering a saliva swab test kit and analysis by a third-party company, San Diego-based Pathway Genomics.

For the nation’s largest drug store chain, this isn’t small change. There was quite a bit of buzz over the original announcement unveiling the service. The marketing pitch highlighted Pathway’s ability to analyze the DNA contained in the swab for a host of health conditions and diseases. Besides diabetes, the list includes obesity and Alzheimer’s, among others.

Yet, an air of skepticism has hung over this science for a few years now. As far back as 2006, federal regulators were expressing serious doubts about home DNA tests. That year, the General Accountibility Office pulled a Dateline NBC stunt and used false identities and health profiles gauge the efficacy of several tests.

The result was a critical report, stating that disease profiles sent back from the various firms “mislead consumers” by providing ambiguous, generalized predictions. At that time, several regional supermarket chains offered similar services, in conjunction with a follow-up visit with the retailer’s health and wellness advisor or pharmacist, who were under orders to direct customers to their doctors should anything remotely alarming show up on the results.

Earlier this year, the hit television reality show, The Biggest Loser publicized the use of the “Know Your Number” test that uses a drop of blood and a questionnaire, In return, customers get a “comprehensive health assessment” that includes a risk appraisal for the three most common diseases. In an interview with us, the CEO of the tests’ maker, BioSignia, Durham, N.C., said the test “does not differentiate from, it adds to” conventional medical check-ups, tests and doctor visits.

Right now, the Walgreen’s program is on hold while Pathway and the FDA hash out their differences. For its part, the agency believes the test should be subject to FDA review and approval.

One part of me hopes these types of tests are assessed by the government, not to disprove them, but to demonstrate some level of accuracy. Because the science is there. All that’s been missing is a measure of accountability on the part of test providers.

Given the way our healthcare system is going, and with the growing emphasis on prevention, personal health insights like DNA analysis could go a long way towards helping people steer clear of serious conditions before they even develop. What could possibly top that?

(Photo credit: DishyMix: Susan Bratton Podcasts & Blogs)