Peddling genetic tests with the threat of death


An American biotech has launched an aggressive marketing campaign for their direct-to-consumer (DTC) genetic tests by playing on parents’ fears. AIBioTech’s press release begins:

“It's a simple home genetic test, but the results it produces can make workouts more effective, children's sports choices more appropriate and trainers' awareness of potential risk factors more precise. It can even save a life.”

The test is marketed on the premise that it will allow people to “maximize strength, power and endurance,” and to “identify the length of time an athlete needs to rest after experiencing a concussion, his or her chances for negative results including cardiac risk factors and various other hazards.”

The company’s CEO is quoted:

“We have found an accurate and affordable way to make these tests available to athletes of all ages so they can maximize their potential while greatly reducing the risk of injury and even death.”

And further: 

“The recent sudden deaths of several gifted young athletes compelled the company's decision to bring the product to market at this time.”

The company provides little more information. The FDA sent AIBioTech a warning on May 11, requesting a meeting “to discuss whether the test you are promoting requires review by FDA and what information you would need to submit in order for your product to be legally marketed.” AIBioTech is trying desperately to spin that it is working with the FDA to “keep its Sports X Factor available to consumers.” The FDA has given them a month to formulate a plan.

Stephen Roth of the University of Maryland presented on the subject at the American College of Sports Medicine’s annual meeting. He separated the technical accuracy of a genetic profile from the ability to interpret the results, concluding: 

“I would not recommend these tests for anyone except adult athletes seeking information for themselves out of curiosity, but I would remind those adults that the science is still shaky.”~ AIBioTech, Apr 27, May 25; Center for Genetics and Society, Jun 7




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