“The main purpose of the test is to maximize performance in the minimum amount of time and minimize risk,” said Bill Miller, chief executive of American International Biotechnology Services in Richmond, which began selling the test three weeks ago.
Critics, however, see the kits as the latest in a flood of questionable genetic tests that entrepreneurs are hawking. No one can accurately gauge the influence of genes on athletic abilities or vulnerabilities, they say. The results may be needlessly alarming or falsely reassuring, they say. Skeptics also fear that the trend will encourage overzealous parents and coaches to push kids into sports they dislike or discourage them from physical activities they enjoy — and might succeed at — despite their genes.
“This is really disturbing,” said Lainie Friedman Ross, a pediatrician and bioethicist at the University of Chicago. “Sports and physical activity should be fun for kids. It shouldn’t be, ‘You’re going to be the world’s greatest athlete’ or ‘Give up now, kid, because you won’t have a chance’ because of your genes.”
FDA as referee?
The growing availability of mail-order DNA scans has spurred excitement about finding genetic clues to ancestry, health and proclivities. But the testing has also raised alarm because genetic data can be misleading, misinterpreted and misunderstood, and it can leave consumers vulnerable to discrimination by employers and insurers.
The plethora of tests has prompted the Food and Drug Administration to begin stepping in, causing one company last year to abandon plans to sell a genetic screen at Walgreens stores, others to discontinue offering tests directly to consumers and some to begin working with the agency to validate their methodology.
On May 11, the FDA sent Miller a letter demanding justification for marketing his Sports X Factor test without the agency’s authorization.
“If you do not believe that you are required to obtain FDA clearance or approval for the Sports X Factor Test Kit, please provide us with the basis for that determination,” wrote James L. Woods of the FDA’s office of in vitro diagnostic device evaluation and safety. The firm plans to meet with the agency Friday, a spokesperson said.
Critics, however, see the kits as the latest in a flood of questionable genetic tests that entrepreneurs are hawking. No one can accurately gauge the influence of genes on athletic abilities or vulnerabilities, they say. The results may be needlessly alarming or falsely reassuring, they say. Skeptics also fear that the trend will encourage overzealous parents and coaches to push kids into sports they dislike or discourage them from physical activities they enjoy — and might succeed at — despite their genes.
“This is really disturbing,” said Lainie Friedman Ross, a pediatrician and bioethicist at the University of Chicago. “Sports and physical activity should be fun for kids. It shouldn’t be, ‘You’re going to be the world’s greatest athlete’ or ‘Give up now, kid, because you won’t have a chance’ because of your genes.”
FDA as referee?
The growing availability of mail-order DNA scans has spurred excitement about finding genetic clues to ancestry, health and proclivities. But the testing has also raised alarm because genetic data can be misleading, misinterpreted and misunderstood, and it can leave consumers vulnerable to discrimination by employers and insurers.
The plethora of tests has prompted the Food and Drug Administration to begin stepping in, causing one company last year to abandon plans to sell a genetic screen at Walgreens stores, others to discontinue offering tests directly to consumers and some to begin working with the agency to validate their methodology.
On May 11, the FDA sent Miller a letter demanding justification for marketing his Sports X Factor test without the agency’s authorization.
“If you do not believe that you are required to obtain FDA clearance or approval for the Sports X Factor Test Kit, please provide us with the basis for that determination,” wrote James L. Woods of the FDA’s office of in vitro diagnostic device evaluation and safety. The firm plans to meet with the agency Friday, a spokesperson said.