Last month, Walgreens, the largest drug store chain the
United States, made news by announcing that it would sell over-the-counter
(OTC) genetics testing kits in 6,000 of 7,500 stores across the country. These
tests are made by Pathway Genomics, a start-up company from San Diego,
California.
According to Pathway's
website, the genetic testing kits can be used to screen for potential
responses to medications, health conditions, ancestry, or in pre-pregnancy
planning. The company's web site also features a complete
list of the conditions that can be detected with Pathway's kits. By
partnering with Walgreens, Pathway hoped to get ahead of its better-known
rivals 23andMe and Navigenics who are working on similar screening kits.
On May 10th, Walgreens announced the sale of
Pathway Genomics kits for a mere $20; however, the actual testing done by
Pathway would cost anywhere from $79 to $249. Though the details were ironed-out, neither Walgreens nor Pathway notified the U.S. Food and
Drug Administration (FDA) about their plan.
Rising Concerns
After learning of the partnership, the FDA immediately began
investigating medical claims made by Pathway since the test had not been
approved by any U.S. regulators. Despite claims from Pathway officials saying the tests
"surely" meet approvals, the kits were widely disputed by scientists who were quick
to point out that diseases like Alzheimers have no definitive test as there is
yet to be a known cause.
Chicago
Breaking Business quoted The National Society of Genetic Counselors, which warned
that issuing such tests "increases the chance for misunderstanding or
misinterpretation of results." Others echoed the concern that most
diseases cannot be marked "yes" or "no". According to Peter Kraft, Deputy
Director of the Program in Molecular and Genetic Epidemiology at Harvard School
of Public Health, "The truth is, for most diseases, no one knows exactly why
one person gets it and another does not."
Backing-Off
Once the FDA began investigating, Walgreens released a
statement saying that it would not be moving forward with providing the Pathway
kits. Walgreens' announcement was commended by Sharon Terry of the advocacy and
research group Genetic Alliance, who said that Walgreens was clearly acting
in the interest of its customers by postponing the distribution of the Pathway
tests.
Results
Since the Walgreens/Pathway move to bring genetic testing to
consumer markets, the FDA has been making moves to begin reviewing them. On June 12th, The San Francisco
Chronicle reported that the agency has begun
issuing regulatory letters, stating its intent to review personal genetics
tests under the same process that is used for medical devices.
The letters indicate that the FDA will begin to crack down
on companies marketing products that claim to predict inheritable diseases. "Premarket
review of medical devices enables FDA to protect the public from medical
products that may pose an unreasonable risk of harm," they write. "It is
important that they be analytically and clinically accurate so that individuals
are not misled by incorrect test results or unsupported clinical
interpretations."
In the meantime, personal health and genetics testing will
remain an open market. But if these kits were to become commercially available,
would you trust them - or would you rely on your doctor instead?
Resources
Jones, Sandra M. and Bruce Jaspen. "Walgreens to Sell
Genetics Tests, FDA Investigating." 11
May 2010. Web. 14 June 2010.
<http://www.chicagobreakingbusiness.com/2010/05/walgreens-to-sell-gene-testing-kits-1.html>
Larkin, Catherine. "FDA to Review Personal Gene-Testing
Kits." The San Francisco Chronicle." 12 June 2010. Web. 14 June 2010.< http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2010/06/11/BUVB1DTQBJ.DTL>
Pollack, Andrew. "Start-Up May Sell Genetic Tests in
Stores." The New York Times. 10 May 2010. Web. 14 June 2010. <http://www.nytimes.com/2010/05/11/health/11gene.html>
Stein, Rob. "Walgreens Won't Sell Over-the-Counter Genetic
Test After FDA Raises Questions." 12 May 2010. Web. 14 June 2010.< http://www.washingtonpost.com/wp-dyn/content/article/2010/05/12/AR2010051205363.html>
http://www.pathway.com/index
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