WASHINGTON A House of Representatives committee is investigating personal genetic testing kits after one company attempted to sell its test through retailers, lawmakers said on Wednesday.
The House Energy and Commerce Committee asked 23andMe Inc, Navigenics Inc and Pathway Genomics Corp to provide information including details on the tests' accuracy and how the companies analyze results.
The lawmakers, two Democrats and two Republicans, said in a statement there was "concern from the scientific community regarding the accuracy of test results."
Pharmacy chain Walgreen Co earlier this month had said it would start selling a saliva genetic test made by Pathway but put those plans on hold after the Food and Drug Administration challenged the sales.
The agency asked Pathway to prove why the test should be sold without the agency's blessing. The FDA said it was unable to identify an approval for the Pathway test. Some tests are allowed on the market without FDA clearance.
Pathway's test contains a small saliva collection kit, instructions, and a postage-paid envelope that customers can use to send their sample back to the Pathway lab.
Then, consumers go on the company's website, www.pathway.com, to order a customized report about their genetic make-up, with prices ranging from $79 to $249.
The reports give consumers genetic information on more than 70 health conditions, including a person's response to some prescription drugs, their propensity for diseases, and whether they could pass any inherited diseases to their children.
Consumers are meant to use the results to modify their lifestyles.
Pathway has said its test can be sold without FDA clearance because it is not intended for use in diagnosis, treatment, mitigation of, or curing a disease.
23andMe, Navigenics and Pathway offer genetic test kits online. Google Inc is an investor in 23andMe.
The FDA is examining various genetic tests, in part to determine if a doctor is involved in helping patients understand results, agency spokeswoman Erica Jefferson said.
Several groups have raised concerns over the sale of such test kits directly to consumers, noting that such tests offer incomplete information, and any results about disease risk, especially for incurable diseases such as Huntington's or Parkinson's, should only be done with counseling that clearly explains the limitations of genetic testing.
Scientists have a limited understanding of genes that contribute to complex diseases, such as heart disease or diabetes, and studies have shown that using genetic information is much less effective than factors such as family history in predicting a person's risk of developing these diseases.
Navigenics Vice President Amy DuRoss said the company had already talked with staff on the House committee and would respond to its request for information.
The company said it has been in contact with the FDA for more than three years and "believes its services comply with all existing federal and state regulations."
23andMe also said it would comply with the committee's request.
"We look forward to sharing information detailing what individuals can learn about their own bodies through personal genetic testing and how our company is facilitating important scientific research in the field," the company said in a statement.
The company added it had had "several conversations with the FDA, the first of which occurred prior to the launch of our product in late 2007, and we continue to welcome dialogue with the agency."
Pathway did not immediately respond to a request for comment on Wednesday.
(Reporting by Lisa Richwine; Editing by Tim Dobbyn, Gary Hill and Carol Bishopric)
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