May 20, 2010

Lawmakers Investigating Genetic Testing Kits

Lawmakers said on Wednesday that a House of Representatives committee is investigating personal genetic testing kits after one company attempted to sell its test through retailers. 

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 said in a statement that there was "concern from the scientific community regarding the accuracy of the test results."

Walgreen Co., the nation's most popular pharmacy chain, 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 approval from the FDA.  The agency 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 use to send their sample back to Pathway's lab.

Customers can then go to the company's website to order a customized report about their genetic make-up.  Prices on the product range between $79 to $249.

The reports allow consumers to find out about their genetic information on over 70 health conditions, including a person's response to some prescription drugs, their propensity for disease, and whether they could pass any inherited diseases to their children.

Consumers are meant to use the results from the test in order to alter their lifestyles.

Pathway said its test can be sold without the approval from the FDA because it is not intended to use in diagnosis, treatment, mitigation or curing a disease.

23andMe, Navigenics and Pathway offer genetic test kits online.  Google Inc. is an investor in 23andMe.

Agency spokeswoman Erica Jefferson told Reuters that the FDA is examining various genetic tests, in part to determine whether or not a doctor is involved in helping a patient understand the test results.

Several groups have criticized the sale of such tests, saying that such tests offer incomplete information and results about disease risk, especially for incurable diseases like 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 disease like heart disease or diabetes.  These types of studies have found that using genetic information is much less effective than factors such as family history when predicting a person's risk of developing these diseases.

Navigenics Vice President Amy DuRoss told Reuters the company had already talked with staff on the House committee and would respond to its request for information.

According to what the company told Reuters, it has been in contact with the FDA for over three years and "believes its services comply with all existing federal and state regulations."

23andMe also said it would comply with the agency'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.

It added that it 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."


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