The Wall Street Journal
A House panel is investigating personal genetic test kits currently sold over the Internet after one company proposed selling its kits through stores operated by Walgreen Co. and CVS Caremark Corp.
Last week, Pathway Genomics, a closely held firm based in San Diego, announced plans to sell its Insight Saliva Collection Kit through 6,000 Walgreens stores for between $20 to $30 a test. Saliva collected from the test would be sent to the company and analyzed for an additional price of $79 to $249.
The test, which Pathway currently sells through its website, is designed to predict a person's risk for developing certain diseases or how they might respond to certain drugs. It can also predict the risk of 37 genetic diseases caused by recessive genes that might be passed to a child from parents.
But after the Food and Drug Administration raised concerns about the test, Walgreen and CVS Caremark both said they would hold off on selling the kits until all the regulatory issues are worked out with the agency.
The test isn't FDA-approved, but Pathway Genomics has said it didn't think the test needed agency approval. The company said it's currently working with the FDA to make sure it is compliant with agency rules.
Now, the House Energy and Commerce Committee is seeking information about Pathway's test along with tests from 23andMe Inc. and Navigenics, two other closely held firms based in California.
All three companies sell tests on the Internet that analyze a person's salvia to determine their risk of certain health conditions. The tests also allow people to obtain genetic ancestry data.
Rep. Henry Waxman, D-Calif., the chairman of the Energy and Commerce Committee, along with other lawmakers on the House panel, sent letters to the three companies Wednesday requesting information about how they analyze the test and how accurate the test results are. The panel is also seeking information about how the firms collect, process and store individual genetic samples collected from consumers.
It wasn't immediately clear if the panel planned to hold a hearing on the genetic tests.
Last week, Pathway Genomics, a closely held firm based in San Diego, announced plans to sell its Insight Saliva Collection Kit through 6,000 Walgreens stores for between $20 to $30 a test. Saliva collected from the test would be sent to the company and analyzed for an additional price of $79 to $249.
The test, which Pathway currently sells through its website, is designed to predict a person's risk for developing certain diseases or how they might respond to certain drugs. It can also predict the risk of 37 genetic diseases caused by recessive genes that might be passed to a child from parents.
But after the Food and Drug Administration raised concerns about the test, Walgreen and CVS Caremark both said they would hold off on selling the kits until all the regulatory issues are worked out with the agency.
The test isn't FDA-approved, but Pathway Genomics has said it didn't think the test needed agency approval. The company said it's currently working with the FDA to make sure it is compliant with agency rules.
Now, the House Energy and Commerce Committee is seeking information about Pathway's test along with tests from 23andMe Inc. and Navigenics, two other closely held firms based in California.
All three companies sell tests on the Internet that analyze a person's salvia to determine their risk of certain health conditions. The tests also allow people to obtain genetic ancestry data.
Rep. Henry Waxman, D-Calif., the chairman of the Energy and Commerce Committee, along with other lawmakers on the House panel, sent letters to the three companies Wednesday requesting information about how they analyze the test and how accurate the test results are. The panel is also seeking information about how the firms collect, process and store individual genetic samples collected from consumers.
It wasn't immediately clear if the panel planned to hold a hearing on the genetic tests.
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