Pathway Genomics’ Marketing Plan for Genetic Tests Draws More Heat
Pathway Genomics’ plan to take genetic testing to the people continues to go badly awry.
A House panel disclosed yesterday that it is investigating personal genetic tests sold over the Internet by San Diego-based Pathway and two other companies. Rep. Henry Waxman, D-Calif., sent the companies letters seeking information about the accuracy of the tests and how they are conducted. The House panel also wants to know what the firms do with the genetic material they collect from consumers. The Wall Street Journal has the story here.
The move came after Pathway announced plans last week to sell its genetic tests in drug stores operated by Walgreen. Subsequent to the announcement, the FDA released a May 10 letter that questioned Pathway’s decision to market the test without agency approval. It told Pathway that it should explain why it believes the test does not need prior approval before it could be sold.
Walgreen and CVS, which had also planned to offer the tests, decided against doing so until the regulatory issues were addressed.
Besides Pathway, the House Energy and Commerce Committee wants information from Navigenics and 23and Me. The three companies sell tests that analyze saliva to determine genetic ancestry or genetic links to certain health conditions.
The House panel said its investigation was motivated by Pathway’s attempt to market the kits in retail stores “despite concern from the scientific community regarding the accuracy of test results.” The letter to Pathway CEO Jim Plante is here.