Pathway Genomics’ Marketing Plan for Genetic Tests Draws More Heat

Xconomy San Diego — 

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.

Pathway Genomics test kit

Pathway Genomics test kit

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.

In a commentary in the Philadelphia Inquirer on Sunday, UPenn bioethicist Arthur Caplan said the genetic tests were too crude to provide useful information about disease risks, and noted no government agency regulates the accuracy of the tests or requires competent counseling.

“The reality is that Internet offers and home-testing kits are not ready for prime time,” he wrote.

Pathway would have been the first to offer an over-the-counter test. The company planned to sell the kits through Walgreens and CVS stores for $20 to $30 each. Customers would pay an additional $79 to $249 to have their saliva analyzed for genetic indications of their bodies respond to caffeine or certain prescription drugs and/or genetic links to certain diseases.

Pathway has been selling a genetic test through its website for $400.

Pathway referred requests for comment to a statement on its website. The company said its laboratory is licensed by the state of California and it is in compliance with “currently applicable” regulations. It said customers have unlimited access to its staff of counselors and physicians who are either certified or eligible to be certified by the American Board of Genetic Counselors. The company said it looked forward to working with Congress and the FDA as any new regulations or guidelines are considered.

In a statement last year, Pathway Genomics said its venture investors include The Founders Fund, Edelson Technology Partners, and Western Technology Investment. The company did not disclose how much it has raised.

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