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.