Personal genetic tests now being sold by five companies require government review, U.S. regulators said, one month after Walgreen Co. scrapped plans to sell a similar product in its stores.
Consumers may make health decisions based on the outcome of the tests, which provide patients with information about their risk of disease or their response to prescription drugs based on their genes. The tests should be reviewed under the process used for medical devices, the Food and Drug Administration said in letters released today to 23andMe Inc., DeCode Genetics Inc., Illumina Inc., Navigenics and Knome Inc.
Walgreen, the largest U.S. drugstore chain, said May 13 it wouldn’t go forward with plans to sell a gene test from San Diego-based Pathway Genomics Corp. after the FDA said the product required review as a medical device. The agency is concerned that patients may take actions that would be detrimental to their health based on inaccurate or inconclusive results, Alberto Gutierrez, director of the FDA office that regulates diagnostic tests, said today in a telephone interview.
“We think that these companies are marketing medical devices and they need to come to the agency with submissions on the claims that they’re making,” Gutierrez said. In the “worst case,” a woman may be wrongly told she has a high risk of ovarian cancer based on the results of a genetic test, Gutierrez said.
“There are many cases where women will get their ovaries taken out because of the risk of ovarian cancer,” he said. “That is a case where people take action based on false results that they shouldn’t be taking.”
The agency will review data supporting the accuracy of each gene variant tested and the validity of the health risks the test-makers attribute to that gene, Gutierrez said. The agency may require the companies not to test for certain genes or to alter the language provided to consumers about the reliability of the information they provide, he said.
As long as the companies submit the requested data, they will be able to continue marketing the tests while the FDA conducts its review “unless the FDA determines that they are putting users at unacceptable risk of harm,” Gutierrez said.
Kari Stefansson, executive chairman and president of research for DeCode of Reykjavik, Iceland, said the FDA’s action was “a terribly important” protection for consumers.
“I welcome this not because I am so arrogant to think that we are the best,” he said. “I welcome this because there is always a nagging little doubt and I want someone like the FDA to tell me we meet the standard.”
DeCode has been careful not to make statements that can’t be supported by solid data, Stefansson said. He said he hopes the FDA “crafts a standard that makes sense and without unnecessary costs for the industry.”
Stefansson said he’d be surprised if all the companies are making tests with the same level of reliability as DeCode.
“Those less qualified may retreat from the space, he said. “This may well change the mix.”
23andMe said in a statement that it will respond to the FDA letter and continue discussions with the agency that began in 2007.
“It is important to note that we disagree with the FDA’s conclusion,” the Mountain View, California-based company said. “We are sensitive to the FDA’s concerns, but we believe that people have a right to know as much about their genes and their bodies as they choose. We believe any government regulation should have an appropriate framework that does not stifle scientific innovation.”
‘We Welcome Oversight’
Foster City, California-based Navigenics also is in discussions with the FDA, Amy DuRoss, vice president of policy and business affairs, said in an e-mailed statement.
“We welcome federal oversight as the next stage” of the evolution of state and federal regulation and “to ensure compliance and develop standards for the industry’s technologies and services,” DuRoss said.
Lawmakers led by Representative Henry Waxman, a California Democrat, have urged companies to supply evidence that their tests are reliable.
Since the agency sent a similar letter to Pathway Genomics on May 10, representatives of the company have met with the agency and discussed their tests, Gutierrez said.
“Pathway was responsive; they seem to want to work with the agency,” he said.
San Diego-based Illumina rose $1.05, or 2.4 percent, to $44.99 at 4 p.m. New York time in Nasdaq Stock Market composite trading. DeCode has shares valued at less than a cent in U.S. over-the-counter trading. The three other companies are closely held.
“We are studying the letter from the FDA,” said Illumina spokesman Wilson Grabill. Adi Lipson, manager of operations at Cambridge, Massachusetts-based Knome, said the company plans to cooperate fully with the FDA and will have no comment while it is reviewing the agency’s letter.