FDA halts sales of home DNA testing kit

In a blow to the burgeoning home genetic testing industry, federal regulators have ordered the most high-profile of the companies to halt sales of its personalized DNA kits.

The U.S. Food and Drug Administration wrote 23andMe Inc. that it is violating federal law because its products have not met regulatory standards and could cause consumers to undergo unnecessary health procedures for many of the more than 250 diseases and health conditions about which it purports to provide risk information.

"(The agency) is concerned about the public health consequences of inaccurate results," the FDA writes in the letter, which is dated Nov. 22 and was posted online Monday. It called some of the tests "particularly concerning ... because of potential consequences that could result from false positive or false negative assessments for high-risk indications."

The move was applauded by Houston geneticists and doctors, who said questions remain about the validity of tests being marketed for medical diagnoses. They also said the information returned to consumers is difficult to understand and easily misinterpreted without accompanying genetic counseling.

Dr. Jennifer Litton, an M.D. Anderson Cancer Center breast oncologist, said she routinely sees patients who have ordered the home genetic testing and think they've had "full testing for a hereditary cancer syndrome when in fact they've only had a tiny snippet." She noted that such snippets of information can give false information.

Alana Cecchi, a genetic counselor at the University of Texas Health Science Center who recently took the 23andMe testing, said the results were complex and confusing enough that she had to "go above and beyond, do additional research" just to understand them.

Backed by Google

The company 23andMe, founded with the backing of Google, is a 7-year-old firm that says its DNA test can detect a range of genetic mutations and provide information about an individual's health risks. Consumers order a kit online for $99, then ship 23andMe a saliva sample for genetic analysis.

The company's name refers to the 23 pairs of chromosomes that make up each individual's genome.

In a statement Monday, 23andMe said it recognizes "we have not met the FDA's expectations." It added that "our relationship with the FDA is extremely important to us, and we are committed to fully engaging with them to address their concerns."

Although the FDA letter said 23andMe must immediately discontinue marketing its test until it receives authorization from the agency, the product was still available online Monday. Asked whether there are plans to change that availability, a company spokeswoman said she could not comment beyond the statement.

The FDA letter says it has worked with 23andMe since 2009 to help it comply with regulatory requirements. The company originally focused mostly on questions about ancestry and recreational genetics, such as family athletic ability or hygiene matters, then became more focused on testing individuals' risk of common and complex disorders, such as cancer and heart disease. Those are the tests that require FDA approval for companies to make claims.

Dr. Sharon Plon, a Baylor College of Medicine professor of molecular and human genetics, said if a patient came to her with 23andMe test results, she'd seek new testing at a certified laboratory because she'd want to be confident of the standard of testing provided. She compared it to a patient coming in with an MRI scan from a commercial company.

Misleading info

Amy McGuire, director of Baylor's Center for Medical Ethics and Health Policy, said that though it's true that many interventions suggested by a 23andMe test would require a doctor who would prevent the procedure if it wasn't indicated, consumers could still be harmed by wrong or misleading information in other ways that do not involve licensed health care professionals.

She noted certain results could cause depression or anxiety, or lead to taking of unnecessary supplements or unproven alternative therapies.

McGuire called the FDA move part of a clear signal it plans to regulate the home genetic testing industry, something she said she actually expects its leaders to welcome,

"The worst thing for a market is regulatory uncertainty," she said.