CEO SUMMARY: There’s been an uneasy standoff between companies that want to sell genetic tests directly to consumers over the Internet and both state and federal regulators. But now it appears that the FDA is ready to take off the gloves and assert greater control over genetic testing. The agency moved swiftly to challenge six genetic testing companies that offer genetic testing directly to consumers. One consequence might be more regulation of laboratory-developed tests (LDTs).
FOR YEARS, pathologists and laboratory professionals have waited for the genetic testing genie to escape from the bottle. That may have happened last month when Walgreens Company announced that it would start selling genetic tests off the shelf directly to consumers, beginning May 14.
Walgreens had teamed up with Pathway Genomics Corporation of San Diego, California. Pathway packaged DNA saliva collection kits that Walgreens would stock on the retail shelves of its 6,000 pharmacies. Consumers would buy the kits and send their specimens to Pathway to be analyzed. The Pathway test panel is designed to produce “personal genetic health disposition results for more than 70 health conditions, including pharmacogenetics (prescription medication response), propensity for complex disease, and carrier status (pre-pregnancy health) information.”
Public reaction to this news was immediate. Just days after its announcement, Walgreens backed down and stated that it would not sell the genetic tests after all. But the brouhaha didn’t end there.
Within days, on May 10, the Food and Drug Administration (FDA) sent a letter to the CEO of Pathway Genomics. The FDA requested information on the Pathway Genomics Genetic Health Report and noted that it had no FDA clearance or approval number for that product.
To make sure that the genetic testing community got the message, on June 11, just four weeks later, the Food and Drug Administration (FDA) sent a strong sign of its displeasure by delivering letters to five companies that provide genome-sequencing tests to consumers. The companies were deCode Genetics, Navigenics, 23andMe, Knome, and Illumina.
FDA Asserts Its Authority
In these letters, the FDA asserted its authority to regulate these types of genetic tests under the statutes covering medical devices intended for use in humans. All six companies that received letters from the FDA—as well as the entire genetic testing industry—were put on notice that federal regulators are now prepared to deal with the issue of how genetic tests should be regulated.
Meanwhile, the original decision by Walgreens to stock genetic tests on its shelves and sell directly to consumers set off a vigorous debate. On one side are those medical professionals who ardently advocate that consumers should only explore their personal genome under the guidance, direction, and counsel of trained experts.
These experts argue that medicine is such a complex science that consumers— when given unfettered access to sophisticated genetic information—are likely to make misinformed decisions which can too often result in serious harm, if not increased risk of death.
On the other side are the ultimate free marketers, who, with equal passion, point out that people have a natural right to any and all information about themselves and their family members. They believe individuals are fully capable of handling this information, just as they do in many other complex or sophisticated areas of modern life.
Of course, most pathologists and medical laboratory professionals fall somewhere in between the two extreme poles of these opposing viewpoints. They see a role for expert advice and some limits on how consumers might access and act upon their own unique genetic information.
Claims For Test Performance
One point is not disputed. When most of these genetic testing companies appeared in the market over the past three or four years, the claims they made to consumers were typically vague and non-specific. That is no longer the case. Among the letters written by the FDA to the six genetic testing companies, the FDA quotes specific claims that have been advertised by the company receiving that letter.
For example, in its letter to 23andMe, the FDA writes that “your website states that the 23andMe Personal Genome Service is intended to tell patients in advance how they will respond to certain medications including warfarin and clopidogrel.” The FDA asks 23andMe to provide scientific data to support that claim.
It goes without saying that any enforcement decisions and new regulatory policies developed by the FDA have the potential to apply to genetic and molecular testing done by clinical laboratories, while also bringing laboratory-developed tests (LDTs) under tighter FDA scrutiny.
A Look at Walgreens’ Genetic Testing Kits
WALGREENS INTENDED TO PUT saliva collection kits on the shelves of its retail pharmacies. Consumers would purchase the kits for between $20 and $30, then send their specimen directly to Pathway Genomics Corporation.
Pathway Genomics was offering to do genetic sequencing of the specimen and report the “personal health disposition” of the customer for as many as 70 health conditions. The cost of the genetic testing was to range from $79 for a basic analysis of 10 genetic sequences to $249 for the complete genetic analysis offered under this program.
