Madison, Wisconsin-based Exact Sciences has begun to air a television commercial urging viewers to speak to their doctors about its direct-to-consumer Cologuard assay, a DNA test for colon cancer. Please correct me if I’m wrong, but I believe this is the first time a clear-cut diagnostic, as opposed to genetic testing to reveal ancestry or predisposition to disease (e.g., 23andMe) has been introduced to the public via such advertising. How this works out may have far-reaching implications for the clinical laboratory industry.
Cologuard is a multi-target stool DNA test (mt-sDNA). Using a stool sample, it detects mutations associated with colorectal cancer in the DNA of cells shed by advanced adenomas as stool moves through the large intestine and rectum. Patients with positive test results are advised to undergo a diagnostic colonoscopy. In August 2014, the U.S. Food and Drug Administration (FDA) approved Cologuard. In October 2014, Cologuard was approved for Medicare coverage.
The 60-second ad features an animated representation of the test—a white square with arms and legs and a face and a mouth that moves—explaining how the test works: it is ordered by the doctor, and then the health consumer collects the sample and ships it to the lab. It’s as easy as “get-go-gone,” the little character tells the viewer.
How well will this ad campaign work? Will Cologuard be accepted by the clinical community? According to some news reports, its reception has been mixed so far. In part, this may be because last October the U.S. Preventive Services Task Force (USPTF) designated stool DNA testing only as an “alternative screening test” (along with CT colonography) for colon cancer. A final recommendation has not yet been made.
More broadly, how will television commercials advertising DTC lab tests—which seems to be an idea whose time is here—be received by the public? That remains to be seen, but it is a safe bet that the FDA will offer cautions and warnings to consumers, as it already does with regard to pharmaceuticals.
In one online publication, for instance, “Keeping Watch Over Direct-to-Consumer Ads,” the FDA considers the drug ads in terms of balance and accuracy, provides a checklist of what advertisers must provide, summarizes different types of ads, and reviews arguments typically made by people and organizations that favor and oppose the ads. A second online source from the FDA, “The Impact of Direct-to-Consumer Advertising,” focuses on physician and consumer surveys about DTC pharmaceutical advertising, measuring both the public and professional perceptions of the value of such advertising. It seems likely that comparable online resources will be created for advertising for diagnostic assays—in the case of something like Cologuard, for example, a resource that compares its accuracy to that of a colonoscopy.
Of course, the FDA has a comprehensive surveillance and enforcement program that is dedicated to keeping pharmaceutical advertisers honest, and we can assume that something analogous will be in place for diagnostics. The ongoing saga of Theranos, the private company that claims to provide comprehensive testing based on a few drops of blood collected via fingerstick, shows how the FDA might proceed when more DTC assays are advertised via TV commercials. Last fall, the FDA reported what it deemed to be major problems with the company’s practices and ordered Theranos to stop using its Edison blood-collection device for all but one of the 200 tests for which it had been offered.
Will television advertising of DTC products be good for the clinical lab industry? Any DTC products, however communicated to their audience, are, in a sense, competition; but they also raise public awareness of clinical lab testing. And it is not hard to imagine some companies diverting some of their testing to labs other than their own. I would love to hear readers’ perspectives.