News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Government agencies in both the United States and the United Kingdom look at direct-to-consumer (DTC) tests

Direct-to-Consumer (DTC) medical tests are under attack by multiple federal agencies here in the United States, even as authorities in the United Kingdom (UK) similarly question the potential of these genetic tests and molecular diagnostic assays to harm and/or mislead consumers.

Of course, many pathologists and clinical laboratory managers here in the United States know that multiple government agencies have spent the last year scrutinizing the DTC market. There is the possibility that new regulations and laws enacted as a result of these investigations could not only bring DTC genetic testing under tighter government oversight, but these same regulations might also ensnare certain genetic tests and medical laboratory assays that have appropriate uses in clinical care.

(Consumers have a growing menu of medical tests that they can purchase either over the counter at their local pharmacy, or from a source on the Internet.)

The latest round in this government crusade against Internet-based companies offering genetic tests to consumers was a damning General Accountability Office (GAO) report that was recently published in the New England Journal of Medicine (NEJM). The GAO unveiled an alarming error rate for Direct-to-Consumer genetic tests offered by some companies operating in the United States.

It was this GAO report—coupled with misleading marketing efforts by the 10 DTC companies the GAO secretly investigated—that caused the Food and Drug Administration (FDA) to conduct a two-day conference to discuss the implications to consumers of DTC tests and possible regulations of the DTC market.

The FDA convened its Molecular and Clinical Genetics Panel on March 8-9, 2011. This panel recommended that “certain types of genetic tests that are available for at-home use without a prescription should not be used without the involvement of a physician or genetic specialist.”

Even the Federal Trade Commission (FTC) is warning consumers about the dangers of genetic tests that can be ordered from a website or similar source. In recent years, it has maintained a page on its website titled “At-Home Genetic Tests: A Healthy Dose of Skepticism May Be the Best Prescription.” 

At the same time that multiple federal agencies have DTC genetic testing on their radar screens, something similar is unfolding across the pond. In the UK, the National Health Service (NHS) recently commented on a report from Which?, an independent consumer group similar to U.S.-based Consumer Reports. In its report, Which? determined that Do-It-Yourself (DYI) health tests “could do more harm than good.”

Dark Daily will provide a detailed e-briefing about the findings of United Kingdom-based Which? on the subject of Direct-To-Consumer/Do-It-Yourself tests, along with the related report published by the NHS. Both organizations had serious criticisms about how Do-It-Yourself medical laboratory tests in that country fall short of the quality and consumer ease-of-use that would be desired.

Tell Us Something We Don’t Already Know!

Astute readers will recall that Dark Daily reported on the GAO report in “Many Genetic Tests Offered to Consumers Over the Internet are Misleading and of No Practical Use.” That researchers in the UK are arriving at similar conclusions should come as no surprise to clinical laboratory and pathologists, who are keenly aware that DTC or DYI tests—genetic or otherwise—can be misleading and potentially harmful to patient outcomes.

Given the continued demand for low-cost tests that patients can take at home without a prescription, it’s probably not much of a stretch to believe that the FDA will be as concerned about DTC test kits manufactured in this country, as are officials in the NHS concerning the DYI test kits manufactured in the UK. Since the FDA, the FTC, and the GAO have all weighed in on the problems with DTC test kits, it’s a fair bet that stricter federal regulation of genetic and other medical tests will happen sooner, rather than later.

—Michael McBride

Related Information:

FDA Weighs Pros, Cons of Home Genetic Testing (Business Week)

DIRECT-TO-CONSUMER GENETIC TESTS: Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices (GAO Report)

Summary from the Molecular & Clinical Genetics Panel Meeting—March 8-9, 2011 

FDA Panel Advises Caution on Personal Genetic Testing 

FTC: At-Home Genetic Tests: A Healthy Dose of Skepticism May Be the Best Prescription

Warning About Self-Test Health Kits