It’s not just in the United States that Direct-to-Consumer (DTC) medical laboratory tests are coming under criticism, as reported in recent weeks by Dark Daily. Two prominent organizations in the United Kingdom (UK) have issued reports with serious criticisms of what are known as “Do-It-Yourself” (DIY) clinical laboratory tests in that country.
Researchers identified the several ways that DIY test in the UK, often bought over-the-counter in pharmacies, could mislead or harm consumers. In our earlier Dark Daily e-briefing titled “Medical Laboratory Tests for Consumers Under Investigation on Two Continents,” we presented pathologists and clinical laboratory managers with the results of a General Accountability Office (GAO) study that was critical of DTC medical laboratory tests.
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.