New world order for STD tests | Red flags on CLIA-waived products | FDA's burst of preholiday actions

Dear LabPulse Member,

How is the increased incidence in sexually transmitted diseases (STDs) impacting the global market for in vitro diagnostics? In a new article, Bruce Carlson, publisher of Kalorama Information, explains how growing STD prevalence is affecting sales of immunoassay analyzers and reagents, molecular STD tests, and point-of-care tests.

The U.S. Food and Drug Administration (FDA) just cleared the first diagnostic tests designed to detect the presence of the bacteria that cause chlamydia and gonorrhea using samples collected outside the genitals. Previously, the tests were cleared only for use with urine, vaginal, and endocervical samples.

News of clearance for the chlamydia and gonorrhea diagnostics came on May 23, an action-packed day from the regulatory point of view for labs and the in vitro diagnostics industry. That day, the FDA announced a recall of three hematology analyzers due to what the agency said were problems with inaccurate recording of platelet counts. But the problem could be fixed through a software update.

On the heels of the recall came good news from the FDA for the world of infectious testing -- the first marketing clearance in the U.S. for a test to detect the potentially disabling Zika virus. Prior to now, tests have been made available through emergency use authorizations. From here on, similar Zika tests may lose their emergency use status, but many other Zika diagnostics will still be available, the agency said.

Finally, I would also like to highlight an article by contributing writer Joseph Constance, who explored concerns about the lack of quality control and oversight of CLIA-waived test kits. CLIA regulations from the U.S. Centers for Medicare and Medicaid Services (CMS) have not been updated quickly enough to keep pace with the introduction of new test methodologies. Hence, providers of proficiency testing are warning about the potential for errors even with seemingly straightforward tests in the absence of external quality assurance testing, which poses risks to patients, they say.

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