FDA Issues its First Emergency Use Authorization for an Antigen-based Diagnostic as Top IVD Manufacturers Race to Supply Medical Laboratories with COVID-19 Tests

Though experts say an antigen test is not as accurate as PCR tests, its low cost, ease of use, and widespread availability make it a boon for clinical labs performing COVID-19 testing While COVID-19 exploded around the world, the US Food and Drug Administration (FDA) unleashed the nation’s in vitro diagnostics developers by issuing dozens of Emergency Use Authorizations for new coronavirus laboratory-developed tests (LDTs). Most of these EUAs are for Reverse Transcription-Polymerase Chain...

Canadian Scientists and Medical Researchers Urge Health Canada to Regulate Laboratory-developed Tests

Lack of regulations and quality management jeopardizes the quality and safety of LDTs, claim experts in clinical laboratory medicine in a commentary to Canadian policymakers Health Canada is the latest government healthcare organization under pressure to enact legislation that regulates laboratory-developed tests (LDTs). In a public commentary, several members of the Institute of Health Policy, Management and Evaluation (IHPME) at the University of Toronto in Ontario, urged Canadian lawmakers...

Biomarker Trends Are Auspicious for Pathologists and Clinical Laboratories

Few anatomical tools hold more potential to revolutionize the science of diagnostics than biomarkers, and pathologists and medical laboratories will be first in line to put these powerful tools to use helping patients with chronic diseases There’s good news for both anatomic pathology laboratories and medical laboratories worldwide. Large numbers of clinically-useful new biomarkers continue to be validated and are in development for use in diagnostic tests and therapeutic drugs. Clinical...

Home-testing IVD Diagnostic Devices Win Rigorous MDEA Design Awards as Part of Ongoing Trend to Move Medical Laboratory Tests Closer to Patient

Innovative designs promote in vitro home-testing medical diagnostic devices that could impact the work done in clinical laboratories With greater frequency, new diagnostic technologies make it possible to move medical laboratory tests out of the traditional central lab facility and closer to the patient—including patient home self-testing. Even as this happens, engineers and designers are delivering elegant, well-designed devices designed for use in clinical laboratories as well as in...
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