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...

Harvard ‘Roadmap’ to Recovery Calls for ‘Massive’ Increase in Clinical Laboratory COVID-19 Testing in Four-Phase Blueprint for Reopening Economy

Report’s authors claim the US needs to be testing 20-million people per day in order to achieve ‘full pandemic resilience’ by August Medical laboratory scientists and clinical laboratory leaders know that the US’ inability to provide widespread diagnostic testing to detect SARS-CoV-2—the novel coronavirus that causes the COVID-19 illness—in the early stages of the outbreak was a major public health failure. Now a Harvard University report argues the US will need to deliver five million tests...

FDA, IBM, Merck, Walmart and KPMG Collaborate on Blockchain Pilot Project to Track Pharmaceuticals

First used to track cryptocurrencies such as Bitcoin, blockchain is finding its way into tracking and quality control systems in healthcare, including clinical laboratories and big pharma Four companies were selected by the US Food and Drug Administration (FDA) to participate in a pilot program that will utilize blockchain technology to create a real-time monitoring network for pharmaceutical products. The companies selected by the FDA include: IBM (NYSE:IBM), Merck (NYSE:MRK), Walmart...

New FDA Regulations of Clinical Decision-Support/Digital Health Applications and Medical Software Has Consequences for Medical Laboratories

Softened FDA regulation of both clinical-decision-support and patient-decision-support software applications could present opportunities for clinical laboratory developers of such tools Late 2017, the Food and Drug Administration (FDA) released guidelines on how the agency intends to regulate—or not regulate—digital health, clinical-decision-support (CDS), and patient-decision-support (PDS) software applications. The increased/decreased oversight of the development of these physicians’ tools...

Important Trends Point to Cloudy Future for Clinical Laboratories and Pathology Groups in the United States

Financial and clinical fortunes may soon shift for many medical laboratory organizations By every measure, the clinical laboratory industry is entering a high-stakes period during the next 24 months. Powerful trends are reducing lab budgets and payers are cutting the prices paid for medical laboratory testing. The question on everyone’s mind is “will it get better or worse in the months ahead?” This question will be asked plenty of times to speakers at the nation’s largest gathering of...
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