FDA Watch

Agency Authorizes First Fully At-Home COVID-19 Testing Kit

With COVID-19 cases surging, the U.S. Food and Drug Administration (FDA) made history on Nov. 17 by granting Emergency Use Authorization (EUA) to an all-in-one COVID-19 diagnostic that allows people … [Read more...]

Lab Safety

“COVID captains” promote safety precautions

By Dan Scungio bio The year 2020 is roaring to a close, and COVID-19 is unfortunately still around. We have made changes to our lives at home, in public, and at work. Lab workers and other … [Read more...]

Innovation

New Artificial Intelligence-Based Risk Score May Help Avoid Unnecessary COVID-19 Hospitalizations

Researchers at Massachusetts General Hospital (MGH) have developed a diagnostic tool that uses artificial intelligence to generate a score to assess the prognosis of individual patients diagnosed with … [Read more...]

DTC

Research Supports Viability of Using Health Data from Consumer Wearables to Diagnose COVID-19

  That Fitbit, smartwatch or other device that many of us wear around our wrist to count our steps, calories burned and other fitness metrics on a daily basis may prove to be an ideal tool for … [Read more...]

NPR Report

CDC Knowingly Sent Flawed COVID-19 Test Kits to Public Laboratories in Early Days of Crisis

Early missteps characterized the federal government’s initial efforts to ensure a supply of reliable COVID-19 diagnostic tests in response to the public health emergency. And now a new National Public … [Read more...]

Industry Trends

Surging COVID-19 Cases Are Pushing Laboratories to the Breaking Point

Long lines for testing. Shortages of critical testing supplies. Case backlogs and long reporting delays. Laboratories across the country and the patients they serve are reliving the nightmares of … [Read more...]

COVID-19

CDC Knowingly Shipped Flawed COVID-19 Test Kits to Public Labs in Early Days of Crisis, Says Report

Early missteps characterized the federal government’s initial efforts to ensure a supply of reliable COVID-19 diagnostic tests in response to the public health emergency. And now a new National Public … [Read more...]

FDA Watch

Agency Temporarily Allows Modifications of Influenza and RSV Tests Without Premarket Notification

On Oct. 13, the U.S. Food and Drug Administration issued new guidance on molecular diagnostic tests for influenza and respiratory syncytial virus (RSV). The upshot of the guidance is to temporarily … [Read more...]

Public Health

Total Shipments of Molecular COVID-19 Tests Top 200 Million Mark

As of Oct. 16, total U.S. shipments of COVID-19 molecular diagnostic tests have topped the 200 million mark, according to the AdvaMed COVID-19 Diagnostic Supply Registry (Registry). On average, … [Read more...]

COVID-19

Leading Lab Organizations Ask White House to Resolve COVID-19 Testing Supplies Shortages

COVID-19 lab testing supplies have been a bottleneck from the moment the public health emergency began. But what’s less well understood is that the supplies problems stem not just from the lack of … [Read more...]


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