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...]

Emerging Tests

Qiagen Launches Portable COVID-19 Antigen Digital Testing Hub

The rapid evolution of COVID-19 testing in response to the need for speed and mobility continues. One notable development on the antigen testing front is Qiagen’s U.S. rollout of a portable digital … [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...]

The Business of Testing

HHS Orders FDA to Resume EUA Review of Laboratory Developed Tests for COVID-19

Oh no you don’t! A month after the U.S. Food and Drug Administration (FDA) announced its decision to discontinue review of applications for Emergency Use Authorization (EUA) submitted by test makers … [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...]

Daily Update

Tests with EUA

COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION ((s) = Serology Test (a) = Antigen Test (t) = Total Antibody Test (m) = Multi-analyte Test) Date Manufacturer(s) Test … [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...]

Tool

Model Substance Abuse and Fitness for Duty Policy

Workplace substance abuse remains a major challenge for labs. Although sound in principle, the traditional zero tolerance policy is ill-suited to the legal complexities of the modern world. This is … [Read more...]

Point of Care

New Low-Cost Sensor Offers Promising Test for Rapid, At Home COVID-19 Testing

Laboratory companies and scientists are working furiously to produce the rapid, point of care testing technology needed to prevent asymptomatic people from spreading SARS-CoV-2. And in a promising new … [Read more...]


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