Industry Buzz

HHS to FDA: Resume EUA Review of COVID-19 LDTs, And Do It Fast

The controversy over FDA Emergency Use Authorization (EUA) of laboratory developed tests (LDTs) for COVID-19 is on high boil once more. A month after the agency announced it would no longer review … [Read more...]

REIMBURSEMENT

Labs and Private Payors Clash Over Reimbursement of COVID-19 Testing

Things are getting ugly. The unfortunate convergence of resurgent COVID-19 cases, lingering testing supply bottlenecks and Thanksgiving are once more stretching labs to the breaking point and fraying … [Read more...]

Consumer Fraud

OIG Warns Medicare Beneficiaries Not to Fall for COVID-19 Scams

Pharma companies, diagnostics manufacturers, labs and other parts of the healthcare industry have done a commendable job in pivoting in response to the current public health industry. Sadly, it seems … [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...]

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...]

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...]


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