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...]

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...]

Reimbursement

CMS Disguises COVID-19 Rate Cut as Incentive to Process Tests Faster

Few would argue that the current turnaround time for COVID-19 testing is too long. But there are good reasons why it’s taking labs so long to process and report test results, including unprecedented … [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...]

Testing Strategy

Saliva and Oral Swabs Emerge as Scalable Alternative to Nasopharyngeal SARS-CoV-2 Testing

The standard method for detecting upper respiratory viruses is to perform tests on tissue sample from the back of the sinus cavity collected by inserting a long nasopharyngeal swab deep into the … [Read more...]

LDTs

FDA Pulls the Plug on EUA Review of Laboratory Developed Tests for COVID-19

On Oct. 9, the U.S. Food and Drug Administration (FDA) dropped a bombshell by announcing that it would no longer review applications for Emergency Use Authorization (EUA) submitted by test makers for … [Read more...]

LDTs

FDA Pulls the Plug on EUA Review of COVID-19 LDTs

Companies like Quest, LabCorp and others have been in the forefront of pandemic response by creating innovative new laboratory diagnostic tests (LDTs) for detecting the SARS-CoV-2 virus. The FDA has … [Read more...]

Industry Buzz

Market for LDTs Expected to Top $17 Billion by 2025

Even as the battle over FDA regulatory control over laboratory developed tests (LDTs) intensifies, the economic stakes get bigger. The current market value for LDTs is $12 billion. But a new report … [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...]


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