EUA

FDA to Issue Emergency Use Authorization for Multi-Analyte Respiratory Panels During the Pandemic

The convergence of flu season with the global COVID-19 pandemic will create the need for new multi-analyte respiratory panel tests that are capable of not only detection of but also differentiation … [Read more...]

LDTs

FDA Breaks New Ground by Authorizing SARS-CoV-2 Tests for Sample Pooling

It’s not uncommon for the FDA to revise the Emergency Use Authorization (EUA) for a particular diagnostics test to permit a new clinical use. In most cases, these expansions don’t even get an official … [Read more...]

FDA Watch

FDA Warns of False-Positives from Becton Dickinson SARS-CoV-2 Test & Reagents

July 6 was a tough day for Becton Dickinson (BD) when the FDA issued a warning letter alerting clinical lab staff and providers of the increased risk of false-positive results from the New … [Read more...]

LDTs

FDA Provides New Guidance on Validation of Sample Pooling for SARS-CoV-2 Test Development   

On June 16, the FDA issued new guidance to help labs and commercial manufacturers use test sample pooling to develop, validate and acquire Emergency Use Authorization (EUA) of qPCR-based SARS-CoV-2 … [Read more...]

Medicare Reimbursement

New CMS Waivers Dramatically Expand Coverage Rules for COVID-19 Testing

CMS doesn’t want the usual compliance red tape to stand in the way of desperately needed COVID-19 testing. So, on May 1, the agency issued regulatory waivers temporarily expanding coverage of testing … [Read more...]

Focus On

Nearly 3 in 4 Physicians Say They Can’t Provide Easy & Rapid COVID-19 Testing

Development of new lab tests to detect the SARS-CoV-2 virus that causes COVID-19 coronavirus has been faster and more prolific than anybody could dare expect for a pathogen that was unknown just a few … [Read more...]

The Coronavirus Crisis

Test-Now, Regulate-Later Strategy Generates Robust Dx Test Pipeline in Record Time

Historically, the lag between Public Health Emergency (PHE) declaration and FDA approval of a lab test to diagnose the pathogen has been a minimum of eight weeks. Eight weeks into the coronavirus PHE, … [Read more...]

LDTs

VITAL Act Would Eliminate FDA Regulation of New Tests During Health Emergencies

In standing aside and allowing test makers to validate and perform COVID-19 laboratory developed tests (LDTs) and not wait for Emergency Use Authorization (EUA), the FDA has actually acknowledged what … [Read more...]

Reimbirsement

Congress Calls on Insurers to Cover Coronavirus Testing without Charging Patients

As labs scramble to come up with a coronavirus detection assay and CMS creates a billing and coding regimen, Congress is working to ensure that private payors provide coverage of SARS-CoV-2 testing. … [Read more...]

ACLA

Lab industry leaders meet with White House on COVID-19 testing

The American Clinical Laboratory Association (ACLA) has issued a statement following a meeting last week with the White House's Coronavirus Task Force. Here is a statement from ACLA President Julie … [Read more...]


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