The roller coaster that has become FDA regulation of laboratory developed tests (LDTs) is about to get even more topsy-turvy now that Joseph Biden has been elected President of the United States. … [Read more...]
FOCUS ON
What a Biden Administration Might Portend for Regulation of Laboratory Developed Tests
November 17, 2020
HHS Announcement
The FDA Drops a Bombshell: No More EUA Review of COVID-19 LDTs
October 19, 2020
Perhaps one of the only positive things to come out of the COVID-19 crisis has been its exposure of the flaws in the FDA’s ham-handed system (if it can be called a system) of premarket regulation of … [Read more...]
EUA
FDA to Issue Emergency Use Authorization for Multi-Analyte Respiratory Panels During the Pandemic
September 17, 2020
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
September 8, 2020
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 20, 2020
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
July 20, 2020
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
May 24, 2020
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
April 17, 2020
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
April 17, 2020
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
April 13, 2020
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...]
