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...]

HHS Announcement

The FDA Drops a Bombshell: No More EUA Review of COVID-19 LDTs

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...]

FDA Watch

Agency to Provide Emergency Clearance for Multi-Analyte Respiratory Panels

We are now seven months into the COVID-19 public health emergency and flu season is rapidly approaching. Several diagnostics test producers have responded to this convergence by creating new … [Read more...]

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...]

FDA Watch

Agency Stripped of Authority to Issue Premarket Approval of SARS-CoV-2 LDTs

The COVID-19 pandemic has exposed how the FDA’s makeshift premarket control over laboratory developed tests (LDTs) stifles innovation and keeps desperately needed new tests from reaching the market. … [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

Saliva COVID-19 Tests Offer Way Around Nasopharyngeal Swab Shortage Bottlenecks

Shortages of the nasopharyngeal swabs used to collect respiratory samples for reverse transcription polymerase chain reaction (RT-PCR) tests has impeded the efforts of laboratories to meet the … [Read more...]

Emerging Tests

FDA Offers New Guidance on Validating SARS-CoV-2 Tests in “Non-Laboratory” Settings

SARS-CoV-2 testing in homes, workplaces, airports, schools, sports venues and other non-traditional diagnostic settings is likely to play an increasingly important role in the months ahead. The FDA … [Read more...]


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