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...]
FDA Watch
Agency Stripped of Authority to Issue Premarket Approval of SARS-CoV-2 LDTs
September 9, 2020
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
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
Saliva COVID-19 Tests Offer Way Around Nasopharyngeal Swab Shortage Bottlenecks
September 4, 2020
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
August 20, 2020
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...]
FDA Watch
Agency Green Lights First SARS-CoV-2 Tests for Sample Pooling
August 20, 2020
Revising an Emergency Use Authorization (EUA) to permit a new clinical use is usually pretty routine stuff. But the expanded EUA the FDA announced on July 18 was both unprecedented and significant … [Read more...]
FDA Watch
Agency Sounds the Warning on False-Positives from Becton Dickinson SARS-CoV-2 Reagents
August 12, 2020
On July 6, the U.S. Food and Drug Administration (FDA) issued a warning letter alerting clinical laboratory staff and providers of the increased risk of false-positive results from Becton Dickinson … [Read more...]
LDTs
FDA Cracks Down on Improper Marketing of SARS-CoV-2 Antibody Tests
August 7, 2020
Bloated and unsubstantiated marketing claims about the capabilities of unproven serologic SARS-CoV-2 antibody tests have been a problem almost since the public health emergency began. After playing … [Read more...]
