On Oct. 13, the U.S. Food and Drug Administration issued new guidance on molecular diagnostic tests for influenza and respiratory syncytial virus (RSV). The upshot of the guidance is to temporarily … [Read more...]
FDA Watch
Agency Temporarily Allows Modifications of Influenza and RSV Tests Without Premarket Notification
November 3, 2020
LDTs
FDA Pulls the Plug on EUA Review of Laboratory Developed Tests for COVID-19
November 2, 2020
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
November 2, 2020
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
October 29, 2020
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
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...]
Technology
CMS Proposes Clarified Medicare Coverage “Reasonable and Necessary” Criteria for Breakthrough Devices
September 17, 2020
On Sept. 1, CMS proposed a new rule that would, among other things, shed some light on an issue that has been a perennial compliance and reimbursement stumbling block for developers of new lab tests: … [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
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...]
LDTs
HHS Clears the Way for Use of New COVID-19 Tests without FDA Emergency Use Authorization
August 29, 2020
One of the unforeseen results of the coronavirus public health emergency has been to bring the perennial controversy over U.S. Food and Drug Administration (FDA) premarket regulation of laboratory … [Read more...]
