A handheld, easy-to-use breathalyzer device capable of accurately detecting COVID-19 at the point of care would represent a major breakthrough in the effort to contain the spread of the virus. That … [Read more...]
Emerging Tests
New Collaboration Seeks to Develop Handheld Breathalyzer Test for COVID-19
January 6, 2021
Inside the Lab Industry
Abbott and Quidel Stake Out Early Claims for Leadership of SARS-CoV-2 Rapid Antigen Testing Market
January 6, 2021
What COVID-19 antigen assays lack in accuracy with regard to RT-PCR testing is offset by their speed, low cost and scalability. In the long term, these advantages make point-of-care COVID-19 antigen … [Read more...]
FDA Watch
Agency Authorizes First Fully At-Home COVID-19 Testing Kit
December 2, 2020
With COVID-19 cases surging, the U.S. Food and Drug Administration (FDA) made history on Nov. 17 by granting Emergency Use Authorization (EUA) to an all-in-one COVID-19 diagnostic that allows people … [Read more...]
Industry Buzz
HHS to FDA: Resume EUA Review of COVID-19 LDTs, And Do It Fast
December 1, 2020
The controversy over FDA Emergency Use Authorization (EUA) of laboratory developed tests (LDTs) for COVID-19 is on high boil once more. A month after the agency announced it would no longer review … [Read more...]
The Business of Testing
HHS Orders FDA to Resume EUA Review of Laboratory Developed Tests for COVID-19
November 24, 2020
Oh no you don’t! A month after the U.S. Food and Drug Administration (FDA) announced its decision to discontinue review of applications for Emergency Use Authorization (EUA) submitted by test makers … [Read more...]
FOCUS ON
What a Biden Administration Might Portend for Regulation of Laboratory Developed Tests
November 17, 2020
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...]
FDA Watch
Agency Temporarily Allows Modifications of Influenza and RSV Tests Without Premarket Notification
November 3, 2020
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...]
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...]
