Emerging Tests

New Collaboration Seeks to Develop Handheld Breathalyzer Test for COVID-19

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...]

Inside the Lab Industry

Abbott and Quidel Stake Out Early Claims for Leadership of SARS-CoV-2 Rapid Antigen Testing Market

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

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

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

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

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

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

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...]


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