Nearly 250 COVID-19 diagnostic tests have gotten Emergency Use Authorization (EUA) from the FDA since the pandemic started. Almost all of them have been prescription products. In addition, 25 test … [Read more...]
FDA Watch
Agency Authorizes First OTC All-in-One At-Home COVID-19 Testing Kit
January 6, 2021
Since the pandemic began, the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for more than 225 COVID-19 diagnostic tests. Among these, 25 have been cleared for … [Read more...]
FDA
Neutralizing Antibodies Detection Test for COVID-19 Gets the FDA Greenlight
January 4, 2021
Innovative new COVID-19 tests continue to emerge from the pipeline. One of the products that has flown slightly under the radar is the cPass SARS-CoV-2 Neutralization Antibody Detection Kit from … [Read more...]
FOCUS ON
The Year in Labs Regulation: The 9 Biggest Stories of 2020
December 20, 2020
When 2020 started, COVID-19 was just a news story unfolding on the other side of the globe in China. The novelty of the pathogen meant that there were no tests specifically targeting the virus on the … [Read more...]
FDA Watch
Lucira Health Secures First EUA for Fully At-Home COVID-19 Testing Kit
December 2, 2020
Although the FDA has previously authorized COVID-19 diagnostic tests for at-home sample collection, it had never before granted Emergency Use Authorization (EUA) for an all-in-one diagnostic kit that … [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 5, 2020
On Oct. 13, the FDA issued new guidance on molecular diagnostic tests for influenza and respiratory syncytial virus (RSV). The upshot of the guidance is to temporarily allow makers of flu and RSV … [Read more...]
