abc7NY

Coronavirus Update: Abbott molecular COVID-19 test gets results in minutes

NEW YORK CITY (WABC) -- It could be a game changer in COVID 19 testing: A company with offices in the Tri-State area received emergency authorization from the FDA for a test that could get results ...
Business Insider

Enzo Announces its GENFLEX™ Molecular Test Detects Current COVID-19 Variants

Results indicate that GENFLEX meets new FDA guidance calling for COVID-19 test developers to assess the impact of viral mutations on testing results Company also publishes new corporate white paper ...
MobiHealthNews

FDA gives Cue Health first EUA for at-home, OTC COVID-19 molecular testing

The FDA has issued its first emergency use authorization for a COVID-19 molecular diagnostic test that does not require a prescription and can be used at home. Developed by Cue Health, the Cue ...
Business Wire

Minute Molecular’s DASH Point-of-Care COVID-19 Rapid PCR Test Gains FDA Emergency Use Authorization

EVANSTON, Ill.--(BUSINESS WIRE)--Minute Molecular Diagnostics today announced that the U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for its rapid DASH ...
Business Wire

Anavasi Diagnostics Receives FDA Emergency Use Authorization for The AscencioDx COVID-19 Test and The AscencioDx Molecular Detector

REDMOND, Wash.--(BUSINESS WIRE)--Anavasi Diagnostics, an NIH/RADx funded medical technology company developing novel molecular diagnostic testing for the point-of-care (POC) market, announced the Food ...
Nasdaq

Cue Health Receives De Novo Authorization From FDA For COVID-19 Molecular Test

(RTTNews) - Cue Health (HLTH), has receive De Novo authorization from the U.S. Food and Drug Administration for its Cue COVID-19 Molecular Test, designed for both home and point-of-care use. This is ...
San Diego Union-Tribune

San Diego’s Cue Health had the first FDA-approved home COVID-19 test. Now the agency says to throw them out.

The U.S. Food and Drug Administration told consumers Monday to throw out any at-home COVID-19 tests made by San Diego biotech Cue Health, because they could give users false results. Early in the ...
Nasdaq

Detect’s PCR-Quality At-Home Rapid Covid-19 Test Now Available for Purchase on Detect.com

FDA-authorized test for home use is the most affordable PCR-quality rapid test on the market and at least 50 times more sensitive than leading rapid antigen tests Detect’s FDA authorized PCR-quality ...
Labroots

New Breath Test Quickly Detects COVID-19 With a Few Puffs

Scientists from Washington University in St. Louis (WUSTL) recently developed an air monitor that can detect particles of SARS-CoV-2, the virus that causes COVID-19. The technology was reported in ...
The New York Times

First At-Home Combination Test for Flu and Covid Is OK’d by the F.D.A.

But the company that created the 30-minute, over-the-counter test has filed for bankruptcy, so the product’s eventual availability to consumers remains unclear. By Christina Jewett and Emily Anthes ...
Benzinga.com

Cue’s Scalable Platform Can Meet the Needs of a $180 Billion Diagnostics Market

The global diagnostics market was valued at approximately $180 billion in 2022 and is projected to grow to over $348 billion by 2030. Some of the key drivers of that growth are molecular diagnostics ...