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 ...
WRAL

Rapid COVID-19 tests: What are they and where do I get one?

More rapid coronavirus tests are now available North Carolina, delivering results in minutes, not days. Doctors at Avance Primary Care said they have plenty of the antigen rapid tests, which yield ...
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 ...
Business Insider

Cue’s Molecular, Point-of-Care COVID-19 Tests Deployed to Five States in HHS and DOD Pilot Program

SAN DIEGO, Nov. 19, 2020 (GLOBE NEWSWIRE) -- Cue Health Inc. (Cue) announced today that, as of November 9, the U.S. Department of Health and Human Services (HHS) began deploying its molecular, ...
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 ...
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 ...
WTEN

Lucira Health Announces FDA Authorization of Combination COVID-19 & Flu Test at Point-of-Care

PCR Lab-quality NAAT/molecular test for both COVID-19 and flu from 1 shallow nasal swab Positive result as quickly as 11 minutes, negative result in 30 minutes, allowing diagnosis during patient visit ...
SlashGear

The COVID-19 Test The FDA Now Says You Can't Trust

San Diego-based medical tech company, Cue Health, bragged about receiving an industry-first De Novo authorization from the U.S. Food and Drug Administration (FDA) for its at-home COVID-19 test kit.
The Manila Times

Healgen Scientific Spotlights the Rapid Check® COVID-19/Flu A&B Antigen Test to Help Families Stay Prepared for the Respiratory Virus Season

As the holiday season approaches, gatherings among family and friends are expected to increase the risk of respiratory virus ...
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 ...
SUNY Cortland

President shares pre-arrival COVID-19 testing details

I am reaching out to you with an important reminder about pre-arrival COVID-19 testing. The following students will need to submit a negative COVID-19 test within five days of their return to campus: ...