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 ...

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 ...

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 ...

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 ...

In September 2020, the SD Biosensor STANDARD Q COVID-19 Ag Test became the first rapid antigen test ever listed under WHO’s ...

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 ...

SPRINGFIELD, Mass. (WWLP) – COVID-19 hospitalizations are steadily rising in Massachusetts, as a new variant leads to an increase in cases nationwide. Free at-home COVID tests are back: Here’s how to ...

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 Food and Drug Administration is making it easier for people to simultaneously test themselves for COVID-19 and the flu at home. The agency this week authorized the Healgen Scientific's Rapid Check ...

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 ...

ZURICH, May 27 (Reuters) - Swiss drugmakers Novartis (NOVN.S), opens new tab and Molecular Partners (MOLN.S), opens new tab said on Thursday they will start clinical trials for an investigational ...