GlobalData on MSN

Co-Diagnostics files FDA 510(k) for flu and RSV PCR test

The molecular diagnostics company's concurrent CLIA Waiver by Application, if granted, would allow testing in decentralised ...

Co-Diagnostics Submits FDA 510(k) Premarket Notification for Upper Respiratory Point-of-Care Test

Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that ...
Nasdaq

Roche introduces the cobas 5800, a new molecular diagnostic system to expand access to PCR testing in the U.S.

cobas 5800 is a new compact addition to the Roche molecular diagnostics portfolio that provides a scalable, high performance testing solution for labs of all sizes. Infectious diseases, such as HIV, ...
InvestorsHub on MSN

Roche expands cyclospora testing portfolio to support US public health response

Key Investor Takeaways ・Roche (USOTC:RHHBY) launched two new research-use PCR assays to expand its cyclospora testing ...
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 ...
News Medical

Revolutionising point-of-care molecular diagnostics with a sub 10 minute PCR test

Polymerase chain reaction (PCR) tests are one of the most popular diagnostic tools for the detection and diagnosis of viral diseases, such as coronavirus (COVID-19), due to their ability to rapidly ...
News Medical

Ultrafast PCR technology shortens the test time by 10-fold

PCR technology is a molecular diagnostics technology that detects target nucleic acids by amplifying the DNA amount. It has brought marked progress in the life sciences field since its development in ...
Nature

Taking syndromic PCR testing to the world

Many people will have experienced being unwell with an unknown infection and having to undergo multiple tests to determine the culprit. This sequential process of elimination can be time-consuming and ...
Morningstar

Roche rapidly develops a PCR test for Ebola within six days as rare Bundibugyo virus drives urgent need for detection

New Roche test targeting detection of Bundibugyo virus supports efforts to address critical need during ongoing outbreaks1 Roche's unique outbreak response capabilities enabled rapid development of ...
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 ...
BioWorld

Roche develops PCR test to detect the Ebola Bundibugyo virus

Roche Holding AG has rapidly developed a research-use only molecular PCR test to detect the rare Ebola Bundibugyo virus, to support response efforts amid the ongoing outbreak in the Democratic ...