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

Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that it developed a Research Use Only (RUO) molecular PCR test, via its subsidiary TIB MOLBIOL, for use on the LightCycler® 480 I & II Systems, ...
MarketWatch

Breaking the PCR-Only Barrier: Dual 510(k) Clearance and CLIA-Waiver Establish FINDER as the First Molecular Point-of-Care Platform with Multifunctional Capabilities

The MarketWatch News Department was not involved in the creation of this content. DURHAM, N.C., March 31, 2026 /PRNewswire/ -- Baebies announced FDA 510(k) clearance and CLIA-waiver approval for the ...
11Alive

Yes, the molecular PCR test is the most accurate way to detect an active COVID-19 infection

Since the start of the COVID-19 pandemic in the United States, over 46 million positive coronavirus test results have been reported to the U.S. Centers for Disease Control and Prevention (CDC). When ...
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, ...

AMDI™ Fast PCR System Receives FDA 510(k) Clearance and CLIA Waiver for Sub-10-Minute Respiratory Panel

Autonomous Medical Devices Incorporated (AMDI) today announced that the U.S. Food and Drug Administration has granted both ...
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 ...
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 ...
TMCnet

Co-Diagnostics Hosts Kingdom of Saudi Arabia Joint Venture CoMira for Unveiling of Future Automated Manufacturing Line

(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 a delegation from ...
technologynetworks

Quidel Receives FDA Clearance for its Lyra™ Molecular PCR Assay

Quidel Corporation has announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market its Lyra Parainfluenza Assay, a real-time PCR test for the ...
News Medical

New molecular test revolutionizes fungal infection diagnosis

Certain serious fungal infections occur in regions of the United States with specific environments and are often tied to soil exposure. These infections can affect both healthy and immunocompromised ...

ABL Diagnostics Announces Renewal of U.S. Patent (US 8,859,198 B2) for Hepatitis B Genotyping and Antiviral Resistance

Reinforcing long-term IP strength in molecular diagnostics and supporting global laboratory partners WOIPPY, FRANCE, ...