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

Baebies announced FDA 510(k) clearance and CLIA-waiver approval for the FINDER® Flu A&B/SARS-CoV-2 Test, an ultra-rapid ...
PharmiWeb

Molecular Infectious Disease Testing Market: Growth, Innovations, and Opportunities

Global Molecular Infectious Disease Testing Market OverviewThe global Molecular Infectious Disease Testing Market encompasses ...
Crain's Chicago Business

FDA approves rapid PCR tests from Northwestern biotech spinout

Minute Molecular Diagnostics, a biotech spinout from Northwestern University that says it’s created rapid PCR COVID-19 tests, has received emergency use authorization for its product from the U.S.
The Verge

Behind the high-tech COVID-19 tests you probably haven’t heard about

If you buy something from a Verge link, Vox Media may earn a commission. See our ethics statement. is a senior reporter and author of the Optimizer newsletter. She has more than 13 years of experience ...
The American Journal of Managed Care

Combined Diagnostic Approach Improves Accuracy in Differentiating Eczema From Psoriasis

Combining traditional dermatopathology with PCR-based molecular testing improves diagnostic accuracy in differentiating ...
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 ...
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, ...

GeneProof Announces CMV IVDR Launch on the myCROBE(TM) Fully Automated System for Transplant Care

MC PCR Kit is now available under the European Union's In Vitro Diagnostic Regulation (IVDR) on the myCROBE platform. The assay meets the stringent requirements of Regulation (EU) 2017/746, ...
GEN

Benefits of PCR-Based Molecular Diagnostics

In vitro diagnostics (IVD) is an umbrella term for tests conducted on blood or tissue samples to detect diseases, determine the efficacy of novel or established treatments, and monitor health.
mccormick.northwestern.edu

Monkeypox Rapid PCR Test in Development

Last spring, a rapid polymerase chain reaction (PCR) test for COVID-19 — developed by Northwestern University spinoff company Minute Molecular Diagnostics — received emergency use authorization (EUA) ...

Molecular Diagnostics Market Size is Expected to Reach USD 43.50 Billion by 2035 Owing to the Surging Demand for Accurate and Early Disease Detection Globally | SNS Insider

U.S. Molecular Diagnostics Market size was valued at USD 5.0 Billion in 2025 and is projected to reach USD 8.07 Billion by 2035 due to increasing chronic diseases in the country.Austin, April 03, 2026 ...