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(R) Flu A&B/SARS-CoV-2 Test, an ultra-rapid RT-PCR assay on the FINDER platform. This establishes FINDER as the first ...
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 ...
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 ...
The Daily Northwestern

Northwestern and Minute Molecular collaborate on potential PCR test for monkeypox

Northwestern spinoff company Minute Molecular Diagnostics is collaborating with the University to develop a monkeypox PCR test. The test could provide positive or negative monkeypox results in about ...
Treasure Coast Newspapers

COVID testing FAQs: Your guide to home, over-the-counter antigen and molecular test kits

Assuming you can get your hands on a COVID-19 home test kit — they’ve been in high demand, thanks to the omicron variant — you probably have questions. Am I testing too early or late? Is this brand or ...
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.
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.

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, ...
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 ...
News Medical

New PCR test uses molecular beacons to identify the specific variant causing COVID-19 infection

After the start of the SARS-C0V-2 pandemic, investigators from ResearchPath LLC and their collaborators at Rutgers University quickly dedicated resources to develop accurate and reliable COVID-19 ...

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 ...