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 ...
PharmiWeb

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

Global Molecular Infectious Disease Testing Market OverviewThe global Molecular Infectious Disease Testing Market encompasses ...
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, ...
Seeking Alpha

Roche launches next-generation qPCR system to advance clinical needs in molecular diagnostics and address public health challenges

The LightCycler PRO System is designed to be the most advanced qPCR technology for both clinical diagnostics and research. The new system will advance personalised healthcare and support outbreak ...
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 ...

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

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 ...
Becker's Hospital Review

Closing the Rural Diagnostic Gap with Next-Morning PCR Tests for Infections

Patients in rural communities often lack timely access to innovative infectious disease testing because diagnostic laboratories are located far away. Long transport times and logistical barriers delay ...
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 ...

Axonia Medical Acquires 51% Stake in Dipylon Medical in Strategic Move to Scale Global Molecular Diagnostics Platform

Backed by strong diagnostics market growth and industry consolidation, the transaction positions Axonia Medical to expand ...
Medical Device Network on MSN

Co-Diagnostics delivers PCR Pro instruments and TB kits to India

The development aligns with recent guidance from the WHO concerning tuberculosis molecular diagnostics in India.