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 ...
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 ...
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 ...
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 ...
MedPage Today

Novel At-Home Test Diagnoses STIs With 'Lab-Equivalent' Accuracy

A novel at-home molecular test proved highly accurate for diagnosing three common sexually transmitted infections (STIs) in females, according to a clinical study from the test's manufacturer. The ...

Countable Labs Brings Innovative, Single-Molecule, Counting-Based PCR to European Markets with CE Mark Clearance

Countable Labs achieves CE marking for its Countable 4 Platform, bringing innovative, single-molecule, counting-based PCR to European markets.