FDA clears Cepheid’s Xpert GI Panel for pathogen detection

The Xpert GI Panel identifies pathogens directly from stool specimens collected in Cary-Blair transport media.

Cepheid Receives FDA Clearance for Xpert® GI Panel to Support Broad Detection of Gastrointestinal Pathogens

Cepheid announced today that it has received FDA clearance for Xpert GI Panel, a multiplex PCR test designed to provide fast ...
360Dx

Cepheid Enters Rapid Syndromic Testing Space With FDA Clearance of GI Panel

The Danaher subsidiary aims to meet clinician needs for flexibility with a range of test size options for its vast installed base.
PharmiWeb

Visby Engages Quest and Labcorp to Broaden Consumer Access to First At-Home, FDA-Authorized PCR Test for STIs

Consumers Now Have More Choices to Purchase the Visby Device Featuring 30-Minute, Lab-Quality ResultsSAN JOSE, Calif.--(BUSINESS WIRE)--Today, Visby Medical announced two new relationships that will ...
Yahoo

Roche’s test for Bordetella infections gains FDA clearance

Add Yahoo as a preferred source to see more of our stories on Google. Roche’s test is intended for diagnosing pertussis and other Bordetella infections. Credit: Hafizgnwn / Shutterstock.com.

At-home STD tests offer new options for screening and treatment

New options for testing and treating some of the most common sexually transmitted diseases are becoming available.
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Co-Diagnostics Initiates Clinical Evaluations for Upper Respiratory Multiplex Point-of-Care Test on Co-Dx™ PCR Platform to Support Submission to the U.S. FDA

SALT LAKE CITY, Nov. 18, 2025 /PRNewswire/ --Co-Diagnostics, Inc. (Nasdaq: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of ...
360Dx

Nuclein HCV Test Proof of Concept Highlights Advantages of Firm's Rapid Molecular Testing System

A recent blood-based hepatitis C virus assay on Nuclein's DASH system highlighted its on-device sample prep, among other features that have been driving its adoption.