Category: Infectious Diseases

Infectious Diseases

Rapid Molecular Test for Flu and COVID-19 Gets FDA Clearance and CLIA-Waiver

The point-of-care platform with multifunctional capabilities provides results in as little as 15 minutes.

FDA Grants CLIA Waiver for Rapid Test That Differentiates Bacterial and Non-Bacterial Respiratory Infections
Roche Launches Respiratory Pathogen Panel With Flexible Syndromic Testing for CE Markets
Breath Test Using Carbon Isotopes May Quickly Confirm Bacterial Infections
Antibody Test for Mpox Validated During Active Outbreak in Rwanda
WHO Recommends Near-Point-of-Care Molecular Tests, Tongue Swabs, and Sputum Pooling for Tuberculosis Diagnosis
FDA Grants Breakthrough Device Designation to MeMed’s Capillary Blood Infection Test
CRISPR Discovery Could Enable Single Test for COVID, Flu, RSV
CDC Selects Cepheid as National Collaborator for Rapid Diagnostic Development
Trinity Biotech Receives Final Regulatory Approval for HIV Test Manufacturing Model

Infectious Diseases

FDA Grants Breakthrough Status to Two Rapid Tests for Drug-Resistant Infections

The FDA has granted Breakthrough Device Designations to two 15-minute rapid tests for detecting Candida auris and carbapenem-resistant Acinetobacter baumannii, both identified by WHO as critical priority pathogens.

Infectious Diseases

Plasma Test Launches for Rapid Detection of Mold Infections

The plasma-based test detects cell-free DNA from 14 mold species and delivers results in less than 24 hours, according to the company.

Emerging & Zoonotic Diseases

Molecular Platform Shows Promise for Detecting Asymptomatic Malaria Cases

A field-deployable test demonstrates high sensitivity in identifying low-level infections that traditional methods miss, potentially supporting elimination efforts.

Flu & Respiratory Infections

Co-Diagnostics Confirms Flu Test Performance Against This Season’s H3N2 Strain

In silico analysis of 3,900 influenza sequences shows comparable sensitivity for the test against the subclade K variant currently circulating.

Gastrointestinal Infections

DiaSorin Seeks FDA Clearance for Customizable GI Pathogen Panel

The Liaison Plex Gastrointestinal Flex Assay detects 24 targets and offers broad parasite coverage with pay-per-target flexibility.

Sexually Transmitted Diseases

Rapid Syphilis Tests Show Economic, Clinical Benefits for High-Risk Populations

Monash University study finds different testing algorithms work best for pregnant women versus men who have sex with men.