Category: Infectious Diseases

Infectious Diseases

Common Lyme Disease Tests Miss Majority of Early Cases, Study Finds

New research indicates that standard and modified two-tiered testing algorithms fail to detect infection in up to 78% of patients during the early stages of the disease.

Infectious Diseases

Blood Test May Improve Risk Assessment for HPV-Related Throat Cancer

Research identifies how circulating tumor DNA can inform personalized treatment and surveillance strategies.

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

Infectious Diseases

FDA Grants Breakthrough Device Designation to MeMed’s Capillary Blood Infection Test

The FDA has granted Breakthrough Device Designation to MeMed BV Flex, an AI-powered capillary blood test designed to distinguish bacterial from viral infections in 15 minutes using host-response biomarkers.

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

Visby Medical Partners with Watchmaker Genomics for At-Home Respiratory Testing

Visby Medical and Watchmaker Genomics have partnered to develop at-home PCR respiratory tests designed to overcome molecular inhibitors found in unprocessed clinical samples, according to a joint announcement.

Gastrointestinal Infections

FDA Clears Cepheid’s Multiplex GI Pathogen Panel

The PCR test detects 11 bacterial, viral, and parasitic pathogens from a stool sample in approximately 74 minutes.

Sexually Transmitted Diseases

Nexus Medical Labs Partners with Lybe Scientific for Nucleic Acid Extraction Technology

Nexus Medical Labs will implement Lybe Scientific’s NAxtra nucleic acid extraction kit in a 60,000-plus test unit deal to enhance high-throughput STI testing, citing improved detection limits and workflow efficiency.