Category: Infectious Diseases

Infectious Diseases

FDA Clears Rapid Molecular Test for Group A Strep

The point-of-care assay provides results in 15 minutes and received a waiver for use in decentralized settings.

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

CDC Lists Dozens of Infectious Disease Tests as Unavailable in Lab Directory

Thirty-one test orders are currently listed as unavailable, requiring labs to seek alternative testing pathways or coordinate with public health partners.

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

HIV Self-Test Receives Health Canada License

The HIV self-test has received Health Canada approval, making it the first oral HIV self-test available in Canada. Results are provided in 20 minutes with an oral swab.