Category: Infectious Diseases

Infectious Diseases

FDA Clears QIAGEN Bloodstream Infection Panel

QIAGEN has received FDA clearance for its QIAstat-Dx BCID GPF Plus AMR Panel, enabling detection of 20 pathogens and 10 antimicrobial resistance markers from positive blood cultures in about one hour.

Infectious Diseases

Revvity Developing Automated Platform for Tuberculosis Testing

Revvity is developing the T-SPOT A201, an automated platform for latent tuberculosis testing in high-volume labs, with planned launch in 2027 pending regulatory approval.

Infectious Diseases

Roche Develops Rapid PCR Test for Rare Ebola Bundibugyo Virus

Roche has developed a rapid PCR assay for the rare Ebola Bundibugyo virus, enabling research-use detection within six days to support outbreak response in Central and East Africa, according to the company.

Emerging & Zoonotic Diseases

Andes Virus Shifts Hantavirus Conversation for US Labs

Emerging Andes virus cases—capable of person-to-person transmission—are prompting US clinical labs to reassess hantavirus protocols and consider travel and epidemiologic exposures beyond rodent contact.

Flu & Respiratory Infections

FDA Clears Rapid PCR System for Rapid Respiratory Virus Testing

The system simultaneously detects RSV, influenza A and B, and SARS-CoV-2 from a nasal swab in under 10 minutes.

Gastrointestinal Infections

bioMérieux Seeks FDA Clearance for Updated Gastrointestinal Testing Panels

The new molecular panels are designed to detect up to 22 pathogens in one hour with enhanced norovirus detection.

Sexually Transmitted Diseases

LotusDx Opens R&D Lab to Develop At-Home STI Tests

The facility will support the clinical validation of diagnostic kits that provide results via a mobile app without the need for laboratory processing.