Category: Infectious Diseases

Infectious Diseases

Fighting Antimicrobial-Resistant HAIs

Diagnostics are key to preventing and controlling this growing global threat.

Infectious Diseases

Extraction-Free Direct RT-PCR Test for Covid-19

BioGX’s high-throughput RT-PCR test for covid-19 has been submitted for FDA EUA.

Infectious Diseases

FDA Clears Molecular Diagnostic for Group B Strep

Providing accurate results in approximately 90 minutes with a specimen from enriched Lim broth, the molecular assay targets a highly conserved region of the CAMP factor gene cfb.

Emerging & Zoonotic Diseases

The Challenge of Lyme

This rapidly emerging bacterial infection needs new diagnostics.

Flu & Respiratory Infections

FDA Issues New Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests

The FDA has issued and immediately implemented a new guidance: Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.

Gastrointestinal Infections

Study Offers Promise for Early Detection of Infections among Childhood Leukemia Patients

A noninvasive blood test may provide a ‘crystal ball’ for early detection of infections, leading to increased cure rates among pediatric leukemia patients.

Sexually Transmitted Diseases

FDA Approves Expanded Use of CINtec Plus Cytology

CINtec Plus Cytology is a triage test based on biomarker technology for women with positive cervical cancer screening results for high-risk types of HPV.