DPYD Genotyping Assay Receives FDA Breakthrough Device Designation
The qPCR-based test detects variants that increase risk of severe fluoropyrimidine chemotherapy toxicity.
Read MorePosted by CLP Edit Staff | Oct 31, 2025 | Immunoassay Reagents & test Kits |
The qPCR-based test detects variants that increase risk of severe fluoropyrimidine chemotherapy toxicity.
Read MorePosted by CLP Edit Staff | Oct 28, 2025 | Tuberculosis |
Single-button device designed to streamline workflow for PCR tuberculosis diagnostics in resource-limited settings, with potential deployment across India’s primary health centers.
Read MorePosted by CLP Edit Staff | Oct 28, 2025 | Company News |
The laboratory services company updates full-year guidance following continued momentum in diagnostics and central laboratory businesses.
Read MorePosted by CLP Edit Staff | Oct 27, 2025 | Sexually Transmitted Diseases |
Electrochemical biosensor aims to simultaneously detect HIV, Hepatitis B, and Hepatitis C in resource-limited settings using RNA-level identification.
Read MorePosted by CLP Edit Staff | Oct 27, 2025 | Molecular Diagnostic Analyzers |
The designation accelerates regulatory review for GeneDx’s ExomeDx and GenomeDx testing platforms designed to diagnose rare diseases.
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