FDA Grants Breakthrough Device Designation for Hemoglobin Variant Test
The test uses miniaturized electrophoresis technology designed to enable decentralized access to quantitative hemoglobin data.
The test uses miniaturized electrophoresis technology designed to enable decentralized access to quantitative hemoglobin data.
The compact, fully automated hemostasis analyzers are designed for routine testing environments and as a reliable backup instrument in larger labs.
AI, new diagnostics, and shifting care delivery models are among the clinical laboratory predictions for 2026.
Peer-reviewed study found 98% concordance between Techcyte's digital workflow and brightfield microscopy in routine clinical laboratory testing.
The collaboration will provide urologists and oncologists nationwide access to AI-powered tools for non-muscle invasive bladder cancer management.
The all-in-one diagnostic platform combines hematology, biochemistry, and immunoassay testing in a single run.
The company's cell analyzer will enable the investigation of 30-plus cellular characteristics to capture key biological insights and support a planned 1,000-person immune profiling study.
Fast, patient-specific blood test results during surgery can help clinicians decide when transfusions are truly needed.Â
The qPCR-based test detects variants that increase risk of severe fluoropyrimidine chemotherapy toxicity.
A 44-metabolite blood test signature identified by Mass General Brigham and Einstein researchers improved type 2 diabetes risk prediction in a study of over 23,000 participants, according to Nature Medicine.
The exsig Mag RapidBead Pro kit features a four-step workflow that reduces extraction time to under 20 minutes.
Bridge Capture, a targeted NGS method, showed higher sensitivity for detecting rare ctDNA variants than two leading liquid biopsy assays, according to research in The Journal of Molecular Diagnostics.
The cobas liat system delivers PCR results in 15 minutes, detecting and differentiating between three Bordetella pathogens including whooping cough.
New recommendations address evolving drug landscape and advancing testing technologies since original 2003 guidance.