The study consolidating data from six published studies confirms the test outperforms traditional pathology or clinical factors alone in identifying esophageal cancer risk.
The proposed order would shift these test systems to Class II with special controls, replacing the current PMA requirement for companion diagnostics and related oncology assays.
The system combines enhanced sensitivity with automation to detect M-proteins at low concentrations, supporting early diagnosis of plasma cell disorders.
The integration is designed to bridge specimen grossing with digital pathology workflows for improved diagnostic accuracy and efficiency.
The collaboration combines Labcorp's clinical expertise with Lunit's AI algorithms to analyze tumor microenvironments and enhance biomarker discovery.
IFCC-IOF committee publishes a tool to help laboratories evaluate 25-hydroxyvitamin D assay performance and improve clinical decision-making.
New plate-based multiplexing can profile up to 384 samples and 100 million cells per week.Â
New recommendations address testing challenges when direct oral anticoagulants interfere with coagulation assays.
The qPCR-based test detects variants that increase risk of severe fluoropyrimidine chemotherapy toxicity.
The extraction-free library preparation technology is designed to deliver full transcriptome coverage for drug screening and toxicology studies.
New clearances expand MALDI-TOF platform capabilities with improved software, faster sample prep, and broader species coverage.
Two studies show the advanced technique can identify chromosomal abnormalities missed by traditional genetic testing methods.
The Seattle biotech company receives a $750,000 Gates Foundation grant to develop a rapid diagnostic using novel protein binders and a luciferase system.
Faster, more accurate testing is helping clinicians identify synthetic opioids sooner and treat overdoses more effectively.