Predicine Submits First PMA Module to FDA for Bladder Cancer Companion Diagnostic
The urine-based NGS assay received Breakthrough Device Designation in 2022 and targets genomic alterations in cancer-associated genes.
Latest Articles
Editor's Top Picks
Clinical Labs Navigate What’s Next After FDA’s LDT Rule Reversal
Greer Massey, PhD, chief scientific officer at Molecular Designs, shares insights on how labs are affected by the rule’s reversal and how they can prepare for future regulatory changes.
Be the First to Know What’s Next in the Lab
Every week, we dig into the biggest shifts, breakthroughs, and tech transforming clinical diagnostics. Straightforward, insightful, and always relevant.Critical Resources
Diagnostic Innovations
AI Model Uses Routine Lab Tests to Predict Genetic Disease Risk
Mount Sinai researchers develop machine learning approach that analyzes common clinical data to determine penetrance of rare genetic variants.
Equipment & Supply Spotlight
Seegene Unveils Fully Automated PCR System and Real-Time Analytics Platform
CURECA and STAgora technologies aim to eliminate manual intervention in molecular testing workflows and provide actionable diagnostic data insights.
News, Know-How & Standards
Disease Detection & Understanding
Host Response Testing Gains Attention in Sepsis Diagnosis and Antibiotic Stewardship
A recent poll highlights growing interest in host response testing for sepsis. Immunexpress CEO Rollie Carlson discusses the findings and the future of rapid diagnostics.
