validation
DiaCarta, Hopkins MedTech Partner to Offer LDT and IVD Validation Services
The companies aim to fill an unmet need by shepherding diagnostic companies through regulatory and clinical lab validation processes.
NewStem, MSK Innovation Hub Team to Validate Cancer Diagnostics Software Platform
The Israeli startup called this collaboration a necessary step toward commercializing its CE-marked NewStem Software Diagnostic Device for reducing oncology drug resistance.
MDIC Launches Initiative to Improve Accuracy of Next-Generation Sequencing-Based Cancer Diagnostics
As part of the initiative, MDIC will manufacture, validate, and distribute reference samples to support the validation of NGS-based cancer diagnostics.
NanoString Technologies, OHSU Partner on Breast Cancer Spatial Protein Profiling Assay Development
A new GeoMx Digital Spatial Profiler assay will have up to 30 protein targets and will be validated for potential use as a laboratory-developed test.
Team Shows Diagnostic Potential for Oxford Nanopore SARS-CoV-2 Assay, Calls for Improvements
A clinical evaluation of LamPore, expected to be CE marked shortly, called it promising for high-throughput testing but recommended a more streamlined workflow.