New: tumor mutational burden recommendations
July 2024—The CAP, Association for Molecular Pathology, and Society for Immunotherapy of Cancer released in June their recommendations for tumor mutational burden assay validation and reporting (Furtado LV, et al. J Mol Diagn. Published online June 5, 2024. doi:10.1016/j.jmoldx.2024.05.002).
The joint publication summarizes the existing knowledge and challenges related to TMB testing. The authors make 13 recommendations related to testing, reporting, and publications on TMB assays. Here’s a sampling:
Laboratories should:
- Validate and report the enrichment method used in the TMB assay.
- Validate and report the size of and describe the genomic regions used for TMB calculation.
- Validate TMB measurement against an orthogonal assay, and document the method of TMB calculation used by the orthogonal comparison assay.
- Include validation samples that reflect the intended use of the TMB assay with respect to specimen type and representative tumor types.
- Establish the performance parameters of bioinformatic pipelines used for TMB calculation during validation.
- Report the assay name, version, and sequencing platform used for clinical TMB assays.
- Report the name, version, properties and/or settings of bioinformatic pipeline software components used for TMB calculation.
To date, the FDA has approved PD-L1 protein expression, microsatellite instability/defective mismatch repair, and TMB as predictive biomarkers for immune checkpoint inhibitors in cancer patients.
FDA clears Horiba Yumizen H2500 hematology analyzer
The Food and Drug Administration issued 510(k) clearance to Horiba’s Yumizen H2500 high-throughput hematology analyzer. It is now available for sale in the U.S.
The analyzer is designed for mid- to large-volume laboratories and processes 120 samples per hour. It reports CBC and WBC differential results and a total immaturity measurement for leukocyte count in one run. Its other offerings include a nucleated red blood cell count, which is platelet aggregate interference free; three new fluorescence-free large platelet parameters; and the six controlled parameters for body fluid analysis.
The Yumizen H2500 can be applied standalone or as a fully automated modular solution HELO 2.0 by combining with a tracking system. It received the 2023 Medical Device Network Excellence Award in the environmental category for reducing reagent use, waste, toxicity, and packaging.
FDA clears Roche digital pathology for diagnostic use
The Food and Drug Administration issued 510(k) clearance to the Roche Digital Pathology Dx (Ventana DP 200). In announcing its news, Roche said it is delivering an end-to-end digital pathology solution, “from tissue staining to producing high-quality digital images that can be reliably assessed using automated AI-based image analysis algorithms.”