type are regulated for proficiency testing by the Centers for Medicare & Medicaid Services (CMS).
Biomarkers can be tested through a variety of methodologies (eg, immunohistochemistry, flow cytometry, next generation sequencing, PCR-based testing, karyotype, FISH, clinical chemistry, etc.). Each modality has different technical strengths and weaknesses, along with varied analytical and clinical specifications such as sensitivity and specificity. Results may not be clearly concordant across the modalities. This program will challenge pathologists to resolve discrepancies between different methods or “multimodality” biomarker testing.