Strategic partner for diagnostic device market entry
BSC brings established regulatory expertise to help you achieve FDA clearance or approval efficiently. Our capabilities in diagnostic accuracy studies, clinical validation, and CLIA compliance position your technology for successful market entry and payer acceptance.
Diagnostics & Laboratory Medicine
Overview
BSC® supports the development of diagnostic tests, laboratory assays, and companion diagnostics through clinical validation studies. Our experience spans molecular diagnostics, imaging-based diagnostics, point-of-care testing, and clinical chemistry.
Specialized Capabilities
Sensitivity and specificity estimation with appropriate confidence intervals. ROC curve analysis and optimal cutpoint determination. Equivalence and concordance studies for diagnostic tests. Clinical utility demonstration through outcomes analysis. Bayesian approaches to diagnostic test evaluation with limited gold standards.
Regulatory Experience
We understand FDA expectations for diagnostic device validation, including appropriate reference standards, handling of indeterminate results, and demonstration of clinical validity and clinical utility. Our team has experience with both de novo and 510(k) pathways for diagnostics.
Representative Studies
Molecular diagnostic assays (PCR, NGS, immunoassays). Medical imaging AI/ML algorithms. Point-of-care rapid diagnostic tests. Companion diagnostics for targeted therapies. Clinical chemistry analyzers and panels.