Diagnostics & Laboratory Medicine
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.
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.
Regulatory-first biostatistics
Support built specifically for FDA-facing programs, from early feasibility through submission and post-market requirements.
Direct communication, faster turn around
Our biostatisticians write the SAP and run the analysis. One person owns both — no separate programmer, no project manager in between.
Versatile Solutions
Engage us for a focused analysis or a full submission, We size the work to the problem.
Proven FDA Experience
Hands-On Experience with FDA Pathways, statistical reviews, and regular interactions, reducing risk and rework.
WHAT CLIENTS SAY
“They listen the first time. I’ve never had to go back and respell out what I needed."
”They work to understand the problem and leverage the information that is already there.”
Former FDA Regulator
WHAT CLIENTS SAY
"Battle ground tested."
"There is nothing that David and team haven’t seen over the years – the good, bad, and ugly.”
Vice President, Clinical Operations
WHAT CLIENTS SAY
"Get stuff done when you have to do something no one else has done before."
"They aren’t afraid to tackle difficult scenarios in compressed timelines."
CEO, Medical Device Company
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