FY24 SBIR PHASE II RD CONTRACT - TOPIC 442 BOSTON CELL STANDARDS, INC. Quantitative Traceable Reference Materials As MDDTs For Tissue Biomarkers

The treatment that a cancer patient receives should not depend on which laboratory performs the test." The objective of this project is to make that statement a reality. Immunohistochemistry (IHC) testing of cancer biopsies is important for both accurate diagnosis and appropriate treatment. The absence of reference standards, calibrators, and even units of measure, has led to astronomically high error rates, ranging from 10 – 30%. In response, recent (2023) editorials called for major regulatory changes. Boston Cell Standards has the only commercially practical solution - the first IHC reference standards, calibrators, and quantitative controls. Phase 1 addressed quality-related improvements in calibrator manufacture. In response to FDA instructions, we also developed an entry-level software program to measure stained calibrator outputs ("Metric", version 1). FDA explained that such software is required for an MDDT submission. In Phase 2, we develop ISO 13485 and ISO/IEC 62304-compliant Metric improvements, making it practical for routine use by clinical IHC and research laboratories. Phase 2 includes 4 stages: (1) changes to calibrator manufacture that address automated imaging requirements, (2) Metric compatibility with whole slide imaging, (3) database development to provide comparative laboratory performance data, and (4) improvements enabling tissue biomarker quantification.