# FY24 SBIR PHASE II RD CONTRACT - TOPIC 442 BOSTON CELL STANDARDS, INC.

> **NIH NIH N44** · BOSTON CELL STANDARDS INC · 2024 · $1,995,119

## Abstract

200 WORDS.
"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.

## Key facts

- **NIH application ID:** 11219741
- **Project number:** 75N91024C00087-0-9999-1
- **Recipient organization:** BOSTON CELL STANDARDS INC
- **Principal Investigator:** STEVE BOGEN
- **Activity code:** N44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,995,119
- **Award type:** —
- **Project period:** 2024-09-16 → 2026-09-15

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11219741

## Citation

> US National Institutes of Health, RePORTER application 11219741, FY24 SBIR PHASE II RD CONTRACT - TOPIC 442 BOSTON CELL STANDARDS, INC. (75N91024C00087-0-9999-1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/11219741. Licensed CC0.

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