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National Immunohistochemistry Standardization Program - Establishment and Launch

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44CA268484-01
Agency Tracking Number: R44CA268484
Amount: $1,999,519.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 102
Solicitation Number: PA20-260
Timeline
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-09-21
Award End Date (Contract End Date): 2023-08-31
Small Business Information
35 CHERYL DR
Sharon, MA 02067-1118
United States
DUNS: 126775860
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 STEVEN BOGEN
 (617) 636-5422
 sbogen@bostoncellstandards.com
Business Contact
 STEVEN BOGEN
Phone: (617) 636-5422
Email: sbogen@bostoncellstandards.com
Research Institution
N/A
Abstract

The overarching goal of this project is to change laboratory practice in the Clinical
Immunohistochemistry (IHC) laboratory. IHC is the only clinical laboratory discipline without reference
standards and traceable units of measure. This is despite the fact IHC is a major testing format in
surgical pathology; a typical hospital IHC lab has a test menu of approximately 200 different tests. As a
result, IHC analytic error rates range from 10 – 30% as compared to lt1% for other types of clinical
laboratory testing. These errors affect both predictive markers (HER2, PD-L1) as well as diagnostic
markers (e.g., TTF-1, p53). From the 1950's to the 1970's, the field of Clinical Chemistry broadly
adopted these higher standards of practice and error rates plummeted. This project is for the purpose of
demonstrating the same benefit in Clinical IHC.
This Applicant is uniquely qualified after having surmounted an important technical hurdle. Boston Cell
Standards developed the first IHC calibrators with analyte concentrations traceable to a recognized
standard - NIST Standard Reference Material 1934. The two Specific Aims of this project are: (1)
Identify quantitative calibration ranges for accurate Clinical IHC testing, and (2) measure the benefit that
calibrators offer towards reporting accurate test results. These will be the first studies correlating
analytic sensitivity with diagnostic sensitivity and specificity. Namely, how many molecules per cell (of
the target analyte) must the assay be capable of detecting in order to produce a diagnostically accurate
test result? This is important even for qualitative tests that are reported as positive/negative, which are
common in IHC. This analysis, while common in other fields of laboratory testing, is new to IHC. The
experimental study design uses a Clinical IHC laboratory survey tool comprising a tissue microarray
(TMA) and IHC calibrators. The TMA generates diagnostic sensitivity and specificity data while
calibrators generate analytic sensitivity data.
This project initiates a novel consortium that includes Boston Cell Standards, international IHC
proficiency testing agencies, and academia. Although there is precedent in creating high-impact
standardization programs for Clinical Chemistry testing, such an organization is unprecedented for IHC.
The goal is to create and launch a National Immunohistochemistry Standardization Program, to oversee
and execute data-driven studies for integrating reference standards to IHC. The consortium members
are active partners in experimental design, execution, and data interpretation. The proposed clinical trial
format has already been successfully tested and published with some of the consortium partners.

* Information listed above is at the time of submission. *

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