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TOPIC 442: QUANTITATIVE TRACEABLE REFERENCE MATERIALS AS MDDTS FOR TISSUE BIOMARKERS

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 75N91022C00032
Agency Tracking Number: 75N91022C00032
Amount: $385,889.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 442
Solicitation Number: PHS-2022-1
Timeline
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
c/o Tufts Med Ctr, 800 Washington St., Box 115
BOSTON, MA 02111-1552
United States
DUNS: 126775860
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 STEVE BOGEN
 (617) 636-5422
 sbogen@bostoncellstandards.com
Business Contact
 STEVE BOGEN
Phone: (617) 636-5422
Email: sbogen@bostoncellstandards.com
Research Institution
N/A
Abstract

This goal of this project is to qualify the first system of reference standards and measurement traceability in immunohistochemistry (IHC) testing as a Medical Device Development Tool (MDDT), topic 442. In all other types of laboratory testing, such as clinical chemistry, these metrologic tools are a standard of laboratory practice. FDA requires test manufacturers to identify methods of assay calibration. IHC is the exception. Instead, there are poorly standardized, improvised systems of calibration based on immunoreactivity with various tissues. This deficiency has led to IHC error rates that are ten times those in other laboratory testing disciplines. Boston Cell Standards developed tools to solve this problem and validated them in 3 large clinical trials. Our proposed MDDT, a system of IHC assay calibration traceable to NIST SRM 1934, is applicable to any manufacturer’s IHC assay. This Phase I proposal addresses 4 improvements that were identified during clinical testing: (1) commutability of reference materials, (2) calculating the difference between “ERF” and molar concentrations, (3) improving traceability to NIST SRM 1934, and (4) developing a better method for calibrator value assignment. These small steps will make a large impact in the field of surgical pathology and IHC.

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

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