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Regulatory Validation of Standardized Clinical Immunohistochemistry Controls

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44CA183203-01
Agency Tracking Number: R44CA183203
Amount: $219,202.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NCI
Solicitation Number: PA13-088
Timeline
Solicitation Year: 2014
Award Year: 2014
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
 STEVEN BOGEN
 (617) 638-4343
 bogen@md-partners.com
Business Contact
 STEVEN BOGEN
Phone: (617) 636-5422
Email: bogen@md-partners.com
Research Institution
 Stub
Abstract

DESCRIPTION (provided by applicant): The broad, long-term goal of this project is consistent, standardized diagnostic testing of surgical biopsies by immunohistochemistry (IHC). The methods to achieve this goal are well understood in the field of clinicallaboratory testing: (1) standardization of reagents and protocols, (2) automation to reduce human errors, and (3) the use of standardized controls to provide test performance feedback. Over the last two decades, the first two of these three methods were implemented for IHC testing. This grant project focuses on the third - standardized controls. Current practice teaches non-standardized controls. Each histopathology lab typically procures test controls from leftover tissue samples in its own paraffin blockarchives. This is a strikingly different practice from clinical blood laboratories, where standardized and validated controls are produced in large quantities and sold through commercial vendors. Since each human tissue is a limited resource, present

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

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