Regulatory Validation of Standardized Clinical Immunohistochemistry Controls

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 clinical laboratory testing standardization of reagents and protocols automation to reduce human errors and 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 block archives 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 practice is inherently non standardized We have developed an innovative technical solution to this problem summarized in a series of papers After both in house testing and a national study performed with the College of American Pathologists the technology ran into a regulatory roadblock As a andquot revolutionaryandquot rather than andquot evolutionaryandquot assay control the FDA set a high regulatory bar that made the project commercially unfeasible in its previous form Using the same chemistry we have re designed the technology so as to address the previous regulatory roadblock The Specific Aims of this Phase I II Fast Track proposal revolve around experimental validation for regulatory purposes of this re designed new class of assay control The Phase I Aims include analytical validation of the new product design including an assessment of sensitivity specificity stability and reproducibility The Phase II aims address clinical validation which will uniquely test and validate the role of standardization in IHC controls Although our focus is initially in the area of breast cancer tests this effort opens an entirely new market to include other IHC controls products The applicant group comprises a broad multi disciplinary team including the original research team statistical and database management staff from the Tufts Clinical andamp Translational Science Institute CTSI surgical pathologists a regulatory affairs consultant and an IHC commercial operations specialist Phase II also includes a collaboration with the College of American Pathologists At the conclusion of Phase II we will have all of the FDA regulatory submission data for transition to commercialization This project will lead to the creation of the first set of FDA cleared nationall standardized IHC test controls In converting clinical laboratories from a homebrew practice the impact will be transformative especially for the newer quantitative tests that demand a higher level of accuracy PUBLIC HEALTH RELEVANCE This project is to fund the clinical regulatory studies for a new first in class type of clinical test control in the field of cancer immunohistochemistry IHC testing Clinical test controls are important for promoting test reproducibility and standardizatio As the first standardized IHC controls product for FDA submission this project will clear a path for the development of an entirely new market