I-Corps: Formaldehyde Scavengers as a Novel Antigen Retrieval Reagent for In Vitro Diagnostic Tests

University Of Houston, Houston TX

Investigators

Abstract

The broader impact/commercial potential of this I-Corps project is the development of a commercial antigen retrieval solution that will be used in academic, government and industrial research laboratories as well as hospitals worldwide with applications for the detection of protein and molecular biomarkers. Formaldehyde is a widely used to preserve tissue in both laboratory and clinical settings. Current tissue-based diagnostic applications for the detection of biomarkers are limited due to the requirement of formaldehyde fixation of tissue samples. Due to a loss of sensitivity associated with formaldehyde fixation, many clinically relevant biomarkers cannot be reliably studied with current technology, resulting in false-negative errors. Due to the financial cost and the effect of misdiagnosis on treatment outcomes associated with false-negative errors in clinical diagnostic testing, the development of improved antigen retrieval technology will have important societal and medical impacts. Given that there are more than 93 million diagnostic tests run worldwide that depend on antigen retrieval agents, the technology is anticipated to have substantial commercial potential in clinical settings. This I-Corps project demonstrates how the detection of protein-epitopes in formalin-fixed paraffin-embedded tissue can be retrieved with higher sensitivity and reproducibility by using formaldehyde scavenging compounds. Current antigen retrieval reagents typically contain sodium citrate or Tris based solutions that rely primarily on heat to reverse formalin fixation from tissue samples. The proposed project expands on the current methods by using chemistry associated with formaldehyde scavenging to significantly enhance the detection of proteins in formaldehyde-fixed tissue samples. The proposed approach consists of novel compositions that contain combinations of formaldehyde scavenging compounds. Currently, we have demonstrated increased sensitivity with a series of structurally diverse compounds using a panel of blood vessel proteins as a model system. This method provides a new and more accurate method for the detection of proteins in tissue-based diagnostic assays used in clinical and research applications.