AFFINERGY, LLC — Department of Health and Human Services SBIR Phase II: NIGMS

Description

SUMMARY ABSTRACT Fine needle aspirationFNAcytology is the standard technique for evaluating thyroid nodulesHemorrhaging is common during the procedurehoweverleading to an aspirate that is significantly diluted by bloodSubsequent slide preparations are often suboptimalresulting in nondiagnostic outcomes that necessitate additional testing or diagnostic surgeryIn factquality is so unpredictable that a pathologist must often be present in the operating room to certify that the slides are adequatethus adding substantial cost and complexity to the procedureAncillary testing such as immunocytochemistry and fluorescence in situ hybridization can also be used for evaluating the aspiratebut such tests are not usually carried out using smears due to a paucity of follicular cells and an abundance of red blood cellsAs a resultadditional slides must be prepared using expensive and time consuming techniquesThusthere is a significant need for increasing the capture and isolation of thyroid cells on FNA slide preparationsAffinergy is developing a novel technology for improving the quality of thyroid FNA slide preparationsWe have identified proprietary peptides that binds with high affinity to thyroid cells but not to red or white blood cellsand we have developed a cell specific coating for glass slides that provides a simplereproducible method for preparing optimal FNA slides from samples contaminated with bloodA reduction in non diagnostic results will lead to improved quality of care and fewer unnecessary tests and diagnostic surgeriesAt the conclusion of this Phase II projectwe will have sufficient data in hand to rapidly bring our peptide conjugated slides to market PROJECT NARRATIVE Thyroid fine needle aspiration cytology is challenging in aspirates contaminated by obscuring blood cellsoften leading to non diagnostic resultsA reduction in non diagnostic outcomes would lead to improved quality of care and a reduction in unnecessary proceduresIn this applicationwe will develop a novel method for reliably separating thyroid cells and blood cellsleading to higher quality slide preparations and fewer non diagnostic results