AFFINERGY, LLC — Department of Health and Human Services SBIR Phase I: SUMMARY/ABSTRACT Fine-needle aspiration (FNA) cytology is the standard technique for evalu

Description

SUMMARY/ABSTRACT Fine-needle aspiration (FNA) cytology is the standard technique for evaluating thyroid nodules. Hemorrhaging is common during the procedure, however, leading to an aspirate that is diluted by blood. Subsequent slide preparations are oftensuboptimal, resulting in nondiagnostic outcomes that necessitate additional testing or diagnostic surgery. In fact, quality is so unpredictable that a pathologist must often be present in the operating room to certify that the slides are adequate, thus adding substantial cost and complexity to the procedure. Furthermore, even with an optimal slide preparation, cytology yields indeterminate results up to 30% of the time. In the absence of a conclusive diagnosis, most indeterminate patients are guided towardsan often unnecessary partial or near-total thyroidectomy. Immunocytochemistry and fluorescence in-situ hybridization are useful tools for diagnosing indeterminate cases, but such tests are not usually carried out on existing smears due to a paucity of fo