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 often suboptimal, 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 towards an 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 follicular cells and an abundance of red blood cells. As a result, additional slides must be prepared using expensive and time-consuming techniques. Thus, there is a significant need for increasing the capture and isolation of follicular cells on FNA slide preparations, in addition to facilitating the development of ancillary diagnostic tests for categorizing indeterminate results. In this application, we propose a novel technology for increasing the capture of follicular cells on a microscope slide, while washing off obscuring cells. We have identified proprietary peptides that binds with high affinity to follicular cells but not to red or white blood cells, and we are developing a cell-specific coating for glass slides that will provide a simple method for preparing optimal FNA slides for improved diagnostic outcomes. At the conclusion of Phase 1, we expect to have a technology that can be scaled up in Phase 2 for cytological analysis and slide-based immunocytochemistry and molecular testing.

Public Health Relevance

Thyroid fine-needle aspiration cytology and subsequent molecular diagnostics are challenging in samples with inadequate cellularity and/or obscuring blood cells. In this application, we propose to develop a novel method for improving the quality of sample preparations by increasing the capture of follicular cells and washing away obscuring red blood cells.

Agency
National Institute of Health (NIH)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43GM106489-01A1
Application #
8646324
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Cole, Alison E
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Affinergy, LLC
Department
Type
DUNS #
City
Durham
State
NC
Country
United States
Zip Code
27713