Novel technologies for improved slide quality of pancreatic fine-needle aspirates

Period of Performance: 07/01/2016 - 06/30/2017

$301K

Phase 1 SBIR

Recipient Firm

Affinergy ,inc
Durham, NC 27709
Principal Investigator

Abstract

? DESCRIPTION (provided by applicant): Endoscopic ultrasound-guided fine needle aspiration biopsy is the standard technique for diagnosis and staging of suspicious pancreatic lesions. Unfortunately, blood and other unwanted debris are frequently present in these fine-needle aspirates, thus diluting and obscuring cells of interest. Subsequent slide preparations from such aspirates are suboptimal, leading to non-diagnostic outcomes that necessitate repeat FNA biopsies and/or additional procedures, adding to both time and cost. If the repeat testing remains inconclusive, then the patients are guided towards surgical biopsies for diagnostic confirmation. However, surgery is not only expensive and morbid, but may be contraindicated in most patients with advanced disease. In such inoperable patients, non-surgical FNA samples are often the only cytological specimens available to the clinicians for diagnosis. Hence, there isa considerable need to develop a product that can improve the consistency and quality of FNA slide preparations, as well as facilitate ancillary molecular testing on the slides. To this end, Affinergy has identified multiple high affinity peptides that specifically bind to pancreatic cells but not to red and white blood cells. In this application, we propose to develop peptide-coated glass slides which will provide a simple and rapid method for preparing optimal pancreatic FNA slides for improved diagnostic outcomes. At the conclusion of Phase I, we expect to have established the feasibility of using our peptide- modified slides for cytological analysis of pancreatic FNA specimens, which can then be validated during Phase II utilizing clinical samples.