Novel technologies to remove obscuring blood from fine needle aspiration biopsies

 描述（由申请方提供）：细针穿刺（FNA）细胞学检查是评价甲状腺结节的标准技术。然而，在手术过程中出血是常见的，导致抽吸物被血液显著稀释。随后的载玻片制备通常是次优的，导致需要额外测试或诊断手术的非诊断结果。事实上，质量是如此不可预测，以至于病理学家必须经常出现在手术室中以证明载玻片是足够的，从而增加了手术的大量成本和复杂性。辅助测试，如免疫细胞化学和荧光原位杂交也可用于评估吸出物，但由于缺乏滤泡细胞和丰富的红细胞，这些测试通常不使用涂片进行。因此，必须使用昂贵且耗时的技术制备额外的载玻片。因此，非常需要增加FNA载玻片制备物上甲状腺细胞的捕获和分离。Affinergy正在开发一种新技术，用于提高甲状腺FNA载玻片制备的质量。我们已经鉴定出与甲状腺细胞具有高亲和力但不与红或白色血细胞结合的专有肽，并且我们已经开发出用于载玻片的细胞特异性涂层，其提供了一种简单、可重复的方法，用于从被血液污染的样品制备最佳的FNA载玻片。非诊断结果的减少将提高护理质量，减少不必要的检查和诊断手术。在第二阶段项目结束时，我们将有足够的 我们的肽结合载玻片能够快速推向市场。

 DESCRIPTION (provided by applicant): 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 significantly 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. Ancillary testing such as immunocytochemistry and fluorescence in-situ hybridization can also be used for evaluating the aspirate, but such tests are not usually carried out using 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 thyroid cells on FNA slide preparations. Affinergy is developing a novel technology for improving the quality of thyroid FNA slide preparations. We have identified proprietary peptides that binds with high affinity to thyroid cells but not to red or white blood cells, and we have developed a cell-specific coating for glass slides that provides a simple, reproducible method for preparing optimal FNA slides from samples contaminated with blood. A reduction in non-diagnostic results will lead to improved quality of care and fewer unnecessary tests and diagnostic surgeries. At the conclusion of this Phase II project, we will have sufficient data in hand to rapidly bring our peptide-conjugated slides to market.