Photoacoustic Needle for Identifying Tumor Content and Margins to Improve Sampling During Core Needle Biopsy

肿瘤活检中动态生物标志物的分析越来越频繁地进行，以帮助医生诊断，选择和评估治疗，并了解疾病复发。目前的活检技术是为了获得足够数量的恶性细胞进行组织病理学诊断的标本。然而，病理学分析所需的活检标本的肿瘤含量远低于低流行率突变的分子谱分析或生物标志物定量所需的含量，这将有助于确定患者的治疗选择。该第二阶段SBIR将完成PSITE（光声系统识别肿瘤边缘）的开发，并将证明使用该技术在两个大型动物体内自发性肿瘤模型中收集的空芯针活检（CNB）样本的诊断潜力。根据第二阶段合同，承包商将继续推进在第一阶段展示的PSITE光声（PA）技术，生产一个现场就绪的原型，其中包含优化的设备设计和性能，并建立生产文件和方法，以实现系统的商业化。将进行具有显著统计功效的脊椎动物研究，以证明PSITE的安全性和有效性，包括一项适用的临床犬研究，该研究将为确定FDA下一阶段人体临床研究的非重大风险（NSR）分类提供数据。

Analysis of dynamic biomarkers in tumor biopsies is being performed with increasing frequency to help physicians in diagnosis, selecting and assessing treatment, and understanding disease recurrence. Current biopsy techniques were developed to acquire specimens with sufficient numbers of malignant cells for histopathologic diagnosis. However, the tumor content of a biopsy specimen required for pathological analysis is much lower than what is required for molecular profiling of low prevalence mutations or biomarker quantification, which would aid in determining therapeutic options for the patient. This Phase II SBIR will finalize the development of the PSITE – Photoacoustic System Identifying Tumor Edges – and will demonstrate the improved diagnostic potential of core needle biopsy (CNB) samples collected using this technology in two large-animal, spontaneous tumor models in vivo. Under the Phase II contract, the contractor will continue progression of the PSITE photoacoustic (PA) technology demonstrated in Phase I, by producing a field-ready prototype that incorporates an optimized device design and performance, and establishment of production documentation and methods towards commercialization of the system. Vertebrate animal studies with significant statistical power will be performed to demonstrate both safety and efficacy of the PSITE, including a fit-for-purpose clinical canine study that will provide data towards determination of a Non-Significant Risk (NSR) classification from the FDA for next-stage human clinical studies.