I-Corps: An efficient automated biopsy diagnostic process

这个i-Corps项目的更广泛的影响/商业潜力将探索市场对高效自动活检诊断过程的需求。在美国，每年有250万例细针抽吸(FNA)活检。其中20%的FNAs将被证明不足以进行诊断或下游分子测试。这一失败导致患者再次入院进行重复的FNA活检，结果是保险公司、医院、医生和患者损失了时间和金钱，患者在等待医疗结果时增加了焦虑。这一失败给各方造成了超过30亿美元的年度损失。拟议的技术将改善患者获得高质量癌症诊断的机会，并减少由于活组织检查过程效率低下而不必要的重复程序。这个i-Corps项目旨在验证自动化活组织检查过程的必要性。作为细针抽吸(FNA)活检的一部分，快速现场评估(ROSE)技术检查样本的充分性。虽然FNA通常是图像引导的(例如，通过计算机断层扫描或超声引导)，但该过程本身仍被视为(半)盲过程。样本不足(有时是无细胞的)，缺乏足够数量的适当材料，导致诊断或治疗指导失败，增加成本，并对患者造成不必要的身体和情感后果，这并不少见。建议的ROSE技术可以极大地提高采样效率和改善患者体验，同时降低成本。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this I-Corps project will explore the market need for an efficient automated biopsy diagnostic process. Annually, 2.5 million Fine Needle Aspiration (FNA) biopsies are performed in the US. Twenty percent of these FNAs will prove to be inadequate for diagnosis or downstream molecular testing. This failure results in patients being re-admitted for repeat FNA biopsies and, as a consequence, insurers, hospital, physicians and patients lose time and money, and patients have added anxiety as they wait for medical results. This failure amounts to over $3 billion in annual losses from all parties. The proposed technology would improve patient access to high quality cancer diagnostics and reduce unnecessary repeat procedures due to inefficiencies in the biopsy processes. This I-Corps project aims to validate the need for an automated biopsy process. The Rapid On-Site Evaluation (ROSE) technology checks the adequacy of a specimen as part of a Fine Needle Aspiration (FNA) biopsy. Although FNA is usually image-guided (e.g. through a computerized tomography (CT) scan or ultrasound guidance), the procedure itself is still regarded as a (semi-) blind procedure. It is not unusual to have inadequate (sometimes acellular) specimens that lack a sufficient amount of appropriate material, leading to diagnostic or therapy guidance failure, increased cost and unnecessary physical and emotional consequences for the patient. The proposed ROSE technology may vastly increase sampling efficiency and improve the patient experience, while reducing costs.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.