I-Corps: An efficient automated biopsy diagnostic process

I-Corps：高效的自动化活检诊断流程

• 批准号: 2107886
• 负责人: Janine Elliott
• 金额: $ 5万
• 依托单位: University of California-Davis
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-03-15 至 2022-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2107886&HistoricalAwards=false
• 关键词: Corps; efficient; automated; biopsy; diagnostic

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.

该I-Corps项目的更广泛影响/商业潜力将探索市场对高效自动活检诊断过程的需求。每年，在美国进行250万次细针抽吸（FNA）活检。这些FNA中的20%将被证明不足以用于诊断或下游分子检测。这种失败导致患者再次入院进行重复FNA活检，因此，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的年度损失超过30亿美元。这项技术将改善患者获得高质量癌症诊断的机会，并减少由于活检过程效率低下而导致的不必要的重复手术。该I-Corps项目旨在验证自动活检过程的必要性。快速现场评估（ROSE）技术检查作为细针抽吸（FNA）活检一部分的标本是否充分。尽管FNA通常是图像引导的（例如，通过计算机断层扫描（CT）扫描或超声引导），但程序本身仍然被视为（半）盲程序。缺乏足够量的适当材料的不适当（有时是无细胞的）标本并不罕见，从而导致诊断或治疗指导失败、增加成本以及对患者造成不必要的身体和情感后果。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。