SBIR Phase I: Predictive ex vivo solid tumor biopsy-chip multiplexer for screening anticancer agents

SBIR 第一阶段：用于筛选抗癌药物的预测性离体实体瘤活检芯片多路复用器

• 批准号: 2321805
• 负责人: Karim Budhwani
• 金额: $ 27.5万
• 依托单位: CERFLUX, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2024-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2321805&HistoricalAwards=false
• 关键词: SBIR; Phase; Predictive; ex; vivo

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project lies in enhancing health outcomes and quality of life for cancer patients. Each year, over 1.7 million Americans are diagnosed with cancer, and treatment turns out to be ineffective for approximately 75% of those receiving systemic therapy. This failure is because every tumor is distinct in makeup and response to treatment. Unfortunately, a generalized treatment approach is forced upon a disease that is uniquely personal due to lack of personalized predictive tools. Consequently, patients are exposed to several rounds of potentially harmful overtreatment until the right regimen is found. Adding insult to injury, over 40% of patients deplete their entire life savings in just 2 years. In discussions with leadership from the Centers for Medicare & Medicaid Services (CMS) and private insurance providers – who currently spend over $35 billion annually on treating just five types of cancer – the inability to match treatments to tumors was unanimously the critical, unmet, and urgent market need. This proposal can make a profound impact on the lives of cancer patients, offer substantial cost savings to insurance providers, and strengthen US leadership in advanced research.This Small Business Innovation Research (SBIR) Phase I project represents a major departure from the traditional, one-size-fits-all approach to cancer treatment. The proposed technology will rapidly match biopsy tissue from a patient’s tumor with various treatment regimens – before treatment, outside the patient – to identify the right treatment for that patient. In order to achieve clinical translation for this technology, during this SBIR Phase I project, the company will address several key objectives: 1) establish standard guidelines for tissue collection, handling, and cold chain logistics to minimize the impact of these factors on the viability of live solid-tumor biospecimens; 2) generate 3D bio-printed mimics of patient biopsies for extensive validation and refinement of the technology; and 3) demonstrate the predictive capacity of this platform for personalized cancer treatment. If successful, this personalized approach will not only reduce the cost of cancer treatment incurred by health insurance providers but, more importantly, also lighten the emotional, physical, and financial burden suffered by patients.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.

这项小企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力在于提高癌症患者的健康结果和生活质量。每年，超过170万美国人被诊断出患有癌症，而接受全身治疗的患者中，大约75%的治疗无效。这种失败是因为每个肿瘤的组成和对治疗的反应都是不同的。不幸的是，由于缺乏个性化的预测工具，一种普遍的治疗方法被迫用于一种独特的个人疾病。因此，在找到正确的治疗方案之前，患者会经历几轮可能有害的过度治疗。更糟糕的是，超过40%的患者在短短两年内耗尽了他们一生的积蓄。在与医疗保险和医疗补助服务中心（CMS）和私人保险提供商的领导进行的讨论中，他们目前每年花费超过350亿美元用于治疗五种类型的癌症，无法将治疗与肿瘤相匹配是一个关键的、未满足的、紧迫的市场需求。这一提议将对癌症患者的生活产生深远影响，为保险公司节省大量成本，并加强美国在先进研究方面的领导地位。这个小企业创新研究（SBIR）第一阶段项目代表了对传统的、一刀切的癌症治疗方法的重大背离。这项拟议中的技术将迅速将患者肿瘤的活检组织与各种治疗方案相匹配——在治疗前，在患者体外——以确定该患者的正确治疗方案。为了实现该技术的临床转化，在SBIR一期项目中，公司将解决几个关键目标：1)建立组织收集、处理和冷链物流的标准指南，以最大限度地减少这些因素对活体实体肿瘤生物标本生存能力的影响；2)生成患者活检的3D生物打印模拟物，以广泛验证和改进该技术；3)验证该平台对癌症个性化治疗的预测能力。如果成功，这种个性化的方法不仅会减少医疗保险公司的癌症治疗费用，更重要的是，还会减轻患者的情感、身体和经济负担。该奖项反映了美国国家科学基金会的法定使命，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。