SBIR Phase I: Enrichment of Cancer DNA for Improved Cancer Diagnostics from Blood

SBIR 第一阶段：富集癌症 DNA 以改善血液癌症诊断

• 批准号: 2321908
• 负责人: Matthew Nelson
• 金额: $ 27.5万
• 依托单位: NEXGEN CANCER DETECTION LLC
• 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 2024-07-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2321908&HistoricalAwards=false
• 关键词: SBIR; Phase; Enrichment; Cancer; DNA

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to improve the diagnosis of residual cancer cells, after treatment of cancer patients. The test will be conducted early and accurately using a simple blood draw. Twenty percent of cancer patients will experience cancer recurrence. Unfortunately, cancer recurrence is not diagnosed until years after initial treatment when the cancer has often metastasized, resulting in poor patient outcomes. As a result, 7% of cancer patients suffer from debilitating fear of cancer recurrence. Early and accurate diagnosing of residual cancer cells will improve the outcome for the 20% of cancer patients who experience recurrence. Additionally, it will help the 7% of cancer patients who suffer from debilitating fear of cancer recurrence. Overall, the costs of treating cancer will be lowered by diagnosing cancer earlier. This Small Business Innovation Research (SBIR) Phase I project seeks to develop a highly accurate diagnostic test for residual cancer from a blood draw. DNA (deoxyribonucleic acid) from cancer cells circulates through the blood stream. This cancer can be detected because of mutations in the DNA of cancer cells. However, cancer DNA is rare compared to normal DNA, which makes diagnosing cancer from a blood draw difficult. Proof-of-concept data has shown that accuracy can be greatly improved through the enrichment of cancer DNA from a sample. After the sample is collected, the DNA goes through rounds of duplication, except a blocker is added to prevent normal DNA from duplicating. Through this process the cancer DNA becomes a larger percentage of the overall DNA in the sample and can be more accurately detected. This project will develop a collection of tests for accurately diagnosing residual colorectal cancer. The key tasks of this project are: 1) demonstrate the clinical robustness of the optimized test method, 2) develop additional tests to cover most colorectal cancers, and 3) demonstrate the sensitivity and specificity of the test methods. This project will lead to earlier and more accurately diagnosed cancer recurrence.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.

该小企业创新研究 (SBIR) 第一阶段项目的更广泛影响/商业潜力是改善癌症患者治疗后残留癌细胞的诊断。该测试将通过简单的抽血尽早准确地进行。百分之二十的癌症患者会经历癌症复发。不幸的是，直到初次治疗数年后才诊断出癌症复发，此时癌症通常已经转移，导致患者预后不佳。因此，7% 的癌症患者因担心癌症复发而感到衰弱。早期准确诊断残留癌细胞将改善 20% 复发癌症患者的预后。 此外，它还将帮助 7% 因癌症复发而感到衰弱的癌症患者。总体而言，早期诊断癌症将降低治疗癌症的成本。这个小型企业创新研究 (SBIR) 第一阶段项目旨在开发一种高度准确的诊断测试，用于检测抽血中残留的癌症。癌细胞的 DNA（脱氧核糖核酸）通过血流循环。这种癌症可以通过癌细胞 DNA 的突变而被检测出来。然而，与正常 DNA 相比，癌症 DNA 很少见，这使得通过抽血诊断癌症变得困难。概念验证数据表明，通过从样本中富集癌症 DNA 可以大大提高准确性。收集样本后，DNA 会经历多轮复制，但会添加阻断剂以防止正常 DNA 复制。通过这个过程，癌症 DNA 在样本中的整体 DNA 中所占的比例更大，并且可以更准确地检测到。该项目将开发一系列测试来准确诊断残留结直肠癌。该项目的主要任务是：1）证明优化测试方法的临床稳健性，2）开发额外的测试以覆盖大多数结直肠癌，3）证明测试方法的敏感性和特异性。该项目将导致更早、更准确地诊断癌症复发。该奖项反映了 NSF 的法定使命，并通过使用基金会的智力优点和更广泛的影响审查标准进行评估，被认为值得支持。