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.

这项小型企业创新研究（SBIR）I期项目的更广泛的影响/商业潜力是在治疗癌症患者后改善残留癌细胞的诊断。该测试将使用简单的抽血来提早，准确地进行。 20％的癌症患者会经历癌症复发。不幸的是，癌症复发直到癌症经常转移后几年后才诊断出癌症，导致患者的结局差。结果，有7％的癌症患者患有使人对癌症复发的恐惧。早期，准确的残留癌细胞诊断将改善20％经历复发的癌症患者的结果。 此外，这将有助于7％的癌症患者患有癌症复发的恐惧。总体而言，治疗癌症的成本将通过更早诊断癌症来降低。这项小型企业创新研究（SBIR）I阶段项目旨在通过抽血来开发针对残留癌症的高度准确的诊断测试。来自癌细胞的DNA（脱氧核糖核酸）通过血流循环。由于癌细胞的DNA突变，可以检测到这种癌症。但是，与正常DNA相比，癌症DNA很少见，这使得从吸血中诊断癌症很难。概念验证数据表明，通过样本中癌症DNA的富集可以极大地提高准确性。收集样品后，DNA会经过重复的弹性，除了添加阻滞剂以防止正常的DNA重复。通过此过程，癌症DNA成为样品中总DNA的较大百分比，并且可以更准确地检测到。该项目将开发一系列测试，以准确诊断残留的结直肠癌。该项目的关键任务是：1）证明优化测试方法的临床鲁棒性，2）开发其他测试以覆盖大多数结直肠癌，3）3）证明了测试方法的敏感性和特异性。该项目将导致更早，更准确地诊断出癌症的复发。该奖项反映了NSF的法定任务，并认为使用基金会的知识分子优点和更广泛的影响评估标准，被认为值得通过评估。