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

这个小企业创新研究（SBIR）一期项目的更广泛的影响/商业潜力是提高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进行早期和准确的检测。20%的癌症患者会经历癌症复发。不幸的是，癌症复发直到最初治疗数年后才被诊断出来，此时癌症通常已经转移，导致患者预后不佳。因此，7%的癌症患者对癌症复发感到恐惧。残留癌细胞的早期准确诊断将改善20%复发癌症患者的预后。此外，它还将帮助7%因癌症复发而感到虚弱的癌症患者。总的来说，早期诊断癌症将降低治疗癌症的费用。这项小型企业创新研究（SBIR）第一阶段项目旨在开发一种高度准确的诊断检测方法，用于检测抽血中残留的癌症。来自癌细胞的DNA（脱氧核糖核酸）在血液中循环。由于癌细胞DNA的突变，这种癌症可以被检测出来。然而，与正常DNA相比，癌症DNA是罕见的，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。样本被收集后，DNA会经历几轮复制，除了添加阻断剂以防止正常DNA复制。通过这一过程，癌症DNA在样本中占总DNA的比例更大，可以更准确地检测到。该项目将开发一套准确诊断残余结直肠癌的检测方法。本项目的主要任务是：1)验证优化检测方法的临床稳健性；2)开发更多的检测方法以覆盖大多数结直肠癌；3)验证检测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。

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.