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

这一小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力是改善癌症患者治疗后残留癌细胞的诊断。该测试将使用简单的抽血早期和准确地进行。百分之二十的癌症患者会经历癌症复发。不幸的是，癌症复发直到最初治疗后数年才被诊断出来，此时癌症通常已经转移，导致患者预后不良。因此，7%的癌症患者患有癌症复发的恐惧。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%的癌症患者，他们因癌症复发而感到虚弱。总的来说，通过早期诊断癌症，治疗癌症的成本将降低。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，用于从抽血中检测残留癌症。来自癌细胞的DNA（脱氧核糖核酸）通过血液循环。这种癌症可以被检测到，因为癌细胞的DNA突变。然而，与正常DNA相比，癌症DNA是罕见的，这使得从血液中诊断癌症变得困难。概念验证数据表明，通过从样品中富集癌症DNA可以大大提高准确性。收集样本后，DNA会进行多轮复制，除了加入阻断剂以防止正常DNA复制。通过这个过程，癌症DNA在样本中的总DNA中所占的比例更大，可以更准确地检测到。该项目将开发一系列用于准确诊断残留结直肠癌的测试。该项目的关键任务是：1）证明优化检测方法的临床稳健性，2）开发涵盖大多数结直肠癌的额外检测，3）证明检测方法的灵敏度和特异性。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。

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.