TAS::75 0849::TAS SMALL BUSINESS INNOVATIVE RESEARCH (SBIR) TOPIC 283

使用患者的FFPE组织来区分基底细胞样乳腺癌和其他亚型的分子测试将被开发和确认。这项检测将基于商业平台--裂解定量核酸酶保护分析(QNPA 1M)。目前为乳腺癌描述的基因表达特征，特别是那些用于区分基底细胞样乳腺癌与其他亚型的基因，将与通过对整个转录组qNPA微阵列进行分析而发现的与乳腺癌相关的表达的SNP和基因融合以及miRNA一起纳入qNPA分析。比较标准将是文献中广泛研究的50个基因标记，这是定义基底细胞样乳腺癌的基础。这一签名将被纳入普罗布林检测中。使用的样本将包括两组存档的ERJPR和HER2状态以及结果，一组主要是高加索人，另一组主要是非裔美国人。该计划将提供qNPA基础乳腺癌分类器“，即qNPA BBCC。qNPA BBCC测试的意义将是低成本、简单、特异性、准确性、重复性、敏感性、稳健性和临床样本的使用，因为它们是今天从活检和手术中收集的-FFPE和H&E染色FFPE。该平台将能够对其他形式的癌症运行诊断测试。qNPA BBCC将识别基底样癌和其他亚型，为患者提供关于其疾病预后的信息，以及肿瘤学家为个体患者选择最佳治疗方案的信息。该测试将用于选择患者进行临床试验，帮助开发新的治疗方法，并可能作为辅助诊断

A molecular test using FFPE tissue from patients to distinguish basal-like breast cancer from other subtypes will be developed and confirmed. The test will be based on a commercial platform, the lysis-on ly quantitative Nuclease Protection Assay (qNPA 1M). Current gene expression signatures described for breast cancer, in particular those for distinguishing basal-like breast cancer from other subtypes, will be incorporated into a profiling qNPA assay along with expressed SNP's and gene fusions associated with breast cancer and miRNA discovered by profiling on a whole transcriptome qNPA microarray. The comparative standard will be a 50 gene signature extensively investigated in the literature, which is the basis for the definition of basallike breast cancer. This signature will be among those incorporated into the profi ling assay. Samples used will include two archived sets for which the ERJPR and HER2 status as well as outcome are defined, one set predominately Caucasian, the other predominately African American. The program will provide a ~qNPA Basal Breast Cancer Classifier", the qNPA BBCC. The significance of the qNPA BBCC test will be low cost, simplicity, specificity, accuracy, reproducibility, sensitivity, robustness, and use of clinical samples as they are collected today from biopsy and surgery - FFPE and H&E stained FFPE. The platronm will be able to run diagnostic tests for other forms of cancer. The qNPA BBCC will identify the basal-like and other subtypes, providing patients information as to the prognosis of their disease and oncologists information for selecting the ~ best therapy" for individual patients. The test will be used to select patients for clinical trials, aid ing in the development of new therapies and potentially serving as a companion diagnostic