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

将开发并确认一种使用患者FFPE组织来区分基底样乳腺癌与其他亚型的分子测试。该测试将基于一个商业平台，即lysis-on定量核酸酶保护试验（qNPA 1M）。目前描述的乳腺癌基因表达特征，特别是那些区分基底样乳腺癌与其他亚型的基因表达特征，将与表达的SNP和与乳腺癌相关的基因融合以及通过全转录组qNPA微阵列分析发现的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，这是基底样乳腺癌定义的基础。该签名将被纳入分析分析。使用的样本将包括两组存档的样本，其中定义了ERJPR和HER2状态以及结果，一组主要是白种人，另一组主要是非洲裔美国人。该计划将提供一个“qNPA基础乳腺癌分类器”，即qNPA BBCC。qNPA BBCC检测的重要意义在于成本低、简单、特异性、准确性、可重复性、敏感性、稳健性，并且使用临床样本，因为它们是今天从活检和手术中收集的- FFPE和H&E染色的FFPE。该平台将能够对其他形式的癌症进行诊断测试。qNPA BBCC将识别基底样亚型和其他亚型，为患者提供有关其疾病预后的信息和肿瘤学家为个体患者选择“最佳治疗”的信息。该测试将用于选择患者进行临床试验，帮助开发新疗法，并可能作为伴随诊断

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