RARE CANCER CELL DETECTION METHOD

荧光原位杂交（FISH）检测越来越多地用于鉴定染色体易位、重复、缺失和其他与特定癌症相关的染色体异常。然而，目前的分析格式依赖于人工和劳动密集型的显微镜检查，使得罕见的细胞检测不切实际。为了早期诊断白血病和检测治疗复发，需要在至少1000个非癌细胞中检测出一个癌细胞的灵敏、高通量的检测方法。通过结合凝胶微滴单细胞包封（GMD）技术、荧光原位杂交（FISH）和流式细胞术，我们开发了一种检测端粒酶mRNA （tmRNA）的方法，由于癌的发生依赖于端粒酶的激活，因此端粒酶mRNA是早期癌症检测的潜在有价值的标志物。通过临床样本，I期研究将识别人类血液中的癌细胞，用于慢性白血病的早期诊断。拟议的商业应用：该检测将允许早期和准确诊断癌症，促进早期治疗和降低死亡率。该检测还将允许监测临床治疗的有效性，促进新疗法和癌症治疗的发展。

Fluorescence in situ hybridization (FISH) assays are increasingly used to identify chromosomal translocations, duplications, deletions, and other chromosomal abnormalities associated with specific cancers. However, current assay formats rely on manual and labor intensive microscopic examination making rare cell detection impractical. For early diagnosis of leukemias and for detecting therapeutic relapse, sensitive, high throughput assays which can detect one cancer cell in the presence of at least 1,000 non-cancerous cells are needed. By combining gel microdrop single cell encapsulation (GMD) technology, fluorescence in situ hybridization (FISH), and flow cytometry, we have developed an assay to detect telomerase mRNA (tmRNA), which is a potentially valuable marker for early cancer detection because carcinogenesis is dependent on telomerase activation. Using clinical samples, Phase I research will identify cancer cells in human blood for early diagnosis of chronic leukemias. PROPOSED COMMERCIAL APPLICATIONS: The assay will permit early and accurate diagnosis of cancer, facilitating early treatment and reducing mortality rates. The assay will also permit monitoring of the effectiveness of the clinical treatment, facilitating development of new therapeutics and cancer treatments.