L2M NSERC - A liquid biopsy blood test for breast cancer detection

有效治疗癌症患者的关键很大程度上取决于准确及时的诊断；这一过程可以提供关于癌症阶段、肿瘤分子特征、可能扩散的部位以及患者预后的重要线索。目前用于诊断癌症的金标准方法是基于图像分析，然后是手术活检——一种高度侵入性的分子检测。对病人来说，这个过程往往是痛苦的，痛苦的，并不能保证准确的结果。十多年来，新兴的分析肿瘤材料的非侵入性技术从根本上改变了癌症治疗的未来。液体活检评估血液中的分析物，如循环肿瘤细胞（CTCs）或循环肿瘤细胞的成分，如循环肿瘤DNA （ctDNA）。液体活检越来越被认为在癌症诊断和许多癌症的临床管理中具有价值。此外，它们远优于组织活检，因为组织样本并不总是代表整个肿瘤的异质性。此外，它们提供了更准确的癌症进展信息，更经济、更实惠，而且不需要专家团队（即外科医生）。在这里，我们提出了mDETECT，第二代液体活检，专门用于提供所有转移性乳腺癌亚型的临床管理。与其他液体活检相比，mDETECT技术的优势在于，它包括对ctDNA中受专利保护的甲基化区域进行测序，具有高精度和灵敏度，几乎可以用于所有患者群体。本提案的目的是评估mDETECT与评估癌症治疗效果的传统金标准相结合或替代的使用情况。我们正在分析mDETECT市场营销的可行性，并评估医疗保健提供者和保险机构的兴趣。

The key to treating cancer patients effectively largely depends on accurate and timely diagnosis; a process that can yield important clues about the stage of cancer, the tumour's molecular signature, where it is likely to spread, and the prognosis for the patient. The current gold standard methods used to diagnose cancers are based on image analysis, followed by surgical biopsies - a highly invasive form of molecular testing. For patients, this process is often painful, distressing, and does not guarantee accurate results. For more than a decade, emerging non-invasive techniques to analyze tumour material are fundamentally changing the future of cancer care. Liquid biopsies assess analytes in the bloodstream, such as circulating tumour cells (CTCs) or components of CTCs such as circulating tumour DNA (ctDNA). Liquid biopsies are increasingly recognized as having value for cancer diagnosis and clinical management of many cancers. In addition, they are far superior to the alternative - tissue biopsies, where tissue samples are not always representative of the overall tumour heterogeneity. Furthermore, they provide more accurate information about cancer progression, are more economical and affordable, and do not require a team of specialists (i.e., surgeons). Here, we present mDETECT, a second-generation liquid biopsy specifically aimed to provide clinical management of all subtypes of metastatic breast cancer. The superiority of mDETECT's technology over other liquid biopsies is it encompasses sequencing of patent-protected methylation regions across ctDNA with high precision and sensitivity and can be used in almost all patient populations. The objective of this proposal is to assess the use of mDETECT in conjunction with or in lieu of traditional gold standards of assessing cancer therapy effectiveness. We are looking to analyze the feasibility of marketing mDETECT and gauging the interest of health care providers and insurance bodies.