Immune-based brain cancer diagnostic for rapid, accurate disease classification

描述（由申请人提供）：准确、早期的疾病诊断和监测是有效预防、治疗和缓解疾病的关键方面。目前可用的大多数诊断方法都不够简单或敏感，不足以显著影响患者对治疗的反应或生存结果。脑癌等疾病往往在早期阶段没有症状，然后迅速发展，造成迅速、致命的后果，从而突出了这种未满足的需求。我们已经发明了免疫标记（IS）作为一种新的疾病诊断方法来解决这些问题。IS是基于查询血清。使用抗体作为疾病的生物标记物，利用了稳定且易于获取的分子和免疫系统的多样性、监视和生物扩增的便利特性。哺乳动物免疫系统的复杂性是惊人的，因此其信息量也是惊人的。成本的降低、无需手术、影像学检查，以及这种快速检测方法的简单性，为频繁、准确地监测处于缓解期和接受新疗法试验的患者铺平了道路。这里介绍的创新项目将使IS成为一种快速、准确的诊断工具，并展示其对脑癌的有效性。

DESCRIPTION (provided by applicant): Accurate, early disease diagnosis and monitoring are critical aspects to effective prevention, treatment, and remission of disease. Most diagnostic methods available today are not simple or sensitive enough to significantly impact patients' response to treatment or survival outcome. This unmet need is highlighted by diseases, such as brain cancers, that often remain asymptomatic at early stages and then grow aggressively- with fast, fatal outcomes. We have invented immunosignatures (IS) as a new approach to disease diagnoses that addresses these problems. IS is based on querying blood-serum. Using antibodies as biomarkers of disease takes advantage of a stable and easily accessible molecule and the immune system's convenient properties of diversity, surveillance, and biological amplification. The complexity of a mammalian immune system is staggering and therefore so is the information content. The reductions in cost, elimination of surgery, imaging, and the simplicity of this rapid assay pave the way to frequent, accurate monitoring of individuals in remission and those in trials with new therapies. The innovative program presented here will build IS into a rapid, accurate diagnostic tool and demonstrate its effectiveness for brain cancer. In phase I we will validate the power of HealthTell's platform to identify peptide mimotopes (selected from a library of 330,000 random sequences) that accurately diagnose gliomas from other cancers, and classify them relative their pathological types and grades, and molecular subtypes. These will be rigorously explored and expanded in phase II to include analyses of additionally important groups: the lower grade primary gliomas and secondary brain cancers such as metastatic lung and breast cancers. Inclusion of sera from healthy volunteers in geographically matched sites relative to patients and additional blinded cohorts studies will provide data for high level performance metrics to be established. Within the term of this program, the peptide signatures will facilitate remission-stage and treatment monitoring, enabling more effective management of gliomas including better modulation of chemotherapy and radiation, and faster, more accurate evaluations of new targeted therapies. We intend to partner with the CAP/CLIA certified DNA Diagnostics Laboratory situated on the St. Joseph's Hospital Medical Center/Barrows Neurological Institute (BNI) campus for commercialization and validation relative to conventional diagnostics. Combined with the fact that BNI sees more brain tumor patients than any other place in the US, we are strongly positioned for moving this diagnostic product quickly into clinical use. Beyond this program, the peptide biomarkers identified and validated in this program will serve as early stage watch-dogs for new brain cancers on a single, universal health chip. This aligns with HealthTell's business plan of commercializing a simple, inexpensive microchip to monitor asymptomatic people for early development of disease. Continuous monitoring of healthy people would permit perturbations, such as brain cancer signatures, to be detected early.