Autoantibody Profiling for Serological Detection of Head and Neck Cancer

描述（由申请人提供）：小型生物技术公司20/20 GeneSystems， Inc.（20/20）正在寻求SBIR拨款支持，以帮助我们推进我们认为将成为第一个常规用于帮助早期检测头颈癌的血液检测。尽管最近在诊断和治疗方式方面取得了进展，但晚期头颈部鳞状细胞癌（HNSCC）患者的长期预后仍然令人沮丧，5年生存率低于40%。这种严峻的预后与早期癌症患者超过80%的治愈机会形成鲜明对比。不幸的是，超过三分之二的HNSCC患者在病情进展后才被诊断出来。这种癌症的早期诊断失败主要是由于缺乏对高危患者的筛查试验以及初级医生对早期癌症的频繁误诊。自体抗体免疫检测头颈部鳞状细胞癌（HNSCC）有望成为一种新的无创早期诊断工具。我们的长期战略是开发一种“烟草使用者芯片”，在一个血液样本中同时筛查HNSCC和肺癌，因为现在和以前的吸烟者患这两种疾病的风险都很高。如果第一阶段的工作取得成功，这将成为第二阶段SBIR拨款申请的主题。血清学检测应对高危人群的医疗保健质量产生重大影响，特别是对美国20%以上的烟草和/或酒精产品使用者。公共卫生相关性：用于头颈癌早期检测的血液检查可提供一种具有成本效益的筛查方法，适用于目前已知的高危人群，包括：吸烟和/或酗酒者、免疫功能低下者和有癌前病变者。这将使降低这种疾病的严重死亡率成为可行的战略。

DESCRIPTION (provided by applicant): SBIR grant support is being sought by 20/20 GeneSystems, Inc. (20/20), a small biotech company, to help us advance what we believe will become the first blood test to be routinely employed to aid in the early detection of head and neck cancer. Despite recent advances in both diagnostic and therapeutic modalities, long-term prognosis for patients affected by advanced stage head and neck squamous cell carcinoma (HNSCC) remains dismal with 5-year survival less than 40%. This grim prognosis is in distinct contrast to the more than 80% chance of cure for those patients who present with early stage cancer. Unfortunately, more than two-third of patients with HNSCC are diagnosed only after the disease is advanced. Failure to diagnose this cancer early is mainly attributed to the unavailability of a screening test for high risk patients as well as frequent misdiagnosis of early stage cancer by primary physicians. An autoantibody immunoassay for head and neck squamous cell carcinoma (HNSCC) is expected to become a novel non-invasive tool for early diagnosis. Our long term strategy, which would become the subject of a Phase II SBIR grant application should Phase I work be successful, is to develop a "tobacco user's chip" to screen for both HNSCC and lung cancer in one blood sample, because current and former smokers are at high risk for both diseases. The serological test should have a significant impact on the quality of medical care for persons at risk, particularly for over 20% of the US population who are users of tobacco and/or alcohol products. PUBLIC HEALTH RELEVANCE: A blood test for early detection of head and neck cancer could provide a cost-effective screening approach when applied to presently known high risk groups, who are: users of tobacco and/or alcohol, the immune-compromised, and those with premalignant lesions. It would enable a viable strategy for reducing the severe mortality rate of this disease.