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赠款支持，以帮助我们推进我们相信将成为第一个常规使用的血液测试，以帮助早期发现头颈部癌症。尽管最近在诊断和治疗方面都取得了进展，但晚期头颈部鳞状细胞癌(HNSCC)患者的长期预后仍然很差，5年生存率不到40%。这一严峻的预后与那些患有早期癌症的患者80%以上的治愈几率形成鲜明对比。不幸的是，超过三分之二的HNSCC患者只有在疾病发展到晚期才被诊断出来。未能及早诊断这种癌症的主要原因是无法对高危患者进行筛查测试，以及初级医生经常误诊早期癌症。头颈部鳞状细胞癌(HNSCC)自身抗体免疫检测有望成为一种新的非侵入性早期诊断工具。如果第一阶段的工作成功，我们的长期战略将成为第二阶段SBIR赠款申请的主题，即开发一种“烟草用户芯片”，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。血清学测试应该对高危人群的医疗质量产生重大影响，特别是对20%以上使用烟草和/或酒精产品的美国人口。公共卫生相关性：用于早期发现头颈部癌症的血液测试在应用于目前已知的高危人群时，可以提供一种具有成本效益的筛查方法，这些高危人群是：烟草和/或酒精使用者、免疫功能受损的人，以及有癌前病变的人。这将为降低这种疾病的严重死亡率提供一个可行的战略。

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.