Commercialization of the OncoE6TM Cervical Test for detection of HPV induced mali

描述(由申请人提供)：用于检测HPV引发的恶性肿瘤的OncoE6TM宫颈检测方法的商业化宫颈癌是导致女性癌症相关死亡的主要原因，每年导致全球超过25万人死亡，其中约80%的总死亡发生在发展中国家和新兴国家。实施适当的筛查技术以检测宫颈癌前期和癌症是减少这一高死亡人数的一个关键因素。宫颈癌筛查在发达国家最为明显；在这些国家，通过实施巴氏试验(细胞学)，如果巴氏试验呈阳性，则随后进行阴道镜检查和组织学检查，从而降低了宫颈癌的患病率。新兴国家缺乏筛查方法是全球宫颈癌死亡率居高不下的主要原因。在发展中国家和新兴国家，巴氏杆菌检测尚未实施，主要是因为需要高度的医疗基础设施。在许多农村低资源环境中，很难重新安置细胞学阳性的妇女，并将她们带回诊所进行后续治疗。PAP检测的临床敏感度和特异度都不太理想(均为50-70%)，解释具有很高的主观性。分子检测(“HPV检测”) 在过去十年中，作为发达国家和希望实施宫颈癌筛查计划的新兴国家的初级宫颈癌筛查解决方案而开发的。根据之前的SBIR第一阶段和第二阶段拨款，Arbor Vita Corporation(与PATH合作)开发了一种简单而可靠的试剂和相关技术，用于直接从宫颈标本中检测E6 HPV癌蛋白。OncoE6TM宫颈测试是为了在新兴国家进行商业化准备而开发的；它(图1)包括一种基于侧向血流的检测隆起的测试 宫颈癌中发现的最常见的HPV类型的E6癌蛋白(HPV16和18型)。OncoE6TM宫颈检测不需要复杂的设备，不需要高级操作员培训，并且在室温下稳定。OncoE6TM宫颈检测提供了新兴国家的宫颈恶性肿瘤分类筛查测试所需的临床特异性和阳性预测值。我们计划进一步开发OncoE6TM宫颈检测，走向商业化。该方法将包括将从临床现场研究中获得的信息应用到持续的产品开发中，以使测试适应护理标准。我们计划进行分析性能研究、保护带研究和扩展稳定性研究。我们计划通过验证和确认，将生产规模从现有的6000个单位批次扩大到10万个单位批次。一个终点将通过不同的样本采集方法在多种地理环境中提供验证。基于客户反馈的最终产品，按照GMP进行更大规模的生产。

DESCRIPTION (provided by applicant): Commercialization of the OncoE6TM Cervical Test for detection of HPV induced malignancy Cervical cancer is a major cause of the cancer-related mortality of women and causes over 250,000 deaths per year worldwide, with about 80% of total mortality occurring in developing and emerging countries. The implementation of appropriate screening technology for the detection of cervical pre-cancer and cancer is one key element towards reduction of this high death toll. Cervical cancer screening has become most visible in developed countries; where cervical cancer prevalence has diminished by implementation of Pap testing (Cytology), followed by colposcopy and histology examination if the Pap test is positive. The lack of screening methods in emerging countries is a major culprit for high cervical cancer mortality worldwide. In developing and emerging countries, Pap testing has not been implemented, mostly due to the high degree of medical infrastructure needed. In many rural low-resource settings, it proves difficult to relocate women with a positive cytology result and bring them back for follow-up treatment to the clinic. Pap testing has suboptimal clinical sensitivity an specificity (both 50-70%), and interpretation is highly subjective. Molecular tests ("HPV testing") have been developed during the past decade as a solution for primary cervical cancer screening in the developed world, and in emerging countries who wish to implement cervical cancer screening programs. Under the preceding SBIR phase I and phase II grants, Arbor Vita Corporation (in collaboration with PATH) has developed the reagents and associated technology for a simple and robust test for direct detection of E6 HPV oncoprotein from cervical specimens. The OncoE6TM Cervical Test was developed to commercialization readiness in emerging countries; it (Fig. 1) consists of a lateral-flow-based test for the detection of elevated E6 oncoprotein of the most prevalent HPV types found in cervical cancer (HPV types 16 and 18). The OncoE6TM Cervical Test does not need complex equipment, advanced operator training, and is stable at room temperature. The OncoE6TM Cervical Test delivers the clinical specificity and positive predictive value required for a triage screening test for cervical malignancy in emerging countries. We plan to further develop the OncoE6TM Cervical Test towards commercialization. The approach will consist of implementing information gained from clinical field studies into continued product development to adapt the test to standard of care. We plan analytical performance studies, guard band studies, and extended stability studies. We plan to scale up manufacturing from the existing 6,000 unit batches to >100,000 unit batches with verification and validation. An endpoint will provide validation in numerous geographic settings with different sample collection methods. A final product based on customer feedback, with larger scale manufacturing in compliance with GMP.