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.
The OncoE6TM Cervical Test prototype has been developed for detection of cervical malignancy in emerging countries, with limited medical and technical infrastructure, and the need for a simple and specific test for detection of cervical malignancy or the risk thereof is high. The OncoE6TM Cervical Test has been developed under previous SBIR phase I and II grants, and has undergone initial clinical validation in a large study in China. We now propose further product development and manufacturing scale-up towards commercialization in countries of urgent medical need.