AVC AVantage HPV E6 Test

Cervical cancer is caused by infection with the human papillomavirus (HPV). For decades, the Pap smear has been the predominant screening method for cervical cancer and pre-cancerous lesions, despite its substantial false negative and false positive rates. Recently, several HPV DNA-based tests were introduced to screen for infection with HPV, which decrease false negative results but suffer from poor positive predictive value. Arbor Vita Corporation's AVantage HPV E6 Test is the first cervical cancer diagnostic based on detection of the cancer-causing viral oncoprotein E6, which increases when cells become cancerous. The AVC AVantage HPV E6 Test promises both sensitivity and a high predictive value for identifying women with cervical pre-cancer and cancer.

AVC is developing this test in collaboration with PATH (the Program of Appropriate Technology in Health, Seattle, WA). The format of the AVantage HPV E6 Test will be a strip that allows for a robust, simple, and cost effective assay, and "point of care" use in low-resource settings in the developing world. Use of the cancer-causing E6 oncoprotein as a diagnostic marker may enable the test to achieve a high positive predictive value for those at risk of progressing to cervical cancer. Besides detection of E6 oncoprotein of cancer-causing HPV types, the AVantage HPV E6 Test will also tell if the detected E6 oncoprotein derives from either HPV types 16, or 18, or 45. The AVantage HPV E6 Test will go into a large clinical trial organized by PATH and the National Cancer Institute, planned to begin in several provinces in China at the end of 2009.