Rapid Strip Test for Cervical Cancer via HPV-E6 Detection
DESCRIPTION (provided by applicant): Cervical cancer is a global health problem that continues to result in over 200,000 deaths a year and has one of the worst survival rates following diagnosis. Early detection of cervical abnormalities using the Pap smear has significantly reduced the number of deaths in industrialized nations, but even in the United States 12,000 new cases and 4,000 deaths are occurring each year. There is a critical need for a rapid, accurate and low cost diagnostic test that can be used at the point of care. Human papillomavirus (HPV) infection is. correlated with greater than 99.7% of cervical cancers. New tests directed at detection of HPV DNA can identify samples infected with high-risk HPV virus types, but a growing body of evidence suggests that the body can clear over 90% of these infections before they progress to cancer, thus potentially creating a large number of false positives in screening. Recent studies suggest that the HPV-E6 onco protein expression is required for maintenance of the cancer state, and that down regulation of E6 protein leads to apoptosis. Thus, the E6 protein is an attractive diagnostic target because it is highly correlated to the cancerous phenotype, not the potential for cancer. Arbor Vita has developed a rapid immunoassay for detection of E6 protein from human cells using a PDZ domain protein able to bind all high-risk HPV-E6 proteins and monoclonal antibodies against E6 subtypes. The current assay can detect 60000 cervical cancer cells. Arbor Vita has established a collaboration with PATH to develop a lateral flow version of this assay suitable for use as a point of care diagnostic. The AIMS of this proposal are to 1) identify the optimal E6 detection reagents for a lateral flow assay format capable of detecting the most prevalent 7 high-risk HPV types (found in > 85% Cervical Cancer), 2) identify a detection system that brings the assay sensitivity to detection of E6 corresponding to ~ 10000 cervical cancer cells, which is appropriate for prediction for cervical cancer 3) determine optimal conditions for sample processing, and 4) develop a prototype that is able to detect E6 protein from any of the top 7 types in a cervical sample. In a Phase II SBIR, we would test prototype efficacy on a large number of clinical samples and optimize, if necessary, for FDA submission.
Small Business Information at Submission:
ARBOR VITA CORPORATION
772 LUCERNE DRIVE SUNNYVALE, CA 94085
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