A novel, simple and specific test for HPV induced neoplasia via direct detection of E6 oncoprotein

Abstract

Cervical cancer is one of the leading causes of cancer related mortality in women worldwide, with 80% of deaths occurring in developing countries. Effective cervical cancer screening in low-resource settings relies on the availability of appropriate screening technology. The OncoE6TM Cervical Test (E6 Test) represents the first test to directly detect elevated levels of the cancer causing viral E6 oncoprotein biomarker, and elevated expression of both E6 and E7 oncoproteins is necessary for cervical cell transformation to occur. The E6 Test format also offers several other key characteristics important for use in low-resource settings: the lateral flow format is easy to use and void of the need for complex equipment (no cold chain), it is amenable to screen and treat due to a short time from sample collection to results, and by detecting the cancer causing E6 oncoprotein it has a very high clinical specificity and positive predictive value (98.9% and 40.8% for CIN3+, respectively, as determined in a large clinical study in China). The E6 Test's clinical performance promises to result in a reduction of unnecessary over treatment of women with clinically irrelevant HPV infection and no pathology. The China clinical study also showed that a positive E6 Test result in HPV positive women with no visible disease predicts a 14.3% risk of CIN3 after only one-year of follow-up, while this risk is only 0.54% for HPV positive and E6 negative subjects. A summary on clinical performance of the OncoE6TM Cervical Test will be presented, and implications of its use as a triage or primary screen, as well as use in detection of HPV induced neoplasia other than cervical cancer will be discussed.