Cervical cancer remains a major cause of cancer related mortality among women living in low and middle income countries (LMICs). A decrease in mortality has been achieved in regions where population wide screening was implemented, yet existing screening technologies have failed to reduce mortality in many LMICs. Reasons for the lack of effective implementation of cervical cancer screening in many regions in need are complex; the infrastructure needs (pathologist, complex instrumentation, cold chains requirements) of existing screening modalities and high false positive rate with regard to detection (and subsequent treatment) of true malignancy are contributing factors.
Cervical cancer is one of the very few cancers where the molecular cause can be pinpointed in nearly 100% of cases: elevated expression of the viral encoded E6/E7 oncoproteins as the consequence of “molecular accidents” allowing such deregulation. This knowledge suggested a very plausible and direct way to detect HPV-induced malignancy via detection of elevated E6/E7 oncoprotein levels. The OncoE6™ Cervical Test (“E6 Test”) has been developed to (i) achieve highest specificity by direct detection of a cancer causing agent, the HPV encoded oncoprotein E6, and to (ii) be robust, and easy of use; this, and the simple training requirements allow implementation in virtually any setting. The E6 Test has been used in studies in many LMIC settings worldwide, and it has consistently revealed high clinical specificity (~ 99%) and positive predictive value for CIN3+. In several instances, the E6 test detected high-grade cervical disease where traditional methods (cytology, colposcopy) have failed to do so.
We will present a synopsis of the clinical accuracy of the E6 Test in a variety of real world settings, including studies on HPV driven oropharyngeal cancer, and we will critically discuss typical use scenarios for the E6 Test.