EDY Diagnostics

Oropharyngeal cancer (OPC) caused by human papillomavirus (HPV) affects over 30,000 new patients every year. Unfortunately, 65% of these cases are diagnosed at advanced stages, requiring more aggressive treatments that can lead to serious long-term effects. Currently, there is no reliable test to detect HPV-caused OPC in its early stages. Consequently, there is a critical need for the timely detection of HPV-caused OPC to reduce the risk of aggressive interventions and improve patients’ quality of life.

To address this problem, EDY diagnostics is developing an in vitro diagnostic test  that will enable physicians to perform timely follow-up assessments, allowing for early interventions that may reduce the need for aggressive treatments and improve patients’ quality of life. Out test uses a multiplex serology technology to detect antibodies against multiple HPV16 early proteins with high sensitivity and specificity. Unlike common transient HPV infections, our biomarker is only detectable upon cancer development caused by HPV. The test itself can be done with just a single drop of blood: Antibodies from the blood bind to HPV proteins attached to fluorescently colored beads, and a secondary antibody plus reporter dye generate a fluorescence signal that can then be quantified. A key advantage of our multiplex platform is its flexibility, allowing other antigens of interest to be included for broader diagnostic applications.

A RUO version of the test was applied in several epidemiological studies and results showed that early antibodies against HPV16 are sensitive and specific biomarkers for HPV-caused OPC. In a population-based proof-of-concept study with almost 5,000 participants (PHORECAST) we have proven that a refined HPV16 biomarker panel can be used to identify individuals at the highest risk and trigger diagnosis of HPV-caused OPC, even at early asymptomatic stages.