From Discovery to Diagnostic: The Science Behind Our Platform
Join us on a scientific journey that made our serology platform possible: from the foundational laboratory studies that proved HPV16 E6 antibodies could identify tumors with near-perfect accuracy, to population-level validation confirming who carries this marker, to the first real-world screening trial that detected asymptomatic stage I cancers in the general population. Each milestone built on the last - transforming a scientific insight into a tangible solution.
Our roadmap ahead includes clinical validation studies, CE-IVD certification for regulated use across Europe, and the expansion of our platform to detect new targets - broadening the impact of early cancer detection.
The Scientific Foundation: Proving Blood-Based Detection Works
In the first large population-based study of its kind, we analyzed over 10 years of data to characterize individuals who test positive for HPV16 E6 antibodies. The study confirmed that E6 serves as a specific marker of persistent oral HPV exposure rather than incidental infection.
First Real-World Screening Study: Detecting Cancer Before Symptoms
2017
Our research group demonstrated for the first time with high statistical rigor that HPV16 E6 antibodies in blood are an exceptionally reliable diagnostic marker for HPV16-driven oropharyngeal cancer with 96% sensitivity and 98% specificity.
2020
Population-Level Validation: Understanding Who Carries the Marker
2022
A proof-of-concept study provided the first real-world clinical evidence that a blood-based HPV serology test can successfully identify early-stage oropharyngeal cancer in asymptomatic individuals from the general population.
We are designing and initiating a clinical validation study to establish the performance of our test. In parallel, we are building our quality management system and technical documentation toward CE-IVDR certification across the European Union.
Expanding the platform:
New Targets, Broader Impact
Currently
Toward Clinical Validation and CE-IVDR Certification
Outlook
Our next step is expanding the platform to detect further biomarkers, transforming a single-target test into a comprehensive early detection solution.