Periodic Reporting for period 4 - HPV OncoPredict (A Groundbreaking Stand-Alone Diagnostic Kit to Predict Human Papilloma Virus Infections Evolving into Cervical Cancer)
Reporting period: 2021-09-01 to 2022-04-30
HPV OncoPredict is unique in its power to discriminate clinically relevant from irrelevant HPV infections by means of a high-throughput molecular reflex testing algorithm: 1) screening assay able to detect all oncogenic HPV infections, 2) triage assays for HPV positive samples comprising of two second line biomarkers as indicators of risk, normalized hrHPV viral load and viral-induced cellular oncogenic transcripts. This innovative diagnostic device will allow reliable testing on self-collected vaginal or urine samples, maximising screening uptake. HPV OncoPredict IVDs developed and validated as part of this project will help identify those women at true risk of developing cervical cancer. Risk-stratification will prevent unnecessary costly and stressful investigations and overtreatment of women with clinically irrelevant infections. Moreover, HPV OncoPredict assays will be clinically validated to ensure reliable results on both clinician-collected and self-collected samples, representing an important public health achievement as recent studies have shown that self-sampling improves adhesion of “non-responders” to screening programs, contributing to improved prevention and costs reduction for the health system.
Overview of results
1. All assays have completed CE marking and have the relevant technical documentations as required (WP2)
2. Completion of inter- and intra- laboratory testing and results added to technical documentations (WP2 & WP4)
3. The assays have been fully automated on high-throughput robotic platform (WP2)
4. Software packages have been delivered according to specification (WP3)
5. We have a complete end-to-end workflow for HPV testing incorporating 2, 3 and 4 above.
6. Completion of the VALGENT-2 study (WP5)
7. Completion of the EU-VALHUDES study (WP6)
8. Completion of recruitment for WP7 by October/November 2022. The subcontractor will make a core report by November 2022 and a full statistical report by January 2023. Final complete triage clinical assessment at 12 months for the HPV-positive women enrolled at screening will be available by Autumn 2023, whereby a core report is expected to become available by November 2023
9. Published and peer-reviewed article “Human papillomavirus (HPV) detection in vaginal self-samples: evaluation of eNat® as an alternative suspension medium to ThinPrep®PreservCyt® for vaginal swabs” in Open Research Europe
Dissemination & exploitation
1. Talks at EUROGIN 2022 include "European VALHUDES Findings” (WP6), “Validation of tests for the triage of HPV+ve women” (WP7), “Clinical validation of HPV OncoPredict® SCR and QT assays using the Valgent-2 framework” (WP5), Validation of the HPV OncoPredict assay on self-collected vaginal and urine samples: preliminary Italian data of the EU-VALHUDES study" (WP6)
2. Poster presentations include “Evaluation of the clinical performance of HPV OncoPredict® QT assay within the VALGENT-2 framework” (WP5) at The British Society for Colposcopy and Cervical Pathology Annual Conference held in Belfast (May 2022).
3. ECCMID 2022 oral presentation “High-risk Human Papillomavirus (hrHPV) genotype-specific viral load in women with persistent infection”
4. Acceptance of talk “High-risk HPV genotyping and viral load assessment for the management of HPV-positive women” at European Society of Clinical Virology (ESCV) Congress 2022
5. Results of HPV OncoPredict Screening (SCR) and Viral Load (QT) have been presented at Society of Italian Virology (SIV) with oral presentation “Self-collection for HPV screening: new approaches for the prevention of cervical cancer”) and at the Society of Italian Microbiology (SIM), oral presentation “Evaluation of HPV genotype-specific viral loads in clinician-collected cervical samples as compared to vaginal self-collected samples in women with cervical dysplasia.”
6. High levels of engagement with the assigned Coach who has been instrumental is supporting the consortium with defining the market and the competition and the business strategy.
7. Engagement with KOLs and regulators on the adoption of HPV OncoPredict as part of the testing workflow
8. Transition of products into the IVDR pathway