VALidation of human PApilloma virus assays on Self-collected first void urine samples

Project Information

VALPAS

Grant agreement ID: 699009

DOI

10.3030/699009

Project closed

EC signature date 15 September 2015

Start date 1 September 2015

End date 31 October 2015

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

NOVOSANIS NV
Belgium

Periodic Reporting for period 1 - VALPAS (VALidation of human PApilloma virus assays on Self-collected first void urine samples)

Reporting period: 2015-09-01 to 2015-10-31

Summary of the context and overall objectives of the project

H2020 SME phase 1 project VALPAS, or VALidation of human Papillomavirus assays on Self-collected first void urine samples, aimed to strengthen and elaborate Novosanis’ business plan & market access strategy for HPV testing on first-void urine samples collected using the Colli-Pee™. HPV testing can be used to detect early stages of cervical cancer. Therefore, several EU-countries are switching from cytology-based to HPV-based screening programmes (e.g. NL in 2016).

VALPAS specific objectives were formulated as: (1) validate and prioritize market segments and EU-28 countries to launch Colli-Pee™, (2) validate business model and positioning of Colli-Pee™ versus competing products, (3) business plan quantification and timing, (4) assessment of usability of different diagnostic assays on first void urine for HPV testing.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The main results of VALPAS include:
*Market segment analysis, consisting of (1) market introduction strategy allowing stepwise implementation of Colli-Pee™ for HPV-based cervical cancer screening, (2) identification of market barriers (social, industrial, technical, economical) and counter-measurements, and (3) identification of user / end-user needs and willingness to use.

*Validation of business model, consisting of (1) thorough information about competing solutions, (2) identification of key stakeholders and value for money (3) insights in organisation of screening programmes (4) new and strengthened partnerships with diagnostic companies and laboratories, (5) validated distribution channels & new production facilities, and (6) validated pricing strategy.

*Updated business plan, based on information of previous two tasks, consisting of a commercialization plan and exploitation plan. These include a.o. financial requirements to reach the commercialisation stage.

*Assessment of diagnostic assays on first void urine for HPV testing, consisting of (1) a selection of PCR-based assays from top 10 diagnostic companies, (2) an established network to perform clinical trials in 5 EU countries, allowing the comparison of Colli-Pee™ to other self-sampling devices and clinician-based sampling (3) determination of clinical accuracy.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Previous discussed information entails the final results from VALPAS phase 1. From these results, Novosanis has identified crucial steps needed to continue the business opportunity, entailing (1) validation of Colli-Pee™ collected samples on commercially available diagnostic assays, via pre-studies and clinical trials, (2) manufacturing and upscaling production capacity, (3) further defining market access strategies at global level, including regulatory approval; European tendering; and reimbursement, (4) communication, dissemination and exploitation, including marketing and PR.

This approach will allow increasing the participation rate of women in cervical screening programmes worldwide. Ultimately, prevalence of cervical cancer can be reduced and health care costs decreased. In the end, no one wants to loose a relative or friend from cervical cancer.

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