Implementation of polygenic risk score guided breast cancer precision prevention

Project facts

Project promoter:
OÜ Antegenes(EE)
Project Number:
EE-INNOVATION-0074
Status:
Completed
Final project cost:
€1,269,961
Donor Project Partners:
Oslo Cancer Cluster SA(NO)
Oslo University Hospital
Cancer Registry of Norway(NO)
University of Oslo(NO)
Vestre Viken HF(NO)
Programme:

Description

Antegenes is a healthcare technology company developing and implementing innovative genetic tests based on polygenic risk score technology to enable personalised prevention of common cancers. 

Breast cancer screening in EU contries is only age-based but mortality could be decreased by around 20% if screening programmes would consider AnteBC individual test results. However, as European healthcare markets are heavily fragmented and regulated, population-wide adoption of a new solution requires public reimbursement to end-users. Clinical adoption requires proof of clinical utility and feasibility of its use in the local medical setting. Project promoter OÜ Antegenes has registered a polygenic breast cancer (BC) risk test, AnteBC as an CE-certified medical device.

The objective of the project is to collect clinical utility and performance evidence on the Antegenes breast cancer risk test (AnteBC) in scientific studies, to drive the clinical adoption with a feasibility pilot of AnteBC in Norwegian medical settings and to generate technical documentation for preparing a Norwegian reimbursement application.

Project consortium brings in the best scientific expertise within Norway to assess the performance and utility of our tests for the local settings, one of the largest hospital trusts to apply this in a clinical practice and a well-connected cancer knowledge cluster to communicate the project outputs to drive further engagement in the local stakeholder community. A novel healthcare application with Estonian source in the Norwegian health system provides a platform for developing mutual professional partnerships between all the project partners and also with external parties engaged via dissemination activities. 

Summary of project results

The challenge of the project is to increase the effectiveness of breast cancer prevention. Current breast cancer prevention is age-based, but implementing AnteBC in screening selection could reduce breast cancer mortality by approximately 20%.

The aim of the project was to implement the AnteBC test in breast cancer screening of Norwegian women. For this, the performance of the AnteBC test was analysed on genetic data from the Norwegian population, a successful clinical trial was conducted in Norwegian healthcare institutions, and the necessary scientific and regulatory documentation for the implementation of precision breast cancer prevention was prepared. The necessary healthcare training has also been conducted.

Project solution is already available as a service. Project consortium has taken plans for the future to continue the cooperation activities, for example with Norwegian Cancer Registry and partners the preparations have started to continue eith “real-world” national-level pilot project. The collaboration continues with the BRIGHT consortium to jointly apply expertise and knowledge for the adoption of precision cancer prevention not only in Norway and Estonia but also in Sweden, Portugal and other European countries.

Summary of bilateral results

The Partners contributed to the implementation of the project tasks according to plan. We managed to involve all partners and collaborate successfully. The cooperation in the project laid the foundation for broader cooperation in the future, for which follow-up projects are also already being planned.

Information on the projects funded by the EEA and Norway Grants is provided by the Programme and Fund Operators in the Beneficiary States, who are responsible for the completeness and accuracy of this information.