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Predictive in vitro diagnostics test for individualized tailoring of chemotherapy in primary breast cancer

Periodic Reporting for period 1 - ChemoPredict (Predictive in vitro diagnostics test for individualized tailoring of chemotherapy in primary breast cancer)

Reporting period: 2015-07-01 to 2015-12-31

Sividon established a prototype diagnostic assay - the ChemoPredict test - to stratify high-risk breast cancer patients and to help in deciding whether it is it necessary to treat the patient with taxanes in addition to anthracycline-based chemotherapy. Previous training and validation studies for ChemoPredict already provided evidence that this test will result in a more precise use of taxanes and a reduction of overtreatment thus avoiding side effects in patients and saving costs for the health care systems. Sividon’s aim for the overall innovation project is to enhance the clinical validation data, to develop ChemoPredict as a CE-marked IVD test and to introduce it as further tool for precision medicine into international markets. The objective of phase 1 of the project was to explore and assess the commercial potential, the economic viability and regulatory issues of that breakthrough idea.
As a result, an elaborated business plan including detailed market analysis was generated. It could be shown that there is a large clinical need for a test like ChemoPredict. Moreover, there is a large market for the test with a target population of 212,361 patients and a total addressable market of €170 million in Europe per year. No competitive test could be found on the market. The existing customer basis of Sividon’s current product EndoPredict® will facilitate market entry of the ChemoPredict test. The commercialization strategy will start with the key opinion leaders to get included into clinical guidelines and is accompanied by discussions with the health insurances. Costs for the clinical validation trials and for product development were calculated and the estimated revenues reveal that ChemoPredict offers an attractive business opportunity. Moreover, regulatory issues with focus on possible changes in the European IVDD were evaluated and the clinical validation as well as product development strategy as well as a development plan were generated.
A careful risk assessment showed basically two risks, the scientific risk is a failure of the validation studies and the economic risk that clinical guidelines might not embrace ChemoPredict and thus health insurances might decline reimbursement.
In conclusion, the results of phase 1 show that the project is an attractive and promising business case in which the potential benefit outweighs the risks. Therefore, the innovation project should be pursued further by an application for phase 2.
Time line for CE development of ChemoPredict as part of Sividon’s development process