Periodic Reporting for period 1 - SeroStrat (The first blood test for the early detection and prognosis of Acute Myeloid Leukaemia)
Reporting period: 2018-05-01 to 2018-09-30
We have identified a new biomarker for the early detection and prognosis of AML. This biomarker is detected and quantified by our innovative In vitro Diagnostic Test (IVD), named Serostrat, via a fast, cheap and routinely clinical blood analysis. We own the exclusive exploitation rights of SeroStrat. SeroStrat specifically targets the AML biomarker in blood cells, discriminates between AML unfavourable risk patients and AML patients with intermediate risks; is low-invasive and painfulness (only requires a blood sample instead of bone marrow samples); is fast and non-expensive (it can be used routinely in clinics in blood samples analysis by Flow cytometry) and will permit risk groups (persons aged >65), AML new patients, and persons in remission to be monitored easily and accurately for signs of recurrence.
The overall objectives are: market survey, regulatory alignment and elaboration of a business plan according to the new data obtained.
Quantify the level of market demand and willingness to pay by main users. Analysis of the risks and potential entry barriers due to acceptance and regulation.
Technical Validation. First steps towards CE auto-certification according to 98/79/EC (IVDD). Identification of further requirements towards FDA and EU IVDR 2017/746 certifications.
Updating the business plan accordingly
Plot the business model, route to market, penetration- marketing strategy, inception and commercialisation for SeroStrat.