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The first blood test for the early detection and prognosis of Acute Myeloid Leukaemia

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

Acute myeloid leukaemia (AML) accounts for about 25% of all leukaemia in the Western world. Its overall survival rate for 5 years is the lowest of all types of leukaemia (27%): above 60% of AML patients will succumb to the disease. Currently, there is no method for early detection of AML. It is diagnosed based on the presence of blasts in bone marrow samples and must be treated immediately to avoid a near-future death. Due to this late detection, AML treatment is of low effectiveness. The aggressive and often fatal nature of AML makes it a priority for developing early and fast diagnostic and prognostic tools.
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.
Demonstration of the market viability.
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.

Regulatory alignment
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.
The most significant finding that emerged from all these analyses came from the possibility of selling Serostrat not only as a diagnostic test to detect Acute Myeloid Leukaemia, but also as a treatment of AML with LK01. Confirming the viability of selling also the treatment represents a key leap forward, not only for us as a company, but also for the medical community and for leukaemia patients, as it can increase the survival rate exponentially. This opens up new commercial possibilities that we intend to fully exploit through the development of the Phase 2 of our project.