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A unique cost-effective and point of care (PoC) kit for the non-invasive rapid in vitro diagnosis of meningococcal disease

Periodic Reporting for period 1 - MeningoSpeed (A unique cost-effective and point of care (PoC) kit for the non-invasive rapid in vitro diagnosis of meningococcal disease)

Período documentado: 2019-03-01 hasta 2019-06-30

Meningococcal disease (MD), caused by Neisseria meningitidis serogroups (mainly ABCXWY), annually affects 1.2 million people worldwide (mainly children). Due to its high lethality (ca. 8-15% treated patients), permanent sequelae and epidemic potential, MD represents a major public health problem. However, despite the societal burden, there remains a lack of rapid and accurate diagnostic tools for timely and early treatment and is very costly for healthcare systems (e.g. direct costs valued in €68 M/hospital/year.)
BioSpeedia (spin-off from Institut Pasteur) develops and manufactures in vitro rapid diagnostic tests that respond to the needs in the field of infectious diseases. In collaboration with the Institut Pasteur, and supported by the World Health Organization, BioSpeedia is developing MeningoSpeed- the first rapid diagnostic test (RDT) able to detect the six Nm serogroups altogether. MeningoSpeed is non-invasive, (urine sample), accurate (sensitivity and specificity >93%), rapid (<15 min), cost-competitive (€45 sample, 25 % cheaper than alternatives) and easy to use on the field and at the bedside, enabling its wide implementation at the point of care (PoC), helping physicians to rapidly prescribe the appropriate antibiotic for the patient.
During feasibility study we have defined the technical requirements to optimize the technology, identified hospitals to perform clinical validation and evaluated the operational capabilities for scale up and industrialization. Commercially, we have performed an analysis of our target market, focus mainly in the meningitis diagnostic segment and paying attention to market trends, competitors and barriers to overcome. We have defined a commercial strategy based on partnering with medical diagnostic distributors to penetrate in our target markets. Moreover, we have updated our Freedom-to-Operate and evaluated our IPR strategy. Finally, on the economic side, financial forecasts on different scenarios have been drafted to evaluate a 5-year-projection.
The wide implementation of MeningoSpeed in clinical routine will positively impact patients, physicians and healthcare systems by significantly improving disease monitoring in an accurate and timely fashion way, reducing deaths and sequelae and preventing global epidemics. In addition, MeningoSpeed will provide economic savings to the healthcare system by offering the appropriate and timely treatment (potential cost savings of €1 billion per year globally).
MeningoSpeed Test- Cassettes for detection of 5 Nm (A, C, Y, W, X)