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

Meningococcal disease (MD), caused by Neisseria meningitidis serogroups (mainly ABCXWY), annually affects 1.2 million people worldwide (mainly children and young). Due to its high lethality (8-15% treated patients), permanent sequelae and epidemic potential, MD represents a major public health problem. Despite the societal burden, there is a lack of rapid and accurate diagnostic tools for timely and early treatment that results very costly for healthcare systems (e.g. direct costs valued in € 68 m/hospital/year). In response to the unmet need, BioSpeedia (spin-off from the Institute Pasteur, France) has vast experience in infectious diseases management and is developing the first-ever gold nanoparticle-based immunochromatographic test with demonstrated diagnostic capability for the six Nm serogroups. MeningoSpeed is a non-invasive, accurate (sensitivity and specificity >93%), rapid (<15 min vs PCR: 3h) and cost-competitive in vitro diagnostic test (€45 sample, at least 25 % cheaper than latex agglutination tests and PCR alternatives) for MD diagnosis. Our one-step solution will result on added value for patients, physicians and healthcare purchasers by improving disease monitoring in an accurate and timely fashion way, reducing deaths and sequelae. MeningoSpeed will provide healthcare systems with limited resources with a reliable and cost-effective diagnostic tool, leading to significant cost-savings. MeningoSpeed´s high accuracy and performance under a faster and cheaper cost make it a disruptive solution with great potential for commercial success in the growing point-of-care market (€33 B by 2022, CAGR 10%). Thus, MeningoSpeed is projected to be a profitable business opportunity and a core source of growth for the company (ca. €33 M of accumulated net profit during 2022-2026). A next feasibility study covering the technological, commercial and financial issues will enable us to finalize our business plan and secure our steps towards the successful market launch.