Periodic Reporting for period 1 - KlotoDx (KlotoDx A quick and cost-effective near-patient tool to identify sepsis-related bacteria and antibiotic resistances)
Reporting period: 2018-09-01 to 2018-12-31
Sepsis is a significant health and economic burden worldwide, affecting more than 30M people/year, leading to 6M deaths and worsened by antimicrobials resistance (AMR) in healthcare-associated infections. Blood culture remains the gold standard for sepsis characterization, but this and other methods are time-consuming, expensive and labor-intensive. Moirai Biodesign is a Spanish start-up with aiming to apply its developed Plug and Play Biodevice technology to the obtention of KlotoDX, a fully automated and portable platform to identify sepsis-causing pathogens and their main resistances to antibiotics. KlotoDX is being developed as a near-patient, ultra-fast, low-cost and end-to-end solution, capable of delivering results at the point of care in 3 hrs. and using non-cultured blood samples. Pending activities until market launch are prototype scaling-up, manufacturing, clinical validation, regulatory certifications obtention, IP protection strategy completion and commercialization preparation.
KlotoDX diagnostics platform has been successfully designed and preliminary developed and tested against human acute promyelocytic leukemia and bacterial biomarkers, as well as the different steps of the process validated using cultured human blood cells and bacteria culture. Thanks to the support of the H2020 SME-Instrument Phase 1 grant, we have been able to identify the main technical and financial requirements to take our product to the market and thanks to it, we have decided to continue developing our project. The establishment of relationships and agreements with key partners and diverse stakeholders will be crucial (manufacturing partners, commercial distributors, KOLs, etc.).
KlotoDX goes beyond current sepsis diagnosis solutions and its core values set it apart: 1) It obtains and delivers results directly from a blood draw in a single step, using one-use disposable kits. 2) It does not require huge or expensive machinery, nor specialized trained personnel or the maintenance of the cold chain for transportation. Thus, it can be used in near-patient settings, e.g. emergency departments, medical offices or field hospitals. 3) It uses low-cost tests capable of simultaneously detect an array of disease-specific biomarkers. 4) It delivers results in less than 3 hours. KlotoDX will allow early sepsis diagnosis, nearly immediate delivery of proper treatment, reduced use of broad- spectrum antibiotics and potential savings of around €10 M per hospital each year.