PathoNostics was founded in 2011 in Maastricht, The Netherlands and became an important player in the fungal diagnostic field. PathoNostics is focussing on the development and commercialization of real-time PCR kits for the diagnosis of superficial and invasive fungal infections. PathoNostics currently has four products on the market: AsperGenius®, DermaGenius®, PneumoGenius® and MucorGenius®.
PCR kits from PathoNostics enable a rapid and accurate diagnosis, leading to timely initiation of targeted therapy. Our proprietary technology platform uses real-time PCR and melting curve analysis to detect and differentiate pathogens and identify resistance markers. By using these real-time PCR kits, incorrect or unnecessary medical treatment, side effects, and costs can be avoided. The early diagnosis of fungal infections can greatly improve the clinical success and infection control. Our first product in the market, AsperGenius®, is now being used in more than 25 countries and is the only clinical validated CE-IVD assay which is able to differentiate A. fumigatus wildtype from the most prevalent azole resistance markers (L98H/TR34– TR46/Y121F/T289A). The DermaGenius® 2.0 is currently the only assay on the market combining a fast DNA extraction (20 minutes) on nail-, hair- and skin-specimens with a multiplex real-time PCR detection of the most clinically relevant (>95%) dermatophyte species. Our latest product, MucorGenius®, can detect mucormycetes which are responsible for invasive fungal infections in immunocompromised patients. This PCR can be used in parallel with the AsperGenius® to enable a fast diagnosis in this vulnerable patient group.
PathoNostics is dedicated to the design, development, validation and production of high quality real-time PCR kits for the detection of fungal pathogens. Our products are designed to work on the most common commercially available real-time PCR systems to enable a rapid introduction into molecular diagnostics laboratories. PathoNostics is committed to continually develop more diagnostic products to answer the clinical demand from the market and our aim is to develop assays which detect the causative fungus and simultaneously screen for their resistance markers.
PathoNostics has an ISO13485:2016 certified Quality Management System (QMS) for the design and development, manufacture and distribution of In-Vitro Diagnostics for infectious diseases. All PathoNostics products are clinically validated according the IVD directive and results are published in scientific journals. PathoNostics participates yearly in the External Quality Assessment (EQA) programs of the Quality Control for Molecular Diagnostics (www.qcmd.org) and other international and national panels with highscores on the performance. Results of these EAQ programs are available on request.