Antigen production (minimum viable product) and prototyping of the Sporothrix-ELISA test

Abstract

Fungal infections, better known as mycoses, are infectious diseases caused by eukaryotic microorganisms, pathogenic fungi. The Fungi kingdom has a biodiversity of about 1.5 million species, many of them have biotechnological interests and are used in industry while some other species have impact on the Health area or related to it. Infections caused by fungi have a huge economic impact on Agriculture as, for example, the witches' broom (Moniliophtora perniciosa) of cacao and, are gaining more and more importance in Human and Animal Health, due to the adaptation and evolution of these microorganisms towards animal parasitism. However, researching and discovering biomarkers or fungal antigens is not a trivial task. For this reason, companies that produce drugs to treat these infections or bring solutions for their diagnosis are still scarce in the world market. The main reasons for this gap in the market is supported by the fact that antifungal drugs are toxic to the animal host (eukaryote-eukaryote) and the discovery of new specific target ate difficult and, on the other hand, fungal biomarkers and/or antigens are, in general, of non-protein nature, mainly carbohydrates - biomolecules that are not clonable and, nor detectable by molecular and genomic techniques. Glycobiology is the area of expertise of the principal investigator and founder of BIDiagnostics, who has been studying glycoconjugates isolated from pathogenic fungi, including antigens, for years. In conclusion, glycoconjugates have an impact on Life Sciences, as well as on Technology and Innovation in the Health area, and few groups have this technological domain. These biomolecules are abundant on the surface of fungi and are excellent markers for the diagnosis of mycotic infections, but cross-reactions can be common. We cite as an example of this market niche the Platelia Aspergillus commercial kit (BioRad), which for over a decade has been the only commercial tool used in the world to diagnose aspergillosis. A pain or a shortage represents an opportunity and, in order to fill this market gap, BIDiagnostics was founded in 2019, with the support of a PIPE Phase 1 project that has been successfully developed in the area of Human Health. During the project we pivoted to the PET market, as it is bigger and more promising, performing, in parallel, the proof of concept of the Sporothrix-ELISA test for either human or feline sporotrichosis (Felis catus domesticus). In the present proposal, we are submitting a PIPE Phase 2 project with the objective of consolidating BIDiagnostics as a national reference company focused on the certified production of fungal antigens - production of critical inputs for diagnosis - for the development and commercialization of kits for the diagnosis of mycosis, among them sporotrichosis. (AU)