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      Precision Diagnostics – From Discovery to Commercialization

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            Abstract

            Precise diagnostics are a pre-requisite for Precision Medicine by enabling a characterization of diseases on a molecular level leading to mechanism-based treatment. Giving the right drug to the right patient at the right dose and at the right time requires novel biomarker signatures to stratify patients accordingly.

            These new biomarker signatures can be derived from various sample sources such as plasma/serum, spinal fluid or cells such as PBMCs or other immune cells. High-throughput analyses of proteins using immuno-based methods can speed up the discovery and validation of potential biomarker candidates while limiting the attrition rate of candidates and enabling fast translation of findings into other immuno-assays.

            The scioDiscover platform is an ideal example for such a biomarker discovery platform as it combines antibodybased profiling with high-throughput, very low sample requirements e.g. 5ul of plasma/serum or spinal fluid per sample and high reproducibility. This platform was used in two of Sciomics’ biomarker projects, one for prediction and early diagnosis of acute kidney injury (AKI) and for predicting a severe Covid-19 disease trajectory.

            The workflow established at Sciomics enables very fast discovery timelines e.g. less than 8 weeks from start of discovery to the patent filling for the Covid-19 project1. Machine Learning assisted biomarker development and the subsequent validation of protein biomarker candidates using e.g. ELISA assays are the next steps in the development process. Validated markers such as S100A8/A9 and CRP show a very good correlation between scioDiscover derived data and commercially available ELISA assays as well as clinical assays highlighting the ease of translation of results obtained with our discovery platform. The AKI project is now the lead project for commercialization at Sciomics and various routes of commercial development are being available.

            Next to yielding biomarker candidates all discovery studies also add insights into the respective disease, the underlying mechanisms and provide further information about the patient collective as more than 1,400 proteins are profiled in a single assay. This approach is ideal to further Precision Medicine as novel biomarkers in combination with mechanistic knowledge and patient cohort characterization from a single analysis speed up research and knowledge generation.

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            Author and article information

            Conference
            REPO4EU
            6 October 2023
            Affiliations
            [1 ] Sciomics GmbH, Heidelberg (Germany);
            Article
            10.58647/REXPO.23025
            60d6de81-21bf-453f-9300-24b4f9be83af
            Authors

            Published under Creative Commons Attribution 4.0 International ( CC BY 4.0). Users are allowed to share (copy and redistribute the material in any medium or format) and adapt (remix, transform, and build upon the material for any purpose, even commercially), as long as the authors and the publisher are explicitly identified and properly acknowledged as the original source.

            RExPO23
            2
            Stockholm, Sweden
            25-26 October 2023
            History
            Product

            REPO4EU

            Categories

            Data sharing not applicable to this article as no datasets were generated or analysed during the current study.
            Pharmacology & Pharmaceutical medicine
            Precision Diagnostics,Precision Medicine,Biomarkers,Biomarker Signatures,Mechanism-based Medicine,Protein Profiling,scioDiscover platform

            References

            1. Hufnagel Katrin, Fathi Anahita, Stroh Nadine, Klein Marco, Skwirblies Florian, Girgis Ramy, Dahlke Christine, Hoheisel Jörg D., Lowy Camille, Schmidt Ronny, Griesbeck Anne, Merle Uta, Addo Marylyn M., Schröder Christoph. Discovery and systematic assessment of early biomarkers that predict progression to severe COVID-19 disease. Communications Medicine. Vol. 3(1)2023. Springer Science and Business Media LLC. [Cross Ref]

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