Funding scheme: SRIN 6/2021
Starting Date: January 1st, 2022
Duration: 3 months
Estimated budget: 94 059,24 €
The main aim of the project is to strengthen the existing cooperation and establish further partnerships in order to develop a functional molecular test for faster, cheaper and robust detection of the state of T cell mediated cellular immunity to SARS-CoV-2 virus. To date, methods based on the determination of antibody immunity are preferred in clinical practice, but the determination of T cell responses to pathogens significantly broadens the picture of a patient’s immune status and allows for better characterization of vulnerability to infection at either individual or population level. The determination of T cell immunity is currently uncommon due to the many technical and practical obstacles that the present project aims to address. The issue of cellular immunity is highly current, especially in connection with the ongoing pandemic of the COVID-19 disease due to the spread of the SARS-CoV-2 virus, but it is also of key importance in other infectious and non-infectious diseases. The proposed project combines several attractive topics with highly relevant and long-term usable outputs. The specific aim of the project is to design, optimize and validate an alternative approach to the detection of peptide-activated immune system T cells from blood PBMCs, using the RT-qPCR method directly from blood samples with no prior RNA extraction. During the project, we also plan to create a functional knowledge platform and, as one of its outputs, move the development of the diagnostic kit to a higher technological level preceding potential commercialization.
Creating a knowledge platform to fight and prevent pandemics
During the project, MultiplexDX intensively increased communication, especially with the Biomedical Research Center of the Slovak Academy of Sciences, in order to intensify cooperation in the development of a diagnostic kit to a higher technological level.
Development of an innovative diagnostic kit for testing cellular immunity on SARS-CoV-2
The focus of the project, the development of a new form of diagnostic test suitable for testing the presence of cellular immunity to SARS-CoV-2 from blood samples, was successfully achieved. We identified specific mRNA targets specifically upregulated by T cell stimulation, designed a highly sensitive multiplexed assay and developed a simple whole blood processing method. Before the project began the technology was in the TRL2 phase, i.e. in the form of a technological concept. The end product is a diagnostic assay based on the RT-qPCR method capable of detecting the activation of immune T-cells and other immune cells by stimulation with SARS-CoV-2 activating peptides, directly from collected and stimulated blood without the need for RNA extraction. These features correspond to the TRL6 technology level, technology demonstrated in a relevant system. Additionally, in cooperation with the Biomedical Research Center of the Slovak Academy of Sciences, we have initiated a clinical validation process, which is actively underway.
MultiplexDX is one of the most innovative biotech corporations, created to bring its revolutionary technologies to the market of personalized molecular diagnostics. The company has representation in both U.S. and European markets. The collaborators of MultiplexDX are from the world’s most prestigious scientific organizations including the National Cancer Institute, Rockefeller University, Albert Einstein University, Vanderbilt University, Cornell University, Queens University (Canada), Hebrew University of Jerusalem (Israel), and the Max Delbrück Center for Molecular Medicine (Germany).
MultiplexDX IP-based and innovative platform merges histopathology methods, biomarker quantification, visualization and gene expression with a single-cell resolution by combining MDX proprietary visual and sequencing technologies into one diagnostic test. This cross-validation approach eliminates diagnostic errors and creates 100% precise cancer profiling for each patient which allows clinicians to suggest specific, personalized cancer treatment.