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Sengenics, the Functional Proteomics Company, today announced the launch of ImmuSAFE™ COVID+, a multi-antigen, multi-domain, fully quantitative serology test. ImmuSAFE™ enables the determination of the target epitopes, titres and Ig class/sub-class (IgG, IgA, IgM; IgG_1-4) of antibodies produced across all stages of COVID-19 infection, from initial exposure, disease development, post-recovery or post-vaccination. These results will provide critical insights on whether individuals have high titres of potentially neutralising antibodies against SARS-CoV-2 that may protect against reinfection or whether booster vaccinations are required. ImmuSAFE™ COVID+ will also enable quantitative assessment of patient response in vaccination trials, including differentiation of whether observed antibody responses are due directly to the vaccine or to prior SARS-CoV-2 exposure.

ImmuSAFE™ is a lab-based biochip test that utilises Sengenics’ patented KREX™ protein folding technology ensuring that viral antigens are correctly folded, preserving all conformational and linear antibody binding sites. The test contains more than ten domains of SARS-CoV-2 Nucleocapsid and Spike proteins including full-length and numerous truncated versions.

Cross-reactivity between immunogenic regions of SARS-CoV-2 and other coronaviruses may lead to an overestimation of sero-prevalence in a given population. ImmuSAFE™ is designed to reduce cross-reactivity by targeting multiple SARS-CoV-2 specific domains, resulting in fewer false positives, and a more accurate determination of sero-prevalence.

Professor Jonathan Blackburn, Sengenics CSO said, “The target epitope of antibodies produced following infection exhibit a significant level of diversity across a population. Some individuals produce antibodies that target locations which are neutralising (protective), whereas others produce antibodies that are non-neutralising. Being able to differentiate between these has major implications for vaccine development and sero-protectivity of individuals following infection.”

The ImmuSAFE™ product range also includes other biochip-based tests that incorporate additional viral antigens such as: SARS-CoV-2 Envelope, Nucleocapsid proteins from 13 other Coronaviruses including 5 human Coronaviruses (SARS-CoV, MERS-CoV, NL63, HKU1 and 229E) as well as Influenza A and B HA antigen subtypes. Content can be customised based on individualised requirements for vaccine clinical trials or sero-prevalence research studies.

About Sengenics

Sengenics is a Functional Proteomics company that leverages its patented KREX™ technology to discover autoantibody biomarker signatures for prediction of drug response and severe immune-related adverse events (irAEs). KREX™ can also be used to identify autoantibody biomarkers that may be used to diagnose cancer, autoimmune, neurodegenerative or infectious diseases with higher sensitivity and specificity than conventional diagnostic tests. Some autoantibodies that are identified as diagnostic biomarkers may be protective and have potential in themselves as therapeutic biomolecules.

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