After months of experimentation in partnership with some world-class schools of medicine and top-tier diagnostic providers, our much-anticipated T-Cell Test based on innovative qPCR technology is finally available for the European market with a CE-IVD mark. The new Test will change the way laboratories and diagnostic providers track and monitor T-cell patients' immunity to SARS-CoV-2, leveraging the unique characteristics of Hyris System™.
A recently published Nature's study confirms that measuring the T cells' response is a new disruptive approach to fighting SARS-CoV-2. Thanks to responsive T cells, an individual negative to an antibody test could still be protected. Although its strategic relevance is acknowledged worldwide, cellular immune response assays are rarely performed due to the associated technical challenges. "Detection of antigen-specific T cells is Typically quantified by flow cytometry, ELISpot or ELISA," explains Lorenzo Colombo, General Manager and CTO at Hyris. "These techniques, while robust and well accepted in the field, require a skilled workforce and are relatively costly and time-consuming."
This is where the new T-Cell test from Hyris comes into play. Fruit of months of experimentation in collaboration with some of the most important medical schools in the world, our new Test is finally available for the EU Market after receiving the CE-IVD mark. "This new T-Cell test overcomes the limitations typically involved with immune cellular response testing, thanks to its unique two-part process", clarifies Colombo. “At first, T Cells are stimulated within a whole blood sample. Secondly, the sample is analyzed via qPCR in direct amplification to detect potential activation of the T Cells".
This new assay has been highly anticipated all over the world, both by the scientific community and healthcare specialists. The Test immediately helps answer the crucial question at this pandemic stage: "how long is your COVID immunity good for, whether from a vaccine or prior infection?" The truth is, we do not know for sure yet: the temporal threshold commonly accepted is about three or four months, but the latest variants circulating proved to be more capable of breaking through our immunity.
"In front of such a challenging frame, we cannot be content with our knowledge about antibody response, which is just half of the picture", holds Stefano Lo Priore, Co-Founder and CEO ad Hyris. "The other half, T-Cell response, is rarely sought due to the technical challenges involved. That is why we aimed for simplicity, by using technology that is widely accessible and can turn around results more quickly. Concludes Lo Priore: "Now that key response about our immunity can be tested affordably and massively, leveraging the immediacy, connectivity, and scalability of the Hyris System™".
The new Test brings attention to the future deployment of portable qPCR-based systems and could enable immunology testing for a much wider number of patients. "Historically, qPCR-based diagnostic approaches have been limited by laborious, error-prone and expensive RNA extraction methods," says Andrea Fabbri, Chief Commercial Officer at Hyris. "The new assay on T Cells response works in direct amplification, making this protocol more efficient, rapid and scalable". Fabbri also addresses the issue of energy consumption, an increasingly sensitive topic in the molecular biology industry. "The Hyris System™ is also green compared to other technologies traditionally used in this field, with an energy consumption similar to a single 20 w light bulb, more than a tenth of that of other comparable devices on the market".