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Hyris Gets CE-IVD Mark for SARS-CoV-2 Cellular Immunity Test

NEW YORK — Hyris said on Friday that it has received CE-IVD marking for its T-Cell Test for tracking and monitoring T-cell immunity to SARS-CoV-2.

The qPCR-based test, which was developed by Mount Sinai researchers and exclusively licensed by London-based Hyris, quantifies the messenger RNA of CXCL10, a chemokine that linearly correlates with the activation of T cells, in whole blood. When a patient is exposed to SARS-CoV-2 antigens, the T cells release interferon gamma, which stimulates monocytes in the blood to produce CXCL10. Measuring the expression of CXCL10 can then be used to quantify immunity.

"Long-term protection from viral infections is mediated by both the humoral … and cellular … immune pathways," Lorenzo Colombo, general manager and chief technology officer at Hyris, said in a statement. "While SARS-CoV-2-specific IgG and neutralizing antibody quantification are being used as the typical clinical endpoints to determine immune protection, a precise measurement of cellular responses underlying virus protection also represents an important parameter of immune defense."