Hyris T-Cell Test Gains CE-IVD Mark
Hyris has received CE-IVD mark certification for its T-cell test for measuring cellular responses that protect against the SARS-CoV-2 virus.
The quantitative polymerase chain (qPCR) reaction assay can be used to systematically monitor “the type of immunity people acquire through infection or vaccination and how the virus evolves, thus maximizing vaccine effectiveness,” the company said.
The assay involves a two-part process that stimulates T cells in a blood sample and then uses qPCR technology to amplify and detect potential activation of the T cells.
The cellular immune response assay was developed to prepare for a future in which the virus is expected to be endemic.
With the CE-IVD mark in hand, Hyris has launched the assay in the EU market. It has not yet been approved, cleared or authorized by the FDA for use in the U.S.