NEW YORK — Pictor said on Thursday that it has received CE-IVD marking for its PictArray SARS-CoV-2 IgG antibody test.
According to the Auckland, New Zealand-based company, the test is designed to detect whether a patient has a spike protein and nucleocapsid protein antibodies from a previous infection or has only spike protein antibodies from vaccination. It is also designed to indicate whether at-risk patients have failed to mount a detectable antibody response from either vaccination or previous infection.
"As we learn more about COVID-19, the separate detection of [spike protein antibodies] and [nucleocapsid protein antibodies] will enable a more precise assessment of a patient's immunity against SARS-CoV-2 and help guide any associated clinical interventions whilst also informing wider public health measures when mass serosurveys are conducted," Pictor Chief Medical Officer Tadd Lazarus said in a statement.
Earlier this year, Pictor raised $6.1 million to support the launch of the PictArray SARS-CoV-2 assay and other in vitro diagnostics. It also partnered with Ohio-based laboratory service provider Mobility Health to market the test as a tool to help identify patients who require a COVID-19 booster.