Pictor has received CE marking for its PictArray SARS-CoV-2 IgG enzyme-linked immunosorbent assay (ELISA) antibody test to enable personalised Covid-19 assessment.

The regulatory approval allows the in-vitro diagnostic company to market the ELISA test in Europe and pursue regulatory approval in Southeast Asia.

Pictor deploys its PictArray multiplexed technology to simultaneously test multiple disease markers in a single test, with high sensitivity, throughput, and low turn-around time.

The PictArray SARS-CoV-2 IgG ELISA kit has been designed to separately identify antibodies from Covid-19 infection and vaccination in a single test.

It detects spike protein and nucleocapsid protein antibodies from patient’s antibodies to determine a previous SARS-CoV-2 infection, and spike protein alone for vaccination.

The test also identifies if at-risk patients fail to mount a detectable antibody response from either vaccination or previous infection.

Pictor CEO Howard Moore said: “Receiving CE registration enables Pictor to establish a footprint with partner laboratories and research bodies within Europe which is an important market for us.

“Our recent successful funding round means we are well equipped to support market development and launches within the European Economic Area while continuing existing work across ANZ, the US, India and Southeast Asia.”

Pictor chief medical officer Tadd Lazarus said: “As we learn more about Covid-19, the separate detection of SP and NP 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 is an in-vitro diagnostics company that provides a patented multiplexed platform for accurate testing of complex and infectious diseases.

The New Zealand-based firm has raised $6.1m in a funding round, which closed earlier this year, to develop PictArray SARS-CoV-2 ELISA kit.

Earlier this month, Pictor unveiled PictArray MAP assay, its multiplexed diagnostic test for Mycobacterium avium paratuberculosis (MAP), also known as Johne’s disease.