Having recently raised $6.1m in a funding round, Biotech company Pictor has now obtained CE mark for its PictArray SARS-CoV-2 IgG enzyme-linked immunosorbent assay (ELISA) antibody test.
The approval will enable the firm to market the antibody test in Europe and obtain regulatory approval in South East Asian markets.
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Claimed to be the first of its kind, the PictArray SARS-CoV-2 ELISA antibody test is designed to separately identify antibodies from vaccines and Covid-19 infection in a single test.
It detects whether a patient has antibodies from a previous SARS-CoV-2 infection (from spike protein (SP) and nucleocapsid protein (NP) antibodies) or from vaccination alone (SP antibodies only).
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.”
Furthermore, the PictArray Covid-19 antibody test enables personalised Covid-19 assessments and will indicate whether patients require a Covid-19 booster.
It also helps identify at-risk patients who do not have a detectable antibody response to SARS-CoV-2, despite being previously vaccinated or infected.
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 Australia and New Zealand (ANZ), the US, India and South East Asia.”
In April, the company partnered with Mobility Health to launch the PictArray SARS-CoV-2 assay.
