22 June 2022 - - Following a recent funding round raising USD 6.1m (NZD 8.8m), biotech company Pictor has received confirmation of CE registration for its PictArray SARS-CoV-2 IgG enzyme-linked immunosorbent assay (ELISA) antibody test as per In Vitro Diagnostic Directive regulations, the company said.

The CE Mark will allow the company to market its COVID-19 antibody test in Europe and gain regulatory approval in Southeast Asia.

Pictor's PictArray SARS-CoV-2 assay, the first test of its kind, will enable personalized COVID-19 assessments by detecting if a patient has antibodies from a previous infection of SARS-CoV-2 (from spike protein and nucleocapsid protein antibodies) or from vaccination alone (SP antibodies only).

It will also indicate whether at-risk patients have failed to mount a detectable antibody response despite vaccination or infection (SP and NP negative).

The COVID-19 pandemic remains a healthcare concern as new strains of the virus have emerged. According to recent data, COVID-19 cases are up significantly in many US states and Europe.

According to a March 31st statement by the World Health Organization in its weekly epidemiological update, "COVID-19 remains a Public Health Emergency of International Concern, and it is too early to reduce the quality of surveillance."

Pictor is an in vitro diagnostics company that offers a patented multiplexed platform for highly accurate and efficient testing of complex and infectious diseases for human and animal health.

PictArray multiplexed technology makes it possible to test multiple disease markers in a single test simultaneously -- with higher sensitivity, faster throughput, and reduced turn-around time.

The company's lead product, PictArray SARS-CoV-2 IgG ELISA Kit, enables more informed clinical intervention to manage the threat of COVID-19.