Following a recent funding round raising $6.1 million (NZD $8.8 million), biotech company Pictor today announced it 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 (IVDD) regulations.
The CE Mark will allow the company to market its COVID-19 antibody test in Europe and gain regulatory approval in Southeast Asia.
“Receiving CE registration enables Pictor to establish a footprint with partner laboratories and research bodies within Europe which is an important market for us,” said Howard Moore, CEO of Pictor. “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 U.S., India and Southeast Asia.”
Pictor’s PictArray antibody test provides personalized results
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 (SP) and nucleocapsid protein (NP) 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).
“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,” explains Pictor’s Chief Medical Officer Tadd Lazarus, MD.
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 U.S. 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.”