Auckland-based diagnostic biotech company Pictor has taken a major step forward in the development of its COVID-19 antibody test, announcing it has signed two US laboratories to conduct clinical trials in the US.
Earlier this year, Pictor announced it had achieved a breakthrough with its COVID-19 IgG antibody test which identifies individuals with antibodies arising from infection with SARS-CoV-2 or as a result of vaccination.
THE US trials will be used to support a regulatory submission to the US Food & Drug Administration (FDA) under the Emergency Use Authorization for market clearance of the company’s SARS-CoV-2 serology test.
The Pictor serology test detects simultaneously antibodies to two major viral antigens – the spike protein and nucleocapsid protein. Antibodies to the nucleocapsid proteins can be used to confirm the previous infection in individuals, while detection of antibodies to the spike antigen can be used to identify individuals vaccinated with anti-spike antigen vaccines.
The test was developed in Pictor’s Auckland lab with funding from the New Zealand Government’s COVID-19 Innovation Acceleration Fund and is the subject of provisional patent submission to the USPTO.
“The Pictor SARS-CoV-2 serology assay is a low-cost, duplex, miniaturised test capable of simultaneous detection of the two antibodies resulting from infection or vaccination,” says Pictor Chief Technology Officer Dr Richard Janeczko.
“In Pictor’s recently concluded Alpha Trial the assay exhibited high clinical performance across samples from different individuals. We chose to work with Boca Bio and Rain Incubator because of their vast experience in COVID-19 testing and look forward to extending and demonstrating the uniqueness and versatility of our assay in the trials at both sites. The trials are expected to begin in late October and conclude in November.”
Pictor Chief Operating Officer Howard Moore says: “As COVID-19 remains a global concern, measuring antibody levels across different populations will be critical for public health initiatives to inform control of potential surges of emerging variants.”
“With the expertise, Boca Biolistics has developed from our involvement in global viral outbreaks, such as Zika and COVID-19, we look forward to contributing our know-how in infectious disease management, laboratory testing, and clinical trial services to Pictor Ltd,” says Valentin Adia, Chief Executive Officer, Boca Biolistics, LLC.
“This type of testing is essential to public health efforts,” says Dr David Hirschberg, Rain founder and neuroimmunologist. “Pictor assays have the potential to help us understand vaccine efficacy against emerging variants, as well as antibody longevity in vaccinated and post-infection individuals. This information will guide public health recommendations on who should get vaccinated or boosted and when which can help reduce the spread of COVID-19 and future disease targets. Technology that can be pivoted to newly emerging diseases is important so that we can more rapidly and effectively address future outbreaks before they become pandemics.”