News and Announcements
Pictor Successfully Completes Validation Trial in U.S. for its SARS-Co-V-2 Antibody Test
- Published January 26, 2022 12:00AM UTC
- Publisher Wholesale Investor
- Categories Company Updates
New Zealand diagnostic biotech company Pictor Ltd. announced today that it has successfully completed validation trials at two separate sites in the United States, one of which was Florida-based Boca Biolistics, for its COVID-19 antibody test.
The Pictor test simultaneously detects the presence of both anti-Spike (SP) antibody and anti-Nucleocapsid (NP) antibody in a single test. The company now aims to fast-track adoption of its low-cost, high-performance, high-throughput tests by obtaining FDA Emergency Use Authorization.
Alpha trials at the company’s New Zealand laboratories last fall demonstrated high performance for Spike (100% sensitivity, 97.8% specificity) and Nucleocapsid (98.9% sensitivity and 96.6% specificity) and paved the way for initiation of the current trials in the USA.
“We were delighted with the performance observed in the Alpha studies which gave us confidence to rapidly proceed with trials in the USA,” said Pictor Chief Technology Officer Dr. Richard Janeczko. “We feel the duplex nature of our test is a unique feature which provides much better data interpretation from serology testing for use the ongoing management of the global pandemic.”
The US Centres for Disease Control and Prevention (CDC) recently provided guidance on interpretation of the results (Interim Guidelines for COVID-19 Antibody Testing | CDC) of serology testing with respect to infection and vaccination status in patients. Interpretations require results for both anti-spike and anti-nucleocapsid antibodies for which the Pictor test is uniquely well suited.
China has announced it will soon require all international arrivals to be tested before departure to China for the two antibodies of the Pictor assay.
“Studies have shown immunity to COVID-19 through vaccination can reduce reinfection by as much as 95%,” said Dr Janeczko. “The CDC has emphasized the importance of documenting antibody levels in communities to help in the fight against COVID-19.”
An Auckland testing laboratory will be making the Pictor test available to interested companies and employers of frontline workers.
Pictor has launched an equity fundraising round to enable it to continue to expand its manufacturing capability in New Zealand and in market resources in key international markets including the US, India and Europe. Pictor CEO
Howard Moore believes the positive clinical trial results and the novelty of Pictor’s COVID-19 test will contribute to a successful funding round.
ABOUT PICTOR
Pictor was founded in 2005 by scientists Dr. Anand Kumble and Dr. Sarita Kumble, who retired in 2017. Pictor has since expanded and now has 33 employees in the United States, New Zealand, Europe and India. In August 2020 Pictor established Pictor Inc. in the United States. New Zealand-based Howard Moore is Pictor’s CEO.
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