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COVID-19 antibody testing regime completes validation trials - Pictor

Contributor:
Fuseworks Media
Fuseworks Media

Pictor's completes successful US clinical trials for unique COVID antibody testing

New Zealand diagnostic biotech company Pictor’s world-leading COVID-19 antibody testing regime has completed validation trials at two separate sites the United States.

The Pictor test simultaneously detects the presence of both anti-Spike Antigen (SP) antibody and anti-Nucleocapsid antigen (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 Authorisation.

Clinical trials conducted by Florida-based Boca Biolistics, showed sensitivity for SP, 99.1%. and for NP, 97.3%. Corresponding specificities were 95.2% for SP and 98.6% for NP.

"We’re delighted with these results because they show the high accuracy of our testing regime. This is an important step in the ongoing fight against the global pandemic," says Pictor Chief Technology Officer Dr Richard Janeczko.

In late 2021 the US Centre for Disease Control (CDC) specified both Spike Protein and Nucleocapsid Protein antibodies be tested as part of a serological program. China has announced it will soon require all international arrivals to be tested before departure to China for antibodies of the two proteins Pictor assay tests for.

Pictor’s PictArrayTMSARS-CoV2 assay is unique in its ability to detect the SP and NP antibodies in one test. This differentiates people who have antibodies from a previous infection (SP and NP antibodies) from those who have been vaccinated (SP antibodies only). "Immunity towards COVID-19 by either vaccination or natural infection can help reduce reinfection by between 82-96%," says Dr Janeczko. "The CDC states it is now important to observe and document the antibody levels in communities to help in the fight against COVID-19."

Dr Janeczko says seroprevalence studies are useful to assess vaccination and actual infection rates in communities. This type of testing is most efficiently carried out through detection of antibodies to both the main viral antigens, SP and NP.

"The latest advice on serology testing and interpretation of results posted on the CDC website identifies the importance of testing for both SP and NP antibodies. To accurately test antibody levels, it is crucial to be able to detect not only the SP used as a target for almost all vaccines due to the neutralising nature of the antibodies which develop but also the NP, which denotes natural infection. Our duplex test uniquely negates the need for two tests to be done for each patient sample so is likely to attract increased interest from US testing laboratories." Primex Laboratories of Van Nuys, California has also conducted clinical testing to evaluate Pictor’s serology test and those results are currently being analysed.

In New Zealand, the company has been approached by the laboratory testing company likely to be charged with carrying out tests of travellers wanting to visit China. Pictor has the capacity to supply tests to meet this emerging need.

The company’s manufacturing capabilities are being significantly increased at its Auckland facility and a manufacturing agreement is in place with South Pacific Sera in Timaru, in New Zealand’s South Island.

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.

An Auckland testing laboratory will be making the Pictor test available to interested companies and employers of frontline workers.

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