NEW YORK – Scottsdale, Arizona-based molecular diagnostics developer PathogenDx said on Monday that South Africa-based laboratory equipment supply company Axiology Labs will distribute its Detectx-Cv SARS-CoV-2 variant assay technology in Africa and Thailand.
The contract enables Axiology Labs to distribute the Detectx-Cv Clade Variant Adaptive Surveillance (CVAS) technology, including equipment and testing kits, to its lab network across 12 countries in Africa and in Thailand. Specifically, Axiology Labs will install the equipment as well as train, support, and service the testing locations.
The Detectx-Cv assay runs on the PathogenDx multiplex array system. The technology can use up to 150 probes and provides results in approximately four hours. PathogenDx said it is looking to apply for both CE-IVD registration and Emergency Use Authorization from the US Food and Drug Administration for the CVAS technology.
"With the emergence of new variants — including over 30 mutations this year alone — it doesn't seem likely the virus is going to stop mutating," said PathogenDx cofounder and CEO Milan Patel. "The world needs a test that's fast enough to detect COVID-19 variants before new ones arise and spread, and our CVAS technology meets this dire need for real-time monitoring."
Patel also stated that the system is affordable and can be run "by the most basic trained PCR lab technicians."
Gideon Burger, CEO of Axiology Labs, noted that low-income countries are seeing high rates of COVID-19 and are in need of testing to mitigate the spread of the virus. "This partnership is critical to supporting the fight against COVID-19 and its variants in Africa and Thailand in an affordable and timely manner," he said.
The firm won funding from the National Institutes of Health's Rapid Acceleration of Diagnostics Tech initiative for the variant assay. It has also received Emergency Use Authorization from the US Food and Drug Administration and obtained CE marking for a SARS-CoV-2 detection kit called Detectx-Rv.
Detectx-Cv was also recently validated in US and European virology labs. PathogenDx said that the Stanford Virology Lab, TriCorp Reference Labs, University of Miami Medical School Virology Lab, and Henri-Mondor Hospital system in Paris each compared the PathogenDx assay with next-generation sequencing on up to 300 clinical COVID-19 samples and found concordant results.