PathogenDx Announces Agreement With Axiology Labs To Distribute Its Detectx-Cv Assay Across Africa And Thailand

Detectx-Cv receives domestic and international validation from top-tier Virology labs in the U.S. and Europe

Scottsdale, AZ /PRNewswire/ - PathogenDx, Inc., an Arizona-based technology company which has developed a multiplexed microarray-based pathogen testing platform, today announced a distribution agreement with Axiology Labs, a South African-based laboratory equipment supply company, for its breakthrough Detectx-Cv assay Clade Variant Adaptive Surveillance ("CVAS") technology to identify SARS-CoV-2 variants. Per the agreement, Axiology Labs will distribute Detectx-Cv Clade Variant equipment and testing kits to its lab network across Africa and Thailand. Axiology Labs will install, train, support and service its locations across these markets.

Detectx-Cv has also received domestic validation from Stanford Virology Lab, TriCorp Reference Labs and the University of Miami Medical School Virology Lab, and international validation from the International Henri-Mondor Hospital system in Paris. Each lab ran 200 to 300 clinical samples from patients, each infected with COVID-19 and a different variant, processed via Next Generation Sequencing (NGS) and on the PathogenDx platform. The labs found that the results from both processes were concordant, thereby validating the accuracy of its Detectx-Cv assay against the industry's gold standard in testing. PathogenDx now looks to apply for both CE-IVD registration for use in the EU as well as Emergency Use Authorization (EUA) of its CVAS technology from the U.S. Food and Drug Administration (FDA) for expanded use across the U.S.

"We are transitioning into the next phase of this pandemic globally, where each country is at a different stage in terms of vaccination at a population scale," said Milan Patel, Co-founder and CEO of PathogenDx. "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. 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. It's affordable and can be run by the most basic trained PCR lab technicians."

There are currently four SARS-CoV-2 variants categorized by The World Health Organization (WHO) and the Centers for Disease Control (CDC) as Variants of Concern (VoC), including the infamous Delta B.1.617.2 variant and two Variants of Interest (VoI). At the time of this release, approximately 42.7% of Americans are not vaccinated, providing an avenue for new variants to arise, spread and further mutate through the unvaccinated population. Real-time monitoring of community spread through COVID-19 variant tests is necessary to mitigate community infection rates and the development of new variants.

"We're thrilled to partner with PathogenDx to distribute their Detectx-Cv assay with the ultimate goal of commercializing the technology to make it available to our own internal lab network," said Gideon Burger, CEO of Axiology Labs. "Low-income countries are seeing the highest cases of COVID-19 and are in dire need of access to testing to help mitigate the spread. This partnership is critical to supporting the fight against COVID-19 and its variants in Africa and Thailand in an affordable and timely manner."

Axiology Labs operates in the Life Science Sector with an established footprint across twelve countries on the African continent and growing. The business offers turn-key solutions across the life science spectrum ranging from sales and distribution of specialised pharmaceutical equipment to the implementation and training of laboratory technicians and ongoing supply chain management. Customers include numerous government entities, research institutions and universities as well as private sector biotech and analytical corporations.

Patel added: "We're proud to partner with Axiology Labs, whose large distribution network will help increase testing of COVID-19 variants across Africa and Thailand, where we are seeing some of the highest death rates. Meanwhile, we've reached a crucial milestone with domestic and international validation of our Detectx-Cv assay, which brings us one step closer to expanded distribution internationally."

PathogenDx's Detectx-Cv assay tests for all variants in a single sample to discern if a positive sample from an EUA authorized platform is from a specific variant. The multiplex array technology can fit 150 different probes to avoid the chance of false negatives by testing for multiple viruses and its mutations, and provides results within just four hours. On the other hand, next generation sequencing takes two to three weeks for results, by which time the COVID-19 variants could have changed, and requires high-end bioinformatics labor. It's also costly from an equipment and consumables standpoint, and unable to identify between variants, whereas PathogenDx's Detectx-Cv is 1/15th the cost of a sequencer and 50-90% less expensive than sequence testing of samples. PathogenDx's innovative technology can support U.S. variant testing capacity, capable of increasing testing to the goal of 15% of samples.

About PathogenDx
Headquartered in Scottsdale, Arizona, PathogenDx's mission is to become the new standard in molecular-based testing through widespread adoption of its advanced microarray testing platform for the human diagnostics, food and agricultural industries. PathogenDx's technology can rapidly identify and detect up to 50 pathogens all in a single test, in 6 hours providing triplicate data per analyte for certainty in results with a simple and easy process. The company's DNA-testing products – DetectX™, QuantX™, and EnviroX™– are disrupting conventional microbial and molecular technologies to identify, detect and quantify pathogens that are a threat to human health, their ecosystem and the environment. This technology will help growing businesses deliver safer products and healthier lives, while preventing billions of dollars in losses from infection and contamination. For more information on how you can utilize this simple, powerful and inexpensive DNA-based pathogen testing, visit www.pathogendx.com.