PathogenDx Receives AOAC INTERNATIONAL Certification for Its EnviroX-Rv Test in Detecting Novel Coronavirus on Surfaces
The one-swab test has a 99% detection rate and is more sensitive than the recommended method from the World Health Organization
SCOTTSDALE, Ariz., Dec. 21, 2020 /PRNewswire/ -- PathogenDx, Inc., an Arizona based technology company which has developed a multiplexed microarray DNA-based pathogen testing platform, announced today that it has been issued a Certificate of Validation for its EnviroX-Rv test kit to detect SARS-CoV-2, the causative agent of COVID-19 illness, on environmental surfaces.
The test is one of the first to pass the rigorous independent evaluation required by the globally-recognized AOAC Research Institute's Performance Tested MethodsSM Program, which implemented an Emergency Response Validation process to accelerate the review process.
To receive the certification, the test underwent a matrix study as well as a ground-breaking in silico analysis which harnesses machine learning to compare results against large databases of viral and bacterial information. Compared to in vivo or "wet-lab" testing, in silico can test against thousands of strains of SARS-CoV-2 and similar viruses and bacteria. PathogenDx's EnviroX-Rv provides unmatchable multiplexing power and can distinguish SARS-CoV-2 from over 41,000 viruses and clades from a single swab - about three times more than required by the AOAC validation. EnviroX-Rv also had a 99% detection rate and was more sensitive than methods recommended by the World Health Organization sampling guidance and the CDC clinical assay.
Compared to the CDC 2019-Novel Coronavirus Real-Time RT-PCR test, the EnviroX-Rv can detect RNA fragments. This means it is able to not only detect live viruses, but also determine if there are dead virus particles on a surface, which indicates prior contamination. While the AOAC validation is specifically for stainless steel, PathogenDx's EnviroX-Rv Test is intended for commercial testing on concrete, plastic and other non-porous high-use surfaces.
"We made it as simple as possible for any industry that needs to test its surfaces for SARS-CoV-2 that is a fast, easy and affordable way and receive same day results," said PathogenDx Co-founder and CEO Milan Patel. "We're so proud to receive this validation from AOAC and to provide a powerful solution for facility operators to ensure their environments are free of pathogens that can harm employees, patients and consumers."
About PathogenDx
Headquartered in Scottsdale, Arizona, PathogenDx's mission is to become the new standard in DNA-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 the century-old practice of petri-dish testing 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.
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MATTIO Communications
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SOURCE PathogenDx
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