“Science-based companies are in a unique position to leverage what they know to find solutions to new challenges,” stated AZBio president & CEO Joan Koerber-Walker. “PathogenDx is an innovative company that has productized multiple assays to combat the war with pathogens. The ability to adapt is at the core of the company’s DNA, making them a shining example of how Arizona Bioscience Companies are stepping up to meet the challenges of our time.”
PathogenDx is being honored with a 2021 AZBio Fast Lane Award.
Meeting the Challenges of our Time
A pathogen is a bacterium, fungal or viral micro-organism that can cause disease. One of our world’s biggest challenges is protecting our water, food supply and environment, so humans and animals that consume it are protected from the diseases these pathogens can cause.
The CDC estimates 48 million people get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases each year in the United States[i]. In 2020, food recalls for onions, peaches, bagged lettuces, Enoki mushrooms, clover sprouts, and other agricultural products. The average cost of a recall to a food company is $10 million in direct costs. The impact on a company’s brand damage and lost sales across the food industry can be hundreds of millions.[ii]
Pathogens are also the cause of infectious diseases. Most notably is SARS-coV-2, the viral pathogen that causes COVID-19 and has impacted every single human on this planet.
PathogenDx
Home to molecular scientists credited with over 50 patents, PathogenDx invented the low-cost, high-throughput microarray technology to enable multiplex testing of multiple pathogens in a single sample. For human, food, agriculture, or the environment, now one technology drives simplicity, cost savings and class-leading accuracy.
PathogenDx systems are used by food producers and other agricultural businesses to help them test their products for safety before the product leaves the plant. Their EnviroX-F system tests for Salmonella Listeria spp and Listeria monocytogenes (L. mono) and their QuantX tests for Total Aerobic Bacteria (TAB), Bile Tolerant Gram Negative Bacteria (BTGN), Total Coliform (TC), Total Enterobacteriaceae (ENT) and Total Yeast & Mold (TYM) being the world’s first AOAC Certified molecular test if its kind with results in less the 6 hours.
Answering the call
As the pandemic emerged in 2020, PathogenDx realized their unique technology could be transformed for COVID-19 testing and quickly pivoted. The company leveraged its technology platform to develop and deliver a test in less than 6 weeks from the time the country declared a public health emergency.
The company developed its DetectX-Rv viral diagnostic assay for the detection of SARS-CoV-2, which received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) in April 2021. The test delivers better sensitivity and specificity than current qRT-PCR FDA-authorized COVID-19 tests while also able to detect other respiratory pathogens, as well as COVID-19 mutations, making it one of the most unique extendable tests in the industry.
As a response to the number of Variants, PathogenDx also developed their DetectX-Cv technology to identify SARS-CoV-2 variant strains from a positive COVID-19 sample in as little as four hours. DetectX-Cv tests for all Variants of Concern and Variants of Interest in positive samples tested from any molecular based EUA authorized platform. In March 2021, DetectX-Cv test received Research Use Only (RUO) authorization for clinical labs, universities, pharmaceutical companies, and research institutions to canvas the test’s capabilities in identifying the myriad of SARS-CoV-2 variants and to expand genomic surveillance
On the environmental monitoring end, PathogenDx launched its Ultra-rapid EnviroX-Rv air and surface environmental testing system to detect SARS-CoV-2 in the air and on stainless steel, concrete, plastic, and other non-porous high-use surfaces. EnviroX-Rv 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 – and can detect not only live viruses, but also determine if there are dead virus particles on a surface.
“Science-based companies are in a unique position to leverage what they know to find solutions to new challenges,” stated AZBio president & CEO Joan Koerber-Walker. “PathogenDx is an innovative company that has productized multiple assays to combat the war with pathogens. The ability to adapt is at the core of the company’s DNA, making them a shining example of how Arizona Bioscience Companies are stepping up to meet the challenges of our time.”
[i] https://www.cdc.gov/foodborneburden/index.html
[ii] https://www.food-safety.com/articles/2542-recall-the-food-industrys-biggest-threat-to-profitability
About the AZBio Awards:
Each year, the AZBio Awards celebrate Arizona’s leading Educators, Innovators and Companies during Arizona Bioscience Week. In 2021, the AZBio Awards will be celebrated as a 1-hour television special – Celebrating Life & Science – which will premiere on ABC15 at 4 PM on October 3, 2021. For more information and additional air dates and times visit https://www.azbio.org/celebrating-life-science-2021
About Arizona Bioscience Week
Each year Arizona Bioscience week is proclaimed at the Arizona Legislature and by the Governor. Arizona Universities, business organizations and economic development agencies host a series of educational events, investor forums, and celebrations to engage the community in one of Arizona’s most important industries. To access the full schedule of events, visit AZBio.org/AZBW2021.
About AZBio
Since 2003, the Arizona Bioindustry Association (AZBio) has supported life science innovation and life science innovators in Arizona. A key component in Arizona’s life science ecosystem, AZBio is the only statewide organization exclusively focused on Arizona’s bioscience industry. AZBio membership includes patient advocacy organizations, life science innovators, educators, healthcare partners and leading business organizations. AZBio works in partnership locally and nationally to advance health innovation and to ensure that the value delivered from life-changing and life-saving innovation benefits people in Arizona and around the world. Learn more at www.AZBio.org