PathogenDx’s mission is to become the new standard in pathogen molecular testing through widespread adoption of its advanced multiplex microarray testing platform for the human diagnostics, food, agriculture and environmental industries. They care deeply about helping partner labs protect lives with the aim to bring faster, lower-cost, and more sensitive and specific pathogen identification to these markets.
PathogenDx’s testing products are disrupting qRT-PCR or plate culture based methods to identify, detect and quantify bacterial, fungal or viral pathogens. Now their technology is being adapted to help combat the spread of COVID-19 and Variants. Their FDA EUA authorized DetectX-Rv COVID-19 microarray, RUO approved DetectX-Cv COVID-19 Variant microarray and AOAC certified EnviroX-Rv air sampling system are just three examples of how PathogenDx is reimaging viral testing to be quick, scalable and accurate, with efficient monitoring technologies in place to prevent widespread SARS-CoV-2 outbreaks.
A majority of the population – businesses and the public alike – benefits from PathogenDx’s technologies. Analytical and clinical testing labs in Clinical Diagnostics, Food Safety and Hemp and Cannabis gain value from PathogenDx’s core services. Their technology identifies pathogens and bacteria in both the food and Cannabis and Hemp supply chains, enabling manufacturers to catch contaminated products before they reach the hands of consumers.
Key Areas of Service
- Keep consumers safe through standardized regulations and comprehensive testing for contaminants
- Mitigate the spread of COVID-19 and Variants through advanced testing technologies that detect SARS-CoV-2 and mutations in individuals, communities, on environmental surfaces and in the air
- Create technology solutions for a new era of Bacterial, Fungal and Viral testing that multiplex test multiple targets and deliver more accurate results in a shorter period of time at lower cost
- Drive simplicity, cost savings and class-leading accuracy via a single test for humans, the food supply chain, agriculture and the environment
This product provides requirements for bacterial and fungal pathogen species level testing for Cannabis and Hemp. Overnight enrichment is not necessary and optional dependent on state-level testing regulations. Additional reagents are available for LIVE organism testing. Detect tests are validated down to 1 CFU (Colony Forming Units) detection of Listeria monocytogenes, Listeria spp, Salmonella spp, E. coli (pathogenic and non pathogenic), Pathogenic E. coli genes Stx1/2, Campylobacter spp, Staphylococcus Aureus, Pseudemonas aeruginosa, and Aspergillus Flavus, Aspergillus Fumigatus, Aspergillus Niger, and Aspergillus Terreus.
DetectX-Rv (FDA EUA approved) 96-well microarray is based on an initial reverse transcription polymerase chain reaction (RT-PCR) amplification and subsequent detection of target SARS-CoV-2 molecules by DNA microarray hybridization. DetectX-Rv is intended for the qualitative detection of N1 and N2 regions of SARS-CoV-2 viral genome in nasopharyngeal, nasal, and oropharyngeal swab specimens from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meets requirements to perform high complexity tests.
DetectX-Cv (RUO approved) identifies SARS-CoV-2 Clade Variants from a positive COVID-19 test in as little as four hours. It can identify UK (B.1.1.7), South African (B.1.351), Brazillian (P1, P2), California-USA (B.1.429), India (N440K) variants. DetectX-Cv is extremely cost effective at 1/15th the cost of a sequencer while sample testing costs 50%-90% less than the testing on sequencing. The affordability and accuracy of this testing can help the U.S. increase its current variant testing capacity of 0.3% of samples to the goal of 15% of samples.
DetectX Dual-Hyb is a combined bacterial and fungal test for the detection of Aspergillus Flavus, Aspergillus Fumigatus, Aspergillus Niger, and Aspergillus Terreus, Pathogenic E. Coli and Salmonella at 1 CFU/g in Cannabis and Hemp. Dual Hybridization of bacterial and fungal pathogens as DetectX Bacterial and DetectX Fungal. This product will save time, consumables and reporting efforts allowing for faster turnaround time.
DetectX Food (pending AOAC Certification Q4 2021) detects bacterial pathogen species level testing in food matrices for same-day results. Overnight enrichment or shortened enrichment will be required. DetectX Food offers detection down to 1 CFU of Listeria spp, Listeria Monocytogenes, Pathogenic E Coli, Campylobacter and Salmonella Enterica to 1 CFU/g.
Environmental Safety Solutions
“Early warning” Surface & Air pathogen detection. EnviroX is an Environmental Screening test for the presence or absence of 30+ bacterial and/or fungal pathogens as well as broad class indicators in Cannabis and Hemp. This assay can be utilized with multiple sample collection types, including but not limited to food, cannabis and agriculture products, environmental or carcass swabs, air sampling and water sampling. EnviroX tests for over a dozen bacterial and fungal pathogens.
AOAC approved “early warning” Surface & Air SARS CoV-2 detection. The EnviroX-Rv test is an aerosolized and surface environmental monitoring test that uses endpoint RT-PCR and PCR-DNA microarray hybridization to detect SARS-CoV-2 from stainless steel environmental sample swabs. It provides high efficiency (multiple samples at a time), high speed (2-hour result turnaround) and 98% detection accuracy to help reduce the risk of infection and determine exact viral presence for remediation and disinfection. EnviroX-Rv targets N1, N2 and N3 targets of the SARS-CoV-2 viral genome for detection on stainless steel and does not preclude detection on plastic, rubber and sealed concrete.
Same-Day AOAC-Certified Surface pathogen detection. EnviroX-F was granted Performance Tested Method Status by the AOAC Research Institute for the multiplex detection of Salmonella spp., Listeria spp., and L. monocytogenes without an enrichment step on four different commonly used food surfaces. The assay is validated down to 1 CFU without the need for sample enrichment. Tests for Listeria spp, Listeria monocytogenes and Salmonella on rubber, plastic, stainless steel and sealed concrete to 1 CFU/gram.
The QuantX test is a Bacterial and Fungal assay that provides a semi-quantitative analysis of several broad class indicators for food safety and Cannabis and Hemp. The assay can be used in parallel with the DetectX assay, without the need for enrichment and additional sample preparation, to meet all state cannabis regulations. This product can also be used for optional testing of Food applications. It tests for multiple yeasts and molds – Total Aerobic, Bile Tolerant Gram Negative, Enterobacteriaceae/Coliform, and Total Yeast and Mold from 100 to 100,000 CFU/gram.
Live vs. Dead
Offered as a supplement to current sample preparation methods, all of PathogenDx’s products can isolate “live” DNA for pathogen detection to prevent non-viable cells from being amplified, thus preventing false positives. This product is a supplement to current sample preparation methods.
Milan Patel, Co-Founder & CEO, PathogenDx
Mr. Patel leads the strategic vision, financial health and global growth of PathogenDx, a Scottsdale and Tucson, AZ based diagnostics company which provides disruptive DNA-based pathogen testing technology and solutions for the food and agricultural and human diagnostics industries.
Previously, Mr. Patel spent over 25 years working with large public, small private and entrepreneurial companies in numerous fields from the life sciences, to biotechnology, to government services and the automotive industry. Milan served as COO/CFO of GMSbiotech.
He also was CFO of 2020 Company, LLC, a leading premier professional services firm that delivered business and technology solutions to the government, in the areas of health, education and science.
Michael Hogan PH.D. Co-founder & Chief Scientific Officer
Dr. Michael Hogan’s expertise is in the area of physical chemistry, biosample processing and genetic testing. He is leading multiple programs in technology development that PathogenDx, with special emphasis on building its proprietary DNA microarray technology into the food safety and agricultural markets.
Dr. Hogan has 30 years of experience in translational science, with special emphasis on the application of physical biochemistry to commerce.
Hogan has invented, developed and commercialized multiple technologies for medical devices, therapeutics, in vitro diagnostics, genomic testing and biological sample preservation and has been awarded more than 50 patents and has more than 90 peer reviewed publications in those several areas.
Benjamin A. Katchman, PH.D. Vice President, Research and Development
Dr. Katchman leads the research and development of sample presentation and assay development at PathogenDx, a Scottsdale, AZ based company which provides disruptive DNA-based pathogen testing technology and solutions for the botanical, food and agricultural industries.
Previously, Dr. Katchman spent 20 years working with various universities and small companies developing novel nucleic acid and proteomic approaches for biomarker discovery and molecular diagnostics.
This includes the development of plate-based and microarray-based diagnostic systems for use in clinical laboratories and point-of-care diagnostics for Arizona State University, FlexBioTech, Inc., and Eccrine Systems, Inc.
April 26, 2021
PathogenDx, Inc. Receives FDA Emergency Use Authorization for Microarray-based COVID-19 Test
March 3, 2021
“PathogenDx Launches Breakthrough Clade Variant Testing and Secures Phase Two Funding as NIH Aims to Increase Capabilities for Viral Mutation Screenings “
December 21, 2020
PathogenDx Receives AOAC INTERNATIONAL Certification for Its EnviroX-Rv Test in Detecting Novel Coronavirus on Surfaces
December 14, 2020
PathogenDx Appoints Dr. David Acheson as a Strategic Advisor to Chair Its New Food Safety Committee
October 19, 2020
PathogenDx Announces Partnership with Prevenio to Provide First Ever Closed-Loop System to Combat Spread of Foodborne Illnesses
October 7, 2020
PathogenDx Earns AOAC Performance Tested Methods Certification for EnviroX-F
September 10, 2020
PathogenDx Selected by U.S. Department of Agriculture-Agricultural Research Service to Collaborate on Rapid Detection of Foodborne Pathogens in Food and Environmental Samples
August 17, 2020
PathogenDx Awarded Second NIH Grant to Develop More Accurate and Faster COVID-19 Testing
July 28, 2020
PathogenDx Receives Federal Grant From the NIH As Part of the RADx Program
June 23, 2020
PathogenDx Announces Partnership with Bertin Instruments to Combat Spread of COVID-19
January 7, 2020
PathogenDx Becomes First Sponsor of Illinois Hemp Growers Association as the Hemp Industry Rapidly Matures Nationwide
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