As America looks to reopen its economy amid the COVID-19 pandemic, how can one be assured that a workplace and other indoor areas are free of the nasty bug?
A Tucson biotech company says it has an answer, with a system to test for the virus on surfaces and in the air.
PathogenDx says its EnviroX-Rv test can rapidly and accurately detect the SARS-CoV-2 virus, which causes COVID-19, and other viral organisms present in the air and surfaces of the surrounding environment.
The company uses a proprietary testing process developed by former University of Arizona research professor Michael Hogan, a Ph.D. expert in DNA testing and chief scientific officer of PathogenDx.
PathogenDx has been providing its patented environmental pathogen testing technology to customers in the cannabis, botanical, agriculture and food-processing markets.
But in late March, after seeing reports from the Centers for Disease Control and other medical authorities that the novel coronavirus can survive in the air for hours and on surfaces for up to three days, the company decided to develop an environmental test for COVID-19, said PathogenDx co-founder and CEO Milan Patel.
The company also has developed a COVID-19 test for patient diagnostics and is awaiting authorization for clinical use from the U.S. Food and Drug Administration, Patel said.
PathogenDx uses a two-step method based on polymerase chain reaction or PCR — a common lab tool to amplify and analyze DNA used in many COVID-19 tests — and DNA microarray analysis to detect viruses including the coronavirus with greater sensitivity and specificity than common PCR tests, Patel said.
“Given the fact that the virus is not concentrated like it is in the back of people’s throats or noses, this (environmental testing) is going to take a different level of technology,” said Patel, who first invested in the company in 2012.
Though Patel noted that the CDC recently said that getting COVID-19 from surfaces is unlikely, environmental testing can still provide assurance that the virus isn’t hanging around.
“In areas where you had high levels of infection and you’re getting people coughing or aerosolizing the virus, there’s still a risk of potential infection from the environment,” Patel said. “The idea behind it is piece of mind, knowing that you can go back to work or school or a social life, with some normalcy in the future.”
Users of PathogenDx’s technology can gather samples from surfaces with wipes or sample air through a simple air-sampling device supplied through a partnership with a French company, Patel said.
PathogenDx says that its EnviroX-Rv test can run multiple samples at one time and deliver results within about two hours with 98% detection accuracy.
Patel said the company, which is headquartered in Scottsdale but has its main research and development in Tucson, has begun marketing its test kits to labs. PathogenDx also is targeting potential direct customers including casinos, banks, nursing homes and food-processing plants, he said.
The cost of each test run, including sample-collection materials, is about $70, but samples from multiple areas can be tested at the same time, keeping costs down, Patel said.
The FDA has told the company it does not require approval of the environmental tests, and no other agency regulates them, Patel said.
However, AOAC International, a nonprofit group of analytic chemists that partners with the FDA on food-safety issues, is looking at potentially evaluating COVID-19 environmental tests, he noted.
A number of companies are developing environmental tests for the COVID-19 virus, and Patel acknowledged that large companies like national meat-packing operations will likely rely on existing providers for coronavirus environmental testing.
But PathogenDx hopes to carve its own niche serving small- to medium-sized businesses, like food-processing plants with 200 to 500 workers, Patel said.
The company’s COVID-19 patient diagnostic test is in the final stages of gaining emergency use authorization from the FDA, he added.
LOCAL LAB PROVIDING TESTs to Pima County
Meanwhile, a partnership of Tucson-based Paradigm Laboratories and Phoenix-based Prorenata Labs are providing thousands of COVID-19 diagnostic tests to the Pima County Health Department.
The two labs, operating collectively as P2 Diagnostics, are using a test developed by the CDC and FDA that high-complexity labs like Paradigm and Prorenta can use under federal emergency authorization.
The companies said they had sold more than 15,000 tests during April alone and were on track to fill another 16,000 orders, with Pima County expected to add 2,500-5,000 orders per week.
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