NEW YORK – A company with expertise in detecting the presence of explosives or drugs may not be the first place someone would go for a SARS-CoV-2 test.
But Stafford, Texas-based DetectaChem is working to change that perception with its COVID-19 tests based on the automated colorimetric technology it has used for 15 years to detect explosives and narcotics. "Our core business is detection, whether it be of explosives, drugs, or now biologics," COO Travis Kisner said.
The firm started out providing explosive detection technology for law enforcement and military use, but since the COVID-19 pandemic began the company has added biologics to its wheelhouse, creating two different tests for the disease: one, a moderate- to high-complexity test, and one a pouch-based test to be used at the point of care.
"We were already doing detection, we already had a platform … and we were able to use our already existing MobileDetect smartphone application to detect COVID as well," Kisner said. "Even though COVID is very dangerous … so are explosives and drugs, and so we're used to dealing with various serious situations and various serious detection schema."
The MobileDetect-Bio BCC19 test kit, which received Emergency Use Authorization from the US Food and Drug Administration in September, uses reverse transcriptase loop-mediated isothermal amplification to detect active SARS-CoV-2 RNA in nasopharyngeal, oropharyngeal, mid-turbinate, anterior nares, and saliva specimens. The test's primers target the SARS-CoV-2 nucleocapsid and small envelope genes, and when the virus is present the pH of the reaction changes the dye color in the test from its red starting color to yellow.
The BCC19 test runs on the firm's MD-Bio Heater, which also received EUA along with the test and retails for less than $900 but can also be used with other thermocyclers for 32 and 96 tests. It returns results for up to 96 tests at once per machine in 30 minutes and is only authorized for use with symptomatic people. It had nearly 98 percent sensitivity and 100 percent specificity, according to the clinical trial results submitted to the FDA. The limit of detection for the BCC19 test is 75 copies per microliter, but outside testing suggests significantly lower limits of detection, Kisner said.
DetectaChem's other test, the MD-Bio RapidRT, had previously received funding from the National Institutes of Health's Rapid Acceleration of Diagnostics (RADx) initiative and uses self-contained test tubes with disposable fixed pipettes, along with a portable heater for the reaction, to detect the virus. Like the BCC19 test, it turns from red to yellow upon a positive result. It returns results in 18 minutes and is for use at the point of care. The test was submitted for EUA recently and the firm expects approval and beginning sales at the end of the second quarter or early in the third quarter.
The tests both cost between $9 and $40 depending on the volume and will "drive to market conditions," as the economy changes, Kisner said. Both tests also have interoperability with smartphones, and the MobileDetect app can read the color of the test to give a test report with the time, date, patient data, location, images, and more. The app also has alignment and calibration to make sure the color is correct, Kisner said.
Because the firm has experience in the smartphone space, Kisner said that could also be a major selling point for the company's push into the home market, since it has experience providing accurate and interpretable results via phone apps. But a smartphone isn't required to run the test, he noted. "It's not prohibitive that you have a cell phone, it's a bonus layer. … We do provide stuff that [enables a user to] read the color manually, but what you lose in that is the automated reading, you lose the automated tutorials," he said.
Via the app, the firm also offers video instructions to guide users through the process step-by-step. That capability is already a part of the app platform, which is another benefit for home use, Kisner said.
For the BCC19 test, the current 2021 manufacturing capacity is 1 million tests per week and "is scaling for growing market demand," Kisner said.
He added that, ultimately, pivoting from narcotics and explosives detection to COVID-19 testing wasn't all that different – the firm is still making reagents for reactions, it's just also mixing biological primers instead of chemicals.
DetectaChem has a presence globally for its other detection products and has sold COVID-19 tests internationally to other countries' militaries and governments, but the focus is first on the US market, Kisner said. Since the EUA was granted, DetectaChem has sold "seven figure quantities" and projects heightened demand of the BCC19 test, as well significantly higher volumes of the MD-Bio RapidRT test.
DetectaChem has sold directly and through distributors and partners, mainly to national and regional testing centers, healthcare providers, schools and universities, laboratories, and federal entities. The firm has used its federal, defense, and homeland security customers to get referrals in the healthcare industry, a spokesperson for the company said.
The tests can be adapted for other viruses and have been adapted for COVID-19 variants, such as the UK and South African strains, as well, Kisner said. Despite the abrupt pivot to infectious disease testing, Kisner said the company has no plans to go back to only drugs and explosives detection once the pandemic is over.
"We do not plan on stopping biologics once the pandemic would slow. We plan on utilizing that capability and growing it to help in other avenues for sure," he said.