As the coronavirus 2019 (COVID-19) evolved from being an isolated disease in China to becoming a global pandemic over the course of just a few months, nearly every industry faced major disruptions. That's why we've seen big automotive companies like General Motors (GM), Ford, and Tesla take medical device production (namely ventilators) for a spin.

So it shouldn't come as too big of a surprise that DetectaChem, a global provider of portable bomb and drug detection technology, has added COVID-19 detection to its portfolio. Specifically, the Sugar Land, TX-based company is trying to address the need for widely accessible point-of-care COVID-19 testing.

"A lot of companies had to reinvent themselves and super pivot in order to keep viable as a business," Travis Kisner, DetectaChem's chief operating officer, told MD+DI. "We didn't actually have to pivot that hard. We were already in the detection business for explosives and drugs, and we have the only automated cell phone mobile detection platform, pretty much in the industry, using a phone's optics to detect a variety of things."

DetectaChem frequently works with U.S. and foreign government agencies which were all busy addressing the pandemic, so it made sense for DetectaChem to switch gears too. Kisner said the company realized that it only needed to make a slight pivot in order to add a COVID-19 detection solution to its existing mobile detection platform.

RADx initiative for COVID-19

This week DetectaChem announced that its MobileDetect Bio (MD-Bio) BCP19 test pouch for COVID-19 detection passed the initial "deep dive" phase in July and is currently advancing through phase I of the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative. The RADx initiative was created to rapidly accelerate innovation in the development, commercialization, implementation, and mass deployment of technologies for COVID-19 testing.

Coming into the RADx program, DetectaChem’s predicate and currently available BCC19 COVID-19 detection kit achieved 100% accuracy for positive and negative samples and has FDA emergency use authorization. The upcoming RADx BCP19 Test Pouch is a simplified evolution of the same core technology.

How the MD-Bio BCP19 test detects COVID-19

DetectaChem’s MD-Bio BCP19 test pouch is a high throughput, portable, point-of-care test designed to produce results for numerous samples simultaneously in 30 minutes. According to the company, the test detects nucleic acids from the SARS-CoV-2 which produces a clear colorimetric reaction to determine positive or negative infection results for active RNA. The solution combines a unique single-use test where the swabbed sample is inserted directly into the pouch combining with reagents, primers, and viral transfer medium and then uses a single-button-operation MD-Bio Thermal Heater. The BCP19 pouch and MD-Bio Thermal Heater are designed from the ground up for maximum ease of use for all point-of-care applications, DetectaChem said.

The MobileDetect App (currently available globally on Apple and Android app stores) can also be used as an optional tool for automated infection result report generation. After analysis, the app automatically generates a PDF result report with time, date, GPS location, test ID, reaction picture, and also allows users to add more pictures, custom patient information, and notes. The user can then send this result report via email or SMS as needed.

“Accurate, fast, easy-to-use, and widely accessible point-of-care testing is required before the nation can safely return to normal life. DetectaChem began intense work on a COVID-19 test immediately when the pandemic began in early 2020, as we knew our detection and manufacturing capabilities would provide a significant advantage in delivering and deploying these tests to the market,” Kisner said. “Our team has been working tirelessly and collaborating with the RADx team to ensure our tests can be delivered to market in the near future while providing the unprecedented reliability and ease-of-use the world needs so urgently in the fight against the COVID-19 pandemic.”

The RADx initiative is providing clinical, technical, and regulatory support, one-on-one guidance to project teams, and funding for solutions like DetectaChem’s BCP19 test pouch that make tests easier to use, access, and scale for mass manufacturing. Through this initiative, the NIH has rigorously reviewed and selected companies to move diagnostic technologies swiftly through the development pipeline toward commercialization and broad availability — with the goal of making millions of tests per week available to Americans, particularly those most vulnerable to and/or disproportionately impacted by COVID-19.

“Testing for COVID-19 is a critical part of bringing the pandemic under control and safely reopening the economy in the U.S. and worldwide. DetectaChem decided early on to develop a COVID-19 test, knowing the unprecedented demand for it, and our expertise in serving first responders, military, and law enforcement customers around the world who count on precision, accuracy, reliability, and accessibility of our tests in large quantities” Kisner said. “The RADx initiative is providing the assistance and funding resources to bring our BCP19 test pouch to the masses in an unprecedented way.”

Kisner told MD+DI that the company also has the ability to further develop its diagnostics technology for the detection of other viruses down the road.

Leveraging manufacturing robotics for quick scale-up

Because DetectaChem's traditional government customers tend to place orders of varying size and often require a short turnaround on orders, the company already has adopted automation in manufacturing in order to be able to scale up quickly and also scale back as needed. Kisner said the company has several robots that it uses in its manufacturing process and those will also be used for COVID-19 testing production. RADx also helps selected companies scale up in manufacturing, not so much in terms of capability but in terms of financial support, he said.

Coupling the company's automated manufacturing process with the help it receives from RADx should enable DetectaChem to produce a large volume of COVID-19 tests.