DetectaChem smartphone-based COVID-19 test advances through NIH RADx (Rapid Acceleration of Diagnostics) Program
SUGAR LAND, Texas -- DetectaChem, the global leader in innovative portable threat detection solutions used extensively by the U.S. Department of Defense and Homeland Security, today announces that their MD-Bio (MobileDetect Bio) BCP19 Test Pouch for COVID-19 detection successfully passed the initial Deep Dive phase in July 2020 and is currently advancing quickly through Phase 1 of the NIH (National Institutes of Health) RADxSM (Rapid Acceleration of Diagnostics) Tech initiative.
The RADxSM initiative was created to rapidly accelerate innovation in the development, commercialization, implementation and mass deployment of technologies for COVID-19 testing.
"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," said DetectaChem COO, Travis Kisner. "Our team has been working tirelessly and collaborating with the RADxSM 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 RADxSM 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 their innovative 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.
Coming into the RADxSM program, DetectaChem's predicate and currently available BCC19 COVID-19 detection kit achieved 100% accuracy for positive and negative samples and has FDA (Food and Drug Administration) EUA (Emergency Use Authorization). The upcoming RADxSM BCP19 Test Pouch is a simplified evolution of the same core technology.
How it Works: DetectaChem's MD-Bio BCP19 Test Pouch is an innovative, high throughput, portable point-of-care test that can produce results for numerous samples simultaneously in 30 mins. 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 utilizes a propriety, 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.
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 then can then immediately send this result report via email or SMS as needed.
"Testing for COVID-19 is a critical part of bringing the pandemic under control and safely reopening the economy in the US 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," said Kisner, "the RADxSM initiative is providing the assistance and funding resources to bring our BCP19 Test Pouch to the masses in an unprecedented way."
DetectaChem is proud to be funded by the NIH RADxSM initiative on the rapid development and commercialization of innovative COVID-19 testing solutions that deliver critical and actionable results to millions of concerned families, medical professionals, first responders and more around the world.
This project is supported by the NIH Rapid Acceleration of Diagnostics Tech initiative and has been funded in whole or in part with federal funds from National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under Grant No. NIH 3 U54 HL143541-02S1.
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About DetectaChem Inc.
DetectaChem is a Texas, USA-based privately-held company and manufacturer of rapidly deployable, handheld, intelligent, and easy-to-operate threat detection systems deployed around the world. The company's solutions are used by extensively by the U.S. Department of Defense, U.S. Department of Homeland Security and thousands of law enforcement and first responder agencies around the world. DetectaChem is proud to be a strong supporter of the U.S. military, law enforcement and all first responders that protect our country. More information at www.DetectaChem.com.