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FDA Grants EUA to DetectaChem for RT-LAMP Portable COVID-19 Diagnostic

The U.S. Food and Drug Administration granted an Emergency Use Authorization (EUA) on Sep. 1 to DetectaChem for the MobileDetect Bio (MD-Bio) BCC19 COVID-19 test kit.

The BCC19 test kit utilizes a reverse transcription loop-mediated isothermal nucleic acid amplification (RT-LAMP) technique that can run up to 96 tests per device in just 30 minutes. The test detects nucleic acids from the SARS-CoV-2 virus to determine positive or negative results and then utilizes the free MobileDetect App for Apple and Android platforms to generate result reports. Generated test reports can then be immediately sent via email or text to healthcare providers, laboratories or any other desired recipient.

Leveraging DetectaChem’s experience in fully-integrated mobile solutions, the BCC19 test kit is also offered in a variety of Mobile Field Lab (MFL) configurations which contain up to 960 tests and all components needed for nasal or oral sampling and analysis in a single ruggedized and lightweight case. This option allows universities, schools, nursing homes, hospitals, police departments, emergency services and many others to deploy high-throughput mass testing solutions anytime, anywhere. As many testing sites can take 24 hours or much longer to produce test results, asymptomatic positive patients waiting for results can unknowingly infect countless others.

With the BCC19 test kit’s 30-minute cycle and diagnostic-level results, the window for spreading COVID-19 is drastically reduced from hours or days to minutes resulting in greater safety for organizations and their communities at large.  

“Accurate, fast, easy-to-use, and widely accessible testing is crucial in enabling a safe return to normal life for organizations and individuals around the world and we’re proud to provide the MD-Bio BCC19 kit as a solution,” said DetectaChem COO, Travis Kisner.

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