BD, BioGX submit FDA emergency use authorization requests for COVID-19 diagnostics tests

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BD, BioGX submit FDA emergency use authorization requests for COVID-19 diagnostics tests

By Sandra Levy - 03/20/2020

BD, a leading global medical technology company, and BioGX, a molecular diagnostics company, today announced that the companies have submitted Emergency Use Authorization requests to the Food and Drug Administration for new diagnostic tests that, if authorized, would increase the potential capacity to screen for COVID-19 by thousands of tests per day.

The new coronavirus tests will be run on the BD MAX Molecular Diagnostic Platform, which is already in use in nearly every state across the United States at hundreds of laboratories, with each unit capable of analyzing hundreds of samples per day. The system is fully automated, reducing the opportunity for human error and increasing the speed to result. Samples are capable of being analyzed start to finish in two to three hours.

The tests would help fill an urgent need across the United States for laboratories to access an easy-to-use, rapid diagnostic test to screen patients for COVID-19. The tests will be run on the BD MAXMolecular Diagnostic Platform, which is already in use in nearly every state across the United States at hundreds of laboratories, with each unit capable of analyzing hundreds of samples per day. The system is fully automated, reducing the opportunity for human error and increasing the speed to result. Samples are capable of being analyzed start to finish in two to three hours. Each BD MAX System can process 24 samples simultaneously.

"The collaboration with BioGX to deliver a COVID-19 diagnostic in the United States is another example of BD's commitment to help with the global COVID-19 pandemic and combat the spread of infectious diseases," said Nikos Pavlidis, vice president and general manager, molecular diagnostics and women's health for BD. "Our BD MAX System is a versatile molecular platform that enables us to rapidly deliver molecular solutions across our laboratory customers and help communities in need during times of high anxiety."

BioGX developed the assay for the BD MAX System in their Sample-Ready ready-to-use format to detect the presence of the SARS-CoV-2 virus, the cause of COVID-19. The assay is based on the same viral RNA targeting sequences and real-time PCR detection method as the test developed by the  Centers for Disease Control and Prevention.

"These are challenging times for all of us, more so for our laboratory partners who have an urgent need for an easy to use, reliable test to detect the SARS-CoV-2 to determine if patients have contracted COVID-19," said Shazi Iqbal, CEO of BioGX. "The foundation of BioGX firmly stands on its team's ability to step up and address such unmet needs with speed.  Authorization to use our test would increase access across the U.S. to an automated, highly reliable SARS-CoV-2 test."

The companies submitted the Emergency Use Authorization requests to FDA today. The Emergency Use Authorization authority allows FDA to help strengthen the nation's public health protections against chemical, biological, radiological and nuclear threats by facilitating the availability and use of medical countermeasures needed during public health emergencies.