Becton, Dickinson and Company (BD), Franklin Lakes, NJ, and BioGX, Birmingham, Ala, have submitted emergency use authorization requests to FDA for new diagnostic tests that, if authorized, would increase the potential capacity to screen for covid-19 by thousands of tests per day.
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 Max molecular diagnostic platform, which is already in use at hundreds of laboratories in nearly every state, 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 2 to 3 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,” says Nikos Pavlidis, vice president and general manager for molecular diagnostics and women’s health at 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 to detect the presence of the SARS-CoV-2 virus, which causes covid-19, based on the same DNA sequencing and methods developed by the Centers for Disease Control and Prevention, and adapted it for use on the BD Max system.
“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 SARS-CoV-2 to determine if patients have contracted covid-19,” says Shazi Iqbal, PhD, chief executive officer 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 United States to an automated, highly reliable SARS-CoV-2 test.”