Image of the the BD MAX molecular diagnostic platform courtesy of BD.
BD (Becton, Dickinson and Company) was one of several medtech companies that joined President Donald Trump when he declared a national emergency last week. Several medtech executives detailed their response to the novel coronavirus (COVID-19) pandemic.
Tom Polen, BD’s CEO and president, reported during President Trump’s announcement that BD is “one of the leading providers of medical devices as well as collection products for testing of coronavirus and we are ramping up our manufacturing capacity to ensure that the right collection devices and testing equipment are ready to address this issue.”
BD reported later that it’s ramping up production of its sample collection tools and increasing access to its automated molecular platform for in vitro diagnostics. A BD spokesperson told MD+DI that “The manufacturing facility that makes our collection devices is running 24/7 with ramped up production and we will be supplying hundreds of thousands of swabs/collection devices to the U.S. market every week.”
This week BD announced a collaboration with molecular diagnostics company BioGX Inc. in which the two companies have submitted Emergency Use Authorization requests (EUA) to the U.S. FDA for new COVID-19 diagnostic tests to be run on the BD MAX Molecular Diagnostic Platform, a system already used by hundreds of U.S laboratories. The automated unit can process samples in under three hours. If FDA grants the EUA, the new testing capability could handle thousands of tests per day, BD reported.
"The collaboration with BioGX to deliver a COVID-19 diagnostic in the U.S. 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, in a statement. "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 a ready-to-use format for detecting the presence of the SARS-CoV-2 virus, the cause of COVID-19, it was reported in the statement. The assay is based on the same viral RNA targeting sequences and real-time PCR detection method as the test developed by the U.S. Centers for Disease Control and Prevention (CDC), it was reported. Stated Shazi Iqbal, Ph.D., BioGX CEO, in the statement: "Authorization to use our test would increase access across the U.S. to an automated, highly reliable SARS-CoV-2 test."
Another BD product could play a role in point-of-care testing. The BD Veritor system, which is currently being used to test for other respiratory infections including Influenza A, Influenza B, RSV, and group A Streptococcus, is being considered for development of a point-of-care test for coronavirus, BD reported.