BD and BioGX have received the US Food and Drug Administration’s (FDA) emergency use authorisation (EUA) for a new coronavirus (Covid-19) test.
The new diagnostic test enables hospitals to screen for Covid-19 onsite and receive results within three hours. It is run on the BD MAX System and is capable of analysing hundreds of samples a day.
The test is expected to fill the current requirements across the US hospitals for a rapid test to screen patients and healthcare workers for the virus.
BD Integrated Diagnostic Solutions president Dave Hickey: “The BioGx molecular test for the BD MAX System and our recently announced serology test that can help detect current and past exposure to Covid-19 are part of BD’s approach to give health care workers choice and access to the right test for the right situation.
“We continue to work diligently on an antigen test for our point-of-care BD Veritor System that would complete a full portfolio of Covid-19 tests.”
The assay for the BD MAX System was developed by BioGX in its Sample-Ready ready-to-use format to detect the presence of the SARS-CoV-2 virus.
BioGX CEO Shazi Iqbal said: “The collaboration with BD, combined with the new emergency use authorisation process from FDA, enabled our companies to bring a new test to the BD MAX System quickly and efficiently.
“The development and launch speed were critical to ensuring hospitals and laboratories can have additional options and capacity for an automated, highly reliable SARS-CoV-2 test for their patients.”
The assay uses the same viral RNA targeting sequences and real-time PCR detection method as the test developed by the US Centers for Disease Control and Prevention (CDC).