The new diagnostic test will allow hospitals to screen patients for SARS-CoV-2 virus on-site and deliver results within three hours
Becton, Dickinson and Company (BD), along with BioGX, has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for a new COVID-19 diagnostic test.
The new diagnostic test has been developed to help hospitals screen patients for SARS-CoV-2 virus on-site and deliver results within three hours.
The BD MAX system is suitable to run the new COVID-19 diagnostic test
The BD MAX system, a molecular diagnostic platform, can be used to run the new COVID-19 diagnostic test.
Each unit holds the capacity to analyse hundreds of samples per day. The fully-automated BD MAX system holds the capacity to process 24 samples simultaneously, and the tests are expected to add capacity for 50,000 tests per week across the country.
BD integrated diagnostic solutions president Dave Hickey said: “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.”
BioGX has used the Sample-Ready ready-to-use format to develop the new assay for the detection of SARS-CoV-2 virus.
The new assay is said to be based on 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).
According to the company, the BioGX SARS-CoV-2 Reagents for the BD MAX system has not yet approved and has been authorised by the regulator under a EUA.
The test was authorised only to detect RNA from SARS-CoV-2 virus to help diagnose SARS-CoV-2 virus infection.
BioGX CEO Dr Shazi Iqbal said: “The collaboration with BD, combined with the new emergency use authorization process from FDA, enabled our companies to bring a new test to the BD MAX™ System quickly and efficiently.”