NEW YORK – Becton Dickinson and BioGX announced Friday that they received Emergency Use Authorization from the US Food and Drug Administration for a hospital SARS-CoV-2 test.
The rapid test is for hospital use on site to screen patients and healthcare workers and offers results in less than three hours from nasopharyngeal and oropharyngeal swabs. BioGX's test will run on the BD Max system, which processes 24 samples at once.
BioGX developed the Sample-Ready ready-to-use assay for the BD Max system, and it is based on the same viral RNA targeting sequences and PCR detection as the assay from the US Centers for Disease Control and Prevention, which received EUA in February.
The fully automated BD Max platform, which can process 24 samples simultaneously, is installed in "hundreds" of laboratories in almost every state in the US, the two companies said, and the new test will add capacity for 50,000 tests per week across the country.
BD and BioGX submitted the test to FDA in mid-March for EUA.