New BD, BioGX coronavirus test can be run on-site at hundreds of U.S. hospitals
Becton Dickinson (NYSE:BDX) and BioGX announced today that the FDA granted emergency use authorization (EUA) to their new diagnostic test for screening for COVID-19 on-site at hospitals.
The new test is designed as an easy-to-use, rapid diagnostic test to screen for coronavirus and receive results in under three hours, according to a news release. The assay detects the presence of SARS-CoV-2, the virus causing COVID-19.
Becton Dickinson’s BD Max molecular diagnostic system, which is already in use at hundreds of laboratories across the U.S., will run the tests. Each unit is automated and capable of analyzing hundreds of samples per day, and can process 24 samples simultaneously, the companies said. They expect to have capacity for 50,000 tests per week around the country.
The BioGX SARS-CoV-2 test for the BD Max system does not yet have FDA clearance, but rather has EUA and it is authorized only for the detection of RNA from SARS-CoV-2, not for any other viruses or pathogens.
“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,” BD president of integrated diagnostic solutions Dave Hickey said in the release. “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.”
Added BioGX CEO Shazi Iqbal: “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. The development and launch speed was critical to ensure hospitals and laboratories can have additional options and capacity for an automated, highly reliable SARS-CoV-2 test for their patients.”