BD Announces Second FDA Emergency Use Authorization for New COVID-19 Molecular Diagnostic Test

The new test also has been CE marked to the IVD Directive (98/79/EC). The assay is 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).

The test, which is run on the BD MAX™ System, provides additional testing capacity for COVID-19 in the US and in countries that recognize the CE Mark to test patients and health care workers. The test is in addition to the other tests already available on the BD MAX™ System from collaborations with BioGX and CerTest and is based on the CDC assay design. The BD MAX™ System, a molecular diagnostic platform, is already in use at thousands of laboratories worldwide, and each unit is capable of analyzing hundreds of samples over a 24-hour period. The majority of BD MAX™ Systems are installed in hospital laboratories, reducing the added time and complexity of needing to send samples to a reference lab. The system is fully automated, reducing the opportunity for human error and increasing the speed to result, and can process 24 samples simultaneously.

"The new BD COVID-19 test for the BD MAX™ System will help increase availability of these much-needed tests around the world," said Dave Hickey, president of Integrated Diagnostics for BD. "We continue to work towards a full portfolio of testing options to give health care workers choice and access to the right test for the right situation."

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