BD secures approval for second Covid-19 molecular diagnostic test

14 April 2020 (Last Updated April 14th, 2020 12:13)

BD has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for an additional molecular diagnostic test for Covid-19 that provides results in two to three hours.

BD secures approval for second Covid-19 molecular diagnostic test
BD has received US FDA’s emergency use authorisation and CE Mark approval for an additional molecular diagnostic test for Covid-19. Credit: BD.

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BD has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for an additional molecular diagnostic test for Covid-19 that provides results in two to three hours.

The test also secured CE Mark in Europe.

This new test, similarly to the previous Covid-19 test released by the company, runs on the BD MAX System. It is expected to scale up the testing capacity for the pandemic in the US and in other countries that accept CE Mark as regulatory approval.

BD Integrated Diagnostics president Dave Hickey said: “The new BD Covid-19 test for the BD MAX System will help increase the availability of these much-needed tests around the world. 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.”

The company’s BD MAX System is a molecular diagnostic platform that is already in use at a number of laboratories across the world. Each unit can analyse hundreds of samples over a 24-hour period.

The fully automated system can process 24 samples simultaneously. The assay is based on the same viral RNA targeting sequences and real-time PCR detection method. It is same as the test developed by the US Centers for Disease Control and Prevention (CDC).

Earlier this month, the company received US FDA emergency use authorisation for a Covid-19 diagnostic test.

This month, BD also rolled out a blood test in collaboration with BioMedomics. The test detects antibodies in the blood to confirm current or past exposure to coronavirus.