Receive our newsletter – data, insights and analysis delivered to you
  1. News
April 14, 2020

BD secures approval for second Covid-19 molecular diagnostic test

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.


Visit our Covid-19 microsite for the latest coronavirus news, analysis and updates


Follow the latest updates of the outbreak on our timeline.


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.”

Content from our partners
Precision wire: The future of bespoke medical treatment
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
“This technique means everything to us”: How CGM devices empower users 

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.

Related Companies

Topics in this article:
NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU