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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.


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BD has secured emergency use authorisation (EUA) from the US F ood and Drug Administration (F DA) 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 F DA 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.

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Build resilience in the face of COVID-19 disruption

COVID-19 has already affected our lives forever. The way we work, shop, eat, seek medical advice, and socialize will all be different in the future. Quite how different remains to be seen, but all industries must plan for multiple eventualities. Are you interested in actionable insights on the business challenges induced by the pandemic? GlobalData's cross-sector report analyzes the significance of this major disruptive theme across industry verticals. It provides side-by-side research of alternative datasets to present you with unique quantitative analysis of the effects of COVID-19 and how these differ across sectors. Additionally, it offers qualitative analysis of each sector and analyzes COVID-19’s impact on leading companies. Whatever your company’s imminent strategic plans, the long-lasting impact of COVID-19 must not be overlooked. Find out how to futureproof your business operations – download our report today.
by GlobalData
Enter your details here to receive your free Report.

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