Testing Our Limits, Episode 4: The Time to Deliver
So the test is ready. It receives Emergency Use Authorization in the U.S. Just one challenge remains: How to make enough of them? And how to do it without delay? With the full support from Abbott CEO Robert Ford through the ranks of the company, we ramped production at record speed to meet a demand that has only continued to grow.
“For something like this, it’s typically an 18- to 24-month timeframe. As you’re thinking about how you can pull this off, you have to undo and basically unlearn a lot of the traditional things. The muscle memory part, you need to set that aside and almost start from a complete white sheet of paper. It feels like you’re flying the plane while you’re trying to change the engines at the same time,” said Scott House, senior vice president for quality assurance and engineering services, Abbott.
Added John R. Hackett Jr., divisional vice president for applied research and technology, Abbott Diagnostics: “You can have the best test in the world and if you can’t manufacture it, you’re not going to do many people a great deal of good.”
Learn more about how Abbott’s diagnostics are helping to slow the COVID-19 pandemic: https://abbo.tt/37ht6os
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RELATED VIDEOS:
TESTING OUR LIMITS, EPISODE 1: A THREAT EMERGES - https://youtu.be/XrOb9F-boUY
TESTING OUR LIMITS, EPISODE 2: THE PATH FORWARD - https://youtu.be/E0PmJgWNBpI
TESTING OUR LIMITS, EPISODE 3: TACKLING THE PROBLEM HEAD-ON - https://youtu.be/izmc8nZdjB4
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The ID NOW COVID-19 EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
