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March 25, 2020
Racing Against the Clock to Combat COVID-19
Bringing a diagnostic test to market typically takes months, even years. We exceeded that by far with our new molecular test for COVID-19. In just weeks, the test was developed, approved, and out the door to hospitals and labs across the United States thanks to the incredible efforts of our colleagues in Diagnostics.
The critical first step in battling a pandemic like COVID-19 is diagnostic testing to help identify those infected to get them care and to stem the spread of the virus.
We helped answered that need with our newly developed
Abbott RealTime SARS-CoV-2 molecular test, designed for use on our
m2000 RealTi
me system. Used in more than 175 hospitals and reference labs in the United States, our
m2000 is an automated system that can process hundreds of specimens in 24 hours, which is critical to helping contain the spread of COVID-19.
On March 18, we received Emergency Use Authorization (EUA) for our test from the U.S. Food and Drug Administration (FDA) and, on that same day, we immediately shipped 150,000 assays to our U.S. customers.
Typically, a test like this would take a year or more to develop and get to market, but we accomplished it in weeks, thanks to the dedication and hard work of our colleagues across Diagnostics.
“We’re so proud to have developed a coronavirus test that will help healthcare providers on the frontline of care,” said Daman Kowalski, Vice President and head of Molecular Diagnostics. “We knew that speed was critical, so we mobilized a cross-functional team quickly from Research and Development across Core Diagnostics and Molecular, Quality, Operations, Manufacturing, and Sales.”
It was a challenge that, to many, may have seemed impossible to meet. But not to us. Abbott has long been a global leader in infectious disease testing, including developing the first HIV test. Our scientists work daily to identify new or unknown pathogens and develop tests to address these new threats.
The team knew that with COVID-19, time was of the essence.
“We were running against the clock,” said Daman. “So, being able to achieve the best we could in the shortest amount of time – without compromising quality, safety, and accuracy – was key.”
And that’s exactly what we did.
“To develop the test, we put a cross-divisional team together of highly skilled scientists who have done this for many years, who knew what was needed to take something from concept and bring it to market,” said Klara Abravaya, Senior Research Fellow in Molecular.
To be most efficient, the team split up into groups, with each operating on different shifts so that testing and development would be performed at all times, 24 hours a day, seven days a week.
“We all worked together,” said Klara. “Knowing the situation, we knew we had to go much, much faster than usual. Every day we went through every single piece of data, took it one step at a time and, because of the expertise of our cross-divisional team, we were able to come up with innovative ideas for getting a high-quality test out the door as quickly as possible.”
From the onset, the team was in frequent contact with our customers to determine the needs for the test.
“We had to collaborate closely with our customers so we could understand the disease, understand what our assay design needed to be, and what we needed to deliver to the market,” said Danijela Lucic, Global Scientific Affairs Manager in Molecular. “As we would get their feedback, we would pass it along to our core research team so they could take those concepts and apply them to their test design. Then, once we outlined our design, we went back to our customers to ensure what we were thinking about for the test would meet their clinical needs.”
It was truly a team effort, with multiple parts happening simultaneously.
“We were really doing everything in parallel,” said Daman. “For example, while our scientists were developing the test, our regulatory colleagues were writing the submission and communicating with the FDA, and the manufacturing facility was making the reagents for the test. So, as soon as we received EUA, we were ready that day to ship the tests. It was one of the best cross-divisional efforts I’ve seen in all my years at Abbott.”
Chris Slachta, Divisional Vice President of Operations in Molecular, echoed that sentiment.
“We were manufacturing product and designing all in the same day,” he said. “We were going right from R&D into manufacturing, doing as many quality checks as we could to make sure the test was robust and would meet our customers’ needs.”
And working with suppliers was key, too, said Chris.
“We can’t make a test unless we have supplies,” he said. “So, we worked with our suppliers to determine how much material they could get us, how fast they could get it, and what kind of capacity they had that they could build up. And we did the same internally as well, based on our available capacity, with regards to our people, the direct and indirect labor needed, all the way through to our equipment, our filling machines, and everything else we needed to make the test so we could get it out to our customers.”
But it wasn’t just the team’s hard work that made a difference – so did their positive attitudes and determination.
“Colleagues were working extraordinary hours for two weeks straight,” said Daman. “They never complained or said ‘we can’t do this.’ Their expertise, combined with their willingness to go the extra mile for our company and all those we serve, really shows the caliber of Abbott people, our caring, our giving, and our commitment to doing the right thing.”
When all was said and done, and the test was developed, approved, and ready to go, it was a moment the team will always remember.
“It was extremely rewarding to know we developed a test that’s urgently needed to fight this pandemic,” said Klara.
Daman said, “It was such a tremendous sense of accomplishment, very humbling. I don’t think it really hit us until we started shipping the test and received so many calls and notes from our customers thanking us and saying how happy they were with the test.
“I’m so proud of our colleagues. Everyone worked tirelessly and with enthusiasm, knowing what a difference we were making. We show up in times that matter the most. Now is an unprecedented time where healthcare is at the center of this global pandemic. And we can proudly say we helped make a difference.”