Significant Volume

The ramp up, and contribution of molecular tests in the fight against COVID-19

The challenge was monumental, and crucial, to the frontline caregivers battling COVID-19. Almost overnight, demand for Quidel’s SARs COV-2 assays skyrocketed as hospital labs scrambled to have the appropriate testing in place at their facilities. 

Quidel responded by adding a significant volume of SARs COV-2 assays across the United States and did so in a significantly short window of time.

Working around the clock

Getting in a position to ship out the SARs COV-2 molecular tests first involved a combination of studies and approvals, said Mike Abney, senior vice president of distribution, Quidel. “We had to perform the quickest set of studies that we’ve ever attempted,” said Abney. “And we had work with the FDA to gain EUA approval with a highly accurate assay.”

Then came the massive ramp up in production. Quidel’s supply chain went from 0 to 1 million tests produced in the first 30 days, and then to 1 million per week going forward, Abney said. “We also enlisted Cardinal to help us with distribution, and to inform the hospital laboratory market about the assay and to pre-qualify customers who needed tests. So, the last step was getting all of the item details and pricing set up in two systems.”

The most unique challenge involved the increase of Quidel’s buying level on swabs, and transport media by 10-20 times the normal rate. “This has been a big challenge for all diagnostic test manufacturers in 2020, but was especially important for Quidel because we aim to provide everything the customer needs to perform the test in every kit we ship out, swabs and transport media included,” said Abney. “The fact that we have been able to hold up against that standard thus far during the pandemic is something that we are very pleased with. This will remain an issue for our industry in some form for the rest of the year.”

The project turned out to be the largest ever tackled at Quidel from a demand perspective, said Abney. “The first quarter of 2020 completed a record U.S. respiratory season, and the COVID-19 pandemic started while Influenza A was still at its peak. While our teams were in the middle of working overtime and weekends to meet the highest demand ever for our line of flu assays, we threw this project at them with the shortest timeline imaginable.”

Quidel’s Jon Dailey, associate director, Supply Chain; Nate Chapman, associate director, Molecular Manufacturing; and Ron Lollar, senior director, Clinical, Regulatory & Scientific Affairs worked around the clock to launch, secure the supply chain, and agree with the regulatory agencies for our Lyra SARs COV-2 assay. Due to the work of these three individuals and their teams, Quidel took the brand over the 1 million test mark in less than 30 days.

“Every team at Quidel has people that have been working around the clock, seven days a week for the last couple of months,” said Abney. “In some cases, the entire team has been doing so. Outside of the essential teams to manufacture the product, we had to do a lot of this on the phone and through video conference, which we had to adapt to quickly. We’re used to getting in a room in San Diego face to face and hashing things out. Many people on the team have commented ‘this is the hardest I’ve ever worked,’ but it’s been thrilling and motivating and we’re all happy to be a part of it.”

Lessons learned

The most obvious lesson from the COVID-19 pandemic? We have all learned “you can’t be too ready for the unexpected,” said Mike Abney, senior vice president of distribution, Quidel. “Our CEO, Doug Bryant, pushed us to hire a few more talented people than we thought we needed, and to beef up manufacturing capacity beyond the level we thought we needed, and suddenly we required all of it and more to answer the call to produce more tests for the pandemic.”

Also, the value of Quidel’s distribution partnerships has never been higher than it is today, Abney said. “We could not achieve the level of customer communication and logistics required to execute what we are trying to accomplish over the next year without them.”

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