Early in the year, leaders at BioFire Diagnostics, a bioMérieux company, were monitoring the news coming out of China about a new and deadly respiratory virus. Executives were naturally concerned about the evolving humanitarian crisis in China and about the possible spread of COVID-19 into countries around the world. But the news about the virus was particularly relevant for BioFire—a Salt Lake City-based company that offers cutting-edge infectious disease testing instruments and reagent panels.
BioFire’s diagnostic reagent panels test for a whole menu of pathogens associated with a particular disease syndrome, an approach called “syndromic testing.” For instance, the BioFire® FilmArray® Respiratory 2 Panel can detect and identify 21 pathogens that cause respiratory illnesses like influenza, whooping cough, or the common cold—all with one test, and with results in about 45 minutes.
The syndromic approach maximizes the chances of finding out what’s making a patient sick. Fast and accurate diagnostic results help physicians quickly provide appropriate treatment. BioFire currently offers diagnostic panels that tackle five infectious disease syndromes: respiratory infections, blood stream infections, gastrointestinal infections, meningitis/encephalitis, and pneumonia.
“We knew in February that the novel coronavirus was spreading very fast and that we needed to help our customers identify it. Infectious disease diagnostics is what we do, and our respiratory products clearly needed to be updated to include the ability to detect this new emerging virus,” said Stephanie Thatcher, vice president of molecular systems at BioFire.
That moment was a jumping-off point for an extraordinary, company-wide effort to develop the test, gain regulatory authorization, and meet unprecedented customer demand for BioFire’s respiratory testing solutions—all while battling supply shortages, manufacturing capacity limits, and the necessity of keeping the workplace safe for BioFire’s essential workers.
Focusing on the science
The first challenge for BioFire scientists was to develop a test that could accurately detect and identify COVID.
To begin with, BioFire Diagnostic teams supported their colleagues at BioFire Defense in its efforts to develop a targeted test for COVID. “Then we looked at what it would take to implement COVID in our syndromic testing systems for respiratory infections, to distinguish it from other pathogens that cause colds, flu, or pneumonia,” Thatcher said. “Our goal was to streamline the development effort as much as possible to get a product out to our customers ASAP.”
As the pandemic worsened globally, materials like swabs and sample transport media became scarce for testing facilities and laboratories. “Testing centers have to buy these materials to run any test, including ours,” Thatcher explained. “Our team has been busy verifying that the variety of swabs and transport liquids commercially available are compatible with our system. Limited sampling materials is an evolving challenge that we are trying to keep ahead of and prepared for the upcoming flu season.”
For Andrew Hemmert, vice president of Molecular Biology, “The biggest obstacle we faced was time.” He added, “We wanted to work as fast as possible and took many risks. Because of our expertise, we felt comfortable taking these risks to respond to the pandemic. Our approach paid off and the test was developed and ready for FDA submission in record time.”
Hemmert said the experience “awoke a fire in the Molecular Biology department. We came up with clever strategies to lower risk and worked efficiently, not only within the team, but also across the broader company. This experience helped BioFire create a new roadmap of how to respond in a crisis.”
Working with regulators
Developing the test was just the first step. The next was obtaining Emergency Use Authorization (EUA) for the test from the FDA and seeking approval from various international regulatory agencies.
This is a daunting hurdle in normal circumstances but “we had the challenge of an uncertain regulatory environment in the early days of this public health emergency, with the FDA’s expectations for EUA evolving along with the pandemic,” noted Kevin Bourzac, vice president of regulatory and clinical affairs.
The effort was also complicated by the fact that half of the department’s staff were working from home so onsite staff could maintain social distancing. “Obviously we did not have the luxury of our normal development cycle and really came together as a team to not only validate this panel, but to prepare and submit the EUA request to the US FDA. There were a lot of very long days and weeks and I’m sure a few sleepless nights,” Bourzac said.
“We are extremely grateful for the lab teams who came in to work to perform the testing necessary to support the submissions despite the overhanging fear and unknowns of being at work during the early days of this global pandemic,” he said. “Their ability to be flexible, to adapt to new cleaning, mask, and social distancing measures very quickly, and still produce superior testing results and reports to support this product was nothing short of amazing.”
Bourzac additionally praised the hardworking personnel within the FDA. “We are extremely thankful to our reviewers at the FDA for their open interactions with us during the review process of our EUA,” he said. “Notably, we received our EUA after midnight on a Friday (which indicates how hard the FDA has been working as well!).”
Ramping up production
Even before the new panel that includes testing for COVID was available, demand for BioFire’s existing respiratory testing panels was on the rise. “In March, shipments for our products increased over 200 percent within a matter of weeks,” said Meghan Kuehn, vice president of reagent manufacturing. And once the new panel was available, customer demand was immediate and overwhelming. Additionally, BioFire faced tremendous demand from new customers for the instrumentation necessary to run the testing.
“We have an essential workforce of nearly 1,000 employees dedicated to manufacturing BioFire reagent kits who continued to report to work throughout the pandemic. We had to quickly review our normal operations and enact new protocols and workflows to help keep our employees safe at work,” she said.
During all of this activity, Reagent Manufacturing was in the process of moving into a new, state-of-the-art manufacturing facility. “While an unplanned pandemic added significant complexity and urgency to these efforts, we were well positioned to leverage these resources to help us respond,” Kuehn said.
Meanwhile, the company significantly stretched its instrument production capacity, according to Ben Smith, vice president of engineering. This was accomplished in part through a hiring mandate that helped nearly double the number of direct labor personnel. Other departments also stepped forward to supply personnel. “We coordinated with multiple other departments to support this increased capacity,” said Smith.
The research and development team assisted with production part shortages. It also changed or delayed development plans to free up resources and space to support production.
Procuring vital materials
In this midst of all this activity, the purchasing department proved to be a key ally for the scientists, the regulatory and clinical affairs department, the manufacturing teams, and many other areas.
“We have needed to work very closely with our purchasing department to coordinate strategically based procurement of raw materials and supplies to support our increased capacity,” Smith said.
While trying to ramp up production to meet demand, manufacturing was challenged by material shortages and supply chain disruptions. “Our purchasing and procurement teams have been relentless in ensuring they could source and provide this necessary material,” Kuehn said. “And our procurement and materials logistics teams adapted quickly to find new channels and alternative solutions.”
A BioFire employee wearing PPE holds a component of a reagent panel pouch.
Communicating with transparency
The marketing department at BioFire faced a unique challenge—marketing leaders found themselves working to launch the new respiratory panel while being careful to manage customers’ expectations about availability. “We tried to mitigate these challenges by not over-promising or under-delivering,” said Mari Hoidal, director of marketing.
Hoidal said that frequent communication and transparency have been key. “We want our customers to know that we are working hard to support them in the fight against this global pandemic,” she said. “We want them to stay updated on our ramp-up progress and manufacturing expansion plans as we continue to deliver our high-quality testing globally.”
Adapting to change
“No one at BioFire started the year planning to combat a global pandemic,” noted Andrea Kendell, ad interim CEO. “Nonetheless, the executive leadership team is impressed and amazed with our team’s ability to mobilize, strategize, adapt, and execute on unprecedented goals in difficult circumstances.”
“During our response to COVID, we were reminded of our strengths such as collaboration, trust, and working in unison toward a shared meaningful purpose,” Thatcher said. “During this difficult time, it gave our teams something to focus on that can really help physicians and patients around the world. Historically we have worked in a fast-paced environment—this was just a reminder of how capable we are of adapting quickly to new challenges and how successful we can be when we all focus on a common goal.”