How Andrea Palm, Promega, Exact Sciences and others created a partnership to test Wisconsin residents.
At 7 a.m. on March 20, a virtual meeting got underway between the state’s secretary of health and leaders of two biotech industry powerhouses headquartered in Madison.
Eight days prior, a public health emergency had been declared by Gov. Tony Evers. Schools were closed. There were 206 cases of COVID-19 and two people had died. Everyone on the call knew they needed to act quickly to counteract the pace of the new virus.
The request that was made that morning by Andrea Palm, secretary of the state Department of Health Services, to the chief executive officer of Exact Sciences, Kevin Conory, Bill Linton, his counterpart at Promega, and Sara Mann, Promega’s general manager of its North American branch, would end up giving Wisconsin the ability to test 12,500 people a day for COVID-19, or 85,000 people per week, by the end of the following month.
States across the country were scrambling to purchase reagents, a critical chemical component that is needed in labs to determine if a COVID-19 nasal swab sample taken from an individual is positive or negative for the virus.
Wisconsin would not need to compete anymore.
The conversation that morning solidified a compact between the state, Exact Sciences and Promega, a company that has been manipulating enzymes to provide test results for a variety of viruses for the past 40 years, to supply Exact Sciences with a steady stream of reagent to assemble COVID-19 testing kits.
“We had been competing with states across the country for these limited testing supplies,” Palm said. “To have a really solid source that we can rely on here in Wisconsin was a game-changer for us.”
That morning, Promega agreed to increase its reagent production. It would then supply those reagents to Exact Sciences, the Madison-based molecular diagnostics company.
With a steady source of reagents, Exact was able to enter into a contract with the state to provide testing kits, which includes the reagent to process the sample but not the swab itself.
As of last week, the first two major shipments totaling 185,000 COVID-19 kits were sent from Exact Sciences to the state of Wisconsin.
The delivery of $18.5 million in tests – each test costs $100 – is being paid for through federal funding in Coronavirus Aid, Relief, and Economic Security, or CARES, Act, according to the state health department. This is allowing the state to offer the tests free to members of the public, Palm said.
“It was an honor to be asked,” said Promega’s Mann. “When you think of the people on the frontlines, this is the least we can do.”
With a branch in China, Promega officials were “well aware” of the virus outbreak in January, Mann said.
“We have been scaling up for the outbreak since January,” Mann said. “We anticipated there would be an increased need for our extraction and amplification products.”
The extraction and amplification products Promega supplies is where the much sought-after reagents come into play. Most people are familiar with the nasal swab that is necessary to test for the virus.
To obtain a result from COVID-19 swabs, reagents are first used to extract RNA – a single strand of genetic information – from the sample. This requires the use of five or six different reagents to isolate the RNA from the nasal swab sample, Mann said.
The RNA then needs to be amplified, using a different group of reagents, before the purified sample is placed into a machine, called a thermo cycler, which determines whether the sample is positive or negative for COVID-19.
Mann said Chinese health officials posted the full 2019-nCoV genome sequence on Jan. 10. Two week later, on Jan. 24, the Centers for Disease Control and Prevention publicly posted the assay protocol for this test, she said.
“Once that first emergency use authorization test was revealed by the CDC we were able to identify how our reagents could be of use,” Mann said.
Before the outbreak of COVID-19, Promega’s production lines were running one shift, five-days a week. They now operate three shifts, seven days a week to meet demand, Mann said.
The company is experiencing a roughly tenfold increase in demand, with most of the manufacturing of the reagent products occurring in Madison as well as some production in facilities in California, South Korea and China.
Promega now provides reagents for approximately 29 COVID-19 test kits manufactured by diagnostic companies around the world and provides other products used in the COVID-19 testing process to 575 clinical labs worldwide.
According to Mann, Promega has produced enough amplification reagents and enzymes since January to test approximately 135.5 million people worldwide.
Having that resource “in our own backyard” was one of the reasons we wanted them on board,” Palm said.
Ten days after the meeting on March 20, Evers announced the creation of the new public-private partnership to increase the state’s testing capacity. It included Promega, Exact Sciences, Marshfield Clinic Health system and UW Health.
“A lot of credit goes to Exact Sciences and the healthcare systems for stepping up,” Mann said. “They all had to get on board to create more lab testing capacity and everyone did.”
Mann said the task force, which up until recently was meeting seven days a week, is now pausing as the focus shifts to getting the tests into the hands of the people who can test Wisconsin residents.
“It is an honor to be part of the team,” Mann said of the lab capacity and testing task force. “The goal was 85,000 tests a week, and we met that initial objective.”
But having the ability to process 85,000 tests per week, or roughly 12,500 per day, is not the same as actually testing 85,000 people per week.
With lab capacity turbocharged, the state had to start performing more than the 2,870 tests that were reported on May 11. There had to be greater outreach. Targeted outreach.
Enter the Wisconsin National Guard. Palm and Evers announced an intention to test all nursing home residents and staff and to provide free drive-through testing sites that are staffed by 600 members of the Guard divided into 25 testing teams across Wisconsin.
After collecting the specimens, the sample is sent to a state lab for analysis. Those tested receive their results within three to five days.
As of Tuesday, these teams had collected samples from nearly 52,000 residents, according to the Wisconsin National Guard. On Thursday, the state reported its highest day of testing yet, with 9,400 COVID test samples collected and processed, Palm said.
“We have the help of the Wisconsin National Guard now, but we can’t (have their help) forever,” Palm said.
To prepare for that day and to meet the need to test 85,000 people a week until a vaccine for COVID-19 is found, the state recently created a website that healthcare systems can access to order free testing supplies or request staffing assistance or masks, gloves or other protective equipment.
She said the state, based on recommendations from scientists and epidemiologists, determined 85,000 people tested per week is necessary to stay ahead of potential surges.
The state’s goal is to have COVID-19 testing on par with flu testing by the start of the upcoming flu season, meaning it can be performed during a visit to a primary care doctor.
“To reach 85,000 tests performed each day, we need to be firing on all cylinders,” Palm said. “We will continue to need all our partners pitching in to help us reach that goal.”