CEO SUMMARY: In a remarkable example of prescience, informed by decades-long experience in clinical lab testing and past epidemics, the president of NorDx Laboratories in Maine saw the December news accounts of a widespread outbreak of a new respiratory disease in China. He warned his lab team to assume the worst and energized them to start work on a test for the novel coronavirus. Before the end of January, NorDx had obtained SARS-CoV-2 specimens from a source in Germany, had acquired probes and primers, and was developing its in-house molecular test for COVID-19 as an LDT.
FOR CLINICAL LABORATORY PROFESSIONALS WITH YEARS OF EXPERIENCE, the appearance of any new respiratory virus can be a déjà vu event. That experience was useful to Stan Schofield, President of NorDx Laboratories in Scarborough, Maine, after he saw news reports late last year about an outbreak of a zoonotic virus transmitted from animals to humans in China. That news led him to alert the lab staff to prepare for what he feared could be a virulent strain of a new virus.
By responding swiftly to these early reports of a novel coronavirus, Schofield’s lab was able to obtain samples of this new infectious agent in January! The lab team then used these samples to develop their own rapid molecular laboratory-developed test (LDT) for SARS-CoV-2. In early March, that enabled the lab to be one of the first in the nation to get an emergency use authorization (EUA) from the federal Food and Drug Administration (FDA). NorDx was also one of the first labs in the United States to obtain an FDA EUA for pooled COVID- 19 testing.
Hospital Labs as Resource
The early and effective responses of NorDx Laboratories—the laboratory division of Maine Health—to the COVID-19 pandemic demonstrate why locally-based laboratories in hospitals and health networks are perfectly positioned to deliver speedy, accurate lab testing, particularly during a crisis like the current pandemic. These are facts that governors and federal health officials continue to overlook or ignore.
Moreover, the actions taken by the lab team at NorDx following the earliest news of the widespread outbreak in China attributed to the novel coronavirus will inspire all clinical pathologists and lab administrators who lead hospital and health network laboratories.
Open Market Supply Chain
Another important aspect of NorDx’s speedy response to the outbreak is that the laboratory’s response incorporated the knowledge and experience gained from three previous global outbreaks of a novel respiratory virus:
• First was the outbreak of Severe Acute Respiratory Syndrome (SARS) in 2003 that appeared in China, then showed up in Hong Kong and Toronto, Canada.
• Second was the outbreak of Influenza A (H1N1), which was first recognized in Mexico in 2009. It spread across the United States and throughout the world.
• Third was the Middle East Respiratory Syndrome (MERS), a novel coronovirus believed to have developed in camels. Identified in 2012, infections have primarily been to individuals living or traveling in the Middle East.
As a lab executive with more than 30 years of experience, Stan Schofield, President of NorDx Laboratories in Scarborough, Maine, has vivid memories of these outbreaks of novel respiratory viruses. Thus, when he read news stories in December 2019 of a novel coronavirus responsible for large numbers of infections in China, he was aware of how quickly a new virus could travel across the globe.
In particular, the December news reports reminded Schofield of 2009, when the novel Influenza A H1N1 virus emerged. It was first identified and reported internationally by Mexico on April 12. Just three days later, on April 15, the first case in this country was reported in California. H1N1 quickly spread across the United States.
In December, Schofield recognized that it was reasonable to assume that this novel respiratory virus could quickly spread worldwide. “Based on my experience with H1N1 in 2009, I knew that could be a problem,” he said.
2009’s Demand for H1N1 Tests
“Here in the United States, public health labs got overwhelmed with specimens and couldn’t handle the demand for respiratory and H1N1 testing in 2009 coming from physicians and hospitals,” he recalled. “The emergency departments were full of people, and labs could not report test results because the the public health system was structured so that hospital labs like us could not get the probes and primers necessary to build a test specific for H1N1.”
Based on those recollections, Schofield told the lab staff at NorDx to prepare for the worst from COVID-19. “I didn’t want to go through that again and so, I asked the staff to get the genetic sequence of the SARS-CoV-2 virus,” he recounted. “At the time, half my staff thought I was a nutcase. They asked me, ‘What are you talking about? We don’t need to do that.’
“We acquired the genetic sequence of SARS-CoV-2 from Germany. We then set about to add the probes and primers and had everything needed to develop our COVID-19 LDT by the end of January.”
“My CFO said I would be wasting the money at the very moment that we are struggling to respond to the PAMA cuts to Medicare Part B lab test fees. ‘Are you sure about this?’ he asked.
“But I knew what might happen, so I insisted,” affirmed Schofield. “We got to work on acquiring the genetic sequence of SARS-CoV-2. That material came from a source in Germany. We then set about to add the probes and primers and had everything needed to develop our COVID-19 LDT by the end of January.”
Assembling Needed Supplies
The NorDx molecular staff were busy the entire month of February building the test and assembling the supplies needed to test for SARS-CoV-2. “This is why, when COVID-19 infections started to rise in March, our lab had enough reagents to test 3,000 patients. Even at that level, I thought the lab might end up wasting money,” he noted.
By early March, NorDx became one of the first clinical laboratories in the United States to earn an emergency use authorization (EUA) for its own laboratory-developed assay for SARS-CoV-2, the virus that causes the COVID-19 illness. In April, NorDx earned a second EUA, this time to pool four COVID-19 samples in each tube.
“Since earning that first EUA, NorDx has run 300,000 PCR COVID-19 tests,” noted Schofield. “About 60% of those tests were in pools of two to four samples in each tube.
“When we started running COVID-19 PCR tests, we could do about 200 tests a day,” he said. “Now, we do 3,000 COVID-19 tests a day. Even though the lab runs seven days a week, 24 hours a day, we’re not quite at full capacity. Later this week, we expect to move up to 4,000 tests a day.”
The pooled testing strategy proved to be so successful that by early May, MaineHealth, NorDx’s parent health system, reopened all 12 of its hospitals that serve much of Maine and six counties in neighboring New Hampshire, Schofield said in an interview with The Dark Report last week.
No Elective Surgeries
Those 12 hospitals were unable to do elective surgeries or ambulatory visits after Maine’s Gov. Janet Mills postponed all non-urgent medical procedures, elective surgeries, and appointments at hospitals and healthcare providers across the state under an emergency order on March 15.
“When the hospitals reduced operations, there was no elective surgery or procedures,” Schofield noted. “But by May 1—and because of our FDA EUA for pooled testing—our lab could begin pooled testing for COVID-19. Because our lab could pool, all of our hospitals could open up again for elective cases.
“Beginning in early May, we had patients come in for a PCR COVID-19 test 72 hours before an MRI, a surgery, or any other procedure,” he said. “If the patient had a negative result on the PCR COVID-19 test, that patient could have that procedure,” he explained. “This testing protocol and our lab’s fast turnaround time for a COVID-19 test result was the key to allow all 12 hospitals to reopen for full services last spring.”
Schofield said that this protocol of pre-procedure testing continues today. “Currently, of the 3,000 PCR COVID-19 tests we run every day, between 1,200 and 1,400 tests are for asymptomatic patients who need to get tested before elective surgery or a procedure such as a CAT scan or MRI,” he reported. “Our lab does those tests so that our 12 hospitals can remain as COVID-free zones.
“We also do about 600 to 900 COVID-19 tests each day for symptomatic patients who visit our doctors’ offices and emergency departments,” he added. “Those tests are for people who have colds, sniffles, fevers, or family members who have been exposed to someone who has COVID-19, such as when a college student returns home, for example.”
In addition, NorDx implemented a COVID-19 antibody test. However, since launching it on June 1, demand for this assay has been low, running at about 100 tests per month. “COVID-19 antibody tests will not be a player until the vaccine comes out,” Schofield predicted. “Then people will want to know if they’ve developed antibodies. At that point, we will need a quantified antibody test for COVID-19.”
One reason NorDx has been successful with its COVID-19 testing program is that its PCR LDT for SARS-CoV-2 does not require test kits and supplies from any particular diagnostic test manufacturer. “Even though it’s difficult to get the supplies we need, we can perform adequate numbers of tests because we have an open-channel, lab-developed assay,” Schofield explained. “That means our lab is not dependent on any one diagnostic company for either the testing platform or the test kits.
Open Market Supply Chain
“Also, we can get reagents, master mix, and pipette tips on the open market,” he added. “Sometimes we have to pay more on the open market than if we were buying these supplies from diagnostic testing companies. But for months now, those companies have been unable to ship adequate quantities of these supplies to us.
“Neither the federal government nor the diagnostic testing companies have been reliable sources of supplies because the government diverts those supplies to the hotspot cities,” noted Schofield. “Therefore, our lab must get universal transport media directly from South Korea. We get pipette tips directly from Germany.
“We’ve also been able to get most of the master mix, probes, primers, extraction units, and similar supplies we need from Thermo Fisher,” he added. “Being in Maine, we’re very low on the priority list for COVID-19 testing supplies. Out of the 50 states, Maine is at something like 48.”
In the first week of December, data on state-level positivity rates showed that only two states were not in the red zone: Hawaii and Maine, he reported.
“Even though it’s difficult to get the supplies we need, we can perform adequate numbers of tests because we have an open-channel, lab-developed assay. It means our lab is not dependent on any one diagnostic company for either the testing platform or the test kits.”
Despite being in the most rural state in the nation, NorDx is no small operation. In the core lab in Scarborough, the laboratory team churns out more than five million billable tests every year. Collectively, the 12 hospital laboratories run about three million tests annually. The core lab staff totals 175 full-timers, and the total staff in the core lab and the hospital labs combined total more than 700 workers, Schofield said. Most of the 12 hospitals are small (25 beds) to mid-size facilities, and one, the Maine Medical Center, has 650 beds.
“Being a rural state has helped to keep our infection rate low,” he noted. “But it’s hurt our ability to respond to the COVID-19 testing needs in the communities we serve. When we’ve ordered big lab systems, some of those shipments were diverted by diagnostic companies to large city hotspots. The thinking of the U.S. government and the diagnostic companies was to send that equipment to other places.
“Every day has been a scavenger hunt because some days we get short on extraction kits. Other days, it’s the supply of pipette tips that gets low,” he commented. “We have to bend all the normal supply chains into pretzels trying to get the supplies we need. In April and May, our lab got master mix from the research divisions at pharmaceutical companies because we couldn’t get anything from the in vitro diagnostic (IVD) manufacturers. Those IVD firms took all the master mix off the market to build more kits.”
Leveraging the Value of LDTs
Using a metaphor, Schofield describe how a clinical lab is similar to running a bakery. “Just as bakeries gather the ingredients they need and then bake cakes, labs collect the ingredients they need to run tests,” he said. “Most labs aren’t like NorDx, where we use the flour, the eggs, the sugar, and the salt, and then produce our own birthday cake—our LDT COVID-19 test result. Most labs have to go buy $50 birthday cakes from the bakery—their IVD manufacturer—to produce their results.”
As mentioned earlier, the innovations of the NorDx Laboratory team show how and why the laboratory of a hospital or health network can be an invaluable community resource for local COVID-19 testing. “NorDx is well-positioned because we have PhDs and molecular-trained lab scientists who have the skills, instrument systems, and supplies they need to perform the COVID-19 tests needed by hospitals, physicians, and patients in our communities,” concluded Schofield.
Ability to Start COVID-19 Pooled Testing EarlyHelped NorDx Extend Limited Quantity of Supplies
IN APRIL, NORDX LABORATORIES IN SCARBOROUGH, MAINE, became one of the first labs in the United States to earn a second emergency use authorization (EUA) from the Food and Drug Administration, this time for pooled testing for COVID-19.
The ability to do pooled testing was significant for two reasons. First, it allowed the lab to support its parent company, MaineHealth, in reopening 12 hospitals for elective surgeries and other care after being shut down under state order. Second, it allowed the lab to conserve testing COVID-19 supplies.
“Pooling is the only reason we’ve been able to stay in business during the times when we couldn’t consistently get reagents,” said NorDx President Stan Schofield. “When we got this EUA, our lab started pooling four COVID-19 samples in each tube. By the third week in April, we were doing most of our PCR COVID-19 testing by pooling specimens. That was for asymptomatic patients.
“We had to pool specimens because we needed to conserve the reagents and the supplies that we had. Running short was a possibility every day,” he noted.
“Not only was it useful in reopening our hospitals, but doing pooled COVID-19 testing has utility in the field for schools, nursing homes, or businesses,” he added.
Seven months later, NorDx continues to pool specimens from asymptomatic patients but has done so with two specimens at a time instead of four because the positivity rate in Maine has started to climb, as it has in every state.
“When our positivity rate climbed in the last couple of weeks, we started pooling two specimens at a time,” noted Schofield. “We are concerned because we see that the COVID-19 positivity rate in other regions can be 8% to 10% or more. When it gets that high, pooling is a lot more work than it’s worth because the lab must do too much retesting.
“When a pool is positive after the first test, the lab must retest each specimen in the pool,” he said. “At four-to-one, that’s five tests. At two-to-one, that’s three tests.
“For symptomatic patients, we don’t pool specimens,” he said. “But with the spike in the last two weeks, we’re testing asymptomatic patients two at time in each pool. In the first week in December, our positivity rate for symptomatic patients was running about 4% to 5%. And our asymptomatic patients were under 1%.”
For now, Schofield does not expect to return to pooling four specimens any time soon. “We’re not going to make any changes until after Christmas, because I think we’ll get slammed next week, which will be two weeks after Thanksgiving,” he warned.
“At the moment we have the reagents we need, and we are pooling two specimens at a time,” he explained. “If we go back to four-to-one and have a spike in COVID-19 infections, that will create more work for the staff and could cause a shortage of reagents.”
For Self-Directed Asymptomatic COVID-19 Testing, NorDx Requires Consumers to Pay $105 in Cash
IN OCTOBER, NORDX LABORATORIES IN MAINE STARTED OFFERING PCR COVID-19 TESTINGto asymptomatic Mainers willing to pay $105 for the test. NorDx calls this strategy community testing.
“We average between 50 and 100 of those tests each day, which are perfect for self-directed asymptomatic testing in the community,” said NorDx President Stan Schofield. “Given that health insurers won’t pay for testing asymptomatic patients, consumers need to pay out of pocket.
“We do not advertise this testing or promote it because reagents are limited and we need to conserve those reagents for our hospitals and for sick patients,” he noted.
“Still, this strategy provides a service to the community because most people can’t get tested unless they go to a national pharmacy chain store, such as CVS or Walgreens,” he explained. “But then it takes a week to get the PCR COVID-19 test results back. We produce our test results in eight to 12 hours.
“The other problem for patients is that health insurance companies don’t pay for surveillance screening of asymptomatic cases,” noted Schofield. “So, when we do community testing, consumers must pay on their own because they are self-requesting this test and can’t use insurance because they’re asymptomatic.
“This strategy has been very successful and financially rewarding for us because the $105 helps to offset all the extra overtime in our laboratory since last spring,” Schofield commented. “It also helps us to cover the cost of reagents, which have been higher than they were when the pandemic broke out.
“Community testing works for people who want a COVID-19 test before they travel, or if grandma is coming to visit or somebody is coming home from college, and they want to get tested to be sure they’re negative,” he said.
Contact Stan Schofield at firstname.lastname@example.org.