This is an excerpt of a 2,995-word article in the December 7, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group.
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 being COVID preparations, starting 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 being COVID preparations, readying 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.
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 begin COVID preparations and be ready 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.’
“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 with COVID preparations, 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, thanks to its COVID preparation, 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.”
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.
When did your lab begin COVID preparation? Please share your experiences with us in the comments below.