Certainly every clinical laboratory in the United States has a unique story about dealing with the challenges of the SARS-CoV-2 outbreak, but only BioReference did testing for multiple professional sports leagues and the cruise ship industry
Few would challenge the assertion that the nation’s clinical laboratories (along with public health officials) were caught flat-footed when the SARS-CoV-2 coronavirus reached the United States in the winter of 2021. Even as the federal Centers for Disease Control and Prevention (CDC) and some labs rushed to develop reliable medical laboratory tests for COVID-19 in the early weeks of the outbreak, the demand for tests far outstripped supply in this country for many months.
This was the moment when the pandemic’s need meant lab testing opportunity for medical laboratories across the nation. This was particularly true for Elmwood Park, New Jersey-based BioReference Laboratories, Inc. (BRLI), a division of OPKO, Inc. BioReference found itself in the nation’s first pandemic hot zone—New York City and surrounding counties.
Not only was this lab company geographically in the center of the first overwhelming surge of COVID-19 cases, but its management team had important relationships across government and business. For that reason, its management team was pulled into the earliest planning sessions by government officials at the city, state, and federal level.
Consequently, in the earliest days of the outbreak, BioReference was one of the nation’s first labs to help organize and support drive-through COVID-19 specimen collection centers. Its management team went on to accomplish many notable firsts in the lab’s response to the pandemic. All of this is described in the recently-published book “Swab–Leadership in the Race to Provide COVID Testing to America.”
As CEO of BioReference Laboratories during the time of the COVID-19 pandemic in 2020 and 2021, physician Jon R. Cohen, MD (above), energized his clinical lab’s management team and staff to rise to a series of unique challenges, ranging from helping set up the nation’s first drive-through COVID-19 sampling sites in New York City to performing testing for professional sports leagues, such as the NBA, the NFL, and the NHL. (Photo copyright: New York Foundling, Inc.)
Harnessing the Creativity and Energy of a Clinical Lab Staff
The book’s author is Jon R. Cohen, MD, who was CEO of BioReference Laboratories throughout the course of the pandemic. Cohen is now CEO of Talkspace, a virtual behavioral health company.
“Swab” documents BioReference lab’s response to the SARS-CoV-2 pandemic and tells the tale of how the lab company harnessed the creativity of its managers and lab scientists to speedily build up daily test volumes at a time when automation, analyzers, test kits, collection supplies, and reagents were in short supply.
Clinical laboratory professionals interested in lab management will gain valuable insights from Cohen’s approach to writing “Swab.”
While describing BioReference lab’s many innovative COVID-19 testing services, Cohen also provides readers with the management lessons and insights he used to impart needed skills to the company managers, while also inspiring BioReference Lab’s staff to devote the extra effort necessary to deliver COVID-19 testing in novel ways and in unusual settings.
When New York City hospitals were overwhelmed by cases in the earliest days of the pandemic, Cohen’s personal contacts with political leaders came into play. Just a few years earlier, Cohen had run for statewide office as a Democrat. He had friendships with the New York City Mayor Bill de Blasio, with the New York State Governor Mario Cuomo, and with Senators Charles Schumer and Kirsten Gillibrand.
Cohen’s Lab Had a Seat at Government Planning Tables
As these government officials convened various task forces to address the pandemic, Cohen describes how BioReference had a seat at the table and a voice in viable ways to organize specimen collection and COVID-19 testing literally overnight and on an unprecedented scale.
The pandemic’s early days in late February, March, and April of 2020 were only the first challenges to be overcome by the management at BioReference. “Swab” describes a remarkable progression of innovative SARS-CoV-2 testing programs initiated by Cohen and his team. Each of these testing programs was tailored to the specific needs of different industries. No other clinical laboratory organization in the United States was as successful at serving this range of clients. For example:
For the last eight games of the National Basketball Association’s 2020 season and playoffs, BioReference created and managed the NBA’s “biosecure bubble” program at Disney World in Orlando. Over the course of 172 games, 150,000 SARS-CoV-2 tests were performed with zero-positivity.
The National Football League watched the NBA play in its bubble that summer. BioReference got the call and worked with NFL management to provide COVID-19 tests. For the 2020 season, in support of 268 games played across the United States, BioReference performed 1.23 million tests for 5,000 players, coaches, and staff, with an infection rate of less than 1%.
Along with the NBA and NFL, BioReference provided SARS-CoV-2 testing for professional soccer and hockey, the Winter X Games, and the US men’s and women’s Olympic soccer teams.
One of the lab company’s more complex SARS-CoV-2 testing programs involved the cruise ship industry. In 2021, BioReference established sites in 13 ports around the US and the Caribbean. The lab placed staff on as many as 24 cruise ships at one time.
Of course, testing for schools, colleges, universities, and employers was part of BRLI’s testing services over the course of the COVID-19 pandemic as well.
Creativity of Clinical Lab Managers and Staff
As the examples above illustrate, “Swab” will give readers a ringside seat in how BioReference Laboratories harnessed the creativity and skills of its management team and staff to address the unprecedented demands for timely, accurate COVID-19 testing from the very beginning of the pandemic through its waning months.
Cohen writes with an accessible style and provides readers with an easy-to-read narrative of his lab company’s journey through the pandemic. Each of the book’s 10 chapters ends with a “Leadership Reflection” that Cohen uses to describe the management methods he utilized to keep BRLI’s thousands of employees on task and on time, so that the end result month after month was “mission accomplished.”
In today’s digital age, the statement “this book is available at a bookstore near you” may not be applicable. What is true is that author Jon R. Cohen’s “Swab–Leadership in the Race to Provide COVID Testing to America” can be ordered at Amazon.com, Alibris.com, and other web-based booksellers.
Little-known Polish company relied on suspect arbitration court to demand thousands of euros from conference speakers
Clinical laboratory and pathology professionals may want to heed the phrase “caveat emptor” (“let the buyer beware”) if invited to speak at events organized by little-known entities. That appears to be the lesson from a rather bizarre story coming out of Poland involving scholars from multiple countries who agreed to speak during a series of online COVID-19 webinars and who were later billed thousands of euros for their participation.
But months after the event, the organizer demanded payment for the researchers’ participation, and in some cases, turned to a Polish arbitration court to enforce the demand. But in a curious twist, the legitimacy of that court has itself been called into question.
“I was interested in the topic, and I agreed to participate,” Björn Johansson, MD, told Science. “I thought it was going to be an ordinary academic seminar. It was an easy decision for me.” Johansson, a physician and researcher at the Karolinska Institute in Sweden, has since “come to regret that decision,” the publication reported.
Villa Europa is now seeking €80,000 ($86,912 in current US dollars) from Johansson, including legal costs and interest, after turning to a Swedish court. Others have received demands for €13,000 to €25,000 ($14,123 to $27,156) in fees, late payment penalties, and court costs, Science reported.
Researchers Axel Brandenburg, PhD (left), and Björn Johansson, MD (right), are two of the 32 scholars from six countries who are now being billed thousands of euros for their participation in the Villa Europa COVID-19 modeling webinars. Pathology and clinical laboratory leaders who receive similar invitations may want to thoroughly read the contracts before agreeing to participate. (Photo copyright: Axel Brandenburg, Björn Johansson.)
How Did It All Happen?
According to Science, the ordeal began when an individual named Matteo Ferensby invited the scientists to speak at the webinars. His email signature indicated an affiliation with the University of Warsaw, but the university “has no employee by that name, according to the institution’s press office,” Science reported, adding that “there is no track record of scientific publications from a Matteo Ferensby.”
By one speaker’s count, the company produced at least 11 webinars between April 2020 and June 2021. “The speakers themselves—about 10 people in each session—were the only audience, but participants were told the recordings would be published open access afterward,” Science reported.
Ferensby did not disclose that speakers would be charged conference fees. In fact, one speaker was told explicitly that no fees would be requested, Science noted.
However, the speakers were later asked to sign a license agreement that would allow the organizer to publish the recordings. It included a clause on the last page stating that they would have to pay fees of €790 and €2785 (US$859 and $3,029) related to publication.
The financial amounts were written in words rather than numbers with no highlighting, according to Science, which reviewed some of the contracts.
“Many of the speakers, already busy studying COVID-19 and under pressure from the transition to remote teaching, did not notice these clauses,” Science reported. Said one speaker: “The contract was unreadable [but] I eventually sent it.”
Questionable Arbitration
Some of the webinar participants told Science that they later received altered versions of the contracts with “an additional page where the fees are made explicit, and [with] modified clauses, one of them stating that disputes can be settled by a Polish arbitration court.”
“In my opinion this is fraud,” Durlik said. Nevertheless, Villa Europa used alleged rulings by PESA to go after some of the speakers in their own local courts.
“For the researchers now under pressure from the courts, ignoring the demands is not an option,” Science reported. “They have all submitted court filings supporting their case.”
The speakers claim that “the demands are illegitimate and that they were deceived about what they were signing in the contracts,” Science noted. One speaker, Axel Brandenburg, PhD, of the Nordic Institute for Theoretical Physics (NORDITA), is awaiting a ruling in September, Science reported.
Warnings against Predatory Conferences
The story comes amid increasing concerns about so-called “predatory conferences,” in which scientists are invited under false pretenses to participate in what appear to be legitimate meetings.
“Would-be attendees should expect missing plenary speakers, multiple fields of research smashed together in a Frankenstein program, and an absence of the important academic rigor that fuels the conferences that scientists know and love,” wrote senior science writer Ruairi J. Mackenzie in Technology Networks. “The companies organizing these events are motivated by profit above all else.”
Mackenzie offered several tips to help both speakers and attendees spot fake conferences:
Examine the promotional materials. “Whether you are studying an unprompted email or a conference webpage, look for shoddy writing quality or outlandish layouts.”
Check with your colleagues. “The dominant conferences in your field are probably in that position because they have proved time and time again that they can deliver a valuable experience for attendees.”
Look at other conferences from the same producer. If a company produces a high volume of conferences on a wide range of topics, that can be a sign that the quality will be shoddy, he suggested.
Look at the contact information. A legitimate conference should have ties to an established society or conference organizer. Get the address, and then look at that location in Google Street View to see if it’s the kind of building where you’d expect a legitimate company to be located.
The experience of these 32 scientific and medical scholars demonstrates that there is always a new twist in how honest citizens can be defrauded. For that reason, clinical laboratory managers and pathologists should be wary when approached by unknown organizations with speaking invitations, particularly in Europe.
Sales of SARS-CoV-2 tests at other IVD companies, including Roche Diagnostics and Danaher’s lab businesses also report declines in COVID-19 test revenue
Clinical laboratory leaders and pathologists seeking a marker that the COVID-19 pandemic has passed may have it in the plunge in SARS-CoV-2 test revenue during the second quarter at Abbott Laboratories, Abbott Park, Illinois.
COVID-19 test sales in Q2 2023 at Abbott fell a “whopping” 89% as people try to “move on” from the SARS-CoV-2 outbreak, the Chicago Tribune reported.
Developer of the BinaxNOW rapid COVID-19 antigen self-test, Abbott saw its COVID-19 sales revenue decline from $2.3 billion in Q2 2022 to $263 million in the quarter ending June 30, the Chicago Tribune noted.
The decline was expected by Abbott. Nonetheless, the company will likely sell more than $1 billion in COVID-19 tests by the end of this year—business it did not have in 2019.
Abbott lowered its forecast for COVID-19 sales in 2023 to $1.3 billion, down from $1.5 billion, MedTech Dive reported.
“We decided to bring our COVID-19 number down a couple of hundred million dollars, because we’re seeing—as the public health emergency ended—a little bit of a decline in testing,” said Abbott’s Chairman and CEO Robert Ford during an earnings call transcribed by Motley Fool. “So, we’ll see how that’s going to play out in Q4 (2023), the first quarter we will see an endemic respiratory season.” Clinical laboratories that performed high numbers of SARS-CoV-2 test during the pandemic will likely experience similar declines in test volumes. [Photo copyright: Abbott Laboratories.)
Overall, Abbott Has ‘Good Recovery’
COVID-19-related diagnostics was just part of the financial report by Abbott, which also develops other clinical laboratory tests, clinical laboratory analyzers and automation, medical devices, pharmaceuticals, and nutritional products such as infant formula.
Abbott said in a news release that its sales—driven by base business performance—were $10 billion in Q2.
“We have had a really, really good recovery here as the health systems are opening up, and are seeing routine testing come back,” said Abbott’s Chairman and CEO Robert Ford during the earnings call.
Here are diagnostics financial results for Q2 2023 as compared to Q2 2022, according to the news release:
Diagnostic sales fell to $2.3 billion from $4.2 billion.
Core laboratory sales were flat at $1.2 billion.
Molecular sales plunged to $141 million from $212 million.
Rapid diagnostics plummeted to $741 million from $2.7 billion.
As need for COVID-19 testing contracts, Abbott is focusing on research and development of assays that may be “missing on the menus,” Ford said during the earnings call.
“We’ve been working on expanding the menu in molecular and point-of-care. One of the most exciting assays that the team has developed for point-of-care is a rapid test for traumatic brain injury,” he added.
COVID-19 Revenue Falls at Roche, Danaher
Abbott is not the only in vitro diagnostics (IVD) manufacturer to report a recent significant decline in demand for COVID-19 products.
Another sign the major wave of the pandemic has passed is the dramatic fall in COVID-19 product revenue at Roche to 0.4 billion Swiss Francs (CHF) (US$460 million) from 3.1 billion CHF (US$3.5 billion) in the first half of 2022, according to a Roche news release.
The Basel, Switzerland company—reporting on six months of financial results—said its Roche Group base business increased 8% and Diagnostics Division base business rose 6% in 2023, as compared to the first six months last year.
Diagnostics Division sales overall fell 23% to 7 billion CHF (US$8 billion) from 9.9 billion CHF (US$11.3 billion), Roche said.
Here are more first-half of 2023 financial results at Roche as compared to the same period in 2022:
Core lab: 3.9 billion CHF ($US 4.4 billion), up 10% from 3.8 billion CHF (US$4.3 billion).
Molecular lab: 1.1 billion CHF (US$1.2 billion), down 40% from 1.9 billion CHF (US$2.1 billion).
Diabetes care: 723 million CHF (US$831.7 million), down 5% from 832 million CHF (US$957 million).
Pathology lab: 687 million CHF (US$790 million), up 12% from 652 million CHF (US$750 million).
Point of care: 635 million CHF (US$730.6 million), plummeted 74% from 2.6 billion CHF (US$2.9 billion).
“In the first half of 2023, sales in the base business of both of our divisions (diagnostics and pharmaceuticals) grew strongly, largely offsetting the impact of declining demand for COVID-19 products,” said Roche CEO Thomas Schinecker, PhD, in the news release.
COVID-19 May Linger as IVD Companies Refresh Menus
As the COVID-19 pandemic wanes, healthcare providers will continue to test patients for the SARS-CoV-2 coronavirus.
But it also appears that IVD companies are aiming to keep their instruments—which ran full tilt performing COVID-19 testing during the pandemic—of high value to clinical laboratories by developing new tests for possible inclusion on labs’ testing menus.
Advances in genome sequencing give virologists and microbiologists new tools for tracking SARS-CoV-2 variants to their sources
Wastewater surveillance has emerged as an essential tool in the detection and tracking of the SARS-CoV-2 coronavirus within communities. Though COVID-19 infections are decreasing in the United States—and clinical laboratories are performing fewer diagnostic tests for the disease—researchers continue to monitor populations for the presence of the coronavirus and its variants to be prepared for the next outbreak.
Genetic sequencing of samples extracted from sewer systems throughout the country have revealed dozens of strains of the coronavirus containing multiple mutations in unusual combinations called cryptic genetic variants (CVG), also known as cryptic lineages. A recent study has indicated that wastewater may also provide answers to questions about long COVID as these mutations can be traced back to individuals who are living with chronic COVID-19 infections.
“Because increases in wastewater [viruses] generally occur before corresponding increases in clinical cases, wastewater surveillance serves as an early warning system for the emergence of COVID-19 in a community,” said Amy Kirby, PhD (above), CDC program lead for the National Wastewater Surveillance System, during a media telebriefing. Wastewater testing for viruses and bacteria may eventually lead to the implementation of systems to alert clinical laboratories in a region whenever infectious agents are detected in wastewater. (Photo copyright: Center for Global Safe Water, Sanitation, and Hygiene.)
Humans Found to Be Primary Source of Cryptic Lineages
To conduct their study, scientist at the University of Wisconsin-Madison and the University of Missouri School of Medicine examined the evolution of a SARS-CoV-2 Omicron subvariant found in wastewater coming from a single facility in Wisconsin that employed about 30 people. The researchers discovered the mutation had been present in the wastewater for more than a year.
Dark Daily originally covered their findings in “New, Cryptic COVID-19 Lineage Found in Ohio Wastewater by Molecular Virologist Tracking Spread of SARS-CoV-2 Variants.” We reported how scientists had tracked the lineage of the cryptic strain to Ohio, where it appeared to have originated from one individual who travels regularly between the cities of Columbus and Washington Court House. They believed the person had a form of long COVID and was unaware that he or she was infected with the coronavirus.
According to Marc Johnson, PhD, Professor of Microbiology and Immunology at the University of Missouri and one of the authors of the study, the individual who shed the mutations had been shedding at least a thousand times more COVID-19 virus than an average infected person sheds. The scientists examined other wastewater monitoring data and identified 37 related cases in the US. They concluded that humans are the main source of the cryptic lineages.
“The fact that someone can have this kind of infection—and there’s every indication that they are still an active member of society and not just lying in the hospital—it’s just amazing,” Johnson told CNN.
Wastewater Surveillance Not an Exact Science, CDC Says
Although not directly involved in this study, through its National Wastewater Surveillance System (NWSS) the US Centers for Disease Control and Prevention (CDC) has been tracking wastewater surveillance programs. The federal agency believes cryptic lineages do not pose a threat to public health.
“The signal we really look for is specific variants increasing in frequency in a community, because that’s what happens at the beginning of a variant surge,” Amy Kirby, PhD, Health Scientist, National Wastewater Surveillance System Lead for the CDC, told CNN. “And it’s not what we’re seeing with these cryptic lineages.”
Kirby also noted that wastewater surveillance is not an exact science and that many factors can impede the interpretation of the data. The mutations observed for this study could be from people with long COVID or even from an infected animal. To be certain of the results, she said, researchers would have to directly link the genetic sequence from a clinical test to a specific wastewater sample.
“Best-case scenario is you find the person, they have long COVID but had no idea they had this infection, and you get them with a doctor who can get them on medicines that will actually give their immune system a bit of an upper hand, and they get better,” Johnson told CNN. “But we only know about the ones we can find, and we don’t know what the implications are, because we still don’t know who those people are.”
Public health messaging in local communities is needed to raise awareness. But though tracking down specific infected individuals could help them receive medical attention, it may not be the most desirable course of action.
“Part of the power of wastewater surveillance is that it is inherently anonymous. It’s a community-level surveillance method,” Kirby said. “And so, tracking back through the wastewater system to identify a person is not what the system is intended for.”
Clinical Laboratories Play Key Role in Public Health
The cryptic lineage that Johnson and his team identified was a mutation that appeared in two watersheds in Ohio—one located in southern Columbus and one in the town of Washington Court House, which is about 40 miles south of Columbus. The researchers hypothesized that an individual living in that area had COVID for more than two years and did not know it, was most likely asymptomatic, and lives in one area and spends a lot of time (perhaps working) in the other area.
“There is almost zero chance the patient in Ohio knew about their infection. There is almost zero chance their doctor would figure it out. It is very likely the infection is causing long term damage,” Johnson wrote in a Twitter tweet. “I’m glad that there is a chance now that they might get appropriate care.”
Wastewater surveillance has materialized as a common method of identifying and monitoring strains of COVID-19 and other infectious diseases. And clinical laboratories play a key role in that process. With genetic sequencing technologies becoming more advanced, lower in cost, faster and more accurate, it’s feasible that those technologies will be utilized more to direct public health initiatives.
Microbiology team has tracked 37 unique strains of the coronavirus since they began researching lineages two years ago
Microbiologists and clinical laboratory scientists will be interested to learn about the discovery of a new strain of SARS-CoV-2, the coronavirus that caused the COVID-19 pandemic, in wastewater sampled in Ohio.
According to an article published in Nature Reviews Genetics, a CVG is “a genetic variation that normally has little or no effect on phenotype but that—under atypical conditions that were rare in the history of a population—generates heritable phenotypic variation.”
Johnson tracked the lineage of the cryptic strain to Ohio, where it appears to have originated from one individual who travels regularly between the cities of Columbus and Washington Court House. He believes this person may have a form of long COVID and is unaware that he or she is infected with the coronavirus.
“This person was shedding thousands of times more material than a normal person ever would,” Johnson told The Columbus Dispatch. “I think this person isn’t well. … I’m guessing they have GI issues.”
“If someone has this infection, the chances are nil that they’re going to figure out what it is,” Marc Johnson, PhD, Professor of Molecular Microbiology and Immunology at the University of Missouri School of Medicine, told Insider. Microbiologists and clinical laboratory scientists in the Columbus, Ohio, area may be able to help locate this person. (Photo Copyright: University of Missouri.)
Other Cryptic COVID-19 Lineages
This isn’t the only “Cryptic COVID” case identified by Johnson and his team. In Wisconsin, another unique strain was discovered and narrowed down to a single facility and about 30 individuals. Two thirds of the employees were tested but, unfortunately, all tests came back negative. The cryptic strain seemed to have disappeared.
“We don’t know why,” Johnson told The Hill. “Either [the infected person] left the job, or got better, or is in remission—we don’t know. But we’re still monitoring it. And we’ve actually now gotten started collecting stool samples from the company.”
“We systematically sampled [sewer] maintenance holes to trace the Wisconsin lineage’s origin. We sequenced spike RBD [receptor-binding domain] domains, and where possible, whole viral genomes, to characterize the evolution of this lineage over the 13 consecutive months that it was detectable.
“The high number of unusual mutations found in these wastewater-specific cryptic sequences raises the possibility that they originate from individual prolonged shedders or even non-human sources. The Wisconsin lineage’s persistence in wastewater, single-facility origin, and heavily mutated Omicron-like genotype support the hypothesis that cryptic wastewater lineages arise from persistently infected humans.”
Johnson and his team have tracked 37 unique strains of the COVID-19 virus, including one in New York City, The New York Times reported.
In a statement to The Columbus Dispatch regarding the Columbus strain, the federal Centers for Disease Control and Prevention (CDC) noted that, “The virus lineage in question is not currently spreading or a public health threat.
“Unusual or ‘cryptic’ sequences identified in wastewater may represent viruses that can replicate in particular individuals, but not in the general population,” the CDC noted. “This can be because of a compromised immune system. CDC and other institutions conduct studies in immunocompromised individuals to understand persistent infection and virus evolution.”
In identifying these lineages, and the individuals who shed them, scientists can learn more about how COVID-19 mutates and spreads.
Mitigating Consequences of COVID-19 Variants
Although the CDC says that particular strain is not a threat to the public it could pose a long-term health risk for the individual suffering. And this individual may hold clues for the future of how the COVID-19 virus mutates and grows. Therefore, locating these people is a priority.
“The coronavirus will continue to spread and evolve, which makes it imperative for public health that we detect new variants early enough to mitigate consequences,” Rob Knight, PhD, Founding Director of the Center for Microbiome Innovation and Professor of Pediatrics, Computer Science and Engineering at the University of California San Diego (UCSD).
“Before wastewater sequencing, the only way to do this was through clinical testing, which is not feasible at large scale, especially in areas with limited resources, public participation, or the capacity to do sufficient testing and sequencing,” said Knight in a UCSD press release. “We’ve shown that wastewater sequencing can successfully track regional infection dynamics with fewer limitations and biases than clinical testing to the benefit of almost any community.”
Although tracing the individuals shedding cryptic COVID-19 lineages may not have an immediate effect on public health, it could lead to future discoveries about the SARS-CoV-2 coronavirus that can help shape public health goals in fighting future pandemics.
At the very least, one individual in Columbus may learn how to treat long COVID’s adverse symptoms. Microbiologists and clinical laboratory scientists involved in COVID-19 wastewater research can learn much from following these research investigations.
