Clinical laboratory managers should prepare for an increase in demand for measles testing, especially for children
Clinical laboratory managers should be on the alert for new cases of measles. The US Centers for Disease Control and Prevention (CDC) has reported a surge in the highly infectious disease. Public health experts pointed to declining vaccination coverage as the primary cause. Officials in other countries have also reported outbreaks.
In 2000, the US declared that measles had been eliminated, meaning it “is no longer constantly present in this country,” the CDC stated on its website. However, the agency noted travelers can still bring the disease into the country and that there have been sporadic outbreaks since then.
In a new study, published April 11, 2024, in the CDC’s Morbidity and Mortality Weekly Report (MMWR), the agency reported that it was notified of 97 confirmed cases in the first quarter of 2024. That compares to an average of five cases during the first quarters of 2020 through 2023, the agency stated. In total, 338 cases were reported to the CDC between Jan. 1, 2020, and March 28, 2024, so the latest outbreaks amount to 29%—nearly a third—of the total.
“While the risk for measles for the majority of the US population still remains low, it’s crucial that we take the necessary steps now to prevent the continued spread of measles and maintain elimination in the US,” Adria D. Mathis, MSPH, lead author of the CDC report, told Healthline. Mathis is affiliated with the CDC’s Division of Viral Diseases at the National Center for Immunization and Respiratory Diseases (NCIRD).
“We have seen, in the region, not only a 30-fold increase in measles cases, but also nearly 21,000 hospitalizations and five measles-related deaths. This is concerning,” Hans Henri P. Kluge, MD (above), WHO Regional Director for Europe, told BBC News. “Vaccination is the only way to protect children from this potentially dangerous disease.” Clinical laboratories in the US that identify a case of measles from a positive test must report that result to public health labs. Thus, wise lab managers will track the rise in measles cases and prepare for increased demand for measles testing. (Photo copyright: World Health Organization.)
Renewed Threat to the US, Other Countries
The recent cases “represent a renewed threat to the US elimination status,” and “underscore the need for additional efforts to increase measles, mumps, and rubella (MMR) vaccination coverage, especially among close-knit and under-vaccinated communities,” Mathis told Healthline.
The MMWR report notes that most of the new cases were in persons under age 20, and that almost all were “in persons who were unvaccinated or whose vaccination status was unknown.” Most of the importations, the report states, were “among persons traveling to and from countries in the Eastern Mediterranean and African WHO [World Health Organization] regions; these regions experienced the highest reported measles incidence among all WHO regions during 2021–2022.”
In the US, vaccination coverage has been below 95% for three consecutive years. That is the “estimated population-level immunity necessary to prevent sustained measles transmission,” according to the federal agency. In 12 states and the District of Columbia, the coverage rate is below 90%. In total, “approximately 250,000 kindergarten children [are] susceptible to measles each year,” the CDC report states.
Measles vaccination coverage has declined globally, “from 86% in 2019 to 83% in 2022.” This left nearly 22 million children under the age of one susceptible to the disease, the report notes.
Earlier Measles Outbreaks in the US
The CDC performed its latest analysis following two larger measles outbreaks in 2019 among under-vaccinated populations in New York state.
The Associated Press (AP) reported that the 2019 epidemic, which totaled 1,274 cases nationwide, “was the worst in almost three decades and threatened the United States’ status as a country that has eliminated measles by stopping the continual spread of the measles virus.”
A vaccine for the disease first became available in 1963. Prior to its availability, “there were some three million to four million cases per year,” AP reported. Most people recover, but “in the decade before the vaccine was available, 48,000 people were hospitalized per year. … About 1,000 people developed dangerous brain inflammation from measles each year, and 400 to 500 died,” AP noted, citing CDC data.
US Not Alone in Fight against Measles
Other countries also are reporting spikes in measles cases. In a recently published rapid risk assessment, the Canadian government reported a total of 29 cases as of March 15, 2024, of which 21 were reported since Feb. 28.
“That’s already the largest annual total since 2019 and more than double the number of cases reported last year, as medical experts fear the number will rise while more Canadians travel in and out of the country this month for March break,” CBC News reported.
“New projections from a team at Simon Fraser University (SFU) in British Columbia show the grim possibilities,” CBC News reported. “The modelling suggests that vaccine coverage of less than 85% can lead to dozens of cases within small communities—or even hundreds if immunization rates are lower.”
Numbers are far worse in parts of Europe. In a February 2024 news release, the World Health Organization reported that in 2023, more than 58,000 people in its European region were infected by the disease, “resulting in thousands of hospitalizations and 10 measles-related deaths.”
According to WHO epidemiological data, countries in Central Asia, which is part of WHO’s European region, reported some of the highest numbers:
15,111 in Kazakhstan,
13,735 in Azerbaijan, and
7,044 in Kyrgyzstan.
The Russian Federation reported 12,723 cases and Turkey reported 4,559.
A WHO European Region Measles and Rubella Monthly Update notes that more than half of the regionwide cases—31,428—were reported in the last three months of 2023. More than 15,000 cases were reported in December. That compares to just 163 cases reported in 2021 and 942 in 2022. Nearly half of the cases were among children under the age of five.
Lack of Vaccinations among Children Blamed for Outbreaks
One factor that has led to the increase in measles cases was the disruption to immunization services caused by the COVID-19 pandemic. “This has resulted in a significant accumulation of susceptible children who have missed their routine vaccinations against measles and other vaccine-preventable diseases,” the WHO reported.
Among the region’s 53 member states, 33 had eliminated measles, WHO reported, but “this achievement remains fragile. To retain this status, a country must ensure that transmission of the virus following any importation is stopped within 12 months from the first reported case.”
In the UK, which reported 231 cases last year, the National Health Service has launched a campaign to improve vaccination rates, the BBC reported, noting that “more than 3.4 million children aged under 16 are unprotected and at risk of becoming ill.”
However, a public health campaign built on vaccination is successful only if a high rate of individuals get vaccinated. The Baby Boomer and Gen X generations had high rates of vaccination for smallpox, polio, etc. because the parents saw individuals in their family and neighborhood who became infected and suffered lifechanging consequences. They recognized that vaccination was a simple thing to provide protection from a potentially deadly infection.
Clinical laboratory managers and pathologists will want to follow the CDC’s ongoing reports of the number of cases of measles in this country. Today, the absolute number of new measles cases is relatively small. At the same time, in communities experiencing an outbreak of even a few measles cases, physicians may want to increase the volume of measles tests they order for their patients.
Clinical laboratories involved in genetic testing may find this welcomed news, after a pair of studies conducted in 2019 raised concerns about CRISPR base editing. The researchers of those studies observed that it “causes a high number of unpredictable mutations in mouse embryos and rice,” Chemical and Engineering News (C&EN) reported, adding, “Other groups have raised concerns about off-target mutations caused when the traditional CRISPR-Cas9 form of gene editing cuts DNA at a location that it wasn’t supposed to touch. The results of the new studies are surprising, however, because scientists have lauded base editors as one of the most precise forms of gene editing yet.”
Nevertheless, UC Berkeley’s latest breakthrough is expected to drive development of new and more accurate CRISPR-Cas genome-editing tools, which consist of base editors as well as nucleases, transposases, recombinases, and prime editors.
Understanding CRISPR Base Editors At a ‘Deeper Level’
Harvard University Chemistry and Chemical Biology Professor David Liu, PhD, who co-authored the study, explained the significance of this latest discovery.
“While base editors are now widely used to introduce precise changes in organisms ranging from bacteria to plants to primates, no one has previously observed the three-dimensional molecular structure of a base editor,” he said in a UC Berkeley news release. “This collaborative project reveals the beautiful molecular structure of a state-of-the-art highly-active base editor—ABE8e—caught in the act of engaging a target DNA site.”
UC Berkeley Professor Jennifer Doudna, PhD (above), who served as senior author of the study, says scientists may now have the information necessary to refine base editors and improve their precision and genome-targeting ability. “This structure helps us understand base editors at a much deeper level,” she said in the UC Berkeley statement. “Now that we can see what we’re working with, we can develop informed strategies to improve the system.” (Photo copyright: UC Berkeley.)
Jennifer Doudna, PhD, UC Berkeley Professor, Howard Hughes Medical Institute Investigator, and senior author of the study, has been a leading figure in the development of CRISPR-Cas9 gene editing. In 2012, Doudna and Emmanuelle Charpentier, PhD, Founding, Scientific and Managing Director at Max Planck Unit for the Science of Pathogens in Berlin, led a team of researchers who “determined how a bacterial immune system known as CRISPR-Cas9 is able to cut DNA, and then engineered CRISPR-Cas9 to be used as a powerful gene editing technology.” In a 2017 news release, UC Berkeley noted that the work has been described as the “scientific breakthrough of the century.”
Viewing the Base Editor’s 3D Shape
CRISPR-Cas9 gene editing allows scientists to permanently edit the genetic information of any organism, including human cells, and has been used in agriculture as well as medicine. A base editor is a tool that manipulates a gene by binding to DNA and replacing one nucleotide with another.
According to the recent UC Berkeley news release, the research team used a “high-powered imaging technique called cryo-electron microscopy” to reveal the base editor’s 3D shape.
Genetic Engineering and Biotechnology News notes that, “The high-resolution structure is of ABE8e bound to DNA, in which the target adenine is replaced with an analog designed to trap the catalytic conformation. The structure, together with kinetic data comparing ABE8e to earlier ABEs [adenine base editors], explains how ABE8e edits DNA bases and could inform future base-editor design.”
The graphic above, taken from the UC Berkeley news release, shows the “3D structure of a base editor, comprised of the Cas9 protein (white and gray), which binds to a DNA target (teal and blue helix) complementary to the RNA guide (purple), and the deaminase proteins (red and pink), which switch out one nucleotide for another.” (Image and caption copyright: UC Berkeley.)
Knowing the Cas9 fusion protein’s 3D structure may help eliminate unintended off-target effects on RNA, extending beyond the targeted DNA. However, until now, scientists have been hampered by their inability to understand the base editor’s structure.
“If you really want to design truly specific fusion protein, you have to find a way to make the catalytic domain more a part of Cas9, so that it would sense when Cas9 is on the correct target and only then get activated, instead of being active all the time,” study co-first author Audrone Lapinaite, PhD, said in the news release. At the time of the study, Lapinaite was a postdoctoral fellow at UC Berkeley. She is now an assistant professor at Arizona State University.
“As a structural biologist, I really want to look at a molecule and think about ways to rationally improve it. This structure and accompanying biochemistry really give us that power,” added UC Berkeley postdoctoral fellow Gavin Knott, PhD, another study co-author. “We can now make rational predications for how this system will behave in a cell, because we can see it and predict how it’s going to break or predict ways to make it better.”
Clinical laboratory leaders and pathologists will want to monitor these new advances in CRISPR technology. Each breakthrough has the power to fuel development of cost-effective, rapid point-of-care diagnostics.
As demand rises, Canadian clinical laboratories must learn to juggle test systems automation, funding challenges, and staffing shortages
Canada’s clinical laboratories are deeply affected by many of the trends impacting the Canadian healthcare system overall. Deployment of new technologies, such as test automation and artificial intelligence (AI) for example, are forcing Canadian labs to adapt during times of changing demographics and funding pressures.
Thus, the Canadian Diagnostic Executive Forum (CDEF), which takes place October 24-25 at the Westin Harbour Castle Hotel in Toronto, will provide an opportunity for clinical laboratory leaders to learn how to leverage technology and create positive change in their medical laboratory operations.
Change Management and Clinical Laboratory Leaders
The development of disruptive new technologies is becoming the norm and the laboratory’s role in healthcare delivery is growing. That’s why change management has become a focus of clinical laboratory leaders.
Sheila Woodcock, Convenor, WG 1 Quality and Competence in the Medical Laboratory at ISO/TC 212, and President and Principal Consultant at QSE Consulting Inc., Nova Scotia, Canada, says “allocation of resources” is a challenge for senior diagnostic executives juggling financial, technology, and staffing decisions.
In an exclusive interview with Dark Daily, Woodcock
said, “The number one lab challenge today is not having enough money; second is
not having enough people. Because if you don’t have enough money, even if there
are people out there, you can’t hire them. Money, people, and trying to keep up
with all the technological innovations bombarding us nowadays are the main
reasons to make changes.”
From deployment of digital pathology services and point-of-care (POC) testing to the introduction of automation and AI, innovation is happening at a rapid pace. It may or may not increase medical laboratory efficiency or support precision medicine, but it definitely alters laboratory infrastructure.
“Change is nearly constant in the clinical laboratory and
the healthcare network worlds, and there are many complexities that go with
that,” Woodcock said. “With the implementation of new technologies, and the
rapidly advancing world of automation in clinical laboratories that have never before
been automated, how do we ensure that when we automate new technology it
doesn’t negatively impact the quality of the testing process?”
Disruptive Changes are Redefining Clinical Laboratories
As Clinical Lab Products (CLP) points out, medical laboratories have become a reservoir of data that can “guide fact-based decisions to improve operational, financial, and clinical performance throughout their institutions.” As a result, clinical laboratories are increasingly shedding their “traditional and narrowly defined roles” in which “physicians order tests and labs report results.”
Emerging technologies also are ushering change outside of the medical laboratory. Drones soon may routinely transport patient specimens across healthcare networks. Dark Daily has reported on several new drone transport systems under development around the globe. One such system in the US involves UPS, the FAA, and WakeMed. Such high-tech specimen tracking and delivery systems could lead to fewer spoiled samples and possibly save lives, and clinical laboratories are at the heart of these innovations.
Kevin D. Orr (above), Senior Director, Hospital Business at In-Common Laboratories, told Dark Daily that laboratory leaders need to keep up with technology breakthroughs. However, knowing which tools and strategies are worth implementing is not so easy. Orr says diagnostic executives should take advantage of opportunities to “network to understand what is going on in everybody’s backyard, and to leverage some of the strategies, tools, and technologies innovators have used elsewhere.” (Photo copyright: LinkedIn.)
Kevin D. Orr, Senior Director, Hospital Business at In-Common Laboratories, believes technology may help laboratories overcome one major issue—a growing demand for testing services at a time when the laboratory workforce is shrinking, and provincial and territorial global funding is not keeping pace with diagnostic utilization rates. Orr points to digital pathology as an example of a technology that may enable labs to “do more with less” in terms of both funding and staffing.
“As people get older, there’s more demand for healthcare
services and because of that more clinical laboratory testing has to be done,”
Orr told Dark Daily. “The peak of the Baby Boomers is starting to get
sick now. We need to focus on innovations and technologies clinical
laboratories are employing to address the overarching issue of doing more with
less.”
How Clinical Laboratories Should Demonstrate Value
Woodcock, however, maintains that clinical laboratories also
need to do a better job of lobbying for funding, so they have the money needed
to implement new technologies.
“Traditionally, when labs are told they have cutbacks, they
do their utmost to work within what they have been assigned. But other
departments might be jumping up and down, getting more attention, and getting
more funding,” she said. “One of the things lab people have to learn—and are
getting better at as time goes on—is giving the lab a voice and making known
the contributions the lab makes to diagnosis and treatment of patients in a
facility.”
The Canadian Diagnostic Executive Forum on October 24-25 at
the Westin Harbour Castle Hotel in Toronto provides such an opportunity for
laboratory leaders to learn how to leverage technology to create positive
change in lab operations.
“We want to inspire people,” Orr told Dark Daily. “We
want people to leave this conference excited about what diagnostics is doing
and where it’s headed and what other people are doing. We want to show them the
bright light at the end of the tunnel, because sometimes when you’re dealing
with the negative aspects of no money or no staff or no this or that, it gets
pretty awful. We want to breathe some life and show them the rainbow and that the
light at the end of the tunnel could be just around the corner.”
The CDEF conference will be hosted by In-Common Laboratories, in conjunction with The Dark Report, Dark Daily’s sister publication. This two-day event will be packed with thought-provoking sessions on digital pathology, next-generation technology, precision medicine, blockchain, sample tracking, and artificial intelligence, as well as updates from across Canada on the latest innovations and technologies being implemented in medical laboratories.
PwC’s list of 12 factors that will shape the healthcare landscape in 2018 calls attention to many new innovations Dark Daily has reported on that will impact how medical laboratories perform their tests
PwC’s Health Research Institute (HRI) issued its annual report, detailing the 12 factors expected to impact the healthcare industry the most in 2018. Dark Daily culled items from the list that will most likely impact clinical laboratories and anatomic pathology groups. They include:
How clinical laboratory leaders respond to these items could, in part, be determined by new technologies.
AI Is Everywhere, Including in the Medical Laboratory
Artificial intelligence is becoming highly popular in the healthcare industry. According to an article in Healthcare IT News, business executives who were polled want to “automate tasks such as routine paperwork (82%), scheduling (79%), timesheet entry (78%), and accounting (69%) with AI tools.” However, only about 20% of the executives surveyed have the technology in place to use AI effectively. The majority—about 75%—plan to invest in AI over the next three years—whether they are ready or not.
One such example of how AI could impact clinical laboratories was demonstrated by a recent advancement in microscope imaging. Researchers at the University of Waterloo (UW) developed a new spectral light fusion microscope that captures images in full color and is far less expensive than microscopes currently on the market.
“In medicine, we know that pathology is the gold standard in helping to analyze and diagnose patients, but that standard is difficult to come by in areas that can’t afford it,” Alexander Wong, PhD, one of the UW researchers, told CLP.
“The newly developed microscope has no lens and uses artificial intelligence and mathematical models of light to develop 3D images at a large scale. To get the same effect using current technologies—using a machine that costs several hundred thousand dollars—a technician is required to ‘stitch together’ multiple images from traditional microscopes,” CLP noted.
Healthcare Intermediaries Could Become Involved with Clinical Laboratory Data
Pricing is one of the biggest concerns for patients and government entities. This is a particular concern for the pharmaceutical sector. PwC’s report notes that “stock values for five of the largest intermediaries in the pharmacy supply chain have slumped in the last two years as demands for lower costs and better outcomes have intensified.”
Thus, according to PwC, pressure may come to bear on intermediaries such as Pharmacy Benefit Managers (PBMs) and wholesalers, to “prove value and success in creating efficiencies or risk losing their place in the supply chain.”
Similar pressures to lower costs and improve efficiency are at work in the clinical laboratory industry as well. Dark Daily reported on one such cost-cutting measure that involves shifting healthcare payments toward digital assets using blockchains. The technology digitally links trusted payers and providers with patient data, including medical laboratory test results. (See, “Blockchain Technology Could Impact How Clinical Laboratories and Pathology Groups Exchange Lab Test Data,” September 29, 2017.)
PwC’s latest report predicts 12 forces that will continue to impact healthcare, including clinical laboratories and anatomic pathology groups, in 2018. Click on the image of the cover above to access an online version of the report. (Photo copyright: PwC/Issuu.)
The Opioid Crisis Remains at the Forefront
Healthcare will continue to feel the impact of the opioid crisis, according to the PwC report. Medical laboratories will continue to be involved in the diagnosis and treatment of opioid addition, which has garnered the full attention of the federal government and has become a multi-million-dollar industry.
Security Remains a Concern
Cybersecurity will continue to impact every facet of healthcare in 2018. Healthcare IT News reported, “While 95% of provider executives believe their organization is protected against cybersecurity attacks, only 36% have access management policies and just 34% have a cybersecurity audit process.”
Patients are aware of the risks and are often skeptical of health information technology (HIT), Dark Daily reported in June of last year. Clinical laboratories must work together with providers and healthcare organizations to audit their security measures. Recognizing the importance of the topic, the National Independent Laboratory Association (NILA) has named cybersecurity for laboratory information systems (LIS) a focus area.
Patient Experience a Priority
Although there have been significant improvements in the area of administrative tasks, there is still an enormous demand for a better patient experience, including in clinical laboratories. Healthcare providers want patients to make changes for the better that ultimately improve outcomes and the patient experience is one path toward that goal.
As they follow healthcare reform guidelines to increase quality while lowering costs, state governments will continue to ramp up pressure on healthcare providers and third parties in the area of pricing. Rather than simply requiring organizations to report on pricing, states are moving towards legislating price controls, as Dark Daily reported in February.
Social Factors Affect Healthcare Access
The transition to value-based care makes the fact that patients’ socioeconomic statuses matter when it comes to their health. “The most important part of getting good results is not the knowledge of the doctors, not the treatment, not the drug. It’s the logistics, the social support, the ability to arrange babysitting,” David Berg, MD, co-founder of Redirect Health told PwC.
One such transition that is helping patients gain access to healthcare involves microhospitals and their adoption of telemedicine technologies, which Dark Daily reported on in March.
“Right now, they seem to be popping up in large urban and suburban metro areas,” Priya Bathija, Vice President, Value Initiative American Hospital Association, told NPR. “We really think they have the potential to help in vulnerable communities that have a lack of access.”
“Physician decision-support software utilizes medical laboratory test data as a significant part of a full dataset used to guide caregivers,” Dark Daily noted. “Thus, if the FDA makes it easier for developers to get regulatory clearance for these types of products, that could positively impact medical labs’ ability to service their client physicians.”
Healthcare Delivery During and Following Natural Disasters
PwC predicts the long-term physical results, financial limitations, and supply chain disruptions following natural disasters will continue to affect healthcare in 2018. The devastation can prevent many people from receiving adequate, timely healthcare.
PwC’s report is an important reminder of from where the clinical laboratory/anatomic pathology industry has come, and to where it is headed. Sharp industry leaders will pay attention to the predictions contained therein.
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