Technology could enable patients to monitor their own oxygen levels and transmit that data to healthcare providers, including clinical laboratories
Clinical laboratories may soon have a new data point to add to their laboratory information system (LIS) for doctors to review. Researchers have determined that smartphones can read blood-oxygen levels as accurately as purpose-built pulse oximeters.
Conducted by researchers at the University of Washington (UW) and University of California San Diego (UC San Diego), the proof-of-concept study found that an unmodified smartphone camera and flash along with an app is “capable of detecting blood oxygen saturation levels down to 70%. This is the lowest value that pulse oximeters should be able to measure, as recommended by the US Food and Drug Administration,” according to Digital Health News.
This could mean that patients at risk of hypoxemia, or who are suffering a respiratory illness such as COVID-19, could eventually add accurate blood-oxygen saturation (SpO2) readings to their lab test results at any time and from any location.
“In an ideal world, this information could be seamlessly transmitted to a doctor’s office. This would be really beneficial for telemedicine appointments or for triage nurses to be able to quickly determine whether patients need to go to the emergency department or if they can continue to rest at home and make an appointment with their primary care provider later,” Matthew Thompson, DPhil, Professor of Global Health and Family Medicine at University of Washington, told Digital Health News. Clinical laboratories may soon have a new data point for their laboratory information systems. (Photo copyright. University of Washington.)
UW/UC San Diego Study Details
The researchers studied three men and three women, ages 20-34. All were Caucasian except for one African American, Digital Health News reported. To conduct the study, a standard pulse oximeter was placed on a finger and, on the same hand, another of the participant’s fingers was placed over a smartphone camera.
“We performed the first clinical development validation on a smartphone camera-based SpO2 sensing system using a varied fraction of inspired oxygen (FiO2) protocol, creating a clinically relevant validation dataset for solely smartphone-based contact PPG [photoplethysmography] methods on a wider range of SpO2 values (70–100%) than prior studies (85–100%). We built a deep learning model using this data to demonstrate an overall MAE [Mean Absolute Error] = 5.00% SpO2 while identifying positive cases of low SpO2 < 90% with 81% sensitivity and 79% specificity,” the researchers wrote in NPJ Digital Medicine.
When the smartphone camera’s flash passes light through the finger, “a deep-learning algorithm deciphers the blood oxygen levels.” Participants were also breathing in “a controlled mixture of oxygen and nitrogen to slowly reduce oxygen levels,” Digital Health News reported.
“The camera is recording a video: Every time your heart beats, fresh blood flows through the part illuminated by the flash,” Edward Wang, PhD, Assistant Professor of Electrical and Computer Engineering at UC San Diego and senior author of the project, told Digital Health News. Wang started this project as a UW doctoral student studying electrical and computer engineering and now directs the UC San Diego DigiHealth Lab.
“The camera records how much that blood absorbs the light from the flash in each of the three color channels it measures: red, green, and blue. Then we can feed those intensity measurements into our deep-learning model,” he added.
The deep learning algorithm “pulled out the blood oxygen levels. The remainder of the data was used to validate the method and then test it to see how well it performed on new subjects,” Digital Health News reported.
“Smartphone light can get scattered by all these other components in your finger, which means there’s a lot of noise in the data that we’re looking at,” Varun Viswanath, co-lead author in the study, told Digital Health News. Viswanath is a UW alumnus who is now a doctoral student being advised by Wang at UC San Diego.
“Deep learning is a really helpful technique here because it can see these really complex and nuanced features and helps you find patterns that you wouldn’t otherwise be able to see,” he added.
Each round of testing took approximately 15 minutes. In total the researchers gathered more than 10,000 blood oxygen readings. Levels ranged from 61% to 100%.
“The smartphone correctly predicted whether the subject had low blood oxygen levels 80% of the time,” Digital Health News reported.
Smartphones Accurately Collecting Data
The UW/UC San Diego study is the first to show such precise results using a smartphone.
“Other smartphone apps that do this were developed by asking people to hold their breath. But people get very uncomfortable and have to breathe after a minute or so, and that’s before their blood-oxygen levels have gone down far enough to represent the full range of clinically relevant data,” said Jason Hoffman, a PhD student researcher at UW’s UbiComp Lab and co-lead author of the study.
The ability to track a full 15 minutes of data is a prime example of improvement. “Our data shows that smartphones could work well right in the critical threshold range,” Hoffman added.
“Smartphone-based SpO2 monitors, especially those that rely only on built-in hardware with no modifications, present an opportunity to detect and monitor respiratory conditions in contexts where pulse oximeters are less available,” the researchers wrote.
“This way you could have multiple measurements with your own device at either no cost or low cost,” Matthew Thompson, DPhil, Professor of Global Health and Family Medicine at University of Washington, told Digital Health News. Thompson is a professor of both family medicine and global health and an adjunct professor of pediatrics at the UW School of Medicine.
What Comes Next
The UW/UC San Diego research team plans to continue its research and gather more diversity among subjects.
“It’s so important to do a study like this,” Wang said. “Traditional medical devices go through rigorous testing. But computer science research is still just starting to dig its teeth into using machine learning for biomedical device development and we’re all still learning. By forcing ourselves to be rigorous, we’re forcing ourselves to learn how to do things right.”
Though no current clinical laboratory application is pending, smartphone use to capture biometrics for testing is increasing. Soon, labs may need a way to input all that data into their laboratory information systems. It’s something to consider.
Findings may help clinical laboratories identify healthcare workers who could work on the front lines of the next pandemic without fear of serious infection
University of California San Francisco researchers have discovered a gene mutation that enables some people’s immune system to recognize and respond to a COVID-19 infection despite having no prior exposure to the SARS-CoV-2 coronavirus (which would produce antibodies against future infections).
This genetic advantage will be of interest to clinical laboratory professionals and pathologists involved in immune system testing. Why some individuals with COVID-19 show few if any symptoms has confounded microbiologists and virologists since the beginning of the pandemic. Now, the UC San Francisco (UCSF) scientists believe they know why.
Dark Daily previously covered the UCSF study in “UCSF Researchers Identify Genetic Mutation That Promotes an Asymptomatic Response in Humans to COVID-19 Infection.” We covered how variations in a specific gene in a system of genes responsible for regulating the human immune system appears to be the factor in why about 10% of those who become infected with the virus are asymptomatic. And we predicted that understanding why some people display no symptoms during a COVID-19 infection could lead to new precision medicine genetic tests medical laboratories could use to identify people with the mutated gene.
“If you have an army that’s able to recognize the enemy early, that’s a huge advantage,” said immunogeneticist Jill Hollenbach, PhD, in a UCSF news release. Hollenbach led the research team that identified a mutated gene responsible for immune response to COVID-19 in individuals who have not been exposed to the SARS-CoV-2 coronavirus. Clinical laboratory professionals and pathologists involved in immune system testing will find the UCSF study useful. (Photo copyright: Elena Zhukova /University of California San Francisco.)
UCSF Study Details
UCSF researchers discovered that individuals who are COVID-19 “super dodgers” have “a mutation in the proteins that helps the immune system recognize what belongs to the body and what doesn’t,” Euronews reported.
The UCSF study showed that HLA-B*15.01—a Human Leukocyte Antigen (HLA) mutation—informs the body of the presence of SARS-CoV-2, regardless of whether it has encountered the invader before. The immune system then deploys T-cells [white blood cells called lymphocytes that help the immune system fight germs and protect the body from disease] to “eliminate” the coronavirus.
“Individuals with this B*15:01 mutation who have these cross-reactive T-cells seem to be particularly effective, very early in infection, at nuking—for lack of a better word—the virus before these folks experience any symptoms at all,” Jill Hollenbach, PhD, and immunogeneticist and Professor in the Department of Neurology and Department of Epidemiology and Biostatistics at UCSF, told STAT. Hollenbach led the team that discovered the gene mutation responsible for COVID-19 super dodgers.
“The mutation—HLA-B*15:01—is quite common, carried by about 10% of the study’s population. It doesn’t prevent the virus from infecting cells but, rather, prevents people from developing any symptoms. That includes a runny nose or even a barely noticeable sore throat,” according to a UCSF news release, which added, “UCSF researchers found that 20% of people in the study who remained asymptomatic after infection carried at least one copy of the HLA-B*15:01 variant, compared to 9% of those who reported symptoms. Those who carried two copies of the variant were far more likely—more than eight times—to avoid feeling sick.”
To find study participants, the team consulted The National Marrow Donor Program (NMDP) Be the Match Registry, which pairs donors with people needing transplants. It’s the largest registry of HLA volunteer donors in the United States. “Researchers suspected early on that HLA was involved, and fortunately a national registry existed that contained the data they were looking for,” the UCSF news release states.
To fully understand how COVID-19 affected the NMDP donors, the team utilized UCSF’s COVID-19 Citizen Science Study, a longitudinal cohort study on UCSF’s Eureka Digital Research Platform which uses a smartphone app developed by UCSF to learn how to predict SARS-CoV-2’s spread throughout the world and combat it.
About 30,000 people from the registry were followed through that first year of the COVID-19 pandemic, which featured frequent testing and no vaccine access for most, UCSF stated.
“We did not set out to study genetics, but we were thrilled to see this result come from our multidisciplinary collaboration with Dr. Hollenbach and the National Marrow Donor Program,” said internal medicine physician Mark Pletcher, MD, Professor of Epidemiology and Biostatistics at UCSF, in the news release. Pletcher’s practice focuses on prevention of cardiovascular disease.
The UCSF scientists dove deep to understand how HLA-B*15:01 tackled coronavirus, and together with researchers from La Trobe University in Australia, “They homed in on the concept of T-cell memory, which is how the immune system remembers previous infections,” UCSF reported.
“It’s just one of these natural lucky breaks,” Hollenbach told STAT.
UCSF Findings Bring Hope for Improved Vaccines and Drug Therapies
HLA was a good hunch to follow. The UCSF researchers’ Nature paper claimed HLA to be “the most polymorphic and medically important human genomic region.” It noted that variations of HLA were linked to myriad diseases, especially viral infections.
“The strongest associations were seen with viral infections, and HLA was associated with rapid progression and viral load of human immunodeficiency virus (HIV), hepatitis B, and C … Also HLA class I and II alleles have been associated with severe acute respiratory syndrome caused by SARS-CoV,” the Nature paper noted.
“Specific focus on asymptomatic infection has the potential to further our understanding of disease pathogenesis and supports ongoing efforts towards vaccine development and the identification of potential therapeutic targets,” the UCSF researchers wrote in Nature.
Should further research and studies confirm these findings, it’s reasonable to speculate that, in a future outbreak of new strains of SARS-CoV-2, clinical laboratories could test individuals to identify those with the mutation making them unlikely to experience a serious infection.
Those individuals could work on the front lines of medical care with a lower risk of infection and serious disease. It might also mean that they would not need vaccinations at all.
Technology enables sampling of an individual’s microbiome over time to observe changes associated with different illnesses or different diets
There is now a pill-sized device that can non-invasively collect and deliver a sample of gut bacteria taken directly from specific areas of a person’s gastrointestinal (GI) tract. One benefit of this new technology is that it can collect samples from the upper digestive system. Although not ready for clinical use, this is the kind of technology that would enable microbiologists and clinical laboratory scientists to add more microbiome assays to their test menu.
Researchers at Stanford University, Envivo Bio, and the University of California, Davis (UC Davis) have developed a vitamin capsule-sized device—dubbed CapScan—that can measure the microbial, viral, and bile acid profiles contained in the human intestines as it passes through on its way to being expelled.
Currently, scientists rely on stool samples to collect similar data as they are easy to gather and readily available. However, stool samples may not provide the most accurate analysis of the various microorganisms that reside in the human gut.
“Measuring gut metabolites in stool is like studying an elephant by examining its tail,” said Dari Shalon, PhD, Founder and CEO at Envivo Bio, one of the authors of the study, in a UC Davis news release. “Most metabolites are made, transformed, and utilized higher up in the intestines and don’t even make it into the stool. CapScan gives us a fuller picture of the gut metabolome and its interactions with the gut microbiome for the first time.” Shalon is the inventor of the CapScan device.
This demonstrates how technological advancements are giving scientists new diagnostic tools to guide selection of therapies and to monitor a patient’s progress.
Microbiologists will take a special interest in this published study because, once confirmed by further studies, it would provide microbiology laboratories and clinical labs with a new way to collect samples. In clinical laboratories throughout the country, handling fecal specimens is considered an unpleasant task. Once cleared for clinical use, devices like CapScan would be welcomed because the actual specimen would be contained within the capsule, making it a cleaner, less smelly specimen to handle than conventional fecal samples.
“This capsule and reports are the first of their kind,” said Oliver Fiehn, PhD, Professor of Molecular and Cell Biology at UC Davis, in a news release. “All other studies on human gut microbiota focused on stool as a surrogate for colon metabolism. However, of course, the fact is that 90% of human digestion happens in the upper intestine, not the colon.” Clinical laboratories have long worked with stool samples to perform certain tests. If CapScan proves clinically viable, labs may soon have a new diagnostic tool. (Photo copyright: UC Davis.)
Collecting Small Intestine Microbiota
Human digestion occurs mostly in the small intestine where enzymes break down food particles so they can later be absorbed through the gut wall and processed in the body. Stool samples, however, only sample the lower colon and not the small intestine. This leaves out vital information about a patient.
“The small intestine has so far only been accessible in sedated people who have fasted, and that’s not very helpful,” Oliver Fiehn, PhD, Professor of Molecular and Cell Biology at UC Davis and one of the study authors, said in the news release.
According to their Nature paper, to perform their research the team recruited 15 healthy adults to participate in the study. Each participant swallowed four CapScan “pills,” either twice daily or on two consecutive days. The pills were designed to respond to different pH (potential of hydrogen) levels.
Each pill’s pH-sensitive outer coating enables scientists to select which area of the intestinal tract to sample. The outer coating dissolves at a certain point as it travels from the upper intestine to the colon. When this happens, a one-way valve gathers miniscule amounts of biofluids into a tiny, inflatable bladder. Once full, the bladder seals shut and the CapScan continues its journey until it is recovered in the stool. The researchers then genetically sequenced the RNA from the collected samples.
The scientists discovered that the microbiome varied substantially at distinctive sections of the GI tract. When compared to collected stool samples, the researchers determined that traditional stool sampling could not capture that variability.
“There’s enormous potential as you think about how the environment is changing as you go down the intestinal tract,” Kerwyn Huang, PhD, Professor of Bioengineering and of Microbiology and Immunology at Stanford, one of the authors of the study, told Drug Discovery News. “Identifying how something like diet or disease affects the variation in the individual microbiome may even provide the potential to start discovering these important health associations.”
The genetic sequencing also revealed which participants had taken antibiotics within one to five months before the study because their data was so incongruous with the other participants. Those individuals had distinctive differences in their microbiome and bile acid composition, which illustrates that antibiotics can potentially affect gut bacteria even months after being taken.
Researchers Use Multiple ‘Omics’ Approach
The researchers used “multiomics” to analyze the samples. They identified the presence of 2,000 metabolites and found associations between metabolites and diet.
According to the Envivo Bio website, the CapScan allows for the regional measurement of:
“Overall, this device can help elucidate the roles of the gut microbiome and metabolome in human physiology and disease,” Fiehn said in the press release.
Future of Collecting Gut Bacteria
Using CapScan is a non-invasive procedure that makes it possible to sample an individual’s microbiome once, or to monitor it over time to observe changes associated with different illnesses or diets. Since it takes time for the device to pass through the digestive system, it is not a rapid test, but initial studies show it could be more accurate than traditional clinical laboratory testing.
“This technology makes it natural to think about sampling from many places and many times from one person, and it makes that straightforward and inexpensive,” Huang said.
Advancements in technology continue to provide microbiology and clinical laboratories with new, innovative tools for diagnosing and monitoring diseases, as well as guiding therapy selection by medical professionals. Though more research and clinical studies are needed before a device like the CapScan can be commonly used by medical professionals, it may someday provide a cutting-edge method for collecting microbiome samples.
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.
Genetic scientists show how rapid WGS is helping doctors determine best treatments for patients with life-threatening conditions
Clinical laboratory scientists will recall that last year, Dark Daily covered how researchers at Stanford University School of Medicine had developed a method for performing rapid whole genomic sequencing (WGS) in as little as five hours. We predicted that their new ultra-rapid genome sequencing approach could lead to significantly faster diagnostics and improved clinical laboratory treatments for cancer and other diseases. And it has.
The research scientist responsible for that breakthrough is cardiologist and Associate Dean of Stanford University School of Medicine, Euan Ashley, MD, PhD. Ashley is also a professor of genomics and precision health, cardiovascular medicine, genetics, and biomedical data science and pathology.
Ashley’s success demonstrates that the drive to reduce the diagnostic time to answer is a market dynamic encouraging research companies to continue finding ways to make WGS faster to accomplish, cheaper to perform, and the DNA sequences generated more accurate.
It is precisely these developments that will provide clinical laboratories and anatomic pathology groups with new means for improving diagnosis and the identification of the most appropriate therapies for individual patients—a core element of precision medicine.
Ashley’s team is now looking at how faster genetic sequencing results could help physicians make life-and-death treatment decisions, STAT reported.
“There’s just never been a better time to be doing genomics,” cardiologist Euan Ashley, MD, PhD, Associate Dean of the Stanford University School of Medicine, told STAT. “Now there are lots of choices. If you’re a genome center and you need to do half a million genomes, you’re going to be extremely price-sensitive. If you’re a clinical lab, where you get a few exomes and a few genomes every day, and what really matters to you is the highest possible accuracy for diagnosis, then you’re definitely going to make a different choice,” he added. (Photo copyright: euanangusashley.com.)
Getting Crucial Genetic Information Faster
Ashley believes that if doctors who work with rare and deadly diseases get crucial genetic information faster, they can more precisely determine which surgical procedures are best for their patients during life-or-death situations.
Already, his work is proving highly successful. In a letter his team published in the New England Journal of Medicine (NEJM), the researchers reported 12 cases of sequencing seriously ill patients, five of whom were diagnosed in seven hours and 18 minutes. Every single case resulted in tangible changes in treatments given to the patients.
“We continue to be interested in sequencing genomes faster and more accurately, for a broader range of clinical applications. We’re recruiting from intensive care units similar kinds of patients to the ones we did before, but with every aspect of the pipeline upgraded, which helps both from a speed but also from an accuracy perspective,” he told STAT.
Ashley and his team continue to delve into the patient care aspects, striving to continue to make a big impact. In addition, the group is being sought out by cancer doctors who need faster diagnoses.
“We also have a lot of interest from cancer doctors saying it’s really important to make a cancer diagnosis quickly. And of course, there is no person who’s ever had the specter of cancer hanging over them for a moment that didn’t want some kind of an answer faster. If you can have it in the next minute, you would take it rather than waiting several weeks,” he noted.
As a result, the group has initiated pilot studies “to look at returning results faster in the same way that we were speeding up the intensive care unit with whole genome sequencing,” Ashley told STAT.
Though the work is in the early stages, the team has a few scenarios where access to genetic data changes medical decision making. For instance, when genetic test results showing a positive BRCA variant alter a doctor’s surgical plan.
“We don’t wait for a cardiac enzyme [test] if somebody’s having a heart attack. That comes back within 10 minutes to a few hours from the lab. I don’t see why you should have to wait for a test to tell you if you’re positive for BRCA variant,” he told STAT.
“Another very obvious place is acute leukemia. And there’s a number of actionable conditions where if they can be detected rapidly, then treatment can be started faster,” he added.
Improving Genetic Sequencing Accuracy while Lowering Costs
STAT asked Ashley about a claim that his team could cut their Guinness World Record sequencing time in half.
“It’s easy to throw that number around, harder to deliver on it. But I think we’re definitely on track to knock hours, not minutes, off that record,” he said.
Additionally, the team continues to work on decreasing cost per genome. In just the time since the record was set, there has already been great strides in this area. The market is filled with new companies and the competition has lowered costs.
“It has definitely come down,” Ashely noted. “In fact, by the time we ended up publishing the [NEJM] paper—as opposed to when we first did this calculation—the cost was already lower. And that was actually before the entry of these new companies to the market, which added downward pressure on costs of sequencing,” he added.
Getting Payers to Reimburse for Genetic Sequencing
Even though costs for WGS is dropping, getting health plans to reimburse for genetic testing remains difficult.
“The challenge now is persuading payers to the very obvious fact that this technology makes patients’ lives better and saves them money,” Ashley told STAT. “And that’s the amazing part. There are so many cost-effectiveness studies now for this technology and yet we are still paying people to sit on the phone all day long and debate with insurance companies.
“And in a world where we pay a very large amount of money for therapeutics, these diagnostics can be cost-saving and lifesaving. At some level, it’s hard to understand why it hasn’t been deployed much more readily,” he concluded.
Clinical laboratory leaders, pathologists, and research scientists should continue to monitor the development of rapid genetic sequencing for diagnostic purposes.
Strike may delay critical blood testing and cause postponement of many surgical procedures
Medical technicians, phlebotomists, and clinical laboratory scientists in New Zealand are once again going on strike for fairer pay in various areas around the island nation. And their complaints mirror similar complaints by healthcare and clinical laboratory workers in the US.
The latest group of New Zealand medical laboratory workers to strike are in the South Island and Wellington regions. They were scheduled to walk off the job on July 28 after a negotiated agreement was not reached between APEX, a “specialist union representing over 4,000 allied, scientific, and technical health professionals,” according to the union’s website, and Awanui Labs, one of the country’s largest hospital and clinical laboratory services providers.
Medical laboratory workers in New Zealand are among some of the poorest paid healthcare professionals in the country’s medical industry, according to New Zealand Institute of Medical Laboratory Science President Terry Taylor who told the New Zealand Doctor that some workers aren’t making a living wage. “These people worked their butts off during the pandemic, so you’d think [Awanui] would be able to come up with a decent offer for its staff,” Taylor said.
On the picket line, New Zealand phlebotomists and medical laboratory technicians express that they do not feel they are being compensated properly. “Without your blood samples, you don’t get your results, you don’t get your treatments, you don’t get admissions, your hospital appointments, your operations,” a phlebotomist told 1News. Clinical laboratory workers in the US who experienced the enormous pressure during the COVID-19 lockdowns would likely agree. (Photo copyright: Otago Daily Times.)
Phlebotomists and lab workers in an around New Zealand are demanding a pay wage to put them on par with healthcare workers in the public sector. According to The Southland Times this raise would average around 23.5%.
However, to date Awanui has only offered the medical laboratory workers a 5% pay increase. The APEX union says that is far below what is acceptable for them.
“It doesn’t even get them to parity with colleagues from the public hospitals, and with inflation the way it is at the moment, it’s effectively a wage cut. So, it looks like these strikes are continuing,” David Munroe, Apex Union Advocacy Lead, told 1News New Zealand.
Patients in these regions can expect to see delays on blood test results as medical laboratories and phlebotomy collection centers close due to the strike action.
Poorest Paid Health Professionals in New Zealand
Last year, Dark Daily reported on a similar strike of New Zealand’s 10,000 healthcare workers—including its 4,000 medical laboratory scientists and technicians—which was scheduled to take place in March.
That strike was also over low pay and poor working conditions.
This year, unionized workers met with Awanui on May 23, but the company declined to make an offer to prevent the strike. A second day of bargaining was scheduled for May 24, but according to Munroe, Awanui refused to show up for negotiations. However, Vicki McKnight, an Awanui General Manager, claimed the company was willing to come to the table but that “APEX declined,” New Zealand Doctor reported.
“To date, there has only been one day of bargaining and the collective agreement has not yet expired, so we are surprised by the comments on potential industrial action after just one day of negotiations,” McKnight told New Zealand Doctor.
McKnight said the parties were unable to come to an agreement because of a significant gap between the claims the parties brought to the bargaining table.
Awanui Pays Out Dividends in the Millions
In reaction to workers taking to the picket line, Awanui Labs acknowledged the strike. The company’s Chief People Officer Emma Kelly told 1News, “We do value our people, and it’s a difficult position to be in strikes for our people, for our patients, for everyone. So, I just want to go into this situation with empathy and respect for all of those involved.”
However, one of the things the New Zealand clinical laboratory workers took particular issue with, in light of Awanui’s 5% offer, was that in the last financial year Awanui paid out $41 million in dividends to its shareholders. According to Munroe, the workers want the company to invest in them—instead of the shareholders.
“They are the business. You can’t run laboratories without scientists, technicians, and phlebotomists. They know it, and it’s about time the company knows it too,” Munroe told 1News.
The medical laboratory workers plan to remain on the picket line until a deal is made.
Clinical laboratory managers in the US should take heed of what the New Zealand strikers are saying about low pay and poor working conditions—situations mirrored in many nations following the COVID-19 pandemic.
