Platform could be next breakthrough in quest for painless technology to replace in-patient phlebotomy blood draws for many clinical laboratory tests
In a proof-of-concept study, scientists from Israel and China have developed a “smart” microneedle adhesive bandage that measures and monitors in real time three critical biomarkers that currently require invasive blood draws for medical laboratory tests commonly performed on patients in hospitals.
According to a Technion news release, the microneedles are short, thin, and relatively painless because they only extend through the outer layer of skin to reach the interstitial fluid underneath. The needle system attaches to the patient’s skin using an adhesive patch and transfers data wirelessly to both doctor and patient in real time through cloud and Internet of Things (IoT) technologies.
Such a novel technology that allows inpatients to be monitored for key biomarkers without the need for a phlebotomist to collect blood for testing will be attractive and would likely improve the patient’s experience.
It also could reduce the volume of specimen required, potentially eliminating the invasive specimen collection procedure altogether.
“To adapt the technology to daily life, we have developed a unique [adhesive bandage] made of a flexible and soft polymer that stretches and contracts along with the skin and therefore does not interfere with any action whatsoever,” said Hossam Haick, PhD (above), in a Technion news release. “Since it is important for us that the system is available to everyone, we made sure to use relatively inexpensive materials, so the final product will not be expensive. The technology we have developed represents a leap forward in diagnosing diseases and continuous physiological monitoring at home and in the clinic.” Such a real-time monitoring device could eliminate clinical laboratory testing for certain biomarkers that currently require invasive blood draws. (Photo copyright: Technion-Israel Institute of Technology.)
Leap Forward in Diagnostic Testing and Disease Monitoring
As pathologists and medical laboratory scientists are aware, sodium is a prominent prognostic biomarker for assessing certain blood conditions such as dysnatremia, the presence of too much or too little sodium. It’s an essential element found in blood cells and blood fluid that plays a vital role in transmitting signals to the nervous system, as well as in other biological functions.
Led by Hossam Haick, PhD, head of the LNDB (Laboratory for Nanomaterials-based Devices) group and Dean of Certification Studies at Technion, the team of scientists tested their device’s effectiveness at monitoring patients’ blood for both hypernatremia (high concentration of sodium in the blood) as well as hyponatremia (low concentration of sodium in the blood).
Both conditions can affect neurological function and lead to loss of consciousness and coma. Thus, early monitoring is critical.
“As of now, detection and monitoring of sodium levels in the human body is carried out by means of laborious and bulky laboratory equipment, or by offline analysis of various bodily fluids,” the study’s authors explained in the news release. Use of the smart microneedle patch, they added, allows the patient to continue about their day as normal, as well as gives their doctor time to attend to more patients.
The “innovative stretchable, skin-conformal and fast-response microneedle extended-gate FET (field-effect transistor) biosensor [integrated with] a wireless-data transmitter and the Internet-of-Things cloud for real-time monitoring and long-term analysis [could] eventually help [bring] unlimited possibilities for efficient medical care and accurate clinical decision-making,” noted the study’s authors in Advanced Materials.
More research will be needed to determine whether this latest medical technology breakthrough will lead to a viable minimally invasive method for measuring, diagnosing, and monitoring medical conditions, but Technion’s platform appears to be another step toward a long-sought alternative to painful blood draws.
Further, pathologists and clinical laboratory managers should expect more products to hit the market that are designed to collect a lab specimen without the need for a trained phlebotomist. Companies developing these products recognize that recruiting and retaining trained phlebotomist is an ongoing concern for medical labs. Thus, to have a method of collecting a lab specimen that is simple and can be done by anyone—including patients themselves—would be an important benefit.
Findings are ‘a vital first step in discovering potentially valuable targets for development of new [COVID-19] treatments,’ noted co-first author of the study
Researchers at King’s College London (KCL) have determined that levels of certain blood proteins specific to each person’s blood type can be “causally linked” to an increased risk of hospitalization and death from a COVID-19 infection. The scientists also found that a person’s genetics play a key role in establishing the levels of those proteins in the blood.
This is relevant for clinical laboratories—particularly hospital/health system laboratories—because testing for specific proteins in the blood by medical laboratories could help flag incoming patients at higher risk for an acute COVID-19 infection.
Also, “By identifying this suite of proteins, the research has highlighted a number [of] possible targets for drugs that could be used to help treat severe COVID-19,” noted a KCL news release.
Identifying certain drugs that would be more effective for specific individuals or healthcare groups is a core goal of precision medicine.
“We have used a purely genetic approach to investigate a large number of blood proteins and established that a handful have causal links to the development of severe COVID-19,” said Alish Palmos, PhD (above), Postdoctoral Research Associate, King’s College London Social, Genetic and Developmental Psychiatry Center, and co-first author of the study. “Honing in on this group of proteins is a vital first step in discovering potentially valuable targets for development of new treatments.” Medical laboratories may soon be able to use this knowledge as a way to determine risk for severe COVID-19 hospitalization, as well as to guide decisions on how to use new precision medicine drugs for combating the infection. (Photo copyright: Twitter.)
Genetic Variants Linked to Causality
Since the COVID-19 pandemic began in late 2019, scientists and researchers have been vigorously trying to understand the SARS-CoV-2 coronavirus and determine why some patients have more severe symptoms than others.
To conduct their study, the KCL researchers screened more than 3,000 blood proteins to identify which proteins have a causal link to hospitalization risk, the need for respiratory support, and death from a severe COVID-19 infection.
“Causality between exposure and disease can be established because genetic variants inherited from parent to offspring are randomly assigned at conception similar to how a randomized controlled trial assigns people to groups,” said Vincent Millischer, MD, PhD, Medical University of Vienna and co-first author of the study in the KCL news release.
“In our study, the groups are defined by their genetic propensity to different blood protein levels, allowing an assessment of causal direction from high blood protein levels to COVID-19 severity whilst avoiding influence of environmental effects,” he added.
The scientists selected genetic variants, known as single nucleotide polymorphisms, that were strongly associated with blood protein levels. They then performed their analysis using Mendelian randomization to test the causal associations of those blood proteins with the development of severe COVID-19 infections.
“Mendelian randomization uses genetic variants associated with a trait [e.g., protein level] and measures their causal effect on disease outcomes, [avoiding] environmental confounding factors, such as lifestyle, being physically ill, etc.,” Alish Palmos, PhD, told Medical News Today. Palmos is a Postdoctoral Research Associate at King’s College London’s Social, Genetic, and Developmental Psychiatry Center and co-first author of the study.
Blood Groups Linked to COVID-19 Hospitalization, Death
One of the most important findings of the KCL research is a causal association between COVID-19 severity and an enzyme called ABO, which determines blood type. This discovery suggests that blood groups perform an instrumental role in whether individuals develop severe forms of the illness.
“The enzyme helps determine the blood group of an individual and our study has linked it with both risk of hospitalization and the need of respiratory support or death,” said Christopher Hübel, PhD, Postdoctoral Research Associate, King’s College and co-last author of the study in the press release. “Our study does not link precise blood group with risk of severe COVID-19, but since previous research has found that proportion of people who are group A is higher in COVID-19 positive individuals, this suggests that blood group A is more likely candidate for follow-up studies.”
The KCL researchers uncovered several compelling findings regarding blood proteins and COVID-19, including:
The discovery of six blood markers that were significantly associated with an elevated risk of hospitalization.
The discovery of nine blood markers that were significantly associated with a decreased risk of hospitalization.
Consistent results indicating hospitalization being significantly associated with decreased levels of macrophage inflammatory protein.
Five blood markers associated with the need for respiratory support or death.
Eight blood markers causally associated with a statistically significantly decreased risk of need for respiratory support or death.
Consistent results with respiratory support or death being significantly causally associated with decreased levels of neprilysin.
Developing New COVID-19 Treatments and Preventative Therapies
“What we have done in our study is provide a shortlist for the next stage of research,” said Gerome Breen, PhD, in the KCL news release. Breen is Professor of Psychiatric Genetics at King’s College London’s Institute of Psychiatry, Psychology and Neuroscience, and co-last author of the study.
“Out of 1000s of blood proteins we have whittled it down to about 14 that have some form of causal connection to the risk of severe COVID-19 and present a potentially important avenue for further research to better understand the mechanisms behind COVID-19 with an ultimate aim of developing new treatments but potentially also preventative therapies,” he added.
Further research and clinical investigation are needed to validate the King’s College London researchers’ findings. However, their insights could result in new clinical laboratory tests and personalized treatments for COVID-19.
With Millennials soon to make up the majority of the medical laboratory workforce, it’s only natural that digital networking is gaining momentum at events like the Executive War College
At any hour during the in-person event in New Orleans, attendees scheduled meetups, participants asked questions to conference organizers, and users discussed important clinical laboratory and anatomic pathology topics. All of those interactions occurred within the Whova meeting application, which served as the Executive War College’s virtual guide.
In many ways, widespread use of the meeting app reflects a younger crowd that lives life on mobile phones. It’s not all that different than the changing face of the clinical lab industry as laboratory veterans retire and new faces come in, said Robert Michel, Founder of the Executive War College (EWC) and Editor-in-Chief of Dark Daily’s sister publication The Dark Report.
“It’s clear from the soaring use of our conference’s meeting app at the Executive War College that a younger generation is changing how business is conducted during and after a lab industry conference,” he observed. “Generation X and Millennials are steadily influencing how people network at live events.”
“It is remarkable that, among the 900 attendees at this year’s event, there were more than 750,000 impressions involving the sponsors and companies supporting this year’s conference,” said Robert Michel (above), Editor-in-Chief of Dark Daily and Founder of the Executive War College. “It shows that these attendees are serious about identifying solutions and vendors who can help them solve the various pain points in their laboratories.” (Photo copyright: Dark Intelligence Group.)
88% of Attendees at Executive War College Used the Event App
Usage numbers aggregated during the EWC conference of people who downloaded and used the meeting app speak for themselves:
A large majority of attendees (88%) downloaded the app.
Users sent 11,398 messages in the app.
There were 136 community board discussions posted.
Users created 80 meetups, with 677 people attending those gatherings.
There were 764,745 sponsor impressions in the app (in other words, clicks on a sponsor link or attendees navigating to sponsor material).
What the numbers don’t convey is that the conference’s meeting app was also fun to use!
Butterworth spoke during a special session at the Executive War College. She also took the No. 1 spot on the meeting app’s leaderboard for the event, collecting an impressive 225,900 points. Users gained points for the leaderboard based on activities they completed in the app.
Spirited competition ensued among the leaderboard’s top users, who jockeyed for position as the conference progressed. Plenty of off-topic conversations took place in the app as well, as attendees helped each other navigate New Orleans with tips about restaurants, local cemetery tours, or where to work out.
The leaderboard on the Whova meeting application (above) at the conclusion of this year’s Executive War College on Laboratory and Pathology Management showed the top point gainers. (Photo copyright: Dark Intelligence Group.)
Clinical Laboratory Sponsors Reached Out to Attendees in New Ways
For sponsors and other vendors visiting the conference, the meeting app provided a different avenue to approach attendees beyond the typical networking that takes place during breaks, cocktail receptions, luncheons, and off-site parties.
For example, some sponsors shared white papers or YouTube videos via the app’s community boards or asked questions about topics of interest. Additionally, sponsors could respond directly to queries from attendees.
“At the Executive War College, there was clearly a sustained exchange between vendors looking to engage business development opportunities and participants who have pain points that need to be addressed and are looking for solutions,” Michel said.
The next Executive War College will return to New Orleans on April 25-26, 2023. Click on this link to access early registration discounts.
Study shows that access to early childhood treatment could have lasting effects and prevent premature adult aging
Researchers in New Zealand have found that people who experienced “daily smoking status, obesity, or a psychological disorder diagnosis” beginning early in life were “biologically older” at midlife than those who did not. The findings suggest that early access to treatments for these health concerns could decrease risk for “accelerated biological aging,” according to the study published in JAMA Pediatrics.
Although these findings do not currently provide a path to a diagnostic test for clinical laboratories, this study is yet another example of how researchers are increasingly using broad swaths of healthcare data to help identify people at risk for certain healthcare conditions.
Such research often presents opportunities for medical laboratories to participate in healthcare Big Data analysis, which in turn helps healthcare providers make precision medicine diagnoses for individual patients.
Study Assessments and Clinical Laboratory Biomarkers
The scientists found that participants who had one of three health conditions as an adolescent—obesity, smoking daily, or psychological disorder (anxiety, attention deficit/hyperactivity disorder, depression)—showed advanced signs of aging at age 45 when compared to others without those conditions, CNN reported.
The signs included:
Walking 11.2 centimeters per second slower.
Brain appears 2.5 years older.
Face appears four years older.
At age 11, 13, and 15, the Dunedin Study participants were assessed by pulmonary specialists and others for asthma, cigarette smoking, and obesity, Fox News reported.
“There’s a long history of that kind of research in terms of how smoking is damaging at the cellular level but also can result in the kinds of health conditions that we associate with biological aging, like (chronic obstructive pulmonary disease), lung cancer, things like that,” the study’s first author Kyle Bourassa, PhD (above), told CNN. “The hope is if we were to study a cohort now, a much higher proportion of those children and adolescents are actually going to be treated for these things, which will reduce the risk of accelerated aging later in life,” he added. Results of the study may also lead to new clinical laboratory diagnostics. (Photo copyright: Duke University.)
According to an earlier DMHDRU statement, the biomarkers used at this point in the study included:
“Participants who had smoked daily, had obesity, or had a psychological disorder diagnosis during adolescence were biologically older at midlife compared with participants without these conditions. Participants with asthma were not biologically older at midlife compared with those without asthma,” the researchers wrote. These findings led the researchers to certain conclusions about receiving early treatments, CNN reported.
“No participants in this cohort were prescribed stimulants for attention-deficit/hyperactivity disorder, and selective serotonin reuptake inhibitors were not yet in use for adolescent depression and anxiety during the study period. Whereas 81.1% of the adolescents with asthma received some type of treatment, which could have mitigated the implications for biological aging,” the authors wrote in their study.
“Our paper reaffirms that those are important treatments and those kinds of investments younger in the lifespan could net big benefits in terms of both health and the cost of healthcare later on as well,” Kyle Bourassa, PhD, told CNN. Bourassa is the study’s First Author and a clinical psychology researcher and advanced research fellow at the Durham VA Health Care System.
Clinical Laboratories Curate Massive Amounts of Healthcare Data
For pathologists and medical laboratory scientists, the University of Otago study is a reminder that clinical laboratories provide a critical tool to diagnostics professionals: housing, sharing, and analyzing data that contribute to precision medicine diagnoses.
The DMHDRU researchers’ findings also highlight the importance of access to common treatments offered early in life for some people to reduce risk of accelerated aging and disease.
Defense attorneys attempted to describe Balwani as simply an investor in Theranos, but prosecutors used the defendant’s own text messages to debunk that claim
Clinical laboratory directors and pathologists following the criminal fraud trial of ex-Theranos President and COO Ramesh “Sunny” Balwani may be experiencing a case of déjà vu as the former executive of the now-defunct blood-testing company has his day in court.
Even as Balwani’s defense team attempted to distance their client from the company’s day-to-day decision-making activities, prosecutors followed an almost identical script from the previous fraud trial of Theranos founder Elizabeth Holmes conducted earlier this year. That trial led to her conviction on four counts of defrauding investors.
As was the case in the Holmes trial, text messages between the two Theranos top executives (Balwani and Holmes) are again center stage in the San Jose, Calif., courtroom of U.S. District Judge Edward Davila.
Balwani Texts Reveal an ‘Unhappy’ Man Under Pressure
Balwani, 56, worked alongside Holmes at Theranos from 2009 to 2016. He purchased $5 million in stock in the company and helped finance the startup by underwriting a $13 million loan. Like Holmes, Balwani faces a dozen counts of fraud and conspiracy to commit wire fraud.
Jurors in the Balwani trial were shown a collection of private text messages between Balwani and Holmes—who also was his girlfriend at the time—that shed light on their business and personal relationships.
“I am responsible for everything at Theranos,” Balwani wrote in a text exchange with Holmes, NBC Bay Area reported. “I worked six years day and night to help you … sad about where we are,” he wrote.
“I am very unhappy because my work sucks,” Balwani told Holmes in another text. NBC Bay Area also reported on other text messages that discussed meeting new investors, meeting revenue goals, and potentially buying a corporate plane.
Just like former Theranos CEO/founder Elizabeth Holmes, former Theranos president/COO Ramesh “Sunny” Balwani (above) faces a dozen counts of fraud and conspiracy to commit wire fraud. Clinical laboratory directors will be particularly interested in the outcome of these trails since the responsibility of CLIA-laboratory directors to report anomalies in medical laboratory testing played a key part in defense testimony. (Photo copyright: The Guardian.)
Defense Counterattacks with Expert Testimony
Balwani’s defense team launched a counterattack the following day when witness Constance Cullen, PhD, a former immunologist at Schering-Plough, stated on cross examination that she dealt only with Holmes and never met Balwani or other Theranos executives, NBC Bay Area reported.
During Holmes’ trial, Cullen testified that Holmes had used the Schering-Plough logo without authorization on studies presented to potential investors which aimed to validate Theranos’ blood-testing technology.
Balwani’s defense team previously described him as a Theranos “shareholder” in an effort to distance him from executive decisions that allegedly misled Theranos investors about the startup’s revenues and accuracy of the company’s “revolutionary” Edison blood-testing device, which Theranos claimed could perform hundreds of clinical laboratory tests using a finger-prick of blood.
According to additional NBC Bay Area coverage of the trial, a former Walgreens executive testified he worked closely with Balwani during the drugstore chain’s failed multiyear partnership with Theranos, which included a $50 million investment to bring in-store medical laboratory testing to its pharmacies.
“As a person who was an investor and essentially serving as the chief operations officer, Sunny Balwani absolutely was intimately involved in the Walgreens relationship and all the relationships Theranos had,” chief legal analyst for Esquire Digital and editor of Today’s Esquire, Aron Solomon, JD, told NBC Bay Area in a video interview.
NBC Bay Area reported that prosecutors introduced text messages between Balwani and Holmes in which Balwani admitted he did not inform Walgreens that third-party equipment—not the Theranos Edison device—was being used for much of the actual clinical laboratory testing done in Walgreens stores.
Prosecutors Claim Balwani, Holmes Worked ‘Together’ to Defraud Investors
Earlier in April, government lawyers responded to claims from Holmes’ defense team that Judge Davila should set aside the convictions in Holmes’ fraud case because evidence at trial did not support a guilty verdict, Fortune reported.
The prosecutors countered in a court filing that the “overwhelming weight of the evidence admitted at trial supports the jury’s conviction” of conspiracy to commit wire fraud and fraud on Theranos investors.
Prosecutors maintained the Holmes trial was “replete with examples” of Holmes and Balwani “working together and conspiring to effectuate a scheme to defraud investors.” The two “were constantly in communication via email, text message, and in-person meetings” about the company’s laboratories, financials, patient blood-testing, and relationships with Walgreens, investors, and visits by regulators, the Fortune article noted.
Holmes was convicted on January 3, 2022, on three counts of wire fraud and one count of conspiracy to commit wire fraud. Her sentencing date is September 26. She faces up to 20 years in prison but remains free on bond while awaiting sentencing. Balwani’s trial is ongoing.
Clinical laboratory managers and pathologists following the Theranos saga with interest should expect more revelations in the weeks to come. Balwani’s trial, which began in March, is expected to last at least three months.
27th annual meeting of medical laboratory and pathology managers delivers insights on the path ahead for diagnostics, ranging from the supply chain shortage and the ‘Great Resignation’ to advances in artificial intelligence and whole genome sequencing in service of precision medicine
What’s coming as healthcare providers move to post-COVID-19 pandemic workflows will be of keen interest to clinical laboratory leaders attending this critical event. Several new and dynamic market changes are reshaping the development of, ordering, and reimbursement for medical laboratory tests. They include:
Millennials as change agents in how care is accessed and delivered.
New buyers of large volumes of clinical lab tests, such as retail pharmacies.
How clinical laboratories can earn new sources of revenue while supporting precision medicine.
Clinical Labs Should Prepare for the ‘Coming Roller Coaster Ride’
Robert L. Michel, Editor-in-Chief of Dark Daily’s sister publication, The Dark Report, and Founder of the Executive War College, described the “coming roller coaster ride” for the pathology and clinical laboratory industries.
Amid the usual operational issues labs deal with (e.g., workforce shortages, supply chain disruptions, regulatory pressures), he noted the emergence of new and powerful forces pulling clinical laboratories and pathology groups in all directions.
“One primary factor is how Millennials will use healthcare differently than Gen Xers and Baby Boomers,” Michel noted. “Similarly, Millennials will make up 75% of the pathologists and the lab workforce by 2025.
“Another major force for change will be new buyers of clinical laboratory tests,” he continued. “For example, expect to see national retail pharmacy chains build thousands of primary care clinics in their retail pharmacies. These clinics will need lab tests and will become major buyers of near-patient analyzers and lab tests.
“A third interesting factor is that a new class of in vitro diagnostics (IVD) manufacturers are developing analyzers and test systems that use minimal amounts of specimens and return answers in minutes. Primary care clinics in retail pharmacies will be interested in buying these lab testing solutions,” Michel concluded.
Robert L. Michel (above), Editor-in-Chief of The Dark Report and Founder of the Executive War College, has studied and worked with leaders of clinical laboratories and pathology groups for more than four decades. During his keynote address, he predicted that powerful economic forces are about to be unleashed on the traditional market for clinical laboratory testing. Those forces include the use of artificial intelligence (AI) in digital pathology, primary care in retail pharmacies, and increased focus on precision medicine. (Photo copyright: The Dark Intelligence Group.)
Peer-to-Peer Learning Opportunities
With approximately 90 presenters scheduled, clinical laboratory leaders from such prestigious institutions as Johns Hopkins Hospital, Mayo Clinic, United Indian Health Services, and more will facilitate peer-to-peer learnings throughout the conference.
In addition, several sessions and panel Q/A discussions will cover critical legal and regulatory issues and payer challenges facing the industry.
New Technologies, Workflows, Analytics
The 2022 Executive War College master classes, breakouts, panel discussions, and benefactor sessions will highlight several significant themes:
Lab data analytics and utilization. Sessions this year are heavily weighted toward data analytics, aggregation, and utilization. Look for case studies demonstrating the value of lab data, and where and how data has become actionable and monetized. As Dark Daily previously reported, useful data structures have been difficult to achieve for clinical laboratories; however, the case studies featured during this week’s conference will demonstrate signs of progress and highlight lessons learned.
Automation. Several case studies are planned that focus on expansion and modernization using laboratory automation. From Butler Health System, an independent hospital system in western Pa., Robert Patterson, MD, Medical Director of Pathology, Laboratory Medicine, and Laboratory Outreach, will detail steps Butler took that enabled its labs to better compete with other area health systems and national reference laboratories. Likewise, Eric Parnell, System Supervisor of Microbiology for Bronson Healthcare in southern Mich., will discuss his lab’s transition to and implementation of total laboratory automation.
Genetic testing and next-generation sequencing (NGS). Quickly becoming the foundational disruptor technology on which many new and powerful clinical laboratory tests and procedures are based, genomic testing has now become accessible and affordable. Many clinical laboratories and pathology groups are using molecular diagnostics testing to deliver clinical value to referring physicians.
Other sessions include:
Launching and scaling clinical NGS testing in a clinical environment (featuring a project at Rady Children’s Hospital in San Diego).
How labs and payers can work together to achieve better outcomes and health equity using genomic testing.
Effective ways to repurpose PCR and other genetic test instruments to build specimen volume and increase lab revenue.
Paths Forward for Clinical Labs and Pathology Groups
Another important topic being discussed at the 2022 Executive War College is how to position clinical laboratories and pathology groups for the next phase of modern healthcare.
Attracting capital for clinical labs and pathology groups.
Emerging concepts in growth strategies.
Business valuation factors.
Unexpected disruptions during sales closings.
These are just a few highlights of the informative sessions and expert speakers scheduled during this week’s 27th annual Executive War College in New Orleans. Look for more coverage in Dark Daily during the days ahead and in upcoming editions of our sister publication The Dark Report.
Full details about the 2022 Executive War College can be found by clicking on this link. (Or copy/paste this URL into your web browser: http://www.executivewarcollege.com.)
Speakers, session topics, and the conference agenda can be viewed by clicking on this link. (Or copy/paste this URL into your web browser: https://executivewarcollege.darkintelligencegroup.com/executive-war-college-agenda-2022.)
