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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Nutromics Receives $14M for Development of Lab-on-a-Patch DNA Sensor Platform That Transmits Biometric Data in Real Time from Interstitial Fluid

Similar health monitoring devices have been popular with chronic disease patients and physicians who treat them; this technology may give clinical laboratories a new diagnostic tool

There is an ever-increasing number of companies working to develop lab testing technologies that would be used outside of the traditional clinical laboratory. One such example is Nutromics, an Australia-based medical technology company which recently announced it has raised US $14 million to fund its new lab-on-a-patch platform, according to a company press release.

Nutromics’ lab-on-a-patch device “uses DNA sensor technology to track multiple targets in the human body, including disease biomarkers and hard-to-dose drugs,” according to MobiHealthNews. Notably, Nutromics’ technology uses interstitial fluid as the sample source.

The funding, which is earmarked for clinical trials, research, and continued development of the technology, comes from health technology company Dexcom (through the Dexcom Ventures capital fund), VU Venture Partners, and global investment management firm Artesian Investments.

Nutromics raised $4 million last year to support a manufacturing facility and an initial human clinical trial of its “continuous molecular monitoring (CMM) platform technology that is able to track multiple targets in the human body via a single wearable sensor. The platform provides real-time, continuous molecular-level insights for remote patient monitoring and hospital-at-home systems,” MobiHealthNews reported.

Peter Vranes

“We are aiming to cause a paradigm shift in diagnostic healthcare by essentially developing a lab-on-a-patch. A lack of timely and continuous diagnostic insights can strongly impact outcomes when dealing with critical disease states. With this strategic industry and VC (venture capital) investment in us, we see more confidence in our technology and hope to accelerate our growth,” said entrepreneur and chemical engineer Peter Vranes (above), co-founder and CEO of Nutromics, in a press release. Clinical laboratory leaders have watched similar biometric monitoring devices come to fruition. (Photo copyright: Nutromics.)


How Nutromics’ Lab-on-a-Patch Works

“Our technology is, in fact, two technologies coming together—a marker and needle. What that does is give us access to fluid under your skin called interstitial fluid. If you’re going to measure something continuously, that’s a really good fluid [to measure],” Vranes told Outcomes Rocket.

Vranes calls the system’s aptamer-based sensor platform technology the “jewel in the crown.” An aptamer is a short sequence of artificial DNA or RNA that binds a specific target molecule. Nutromics’ aptamer sensor, Vranes said, enables targeting of analytes, unlike continuous glucose monitors (CGMs). 

“[CGMs] are limited to metabolites—things that are already in the body like glucose and lactate. We’re not limited to those. We can do a whole range of different targets. And what that gives us is a ‘blue ocean’ opportunity to go in and solve problems in areas that other technologies just can’t solve,” Vranes said.

Nutromics plans to develop multiple aptamer-based sensors that measure a variety of analytes in interstitial fluid, Medtech Insight noted.

Nutromics' wearable DNA sensor lab-on-a-patch

Nutromics’ wearable DNA sensor lab-on-a-patch technology (above) enables monitoring of multiple targets, including disease biomarkers and some medications, MobiHealthNews explained. The wearable patch contains microneedles that painlessly access interstitial fluid under the skin. Collected data is wirelessly transmitted to a software application and integrates with consumer health software and provider platforms, according to Nutromics. Medical laboratories could have a role in collecting this data and adding it other test results from patients using the wearable patch. (Photo copyright: Nutromics.)

Initial Launch Will Include Antibiotic Monitoring

Nutromics expects to initially launch therapeutic monitoring of vancomycin, a glycopeptide antibiotic medication used to treat various bacterial infections. The company says 60% of doses for this prescription antibiotic are not within therapeutic range.

The smart patch enables clinicians to give patients medicine “at the right dose and at the right time,” Sophie Stocker, PhD, a senior hospital scientist at St. Vincent’s Hospital Sydney and Senior Lecturer, University of Sydney School of Pharmacy in New South Wales, Australia, told MobiHealthNews.

Nutromics also envisions opportunity in acute kidney injury (AKI).

Other Research Using Microneedle Patch to Sample Interstitial Fluid

Nutromics is not alone in its use of a microneedle patch to access interstitial fluid (ISF) for diagnostics. In “Researchers at Washington University in St. Louis Use Microneedle Patch with Fluorescent Nanolabels to Detect Biomarkers in Skin’s Interstitial Fluid,” Dark Daily reported how engineers at the McKelvey School of Engineering at Washington University in St. Louis in Missouri have developed a disposable microneedle patch that one day could be a painless alternative to some blood draws for diagnostics tests and health monitoring.

Scientists at the Georgia Institute of Technology and Emory University in Atlanta have been studying interstitial fluid as a source of biomarkers, as compared to blood, for years.

“Interstitial fluid originates in the blood and then leaks out of capillaries to bring nutrients to cells in the body’s tissues. Because interstitial fluid is in direct communication with the cells, it should have information about the tissues themselves beyond what can be measured from testing the blood,” said Mark Prausnitz, PhD, Regents Professor and J. Erskine Love Jr. Chair, Georgia Tech School of Chemical and Biomolecular Engineering, in a 2020 news release announcing results of human trials of microneedle-based ISF sampling.

The scientists published their findings in the journal Science Translational Medicine titled, “Sampling Interstitial Fluid from Human Skin Using a Microneedle Patch.”

“We sampled interstitial fluid from 21 human participants and identified clinically relevant and sometimes distinct biomarkers in interstitial fluid when compared to companion plasma samples based on mass spectrometry analysis,” the scientists wrote.

Clinical laboratory leaders and pathologists will find it useful to monitor the development of diagnostics for use outside the lab. Nutromics is an example of a company developing wearable health technology that painlessly gathers data for lab tests to be conducted in point-of-care and near-patient settings.     

—Donna Marie Pocius

Related Information:

Nutromics Raises US$14 Million For Its Ground-breaking Wearable Diagnostic Platform

Lab-on-a-Patch Maker Nutromics Scores $14M From Dexcom Ventures, Others

Peter Vranes, Co-founder of Nutromics, Nutromics Smart Patch—The Next Evolution of the Continuous Glucose Monitor

Nutromics Raises $14m as Dexcom Signals Move into Wider Sensing Capabilities

Australian Medtech Start-up Nutromics Bags $4M in Pre-Market Funding for Continuous Monitoring Device

Extraction of Largely Unexplored Bodily Fluid Could be a New Source of Biomarkers

Sampling Interstitial Fluid from Human Skin Using a Microneedle Patch

Researchers at Washington University in St. Louis Use Microneedle Patch with Fluorescent Nanolabels to Detect Biomarkers in Skin’s Interstitial Fluid

How Clinical Laboratories Can Avoid COVID-19 Superspreaders, Protect Their Customers and Their Hospital Networks

Understanding how superspreading occurs can help clinical lab leaders slow and even prevent the spread of SARS-CoV-2 within their communities and health systems

Clinical laboratories understand the critical importance of preventing the spread of infection. However, according to the Boston Globe, researchers worldwide are learning that roughly 80% of new COVID-19 cases are caused by just 10% of infected people. Those people are called superspreaders.

It’s critical that medical laboratory managers are aware of the role superspreaders play in transmitting SARS-CoV-2, the coronavirus that causes the COVID-19 illness.

Clinical lab leaders who understand how superspreading occurs can take steps to protect staff, patients, and anyone who visits the facility. Because lab personnel such as couriers and phlebotomists, among others, come into contact with large numbers of people daily, understanding how to identify superspreaders could limit transmissions of the coronavirus within the laboratory, as well as within hospital networks.

Superspreading versus Plodding

Influenza and other viruses tend to spread in a way that epidemiologists call “plodding.” One person infects another, and the virus slowly spreads throughout the population. However, scientists around the globe are finding that SARS-CoV-2 transmission does not fit that pattern. Instead, a few infected people appear to be transmitting the virus to dozens of other people in superspreading events, Boston Globe reported.

“You can think about throwing a match at kindling. You throw one match, it might not light the kindling. You throw another match, it may not light the kindling. But then one match hits the right spot and all of a sudden the fire goes up,” Ben Althouse, PhD, principal scientist and co-chair of epidemiology at the Institute for Disease Modeling in Bellevue, Wash., told the Boston Globe.

But because roughly 90% of infected people aren’t spreading the virus, identifying who the superspreaders are can be a challenge. Nevertheless, limiting situations in which superspreading is likely to occur could greatly reduce the spread of infection.

Samuel Scarpino, PhD Assistant Professor in the Network Science Institute at Northeastern University writing at the class board
Samuel Scarpino, PhD (above), Assistant Professor in the Network Science Institute at Northeastern University, says that “preventing superspreader events could go a long way toward stopping COVID-19,” Scientific American reported. “All of the data I’m seeing so far suggest that if you tamp down the superspreader events, the growth rate of the infections stops very, very quickly,” Scarpino said. (Photo copyright: University of Vermont.)

Examples of Superspreading Events

One of the first big outbreaks in the United States was an example of a superspreading event. The Biogen (NASDAQ:BIIB) leadership conference in late February in Boston resulted in at least 99 cases of COVID-19 just in Massachusetts, reported the Boston Globe.

Several superspreading events have occurred in houses of worship. One well-documented example prompted a CDC Morbidity and Mortality Weekly Report, titled, “High SARS-CoV-2 Attack Rate Following Exposure at a Choir Practice—Skagit County, Washington.” The 122-member choir met for practice twice in March. On March 3 no one had symptoms, but one person had cold-like symptoms at the March 10 practice. Eventually, 53 members tested positive for SARS-CoV-2.

On May 30, a Texas family held a birthday party, Medical Xpress reported. Twenty-five people attended the party, which only lasted a few hours. The family followed the state’s guidelines for gatherings, however one of the hosts was infected with the SARS-CoV-2 coronavirus and wasn’t aware of it. Seven attendees contracted it, and those seven spread the virus to an additional 10 family members. A total of 18 members of a single family were infected.

There are commonalities among the documented superspreading events. Most occur indoors, often in poorly ventilated areas. Some activities cause more respiratory droplets to be expelled than others, such as singing. Some respiratory droplets are released simply by breathing, and many more are expelled when a person talks. Talking louder expels even more droplets into the air.

Are Some People More Likely to Spread the Coronavirus than Others?

The fact that so few people are responsible for the majority of transmissions of the virus raises questions. Do some people simply have more virus particles to shed? Is biology a factor?

“I think the circumstances are a lot more important,” Kristin Nelson, MPH, PhD, Assistant Professor of Epidemiology at Emory University told the Boston Globe.

One factor may be how long the SARS-CoV-2 coronavirus is in the body before symptoms of the COVID-19 illness manifest.

“If people got sick right away after they were infected, they might stay at home in bed, giving them few opportunities to transmit the virus,” noted Scientific American in “How ‘Superspreading’ Events Drive Most COVID-19 Spread.” However, CDC states on its website that “The incubation period for COVID-19 is thought to extend to 14 days, with a median time of 4-5 days from exposure to symptoms onset. One study reported that 97.5% of persons with COVID-19 who develop symptoms will do so within 11.5 days of SARS-CoV-2 infection.”

During that time, infected individuals may transmit the virus to dozens of other people. The CDC estimates that about 40% of transmission occurs in pre-symptomatic people, Scientific American reported.

But it’s not all bad news. The fact that circumstances may be more important than biology might be good news for clinical laboratories. “Knowing that COVID-19 is a superspreading pandemic could be a good thing. It bodes well for control,” Nelson told the Boston Globe.

Clinical laboratory managers are encouraged to follow CDC recommended safety protocols, titled, “Guidance for General Laboratory Safety Practices during the COVID-19 Pandemic.” They include social distancing, setting up one-way paths through lab areas, sanitizing shared surfaces such as counters and benchtops, and implementing flexible leave policies so that sick employees can stay home.

Following these guidelines, and being aware of superspreaders, can help medical laboratories and anatomic pathology groups keep staff and customers free of infection.

—Dava Stewart

Related Information:

Most People with Coronavirus Won’t Spread It. Why Do a Few Infect So Many?  

Birthday Party Leaves 18 in Texas Family with Coronavirus

How the Biogen Leadership Conference in Boston Spread the Coronavirus

Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease (COVID-19)

COVID-19 Pandemic Planning Scenarios Guidance for General Laboratory Safety Practices during the COVID-19 Pandemic

IBM’s Watson Not Living Up to Hype, Wall Street Journal and Other Media Report; ‘Dr. Watson’ Has Yet to Show It Can Improve Patient Outcomes or Accurately Diagnose Cancer

Wall Street Journal reports IBM losing Watson-for-Oncology partners and clients, but scientists remain confident artificial intelligence will revolutionize diagnosis and treatment of disease

What happens when a healthcare revolution is overhyped? Results fall short of expectations. That’s the diagnosis from the Wall Street Journal (WSJ) and other media outlets five years after IBM marketed its Watson supercomputer as having the potential to “revolutionize” cancer diagnosis and treatment.

The idea that artificial intelligence (AI) could be used to diagnose cancer and identify appropriate therapies certainly carried with it implications for clinical laboratories and anatomic pathologists, which Dark Daily reported as far back as 2012. It also promised to spark rapid growth in precision medicine. For now, though, that momentum may be stalled.

“Watson can read all of the healthcare texts in the world in seconds,” John E. Kelly III, PhD, IBM Senior Vice President, Cognitive Solutions and IBM Research, told Wired in 2011. “And that’s our first priority, creating a ‘Dr. Watson,’ if you will.”

However, despite the marketing pitch, the WSJ investigation published in August claims IBM has fallen far short of that goal during the past seven years. The article states, “More than a dozen IBM partners and clients have halted or shrunk Watson’s oncology-related projects. Watson cancer applications have had limited impact on patients, according to dozens of interviews with medical centers, companies and doctors who have used it, as well as documents reviewed by the Wall Street Journal.”

Anatomic pathologists—who use tumor biopsies to diagnose cancer—have regularly wondered if IBM’s Watson would actually help physicians do a better job in the diagnosis, treatment, and monitoring of cancer patients. The findings of the Wall Street Journal show that Watson has yet to make much of a positive impact when used in support of cancer care.

The WSJ claims Watson often “didn’t add much value” or “wasn’t accurate.” This lackluster assessment is blamed on Watson’s inability to keep pace with fast-evolving treatment guidelines, as well as its inability to accurately evaluate reoccurring or rare cancers. Despite the more than $15 billion IBM has spent on Watson, the WSJ reports there is no published research showing Watson improving patient outcomes.

Lukas Wartman, MD, Assistant Professor, McDonnell Genome Institute at the Washington University School of Medicine in St. Louis, told the WSJ he rarely uses the Watson system, despite having complimentary access. IBM typically charges $200 to $1,000 per patient, plus consulting fees in some cases, for Watson-for-Oncology, the WSJ reported.

“The discomfort that I have—and that others have had with using it—has been the sense that you never know how much faith you can put in those results,” Wartman said.

Rudimentary Not Revolutionary Intelligence, STAT Notes

IBM’s Watson made headlines in 2011 when it won a head-to-head competition against two champions on the game show “Jeopardy.” Soon after, IBM announced it would make Watson available for medical applications, giving rise to the idea of “Dr. Watson.”

In a 2017 investigation, however, published on STAT, Watson is described as in its “toddler stage,” falling far short of IBM’s depiction of Watson as a “digital prodigy.”

“Perhaps the most stunning overreach is in [IBM’s] claim that Watson-for-Oncology, through artificial intelligence, can sift through reams of data to generate new insights and identify, as an IBM sales rep put it, ‘even new approaches’ to cancer care,” the STAT article notes. “STAT found that the system doesn’t create new knowledge and is artificially intelligent only in the most rudimentary sense of the term.”

STAT reported it had taken six years for data engineers and doctors to train Watson in just seven types of cancers and keep the system updated with the latest knowledge.

“It’s been a struggle to update, I’ll be honest,” Mark Kris, MD, oncologist at Memorial Sloan Kettering Cancer Center in New York and lead Watson trainer, told STAT. “Changing the system of cognitive computing doesn’t turn on a dime like that. You have to put in the literature, you have to put in the cases.” (Photo copyright: Physician Education Resource.)

Watson Recommended Unsafe and Incorrect Treatments, STAT Reported

In July 2018, STAT reported that internal documents from IBM revealed Watson had recommended “unsafe and incorrect” cancer treatments.

David Howard, PhD, Professor, Health Policy and Management, Rollins School of Public Health at Emory University, blames Watson’s failure in part to the dearth of high-quality published research available for the supercomputer to analyze.

“IBM spun a story about how Watson could improve cancer treatment that was superficially plausible—there are thousands of research papers published every year and no doctor can read them all,” Howard told “However, the problem is not that there is too much information, but rather there is too little. Only a handful of published articles are high-quality, randomized trials. In many cases, oncologists have to choose between drugs that have never been directly compared in a randomized trial.”

Howard argues the news media needs to do a better job vetting stories touting healthcare breakthroughs.

“Reporters are often susceptible to PR hype about the potential of new technology—from Watson to ‘wearables’—to improve outcomes,” Howard said. “A lot of stories would turn out differently if they asked a simple question: ‘Where is the evidence?’”

Peter Greulich, a retired IBM manager who has written extensively on IBM’s corporate challenges, told STAT that IBM would need to invest more money and people in the Watson project to make it successful—an unlikely possibility in a time of shrinking revenues at the corporate giant.

“IBM ought to quit trying to cure cancer,” he said. “They turned the marketing engine loose without controlling how to build and construct a product.”

AI Could Still Revolutionize Precision Medicine

Despite the recent negative headlines about Watson, AI continues to offer the promise of one day changing how pathologists and physicians work together to diagnose and treat disease. Isaac Kohane, MD, PhD, Chairman of the Biomedical Informatics Program at Harvard Medical School, told Bloomberg that IBM may have oversold Watson, but he predicts AI one day will “revolutionize medicine.”

“It’s anybody’s guess who is going to be the first to the market leader in this space,” he said. “Artificial intelligence and big data are coming to doctors’ offices and hospitals. But it won’t necessarily look like the ads on TV.”

How AI and precision medicine plays out for clinical laboratories and anatomic pathologists is uncertain. Clearly, though, healthcare is on a path toward increased involvement of computerized decision-making applications in the diagnostic process. Regardless of early setbacks, that trend is unlikely to slow. Laboratory managers and pathology stakeholders would be wise to keep apprised of these developments.

—Andrea Downing Peck

Related Information:

IBM’s Watson Supercomputer Recommended ‘Unsafe and Incorrect’ Cancer Treatments, Internal Documents Show

IBM Pitched its Watson Supercomputer as a Revolution in Cancer Care. It’s Nowhere Close

IBM’s Watson Wins Jeopardy! Next Up: Fixing Health Care

IBM’s Watson Supercomputer Wins Practice Jeopardy Round

Memorial Sloan-Kettering Cancer Center, IBM to Collaborate in Applying Watson Technology to Help Oncologists

IBM Has a Watson Dilemma

MD Anderson Cancer Center’s IBM Watson Project Fails, and So Did the Journalism Related to It

What Went Wrong with IBM’s Watson?

IBM’s Watson Failed Against Cancer but AI Still Has Promise

Will IBM’s ‘Watson on Oncology’ Give Oncologists and Pathologists a Useful Tool for Diagnosing and Treating Various Cancer

Pathologists Take Note: IBM’s Watson to Attack Cancer with Help of WellPoint and Cedars-Sinai

New Point of Care Test for Anemia That Patients Can Administer Themselves Has Potential to Impact Pathology Groups and Clinical Laboratories

Developed by researchers at Emory University, Children’s Healthcare of Atlanta, and the Georgia Institute of Technology, the anemia test device is awaiting clearance by the FDA

New diagnostic technology may shift some hemoglobin testing for anemia out of clinical laboratories and into near-patient settings. It may also be possible to use this new diagnostic device for patient self-testing.

The developers describe this as a new, easy, inexpensive point-of-care test (POCT) that detects anemia. The device may be available as early as 2016. It is possible for the test to be used in situations where resources are low and illiteracy is high.

The new medical laboratory test is called AnemoCheck and was developed by scientists and students at Emory University, Children’s Healthcare of Atlanta and the Georgia Institute of Technology in Atlanta. (more…)

In the New Health Engagement Model of Health Benefits, Clinical Pathology Laboratories Can Help Beneficiaries through Timely Medical Lab Testing

Oregon adopts health engagement model for its state employees, as evidence of cost savings grows

Across the nation, pathologists and clinical laboratory managers will want to learn about a new model of healthcare reform. It is the “health engagement model” (HEM) and it is being rolled out by a number of health insurers.

Variations of the HEM model are gaining ground in states around the country because health insurers see HEMs as a way to reduce costs and improve quality of healthcare. One new HEM is taking root in the Pacific Northwest. The Oregon Public Employees’ Benefit Board (PEBB) recently adopted a new HEM for state employees, according to a story published by the Lund Report.

What may cause some medical laboratory managers to sit up and take notice is the fact that PEBB’s HEM is producing impressive participation numbers. “Thus far, 48% of members have enrolled for health plans,” stated Ingrid Norberg, Communications Coordinator at PEBB. “And 87% of participating members chose to participate in the health engagement model.”