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Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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What is Swarm Learning and Might It Come to a Clinical Laboratory Near You?

International research team that developed swarm learning believe it could ‘significantly promote and accelerate collaboration and information exchange in research, especially in the field of medicine’

Swarm Learning” is a technology that enables cross-site analysis of population health data while maintaining patient privacy protocols to generate improvements in precision medicine. That’s the goal described by an international team of scientists who used this approach to develop artificial intelligence (AI) algorithms that seek out and identify lung disease, blood cancer, and COVID-19 data stored in disparate databases.

Since 80% of patient records feature clinical laboratory test results, there’s no doubt this protected health information (PHI) would be curated by the swarm learning algorithms. 

Researchers with DZNE (German Center for Neurodegenerative Diseases), the University of Bonn, and Hewlett Packard Enterprise (HPE) who developed the swarm learning algorithms published their findings in the journal Nature, titled, “Swarm Learning for Decentralized and Confidential Clinical Machine Learning.”

In their study they wrote, “Fast and reliable detection of patients with severe and heterogeneous illnesses is a major goal of precision medicine. … However, there is an increasing divide between what is technically possible and what is allowed, because of privacy legislation. Here, to facilitate the integration of any medical data from any data owner worldwide without violating privacy laws, we introduce Swarm Learning—a decentralized machine-learning approach that unites edge computing, blockchain-based peer-to-peer networking, and coordination while maintaining confidentiality without the need for a central coordinator, thereby going beyond federated learning.”

What is Swarm Learning?

Swarm Learning is a way to collaborate and share medical research toward a goal of advancing precision medicine, the researchers stated.

The technology blends AI with blockchain-based peer-to-peer networking to create information exchange across a network, the DZNE news release explained. The machine learning algorithms are “trained” to detect data patterns “and recognize the learned patterns in other data as well,” the news release noted. 

Joachim Schultze, MD

“Medical research data are a treasure. They can play a decisive role in developing personalized therapies that are tailored to each individual more precisely than conventional treatments,” said Joachim Schultze, MD (above), Director, Systems Medicine at DZNE and Professor, Life and Medical Sciences Institute at the University of Bonn, in the news release. “It’s critical for science to be able to use such data as comprehensively and from as many sources as possible,” he added. This, of course, would include clinical laboratory test results data. (Photo copyright: University of Bonn.)
 

Since, as Dark Daily has reported many times, clinical laboratory test data comprises as much as 80% of patients’ medical records, such a treasure trove of information will most likely include medical laboratory test data as well as reports on patient diagnoses, demographics, and medical history. Swarm learning incorporating laboratory test results may inform medical researchers in their population health analyses.

“The key is that all participants can learn from each other without the need of sharing confidential information,” said Eng Lim Goh, PhD, Senior Vice President and Chief Technology Officer for AI at Hewlett Packard Enterprise (HPE), which developed base technology for swarm learning, according to the news release.

An HPE blog post notes that “Using swarm learning, the hospital can combine its data with that of hospitals serving different demographics in other regions and then use a private blockchain to learn from a global average, or parameter, of results—without sharing actual patient information.

“Under this model,” the blog continues, “‘each hospital is able to predict, with accuracy and with reduced bias, as though [it has] collected all the patient data globally in one place and learned from it,’ Goh says.”

Swarm Learning Applied in Study

The researchers studied four infectious and non-infectious diseases:

They used 16,400 transcriptomes from 127 clinical studies and assessed 95,000 X-ray images.

  • Data for transcriptomes were distributed over three to 32 blockchain nodes and across three nodes for X-rays.
  • The researchers “fed their algorithms with subsets of the respective data set” (such as those coming from people with disease versus healthy individuals), the news release noted.

Findings included:

  • 90% algorithm accuracy in reporting on healthy people versus those diagnosed with diseases for transcriptomes.
  • 76% to 86% algorithm accuracy in reporting of X-ray data.
  • Methodology worked best for leukemia.
  • Accuracy also was “very high” for tuberculosis and COVID-19.
  • X-ray data accuracy rate was lower, researchers said, due to less available data or image quality.

“Our study thus proves that swarm learning can be successfully applied to very different data. In principle, this applies to any type of information for which pattern recognition by means of artificial intelligence is useful. Be it genome data, X-ray images, data from brain imaging, or other complex data,” Schultze said in the DZNE news release.

The researchers plan to conduct additional studies aimed at exploring swarm learning’s implications to Alzheimer’s disease and other neurodegenerative diseases.

Is Swarm Learning Coming to Your Lab?

The scientists say hospitals as well as research institutions may join or form swarms. So, hospital-based medical laboratory leaders and pathology groups may have an opportunity to contribute to swarm learning. According to Schultze, sharing information can go a long way toward “making the wealth of experience in medicine more accessible worldwide.”

Donna Marie Pocius

Related Information:

AI With Swarm Intelligence: A Novel Technology for Cooperative Analysis of Big Data

Swarm Learning for Decentralized and Confidential Clinical Machine Learning

Swarm Learning

HPE’s Dr. Goh on Harnessing the Power of Swarm Learning

Swarm Learning: This Artificial Intelligence Can Detect COVID-19, Other Diseases

Las Vegas Clinical Laboratory UMC Prioritizes STAT Runs, Streamlines Through Consolidation

By automating clinical chemistry and immunoassay testing, clinical laboratory leaders can improve throughput while reducing the stress on staff, laboratory expert says

The American Society for Clinical Pathology regularly conducts a vacancy survey of medical laboratories throughout the US. While the problem of lab department vacancy rates has been ongoing, the last survey reported showed increased rates for laboratory positions across all departments surveyed. Last year, burnout among healthcare workers reached a crisis level, reported Clinical Laboratory News.

As a result, staffing the clinical laboratory with qualified lab professionals resounds as a top concern—and at a time when expectations are perhaps the highest they have ever been for performance in healthcare operations, from general hospitals to the most complex integrated delivery networks.

Even in the midst of the clinical laboratory workforce shortage and chronic strain, laboratory leaders must still improve their labs’ processes and workflows; increase productivity; and expand routine and specialty testing to better serve patient populations.

Faced with unrelenting pressures to do more with less, lab directors are turning to automating certain departments of the laboratory as a way to:

  • Relieve the problems caused by an ongoing workforce shortage;
  • Improve workflows and processes through standardization;
  • Keep lab staff working on the most important tasks; and
  • Enhance the laboratory’s reach and grow the lab business in necessary ways.

How UMC Southern Nevada Prioritized STAT Runs, Consolidated Operations

One case in point highlights the University Medical Center (UMC) of Southern Nevada’s clinical laboratory. Located in Las Vegas, UMC is among the largest public hospitals in the United States. It is part of a recent master-planned Las Vegas Medical District (LVMD), and it is the only Level I trauma center in Nevada.

The laboratory needed to improve turnaround time and expand the test menu, among other goals, explained Scott Keigley, one of two General Laboratory Services Managers at UMC. While limited laboratory automation had already been applied broadly, the lab took its automation initiative one step further by connecting three high-volume automated clinical chemistry and immunoassay analyzers (CC/IA), an automated hematology line, and a coagulation analyzer.

Consolidated automated clinical chemistry and immunoassay analyzer

The University Medical Center of Southern Nevada improved efficiency and
streamlined workflow by integrating a consolidated automated clinical chemistry and immunoassay analyzer (above) into the laboratory’s workflow. (Photo copyright: Siemens Healthineers) 

An immediate benefit that UMC realized was consolidation of clinical lab operations. “Up until implementing our automated platform, we had a dedicated laboratory in our emergency room specifically to triage our emergency room tests,” Keigley explained. “You’re talking about not only a duplication of consumables, resources, and supplies, but also personnel.

“A big part of automating was showing our administration we were going to be able to eliminate that emergency room lab and still turn our results around as quickly and as efficiently without it,” Keigley added.

One of the ways that using an automated platform enabled consolidation of lab operations was by decreasing the turnaround times of STAT samples. “Our STAT turnaround times are way below many of the national thresholds or standards,” Keigley explained. “I’ll use troponin as an example. National threshold is 60 minutes from received to result, but we average about 30 minutes.

“Throughput definitely increased,” Keigley added, emphasizing that this increased throughput was actually accompanied by a reduced workload. “We’ve seen a reduction in the amount of hands-on time required to do the daily maintenance and quality controls. Once the daily maintenance and controls are completed, the chemistry department can usually be run by one person.”

Choosing a Consolidated Automated Chemistry and Immunoassay Platform

Described as flexible for adding components, modular, and scalable, a consolidated clinical chemistry and immunoassay analyzer (CC/IA) can run from 1 million to 3 million tests per year. Designed with innovative technological internal controls and sample handling—and other capabilities that include automated instrument calibration, maintenance, and quality control (QC) functions—the CC/IA platform also works as a standalone and is a first step toward implementing laboratory automation.

At UMC, multiple factors influenced the decision to add the platform, explained Keigley. “One reason was the increased productivity that it (the Atellica Solution) from Siemens Healthineers offers. This technology frees up our techs to do what we went to school to do. I can show anyone how to load samples on these analyzers in five minutes, but that’s not what it’s about.

“We were able to expand our test menu and our services. The platform allowed us to grow.” Keigley estimates that UMC’s test menu grew up to 20% after the change, both expanding the types of testing that could be offered and decreasing the number of send-outs. He estimates that the chemistry lab now processes about 2.6 million reportable results per year.

There were several (QC) features that Keigley believes UMC’s laboratory benefits from. The key QC features Keigley identified include onboard temperature-controlled storage, programmable run times, and barcode-labelled tube options from the control manufacturer that eliminate manual programming.

Operational Evaluation—Nexus Global Solutions, Inc. (Nexus), Plano, TX

While the primary driving factor in UMC’s decision to use the Atellica Solution platform was based on its individual laboratory’s needs, a recent study commissioned by Siemens Healthineers illustrated the benefits of this system.

An operational comparison report by Nexus found that there are multiple advantages associated with this integrated automation platform—as a standalone component—when compared to a similar offering.

Specifically, the Nexus report found:

  • Start-up and maintenance time was almost an hour and a half less;
  • Manual start-up time requirements were 28 minutes, compared to 46 minutes;
  • From 65% to 69% of samples had a faster turnaround time; and
  • A system footprint that used 20square feet less space and four fewer analyzers.

Clinical laboratory leaders can review the methodology and results of the Nexus Global report by clicking on this link: www.siemens-healthineers.com/operational.

This article was produced in partnership with Siemens Healthineers.

—Caleb Williams

Related Information:

Vacancy Survey of Medical Laboratories in the United States

Your Burnout is Real

University Medical Center of Southern Nevada

Atellica Solution

American Association for Clinical Chemistry

Siemens Healthineers

Genomics England Increases Goal of Whole Genome Sequencing Project from 100,000 to 500,000 Sequences in Five Years

Genomic sequencing continues to benefit patients through precision medicine clinical laboratory treatments and pharmacogenomic therapies

EDITOR’S UPDATE—Jan. 26, 2022: Since publication of this news briefing, officials from Genomics England contacted us to explain the following:

  • The “five million genome sequences” was an aspirational goal mentioned by then Secretary of State for Health and Social Care Matt Hancock, MP, in an October 2, 2018, press release issued by Genomics England.
  • As of this date a spokesman for Genomics England confirmed to Dark Daily that, with the initial goal of 100,000 genomes now attained, the immediate goal is to sequence 500,000 genomes.
  • This goal was confirmed in a tweet posted by Chris Wigley, CEO at Genomics England.

In accordance with this updated input, we have revised the original headline and information in this news briefing that follows.

What better proof of progress in whole human genome screening than the announcement that the United Kingdom’s 100,000 Genome Project has not only achieved that milestone, but will now increase the goal to 500,000 whole human genomes? This should be welcome news to clinical laboratory managers, as it means their labs will be positioned as the first-line provider of genetic data in support of clinical care.

Many clinical pathologists here in the United States are aware of the 100,000 Genome Project, established by the National Health Service (NHS) in England (UK) in 2012. Genomics England’s new goal to sequence 500,000 whole human genomes is to pioneer a “lasting legacy for patients by introducing genomic sequencing into the wider healthcare system,” according to Technology Networks.

The importance of personalized medicine and of the power of precise, accurate diagnoses cannot be understated. This announcement by Genomics England will be of interest to diagnosticians worldwide, especially doctors who diagnose and treat patients with chronic and life-threatening diseases.

Building a Vast Genomics Infrastructure

Genetic sequencing launched the era of precision medicine in healthcare. Through genomics, drug therapies and personalized treatments were developed that improved outcomes for all patients, especially those suffering with cancer and other chronic diseases. And so far, the role of genomics in healthcare has only been expanding, as Dark Daily covered in numerous ebriefings.

In the US, the National Institute of Health’s (NIH’s) Human Genome Project sequenced the first whole genome in 2003. That achievement opened the door to a new era of precision medicine.

Genomics England, which is wholly owned by the Department of Health and Social Care in the United Kingdom, was formed in 2012 with the goal of sequencing 100,000 whole genomes of patients enrolled in the UK National Health Service. That goal was met in 2018, and now the NHS aspires to sequence 500,000 genomes.

Richard Scott, MD, PhD

“The last 10 years have been really exciting, as we have seen genetic data transition from being something that is useful in a small number of contexts with highly targeted tests, towards being a central part of mainstream healthcare settings,” Richard Scott, MD, PhD (above), Chief Medical Officer at Genomics England told Technology Networks. Much of the progress has found its way into clinical laboratory testing and precision medicine diagnostics. (Photo copyright: Genomics England.)

Genomics England’s initial goals included:

  • To create an ethical program based on consent,
  • To set up a genomic medicine service within the NHS to benefit patients,
  • To make new discoveries and gain insights into the use of genomics, and
  • To begin the development of a UK genomics industry.

To gain the greatest benefit from whole genome sequencing (WGS), a substantial amount of data infrastructure must exist. “The amount of data generated by WGS is quite large and you really need a system that can process the data well to achieve that vision,” said Richard Scott, MD, PhD, Chief Medical Officer at Genomics England.

In early 2020, Weka, developer of the WekaFS, a fully parallel and distributed file system, announced that it would be working with Genomics England on managing the enormous amount of genomic data. When Genomics England reached 100,000 sequenced genomes, it had already gathered 21 petabytes of data. The organization expects to have 140 petabytes by 2023, notes a Weka case study.

Putting Genomics England’s WGS Project into Action

WGS has significantly impacted the diagnosis of rare diseases. For example, Genomics England has contributed to projects that look at tuberculosis genomes to understand why the disease is sometimes resistant to certain medications. Genomic sequencing also played an enormous role in fighting the COVID-19 pandemic.

Scott notes that COVID-19 provides an example of how sequencing can be used to deliver care. “We can see genomic influences on the risk of needing critical care in COVID-19 patients and in how their immune system is behaving. Looking at this data alongside other omics information, such as the expression of different protein levels, helps us to understand the disease process better,” he said.

What’s Next for Genomics Sequencing?

As the research continues and scientists begin to better understand the information revealed by sequencing, other areas of scientific study like proteomics and metabolomics are becoming more important.

“There is real potential for using multiple strands of data alongside each other, both for discovery—helping us to understand new things about diseases and how [they] affect the body—but also in terms of live healthcare,” Scott said.

Along with expanding the target of Genomics England to 500,000 genomes sequenced, the UK has published a National Genomic Strategy named Genome UK. This plan describes how the research into genomics will be used to benefit patients. “Our vision is to create the most advanced genomic healthcare ecosystem in the world, where government, the NHS, research and technology communities work together to embed the latest advances in patient care,” according to the Genome UK website.

Clinical laboratories professionals with an understanding of diagnostics will recognize WGS’ impact on the healthcare industry. By following genomic sequencing initiatives, such as those coming from Genomics England, pathologists can keep their labs ready to take advantage of new discoveries and insights that will improve outcomes for patients.

Dava Stewart

Related Information:

The 100,000 Genomes Project

Genome Sequencing in Modern Medicine: An Interview with Genomics England

WekaIO Accelerates Five Million Genomes Project at Genomics England

Genomics England Improved Scale and Performance for On-Premises Cluster

Whole Genome Sequencing Increases Rare Disorder Diagnosis by 31%

Genome UK: The Future of Healthcare

Ex-Theranos CEO Elizabeth Holmes Will Be Free on Bail Until September 26 Sentencing Hearing for Criminal Fraud Conviction

Start of ex-Theranos president and COO Sunny Balwani’s federal trial will be pushed to mid-March due to COVID-19 spike in California

Just when most clinical laboratory managers and pathologists thought the guilty verdict in the Elizabeth Holmes fraud case would bring an end to the saga, we learn her chapter in the Theranos story will instead extend another eight months to September when the former Silicon Valley CEO will be sentenced. However, a brand-new chapter will begin in March when the fraud trial of ex-Theranos president and COO Ramesh “Sunny” Balwani begins.

Holmes’ fraud trial concluded on January 3 with the jury convicting her on one count of conspiracy to defraud investors and three counts of wire fraud after seven days of deliberation and nearly four months of trial proceedings.

Holmes remains free on a $500,000 bond while awaiting sentencing.

Elizabeth Holmes

Elizabeth Holmes is seen above arriving at the US District courthouse in San Jose, Calif. On January 3, the former Theranos CEO was convicted on three counts of wire fraud and one count of conspiracy to defraud investors. US District Judge Edward Davila set Holmes’ sentencing date for September 26. Clinical laboratory directors and pathologists who have closely followed the trial will have to wait eight months for the conclusion of this chapter in the Theranos saga. (Photo copyright: The Guardian.)

“I would be utterly shocked if she wasn’t sentenced to some term of imprisonment,” Amanda Kramer, JD, a former federal prosecutor who is now a partner with New York-based Covington & Burling LLP, told NPR.

“What is the sentence that will deter others who have a failing business from making the choice to commit fraud, rather than owning up to the failings and losing their dream?” she added.

Holmes, 37, faces a possible prison sentence of 20 years in prison as well as a $250,000 fine and possible restitution. But some legal experts expect a much shorter prison sentence for the disgraced CEO, who has no prior criminal history and is a first-time mother of a son born last July.

While sentencing typically takes place within a few months of a verdict being reached in a federal criminal trial, US District Judge Edward Davila set 1:30 p.m. September 26, 2022, as the date for Holmes’ sentencing hearing, according to his order dated January 12.

The Mercury News reported the lengthy delay in sentencing may be due to the start of Balwani’s upcoming trial on identical fraud charges. The delay in Holmes’ sentencing will allow for Balwani’s trial to begin in mid-March after being pushed back one month due to a spike in COVID-19 cases in California, The Mercury News reported.

Judge Davila will preside over Balwani’s trial as well.

Jury Acquits Holmes on Patient-related Charges

Holmes was acquitted of conspiracy to defraud patients of the now-defunct blood-testing laboratory and the jury failed to reach a unanimous decision on three other wire fraud charges.

University of Michigan Law Professor Barbara McQuade, a former US Attorney and an NBC News Legal Analyst, told CNBC she expects prosecutors to rethink their strategy in the Balwani trial based on the jury’s acquittal of Holmes on conspiracy and fraud charges involving Theranos patients.

“Knowing that this jury acquitted on all of the patient counts, I think that strategically, they should look to find a more direct way to explain why that is part of the fraud, that they necessarily knew that ultimately patients would be defrauded. And that although they didn’t know these individual patients by name, they knew that they existed in concept,” McQuade said.

One of the jurors in the Holmes’ trial, Wayne Kaatz, told ABC News he and other jurors were dismayed by their inability to come to a unanimous consensus on the three of the charges. A mistrial was declared on those three counts.

“We were very saddened,” Kaatz said. “We thought we had failed.”

Did Holmes Charm the Jury?

When Holmes dropped out of Stanford at age 19 to form Theranos, her goal, she claimed during testimony, was to transform healthcare by creating a blood-testing device capable of performing hundreds of clinical laboratory tests using a finger-stick of blood. She became a Silicon Valley sensation because of her charisma and charm, which she used to sell her dream to big money investors such as Oracle co-founder Larry Ellison and former US Secretary of State George Shultz.

Kaatz acknowledged Holmes’ personality also impacted the jury.

“It’s tough to convict somebody, especially somebody so likable, with such a positive dream,” Kaatz explained to ABC News, noting, however, that he voted guilty on the three counts on which the jury could not agree. “[We] respected Elizabeth’s belief in her technology, in her dream. [We thought], ‘She still believes in it, and we still believe she believes in it.’”

In the light of Holmes’ conviction, McQuade suggested it would not be shocking to see Balwani consider a plea deal in exchange for a lighter sentence.

“Could we perhaps, enter a guilty plea and get a reduction for acceptance of responsibility?” she said. “It’s certainly something that you have to look at.”

And so, the saga continues. Clinical laboratory directors and pathologists who followed Holmes’ trial with rapt interest should prepare for a new set of twists and turns as Ramesh Balwani prepares to face his own day in court.

Andrea Downing Peck

Related Information:

Exclusive: Jury Speaks Out After Convicting Elizabeth Holmes

Elizabeth Holmes: Theranos Fraudster to Avoid Sentencing for at Least Eight Months

Theranos Ex-President’s Fraud Trial Delayed by COVID Surge

United States v. Elizabeth Holmes, et al.: 18-CR-00258-EJD

Former Theranos CEO Elizabeth Holmes to be Sentenced on Sept. 26

Elizabeth Holmes Verdict Complicates Upcoming Trial of Her Ex-Boyfriend and Former Theranos COO Sunny Balwani

Two Important Aspects for Clinical Laboratories to Consider Following Elizabeth Holmes’ Conviction

Theranos Ex-CEO Elizabeth Holmes Convicted on Three Counts of Wire Fraud and One Count of Conspiracy to Commit Fraud after Seven Days of Jury Deliberations

Theranos Whistleblower Tyler Shultz Celebrates Former CEO Elizabeth Holmes’ Guilty Verdict by Popping Champagne with Family Members

UCLA’s Virtual Histology Could Eliminate Need for Invasive Biopsies for Some Skin Conditions and Cancers

Though the new technology could speed diagnoses of cancers and other skin diseases, it would also greatly reduce dermatopathology biopsy referrals and revenue

What effect would elimination of tissue biopsies have on dermatopathology and clinical laboratory revenue? Quite a lot. Dermatologists alone account for a significant portion of skin biopsies sent to dermatopathologists. Thus, any new technology that can “eliminate the need for invasive skin biopsies” would greatly reduce the number of histopathological referrals and reduce revenue to those practices.

Nevertheless, one such new technology may have been created by Ozcan Research Group in a proof-of-concept study they conducted at the University of California, Los Angeles (UCLA).

Called Virtual Histology, the technology applies artificial intelligence (AI) deep learning methods to reflectance confocal microscopy (RCM) images “to rapidly perform virtual histology of in vivo, label-free RCM images of normal skin structure, basal cell carcinoma, and melanocytic nevi with pigmented melanocytes, demonstrating similar histological features to traditional histology from the same excised tissue,” the UCLA scientists wrote in their study, published in the Nature peer-reviewed journal Light: Science and Applications.

Aydogan Ozcan, PhD

“What if we could entirely bypass the biopsy process and perform histology-quality staining without taking tissue and processing tissue in a noninvasive way? Can we create images that diagnosticians can benefit from?” asked Aydogan Ozcan, PhD (above), Chancellor’s Professor of Electrical and Computer Engineering at UCLA’s Samueli School of Engineering, one of the scientists who developed UCLA’s new virtual histology method, during an interview with Medical Device + Diagnostic Industry (MD+DI). (Photo copyright: Nature.)

Could Skin Biopsies be Eliminated?

The UCLA researchers believe their innovative deep learning-enabled imaging framework could possibly circumvent the need for skin biopsies to diagnose skin conditions.

“Here, we present a deep learning-based framework that uses a convolutional neural network to rapidly transform in vivo RCM images of unstained skin into virtually-stained hematoxylin and eosin-like images with microscopic resolution, enabling visualization of the epidermis, dermal-epidermal junction, and superficial dermis layers.

“This application of deep learning-based virtual staining to noninvasive imaging technologies may permit more rapid diagnoses of malignant skin neoplasms and reduce invasive skin biopsies,” the researchers added in their published study.

“This process bypasses several standard steps typically used for diagnosis, including skin biopsy, tissue fixation, processing, sectioning, and histochemical staining,” Aydogan Ozcan, PhD, Chancellor’s Professor of Electrical and Computer Engineering at UCLA’s Samueli School of Engineering, told Optics.org.

AI and Deep Learning in Dermatopathology

According to the published study, the UCLA team trained their neural network under an adversarial machine learning scheme to transform grayscale RCM images into virtually stained 3D microscopic images of normal skin, basal cell carcinoma, and pigmented melanocytic nevi. The new images displayed similar morphological features to those shown with the widely used hematoxylin and eosin (H&E) staining method.

“In our studies, the virtually stained images showed similar color contrast and spatial features found in traditionally stained microscopic images of biopsied tissue,” Ozcan told Photonics Media. “This approach may allow diagnosticians to see the overall histological features of intact skin without invasive skin biopsies or the time-consuming work of chemical processing and labeling of tissue.”

The framework covers different skin layers, including the epidermis, dermal-epidermis, and superficial dermis layers. It images deeper into tissue without being invasive and can be quickly performed.

“The virtual stain technology can be streamlined to be almost semi real time,” Ozcan told Medical Device + Diagnostic Industry (MD+DI). “You can have the virtual staining ready when the patient is wrapping up. Basically, it can be within a couple of minutes after you’re done with the entire imaging.”

Currently, medical professionals rely on invasive skin biopsies and histopathological evaluations to diagnose skin diseases and cancers. These diagnostic techniques can result in unnecessary biopsies, scarring, multiple patient visits and increased medical costs for patients, insurers, and the healthcare system.

Improving Time to Diagnosis through Digital Pathology

Another advantage of this virtual technology, the UCLA researchers claim, is that it can provide better images than traditional staining methods, which could improve the ability to diagnose pathological skin conditions and help alleviate human error.

“The majority of the time, small laboratories have a lot of problems with consistency because they don’t use the best equipment to cut, process, and stain tissue,” dermatopathologist Philip Scumpia, MD, PhD, Assistant Professor of Dermatology and Dermatopathology at UCLA Health and one of the authors of the research paper, told MD+DI.

“What ends up happening is we get tissue on a histology slide that’s basically unevenly stained, unevenly put on the microscope, and it gets distorted,” he added, noting that this makes it very hard to make a diagnosis.  

Scumpia also added that this new technology would allow digital images to be sent directly to the pathologist, which could reduce processing and laboratory times.

“With electronic medical records now and the ability to do digital photography and digital mole mapping, where you can obtain a whole-body imaging of patients, you could imagine you can also use one of these reflectance confocal devices. And you can take that image from there, add it to the EMR with the virtual histology stain, which will make the images more useful,” Scumpia said. “So now, you can track lesions as they develop.

“What’s really exciting too, is that there’s the potential to combine it with other artificial intelligence, other machine learning techniques that can give more information,” Scumpia added. “Using the reflectance confocal microscope, a clinician who might not be as familiar in dermatopathology could take images and send [them] to a practitioner who could give a more expert diagnosis.”

Faster Diagnoses but Reduced Revenue for Dermatopathologists, Clinical Labs

Ozcan noted that there’s still a lot of work to be done in the clinical assessment, validation, and blind testing of their AI-based staining method. But he hopes the technology can be propelled into a useful tool for clinicians.

“I think this is a proof-of-concept work, and we’re very excited to make it move forward with further advances in technology, in the ways that we acquire 3D information [and] train our neural networks for better and faster virtual staining output,” he told MD+DI.

Though this new technology may reduce the need for invasive biopsies and expedite the diagnosis of skin conditions and cancers—thus improving patient outcomes—what affect might it have on dermatopathology practices?

More research and clinical studies are needed before this new technology becomes part of the diagnosis and treatment processes for skin conditions. Nevertheless, should virtual histology become popular and viable, it could greatly impact the amount of skin biopsy referrals to pathologists, dermatopathologists, and clinical laboratories, thus diminishing a great portion of their revenue. 

—JP Schlingman

Related Information:

Virtual Histology Eliminates Need for Invasive Skin Biopsies

UCLA Deep-learning Reduces Need for Invasive Biopsies

AI Imaging Method Provides Biopsy-free Skin Diagnosis

Light People: Professor Aydogan Ozcan

Histology Process Bypasses Need for Biopsies, Enables Diagnoses

Reflection-Mode Virtual Histology Using Photoacoustic Remote Sensing Microscopy

Introduction to Reflectance Confocal Microscopy and Its Use in Clinical Practice

Biopsy-free In Vivo Virtual Histology of Skin Using Deep Learning

Can This New Tech Reduce the Need for Skin Biopsies?

An Unlikely Pandemic Pairing: Facemasks Embedded with Ostrich Antibodies That Detect COVID-19 under UV Light

Japanese scientists who developed the detection method hope to use it to create ‘easy testing kits that anyone can use’

What do ostriches and humans have in common during the current COVID-19 pandemic? The unexpected answer is that ostrich antibodies can be used to identify humans infected with COVID-19. If proven viable in healthcare settings, the possibility exists that new clinical laboratory tests could be developed based on wearable diagnostics technologies that pathologists would interpret for doctors and patients.

This insight was the result of research conducted at Japan’s Kyoto Prefectural University. The KPU scientists found that a paper facemask coated with ostrich antibodies will give off a fluorescence in the presence of the SARS-CoV-2 coronavirus under ultraviolet (UV) light.

Yasuhiro Tsukamoto, PhD

According to Study Finds, scientists at Kyoto Prefectural University in Japan have created a removable mask filter that, when sprayed with a fluorescent dye coated with antibodies extracted from ostrich eggs, will glow under UV light when COVID-19 is detected. The discovery by Yasuhiro Tsukamoto, PhD (above), President of Kyoto Prefectural University, and his researchers could lead to development of low-cost at home COVID-19 testing kits using the same ostrich-antibody-based technique. (Photo copyright: Kyoto Prefectural University/Reuters.)

The KPU scientists conducted a small study with 32 COVID-19 patients over a 10-day span. The surgical-style masks they wore later glowed around the nose and mouth areas but became dimmer over time as their viral load decreased.

“The ostrich antibody for corona placed on the mouth filter of the mask captures the coronavirus in coughing, sneezing, and water,” the researchers explained in Study Finds.

Tsukamoto himself learned he had contracted COVID-19 after wearing a prototype mask and noticing it glowed under UV light. A PCR test later confirmed his diagnosis, Kyodo News reported.

The KPU team “hopes to further develop the masks so they will glow automatically, without special lighting, if the [COVID-19] virus is detected.” Reuters noted in its coverage of the ostrich-antibody masks.

Making Medicine from Ostrich Antibodies

A profile in Audubon noted that Tsukamoto, who also serves as a veterinary medicine professor at Kyoto Prefectural University, made ostriches the focus of his research since the 1990s as he looked for ways to harness the dinosaur-like bird’s properties to fight human infections. He maintains a flock of 500 captive ostriches. Each female ostrich can produce 50 to 100 eggs/year over a 50-year life span.

Tsukamoto’s research focuses on customizing the antibodies in ostrich eggs by injecting females with inactive viruses, allergens, and bacteria, and then extracting the antibodies to develop medicines for humans. Antibodies form in the egg yolks in about six weeks and can be collected without harming the parent or young.

“The idea of using ostrich antibodies for therapeutics in general is a very interesting concept, particularly because of the advantages of producing the antibodies from eggs,” Ashley St. John, PhD, an Associate Professor in Immunology, at Duke-NUS Medical School in Singapore, told Audubon.

While more clinical studies will be needed before ostrich-antibody masks reach the commercial marketplace, Tsukamoto’s team is planning to expand their experiment to 150 participants with a goal of receiving Japanese government approval to begin selling the glowing COVID-detection masks as early as 2022. But they believe the ostrich-antibody technique ultimately may lead to development of an inexpensive COVID-19 testing kit.

“We can mass-produce antibodies from ostriches at a low cost. In the future, I want to make this into an easy testing kit that anyone can use,” Tsukamoto told Kyodo News.

Harvard, MIT Also Working on COVID-19 Detecting Facemask

Not to be out done, scientists at the Massachusetts Institute of Technology (MIT) and Harvard University are participating in a similar effort to create a facemask capable of detecting COVID-19.

According to Fast Company, the MIT/Harvard COVID-19-detecting masks use the same core technology as previous paper tests for Ebola and Zika that utilize proteins and nucleic acids embedded in paper that react to target molecules.

New facemask

Fast Company explained that the mask wearer launches a test by pushing a button to release a small water reservoir embedded in the mask (above). Droplets from their breath are than analyzed by the sensors in the masks, which could be adapted to test for new COVID variants or other respiratory pathogens. In addition to eliminating the use of a nasal swab, the mask-based testing system may compete with clinical laboratory-based results. (Photo copyright: Felice Frankel/MIT.)

“Our system just allows you to add on laboratory-grade diagnostics to your normal mask wearing,” Peter Q. Nguyen, PhD, lead author of a study published in Nature Biotechnology, titled, “Wearable Materials with Embedded Synthetic Biology Sensors for Biomolecule Detection.” Nguyen is a research scientist at the Wyss Institute for Bioinspired Engineering at Harvard.

“They would especially be useful in situations where local variant outbreaks are occurring, allowing people to conveniently test themselves at home multiple times a day,” he told Fast Company.

“It’s on par specificity and sensitivity that you will get in a state-of-the-art [medical] laboratory, but with no one there,” Luis Ruben Soenksen, PhD, Venture Builder in Artificial Intelligence and Healthcare at MIT and one of the co-authors of the Nature Biotechnology study, told Fast Company.

Wearable Diagnostics

This isn’t the first-time unlikely sources have led to useful diagnostic information. In “Researchers in Japan Have Developed a ‘Smart’ Diaper Equipped with a Self-powered Biosensor That Can Monitor Blood Glucose Levels in Adults,” Dark Daily reported on another Japanese research team that developed self-powered wearable biosensors in undergarments that could detect blood glucose levels in individuals with diabetes as well as “smart diapers” that detect urine changes in babies.

As the definition of “wearable diagnostic technology” broadens, pathologists and clinical laboratory scientists may see their roles expand to include helping consumers interpret data collected by point-of-care testing technology as well as performing, evaluating, and interpreting laboratory test results that come from non-traditional sources. 

Andrea Downing Peck

Related Information:

Wearable Materials with Embedded Synthetic Biology Sensors for Biomolecule Detection

Face Mask Made with Ostrich Extract Detects COVID-19 by Glowing Under UV Light

How the Biggest Birds on Earth Could Help Fend Off Epidemics

Scientists Use Ostrich Cells to Make Glowing COVID Detection Masks

Japan Researchers Use Ostrich Cells to Make Glowing COVID-19 Detection Masks

This Mask Glows If You Have COVID

This New Face Mask Tests You for COVID while Protecting You from It

Researchers in Japan Have Developed a ‘Smart’ Diaper Equipped with a Self-powered Biosensor That Can Monitor Blood Glucose Levels in Adults

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