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Clinical Laboratories and Pathology Groups

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University of Southern California Researchers Develop Vaccine That Boosts Immunity and Helps Patients Avoid Deadly Infections While in Hospitals

New vaccine could give clinical laboratories and antimicrobial stewardship programs the tool they need to dramatically reduce hospital-acquired infections

Healthcare providers and clinical laboratories continue to struggle against hospital-acquired infections (HAIs) and ever-evolving antimicrobial resistant (AMR) bacteria. But now, the University of Southern California (USC) has developed and patented an experimental vaccine that has been shown to protect against so-called “superbugs,” such as methicillin-resistant Staphylococcus aureus (MRSA), an AMR bacteria that causes potentially deadly staph infections in hospitals and other healthcare settings.

The innovative approach focuses on bolstering the patient’s immune system itself, rather than relying on proteins to fight infections, according to a USC Today article. 

Developed by senior study author Brad Spellberg, MD, Chief Medical Officer at the Los Angeles General Medical Center, and colleagues, “The experimental vaccine takes an entirely different approach: It gooses the body’s preexisting supply of pathogen-gobbling immune cells called macrophages, which engulf and digest bacteria, fungi, and other bad actors. These activated fighters, found in all tissues, quickly neutralize incoming invaders which might otherwise multiply rapidly and overwhelm the body’s defenses,” USC Today reported. 

“This is very different from developing new antibiotics,” Jun Yan, a doctoral student at Keck School of Medicine and the study’s first author, told USC Today. “This is using our own immune system to fight against different superbugs, which is a different approach than everybody else.”

To develop the vaccine [the USC researchers] formed a biotechnology startup called ExBaq LLC in Bethesda, Md.

They published their findings in the journal Science Translational Medicine title, “A Protein-Free Vaccine Stimulates Innate Immunity and Protects against Nosocomial Pathogens.”

Ishwar K. Puri, PhD

“The pandemic stimulated unprecedented innovation in vaccine development, where federal funding and university-industry partnerships were game changers for translating promising discoveries from academic labs for the good of all,” said Ishwar K. Puri, PhD (above), senior vice president of research and innovation at USC. “We are both pleased and proud of the critical support the USC Stevens Center provided to enable the development of ExBaq’s experimental vaccine that protects vulnerable populations from serious infections.” Clinical laboratories that work with hospitals in the fight against hospital-acquired infections understand the importance of this discovery. (Photo copyright: University of Southern California.)

USC Vaccine Details

The USC team developed a “protein-free vaccine, composed of aluminum hydroxide, monophosphoryl lipid A, and fungal mannan, that stimulates the innate immune system and confers protection,” the researchers wrote in Science Translational Medicine.

“Tested in two independent labs, the vaccine works within 24 hours and lasts for up to 28 days. In lab models, the number of pathogen-eating immune cells in the blood increased dramatically, and survival time of invasive blood and lung infections improved. Early data suggest that a second dose could extend the window to prevent infection,” USC Today reported.

Unlike anything currently available, the new vaccine focuses on boosting the body itself instead of creating antibodies against certain pathogens. A mere dose of the vaccine is described to “provide rapid protection against nine different bacteria and fungi species,” USC Today noted.

“It’s an early warning system. It’s like Homeland Security putting out a terror alert. Everybody, keep your eyes open. Keep an eye out for suspicious packages. You’re alerting the soldiers and tanks of your immune system. The vaccine activates them,” Spellberg told USC Today

“The vaccine acted through stimulation of the innate, rather than the adaptive, immune system, as demonstrated by efficacy in the absence of lymphocytes that were abrogated by macrophage depletion. A role for macrophages was further supported by the finding that vaccination induced macrophage epigenetic alterations that modulated phagocytosis and the inflammatory response to infection. Together, these data show that this protein-free vaccine is a promising strategy to prevent deadly antimicrobial-resistant healthcare-associated infections,” the researchers wrote in Science Translational Medicine.

Great Need for This Protection

According to the federal Centers for Disease Control and Prevention (CDC), 1.7 million infections and 99,000 deaths are caused by HAIs annually.

“Patients who acquire infections from surgery spend, on average, an additional 6.5 days in the hospital, are five times more likely to be readmitted after discharge and twice as likely to die. Moreover, surgical patients who develop infections are 60% more likely to require admission to a hospital’s intensive care unit. Surgical infections are believed to account for up to 10 billion dollars annually in healthcare expenditures,” the CDC reports.

“All hospitalized patients are susceptible to contracting a [hospital-acquired] infection. Some patients are at greater risk than others: young children, the elderly, and persons with compromised immune systems are more likely to get an infection. Other risk factors are long hospital stays, the use of indwelling catheters, failure of healthcare workers to wash their hands, and overuse of antibiotics,” the CDC notes.

Therefore, USC’s new vaccine may be just what the doctor ordered to protect patients in hospitals and other healthcare settings from deadly HAIs.

Looking Ahead

There are currently no vaccines that are FDA-approved that treat “the most serious antibiotic resistant infections,” USC Today reported.

“Even if there were such vaccines, multiple vaccines would have to be deployed simultaneously to protect against the full slate of antibiotic-resistant microbes that cause healthcare-acquired infections,” Brian Luna, PhD, assistant professor of molecular microbiology and immunology at USC’s Keck School of Medicine, told USC Today

Thus, USC’s new vaccine could be a boon to hospital antimicrobial stewardship programs. But so far, it has only been tested on mice.

“The next step is getting guidance from the US Food and Drug Administration (FDA) on the design of a clinical trial. The first such trial would be done in healthy volunteers to find the right dose of vaccine that is safe and triggers the same kind of immune response in people as seen in the mice,” USC Today reported.

ExBaq LLC has begun talking with potential larger partners who might be willing to help develop the vaccine into clinical testing.

For years hospitals and other healthcare settings—such as long-term care facilities, urgent care clinics, and clinical laboratories—have fought an uphill battle against superbugs. So, for a vaccine to be on the horizon that can prevent life-threatening hospital-acquired infections would be a game changer.

With antimicrobial stewardships being a requirement in all hospitals, medical laboratory managers and microbiologists may celebrate this new development and its potential to be a useful tool in fighting antimicrobial resistant bacteria in their facilities.

—Kristin Althea O’Connor

Related Information:

Superbugs Including MRSA Thwarted by Unconventional Vaccine

A Protein-Free Vaccine Stimulates Innate Immunity and Protects Against Nosocomial Pathogens

Superbug Vaccine “Hulkifies” Macrophages in Mouse Model

Cambridge Researchers in UK Develop ‘Unknome Database’ That Ranks Proteins by How Little is Known about Their Functions

Scientists believe useful new clinical laboratory assays could be developed by better understanding the huge number of ‘poorly researched’ genes and the proteins they build

Researchers have added a new “-ome” to the long list of -omes. The new -ome is the “unknome.” This is significant for clinical laboratory managers because it is part of an investigative effort to better understand the substantial number of genes, and the proteins they build, that have been understudied and of which little is known about their full function.

Scientists at the Medical Research Council Laboratory of Molecular Biology (MRC-LMB) in Cambridge, England, believe these genes are important. They have created a database of thousands of unknown—or “unknome” as they cleverly dubbed them—proteins and genes that have been “poorly understood” and which are “unjustifiably neglected,” according to a paper the scientist published in the journal PLOS Biology titled, “Functional Unknomics: Systematic Screening of Conserved Genes of Unknown Function.”

The Unknome Database includes “thousands of understudied proteins encoded by genes in the human genome, whose existence is known but whose functions are mostly not,” according to a news release.

The database, which is available to the public and which can be customized by the user, “ranks proteins based on how little is known about them,” the PLOS Biology paper notes.

It should be of interest to pathologists and clinical laboratory scientists. The fruit of this research may identify additional biomarkers useful in diagnosis and for guiding decisions on how to treat patients.

Sean Munro, PhD

“These uncharacterized genes have not deserved their neglect,” said Sean Munro, PhD (above), MRC Laboratory of Molecular Biology in Cambridge, England, in a press release. “Our database provides a powerful, versatile and efficient platform to identify and select important genes of unknown function for analysis, thereby accelerating the closure of the gap in biological knowledge that the unknome represents.” Clinical laboratory scientists may find the Unknome Database intriguing and useful. (Photo copyright: Royal Society.)

Risk of Ignoring Understudied Proteins

Proteomics (the study of proteins) is a rapidly advancing area of clinical laboratory testing. As genetic scientists learn more about proteins and their functions, diagnostics companies use that information to develop new assays. But did you know that researchers tend to focus on only a small fraction of the total number of protein-coding DNA sequences contained in the human genome?

The study of proteomics is primarily interested in the part of the genome that “contains instructions for building proteins … [which] are essential for development, growth, and reproduction across the entire body,” according to Scientific American. These are all protein-coding genes.

Proteomics estimates that there are more than two million proteins in the human body, which are coded for 20,000 to 25,000 genes, according to All the Science.

To build their database, the MRC researchers ranked the “unknome” proteins by how little is known about their functions in cellular processes. When they tested the database, they found some of these less-researched proteins important to biological functions such as development and stress resistance. 

“The role of thousands of human proteins remains unclear and yet research tends to focus on those that are already well understood,” said Sean Munro, PhD, MRC Laboratory of Molecular Biology in Cambridge, England, in the news release. “To help address this we created an Unknome database that ranks proteins based on how little is known about them, and then performed functional screens on a selection of these mystery proteins to demonstrate how ignorance can drive biological discovery.”

Munro created the Unknome Database along with Matthew Freeman, PhD, Head of England’s Sir William Dunn School of Pathology, University of Oxford.

In the paper, they acknowledged the human genome encodes about 20,000 proteins, and that the application of transcriptomics and proteomics has “confirmed that most of these new proteins are expressed, and the function of many of them has been identified.

“However,” the authors added, “despite over 20 years of extensive effort, there are also many others that still have no known function.”

They also recognized limited resources for research and that a preference for “relative safety” and “well-established fields” are likely holding back discoveries.

The researchers note “significant” risks to continually ignoring unexplored proteins, which may have roles in cell processes, serve as targets for therapies, and be associated with diseases as well as being “eminently druggable,” Genetic Engineering News reported.

Setting up the Unknome Database

To develop the Unknome Database, the researchers first turned to what has already come to fruition. They gave each protein in the human genome a “knownness” score based on review of existing information about “function, conservation across species, subcellular localization, and other factors,” Interesting Engineering reported.

It turns out, 3,000 groups of proteins (805 with a human protein) scored zero, “showing there’s still much to learn within the human genome,” Science News stated, adding that the Unknome Database catalogues more than 13,000 protein groups and nearly two million proteins. 

The researchers then tested the database by using it to determine what could be learned about 260 “mystery” genes in humans that are also present in Drosophila (small fruit flies).

“We used the Unknome Database to select 260 genes that appeared both highly conserved and particularly poorly understood, and then applied functional assays in whole animals that would be impractical at genome-wide scale,” the researchers wrote in PLOS Biology.

“We initially selected all genes that had a knownness score of ≤1.0 and are conserved in both humans and flies, as well as being present in at least 80% of available metazoan genome sequences. … After testing for viability, the nonessential genes were then screened with a panel of quantitative assays designed to reveal potential roles in a wide range of biological functions,” they added.

“Our screen in whole organisms reveals that, despite several decades of extensive genetic screens in Drosophila, there are many genes with essential roles that have eluded characterization,” the researchers conclude.

Clinical Laboratory Testing Using the Unknome Database

Future use of the Unknome Database may involve CRISPR technology to explore functions of unknown genes, according to the PLOS Biology paper.

Munro told Science News the research team may work with other research efforts aimed at understanding “mysterious proteins,” such as the Understudied Proteins Initiative.

The Unknome Database’s ability to be customized by others means researchers can create their own “knownness” scores as it applies to their studies. Thus, the database could be a resource in studies of treatments or medications to fight diseases, Chemistry World noted.

According to a statement prepared for Healthcare Dive by SomaLogic, a Boulder, Colorado-based protein biomarker company, diagnostic tests that measure proteins can be applied to diseases and conditions such as:

In a study published in Science Translational Medicine, SomaLogic’s SomaScan assay was reportedly successful in predicting the likelihood within four years of myocardial infarction, heart failure, stroke, and even death.

“The 27-protein model has potential as a ‘universal’ surrogate end point for cardiovascular risk,” the researchers wrote in Science Translational Medicine.

Proteomics definitely has its place in clinical laboratory testing. The development of MRC-LMB’s Unknome Database will help researchers’ increase their knowledge about the functions of more proteins which should in turn lead to new diagnostic assays for labs.

—Donna Marie Pocius

Related Information:

Mapping the ‘Unknome’ May Reveal Critical Genes Scientists Have Ignored

How Many Proteins Exist?

Unknome: A Database of Human Genes We Know Almost Nothing About

Functional Unknomics: Systematic Screening of Conserved Genes of Unknown Function

Unknome Database Ranks Proteins Based on How Little is Known about Them

How a New Database of Human Genes Can Help Discover New Biology

The Unknome Catalogs Nearly Two Million Proteins. Many are Mysterious

Into the Unknome: Scientists at MRC LMB in Cambridge Create Database Ranking Human Proteins by How Little We know About Them

Scientists Hope to Illuminate Unknown Human Proteins with New Public Database

Proteomic Tests Empower Precision Medicine

A Proteomic Surrogate for Cardiovascular Outcomes That is Sensitive to Multiple Mechanisms of Change in Risk

Dermatopathologists May Soon Have Useful New Tool That Uses AI Algorithm to Detect Melanoma in Wide-field Images of Skin Lesions Taken with Smartphones

MIT’s deep learning artificial intelligence algorithm demonstrates how similar new technologies and smartphones can be combined to give dermatologists and dermatopathologists valuable new ways to diagnose skin cancer from digital images

Scientists at the Massachusetts Institute of Technology (MIT) and other Boston-area research institutions have developed an artificial intelligence (AI) algorithm that detects melanoma in wide-field images of skin lesions taken on smartphones. And its use could affect how dermatologists and dermatopathologists diagnose cancer.

The study, published in Science Translational Medicine, titled, “Using Deep Learning for Dermatologist-Level Detection of Suspicious Pigmented Skin Lesions from Wide-Field Images,” demonstrates that even a common device like a smartphone can be a valuable resource in the detection of disease.

According to an MIT press release, “The paper describes the development of an SPL [Suspicious Pigmented Lesion] analysis system using DCNNs [Deep Convolutional Neural Networks] to more quickly and efficiently identify skin lesions that require more investigation, screenings that can be done during routine primary care visits, or even by the patients themselves. The system utilized DCNNs to optimize the identification and classification of SPLs in wide-field images.”

The MIT scientists believe their AI analysis system could aid dermatologists, dermatopathologists, and clinical laboratories detect melanoma, a deadly form of skin cancer, in its early stages using smartphones at the point-of-care.  

Luis Soenksen, PhD

“Our research suggests that systems leveraging computer vision and deep neural networks, quantifying such common signs, can achieve comparable accuracy to expert dermatologists,” said Luis Soenksen, PhD (above), Venture Builder in Artificial Intelligence and Healthcare at MIT and first author of the study in an MIT press release. “We hope our research revitalizes the desire to deliver more efficient dermatological screenings in primary care settings to drive adequate referrals.” The MIT study demonstrates that dermatologists, dermatopathologists, and clinical laboratories can benefit from using common technologies like smartphones in the diagnosis of disease. (Photo copyright: Wyss Institute Harvard University.)

Improving Melanoma Treatment and Patient Outcomes

Melanoma develops when pigment-producing cells called melanocytes start to grow out of control. The cancer has traditionally been diagnosed through visual inspection of SPLs by physicians in medical settings. Early-stage identification of SPLs can drastically improve the prognosis for patients and significantly reduce treatment costs. It is common to biopsy many lesions to ensure that every case of melanoma can be diagnosed as early as possible, thus contributing to better patient outcomes.

“Early detection of SPLs can save lives. However, the current capacity of medical systems to provide comprehensive skin screenings at scale are still lacking,” said Luis Soenksen, PhD, Venture Builder in Artificial Intelligence and Healthcare at MIT and first author of the study in the MIT press release.

The researchers trained their AI system by using 20,388 wide-field images from 133 patients at the Gregorio Marañón General University Hospital in Madrid, as well as publicly available images. The collected photographs were taken with a variety of ordinary smartphone cameras that are easily obtainable by consumers.

They taught the deep learning algorithm to examine various features of skin lesions such as size, circularity, and intensity. Dermatologists working with the researchers also visually classified the lesions for comparison.

Smartphone image of pigmented skin lesions

When the algorithm is “shown” a wide-field image like that above taken with a smartphone, it uses deep convolutional neural networks to analyze individual pigmented lesions and screen for early-stage melanoma. The algorithm then marks suspicious images as either yellow (meaning further inspection should be considered) or red (indicating that further inspection and/or referral to a dermatologist is required). Using this tool, dermatopathologists may be able to diagnose skin cancer and excise it in-office long before it becomes deadly. (Photo copyright: MIT.)

“Our system achieved more than 90.3% sensitivity (95% confidence interval, 90 to 90.6) and 89.9% specificity (89.6 to 90.2%) in distinguishing SPLs from nonsuspicious lesions, skin, and complex backgrounds, avoiding the need for cumbersome individual lesion imaging,” the MIT researchers noted in their Science Translational Medicine paper.

In addition, the algorithm agreed with the consensus of experienced dermatologists 88% of the time and concurred with the opinions of individual dermatologists 86% of the time, Medgadget reported.

Modern Imaging Technologies Will Advance Diagnosis of Disease

According to the American Cancer Society, about 106,110 new cases of melanoma will be diagnosed in the United States in 2021. Approximately 7,180 people are expected to die of the disease this year. Melanoma is less common than other types of skin cancer but more dangerous as it’s more likely to spread to other parts of the body if not detected and treated early.

More research is needed to substantiate the effectiveness and accuracy of this new tool before it could be used in clinical settings. However, the early research looks promising and smartphone camera technology is constantly improving. Higher resolutions would further advance development of this type of diagnostic tool.

In addition, MIT’s algorithm enables in situ examination and possible diagnosis of cancer. Therefore, a smartphone so equipped could enable a dermatologist to diagnose and excise cancerous tissue in a single visit, without the need for biopsies to be sent to a dermatopathologist.

Currently, dermatologists refer a lot of skin biopsies to dermapathologists and anatomic pathology laboratories. An accurate diagnostic tool that uses modern smartphones to characterize suspicious skin lesions could become quite popular with dermatologists and affect the flow of referrals to medical laboratories.

JP Schlingman

Related Information:

Software Spots Suspicious Skin Lesions on Smartphone Photos

An Artificial Intelligence Tool That Can Help Detect Melanoma

Using Deep Learning for Dermatologist-level Detection of Suspicious Pigmented Skin Lesions from Wide-field Images

Proof-of-Concept Study at University of Colorado Boulder Shows Dynamic Tattoos Can Help Detect and Track Health Issues

If tattoos can accurately be used in the diagnostic process, might clinical laboratories soon offer these types of diagnostic tattoos at their patient service centers?

Could color-changing tattoos help diagnose illnesses? Researchers at the ATLAS Institute at the University of Colorado Boulder think so. They are working on prototypes of permanent tattoos that can detect chemical changes in the body and smart tattoo ink that would take the concept of wearable medical devices to a whole new level.

Called “dynamic” or “smart” tattoos, these color-changing tattoos have a biomedical purpose. They alert individuals to potential health issues due to changes in the biochemistry in their body. The technology has already been used in animal studies to detect sodium, glucose, electrolytes, and pH levels. Pathologists and clinical lab manager will recognize the value of a relatively non-invasive way to measure and track changes in these types of biomarkers.

The ATLAS Institute published its findings in ACS Nano, a publication of the American Chemical Society, titled, “Solar Freckles: Long-Term Photochromic Tattoos for Intradermal Ultraviolet Radiometry.”

“We developed a photochromic tattoo that serves as an intradermal ultraviolet (UV) radiometer that provides naked-eye feedback about UV exposure in real time. These small tattoos, or ‘solar freckles’, comprise dermally implanted colorimetric UV sensors in the form of nano encapsulated leuco dyes that become more blue in color with increasing UV irradiance,” the ATLAS scientists wrote.

Studies analyzing the efficacy of dynamic tattoos have provided strong evidence that they can be engineered to change color and sense and convey medical information. This field is called “dynamic tattoos” and in recent years various proof-of-concept studies have demonstrated that tattoos can be used to “pick up changes in sodium, glucose, electrolytes or pH levels in animal models,” Labroots reported.

“We demonstrate the tattoos’ functionality for both quantitative and naked-eye UV sensing in porcine skin ex vivo, as well as in human skin in vivo. Solar freckles offer an alternative and complementary approach to self-monitoring UV exposure for the sake of skin cancer prevention,” the researchers explained in their ACS Nano article.

“Activated solar freckles provide a visual reminder to protect the skin, and their color disappears rapidly upon removal of UV exposure or application of topical sunscreen. The sensors are implanted in a minimally invasive procedure that lasts only a few seconds yet remain functional for months to years,” they added.

“These semipermanent tattoos provide an early proof-of-concept for long-term intradermal sensing nanomaterials that provide users with biomedically relevant information in the form of an observable color change,” the ATLAS researchers concluded.

Nanotechnology Gives Dynamic Tattoos Functionality

“When you think about what a tattoo is, it’s just a bunch of particles that sit in your skin,” Carson Bruns, PhD, Assistant Professor, Laboratory for Emergent Nanomaterials, ATLAS Institute, Mechanical Engineering, told Technology.org. “Our thought is: What if we use nanotechnology to give these particles some function?”

The invisible tattoos Bruns and the ATLAS team created turn blue in the presence of harmful levels of ultraviolet radiation to inform wearers that their skin needs protection and to apply or reapply sunscreen.

Carson Bruns, PhD

“I have always been interested in both art and science. My favorite type of art is tattooing and my favorite type of science is nanotechnology,” Carson Bruns, PhD (above), Assistant Professor, Mechanical Engineering, ATLAS Institute, told Inked. “When I had an opportunity to start a new research program, I thought it would be really fun and interesting to try and put the two together.” Might innovative medical laboratories one day operate “tattoo parlors” in their patient service centers to provide patients with tattoos that monitor key biometrics? (Photo copyright: Inked.)

The tattoo ink used for these tattoos contains a UV-activated dye inside of a plastic nano capsule that is less than a thousandth of a millimeter in size, or several sizes smaller than the width of a human hair. The capsules protect the dyes from wear and tear while allowing them to sense and respond to biochemical changes in the body. These tattoos are implanted into the skin using tattoo machines, much like getting a regular tattoo.

“I call them solar freckles because they’re like invisible freckles that are powered by sunshine,” Bruns told Inked, adding, “Millions of cases of preventable skin cancer are treated every year. I hope that the UV-sensitive tattoo will help us reduce the number of those cases by reminding people when their skin is exposed to unsafe levels of UV light.”

Dynamic Tattoos May Help People Lead Healthier Lives

One downside to these tattoos is that they only last a few months before they begin to degrade, requiring the wearer to get a “booster” tattoo.

The researchers hope that someday similar tattoo technologies will be applied to a wide variety of preventative and diagnostic applications. The goal is to enable people to detect health issues and allow them to lead healthier lives. 

“We want to make tattoos that will allow you to, for example, sense things that you can’t currently sense,” Bruns told Inked. “Sometimes I joke that we want to make tattoos that give you superpowers.”

The ATLAS scientists imagine a future where tattoos can detect things like blood alcohol levels or high/low blood sugar levels or other changes in a person’s biochemistry.

“More generally, I hope that smart tattoos will help people stay healthy and more informed about their body, while also giving people new ways to express themselves creatively,” Bruns said.

Using Dynamic Tattoo to Detect Cancer

In 2018, a team of biologists created a tattoo comprised of engineered skin cells and an implantable sensor which could detect elevated blood calcium levels that are present in many types of cancers. These cancer-detecting tattoos were tested on living mice and would darken to notify researchers of potential problems.

Scientists at the Department of Biosystems Science and Engineering at the Swiss Federal Institute of Technology Zurich (ETHZ), Switzerland, developed a biomedical tattoo that uses bio sensitive ink and changes color based on variations in the body’s interstitial fluid. It recognizes four widespread cancers:

  • breast,
  • colon,
  • lung, and
  • prostate.

“Nowadays, people generally go to the doctor only when the tumor begins to cause problems. Unfortunately, by that point it is often too late,” Martin Fussenegger, PhD, Professor of Biotechnology and Bioengineering at the Department of Biosystems Science and Engineering (D-​BSSE) of the ETH Zurich in Basel as well as at the University of Basel, told Medical News Today.

“For example, if breast cancer is detected early, the chance of recovery is 98%,” he continued. “However, if the tumor is diagnosed too late, only one in four women has a good chance of recovery.”

Fussenegger and his team hope their specialized biomedical tattoo may help detect the presence of cancer cells early and significantly improve patient outcomes. They published the results of their research in the journal Science Translational Medicine, titled, “Synthetic Biology-Based Cellular Biomedical Tattoo for Detection of Hypercalcemia Associated with Cancer.”

Though it appears that dynamic tattoos may be a functional and decorative way to track health, rigorous research and safety testing on human subjects will be required before clinical laboratories can set up diagnostic tattoo parlors in their offices.

Nevertheless, this concept demonstrates how different technologies under development may provide clinical laboratories with innovative and unusual diagnostic tools in the future.

JP Schlingman

Related Information

A Smart Tattoo That Could Save Your Life

‘Smart’ Tattoo Inks That Could Save Your Life

Color-changing Tattoos? One Could Save Your Life

Solar Freckles: Long-Term Photochromic Tattoos for Intradermal Ultraviolet Radiometry

Inked Talks to the Creator of the New “Smart Tattoo” That Can Indicate When You Need to Reapply Sunscreen

‘Chameleon’ Tattoos Change Color, May Help Diagnose Illness

Dynamic Tattoos Promise to Warn Wearers of Health Threats

Epidermal Electronics—A Step Closer to Wearable Diagnostic ‘Labs’

‘Biomedical Tattoo’ Might Catch Cancer Early

Synthetic Biology-based Cellular Biomedical Tattoo for Detection of Hypercalcemia Associated with Cancer

New Test Under Development That Detects Breast Cancer within One Hour with 100% Accuracy Has Potential to Help Pathologists Deliver More Value

Such a test, if proved safe and accurate for clinical use, could be a useful diagnostic tool for anatomic pathologists

What would it mean to anatomic pathology if breast cancer could be diagnosed in an hour from a fine needle aspiration (FNA) rather than a core biopsy? A new test created by researchers affiliated with Massachusetts General Hospital in Boston may be just such a game changer. Especially in remote locations where clinical laboratory resources are in short supply.

Regardless of how the next round of research and clinical studies turn out, one reason this development is significant is that it demonstrates how newer technologies and analytical software are being combined to create a faster diagnostic test for different types of cancer.

Another benefit to this research is that it may utilize simpler, less expensive instruments. In fact, the researchers said this test can be performed for about $5. For these reasons, pathologists may want to follow the progress of these researchers as they work to improve this test so it can be used in clinical care.

Affordable Image Cytometry of FNA Specimens

Though still in development, the new image cytometry system, dubbed CytoPAN, has demonstrated the ability to diagnose breast cancer within a one-hour time frame, and, according to the study published in Science Translational Medicine, “is devoid of moving parts for stable operations, harnesses optimized antibody kits for multiplexed analysis, and offers a user-friendly interface with automated analysis for rapid diagnoses.”

The international researcher team included scientists from:

“Here, we report the development and validation of an affordable image cytometry system that allows automated and same-day molecular analyses of fine needle aspiration (FNA) specimens. Termed CytoPAN, for portable fluorescence-based image cytometry analyzer, the system performs multichannel imaging for cancer diagnosis and subtyping,” the researchers wrote.

The CytoPAN technique is minimally invasive, they note, and only requires a few cellular specimens to determine if breast cancer cells are present, with results available in one hour.

CytoPAN rapid diagnostic tool for cancer diagnosis.
The researchers are hopeful the CytoPAN diagnostic tool (above) can be a valuable resource in developing countries and remote areas where patients face long wait times before receiving a cancer diagnosis. In these areas, diagnoses typically come after advanced symptoms, such as palpable mass lesions and malaise, become present, which can have a negative impact on patient outcomes. And anatomic pathologists worldwide would benefit greatly from such an advance in cancer diagnostics. (Photo copyright: Jouha Min, Lip Ket Chin Center for Systems Biology, Massachusetts General Hospital.)

“Unfortunately, in many low- and middle-income countries, [breast cancer] diagnosis often takes an extraordinarily long time—up to a few months—due to a lack of specialists and limited laboratory infrastructure,” Hyungsoon Im, PhD, Assistant Professor at Harvard Medical School and one of the researchers involved in the project, told United Press International (UPI).

“From a public health aspect, it is critically important to develop new diagnostic methods that overcome these barriers,” he added.

Because FNA testing is less invasive than surgical biopsy collection, it has fewer complications and is generally considered safe. Thus, it is “feasible to be performed even in resource-limiting settings at much lower costs,” Im told UPI. “This could lead to earlier treatment and accelerate new drug testing in clinical trials.”

CytoPAN Testing and Additional Trials

The researchers tested CytoPAN on 68 breast cancer patients in South Korea.

“To determine the clinical utility of the approach,” they wrote in the published study, “we next conducted a prospective clinical study in which the FNA could be directly compared to conventional pathology results. We enrolled treatment-native patients at the Kyungpook National University Chilgok Hospital (Daegu, South Korea) and who were referred for primary surgery. All patients consented to have a preoperative breast FNA before clinically indicated surgery. The breast masses were visualized by ultrasound or computed tomography, and a coaxial needle was introduced through which FNA samples (CytoPAN) and core biopsies were obtained. Surgical specimens and/or core biopsies were processed by routine pathology and served as the gold standard.”

The CytoPAN platform detected the presence of breast cancer cells with a 100% accuracy, using as few as 50 harvested cells per collected specimen.

The test also successfully identified two key breast cancer biomarkers:

 “We are also preparing additional trials in the US and other countries,” Im told UPI. “The success in those trials will (hopefully) accelerate … widespread adoption of the technology.”

The researchers are currently testing CytoPAN on a larger number of patients in Botswana, with funding from the US federal National Institutes of Health (NIH).

According to the American Cancer Society (ACS), approximately 300,000 individuals are diagnosed with breast cancer annually in the US. The Union for International Cancer Control (UICC) states on their website that, globally, there are more than two million new cases of breast cancer diagnosed each year. And more than 600,000 people died from breast cancer worldwide in 2018. A disproportionate number of those deaths occurred in developing countries that have limited resources to diagnose and treat the disease.

Additional Research for Other Applications in Cancer Testing and Pathology

The new CytoPAN technology requires minimal training, according to the researchers, and only costs about $5 per test kit. This is substantially less expensive than the price associated with other tests available on the market, UPI noted.

Though additional research and clinical trials are needed before CytoPAN will be available for widespread clinical use, a cost-effective, relatively non-invasive test that can accurately diagnose cancer within an hour would be transformational for anatomic pathology and, potentially, could save many lives.

—JP Schlingman

Related Information:

CytoPAN—Portable Cellular Analyses for Rapid Point-of-care Cancer Diagnosis

System Provides ‘Faster, Less Invasive’ Method for Breast Cancer Detection

Cheap, Fast Breast Cancer Test 100% Accurate, Study Finds

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