Level 3 bio labs handle Ebola, smallpox and other deadly diseases, and may play a role in research into the human genome
Because of the COVID-19 pandemic, there is a concerted effort to improve public health laboratories and increase the growth of bioresearch. Clinical laboratories across the country are required by law to send specimens of certain infectious diseases to public health labs for testing and analysis. The results of those tests are then reported to the federal Centers for Disease Control and Prevention (CDC), which is working to foster robust connections and relationships between clinical labs and public health labs.
A land transaction for a 1.6-acre purchase between Dallas County and TXRE Properties closed in April. The development of the lab is expected to cost $52 million and should be completed by late 2025 with occupancy as early as January 2026.
The graphic above is an artist rendering of what the new Dallas County Health and Human Services Public Health Laboratory may look like. For some time now, Dallas County has been working to create a hub centered around infrastructure and buildings to be used for bio development and research, public health labs, and even clinical laboratories. (Graphic copyright: 5G Studio Collaborative.)
Continuing Support for HHS
“The large-scale response required for COVID-19 demonstrated the need for the acquisition that will permit the continued support of the HHS efforts in response to the ongoing safety, containment, incident response to emerging and high consequence diseases that could operate at the peak of a crisis without hindering or being hindered by other county operations,” states a Dallas County Commissioners Court Order, D Magazine reported.
“The county currently utilizes owned facilities to provide laboratory services, testing services, and other initiatives,” according to the court order. “These facilities have performance and design shortcomings and have required significant capital expenditure for their ongoing use.
“To avoid leasing space and avoid additional capital investment into deferred and ongoing maintenance, the county has been searching for a suitable location/acquisition to collocate uses/departments into a centralized, efficient, and suitable laboratory,” the court order continued.
Lab Will Conduct Research into Potentially Fatal Diseases
The facility will pursue becoming a Biological Safety Level-3 laboratory. BSL-3 labs typically conduct research or work on microbes that can cause serious and potentially fatal disease through inhalation. These labs are required to be easily decontaminated. They must also have additional safety measures, including interlocked doors, sealed windows, floors, and walls, and filtered ventilation systems.
“The core diagnostic functions are—along with safety—related to identification, containment, security, and incident response to emerging and high consequence diseases,” the court order notes.
A Georgetown University article published last year concluded there are 148 institutions with BSL-3 laboratories in the US. This number was established by identifying and totaling the number of BSL-3 facilities that published research between 2006 and 2021 using PubMed Central, a full-text archive of biomedical and life sciences journal literature at the US National Institutes of Health’s National Library of Medicine (NIH/NLM).
The creation of this new biosafety lab in Dallas is consistent with the trend of investment dollars being poured into research into the human genome. This type of research, along with the creation of new facilities, can directly lead to new biomarkers that can be utilized in clinical laboratory testing and disease prevention.
Not the first smart diaper to come along, but consumers seem unready for diapers that can flag urinary tract infections and other biomarkers usually tested by clinical laboratories
Will wonders never cease? For centuries, parents had only their own senses to determine when infants needed diaper changing. Today, however, caregivers can rely on “smart diapers” to send alerts when a diaper is soiled. Crying, smelly babies may no longer be the gold standard in diaper management. But are smart diapers practical?
The sensor array is “so cheap and simple” it “could clear the way for wearable, self-powered health monitors for use not only in ‘smart diapers’ but also to predict major health concerns like cardiac arrest and pneumonia,” a Penn State new release noted.
However, clinical laboratory managers following similar developments probably know that this is not the first scientific effort to develop a smart diaper that uses some type of sensor to detect a biomarker and issue an alert to the wearer or caregivers.
“Our team has been focused on developing devices that can capture vital information for human health,” said Huanyu “Larry” Cheng, PhD (above), the James L. Henderson, Jr. Memorial Associate Professor of Engineering Science and Mechanics at Penn State in a news release. “The goal is early prediction for disease conditions and health situations, to spot problems before it is too late.” This is yet another example of how researchers are working to take more testing out of clinical laboratories and offer unique assays that can be used as wearables—whether as a diaper, a skin patch, or a smart watch. (Photo copyright: Penn State University.)
This Smart Diaper Is as Simple to Use as Paper and Pencil
The Penn State sensor array takes advantage of how paper naturally reacts to wetness and utilizes the graphite in pencil marking to interact with the water molecules and sodium chloride.
Once the water molecules are absorbed by the paper, the sodium chloride solution becomes ionized and electrons start to stream towards the graphite. This movement sets off the sensor, which is extremely sensitive to humidity. According to the study, the sensor can provide accurate readings over a wide range of humidity levels, from 5.6% to 90%.
“We wanted to develop something low-cost that people would understand how to make and use, and you can’t get more accessible than pencil and paper,” said Li Yang, PhD, a professor in the School of Artificial Intelligence at China’s Hebei University of Technology and one of the authors of the study, in the Penn State news release.
“You don’t need to have some piece of multi-million-dollar equipment for fabrication. You just need to be able to draw within the lines of a pre-drawn electrode on a treated piece of paper. It can be done simply and quickly.”
The diaper is connected to a tiny lithium battery. When the sensor recognizes an increase in humidity the battery powers transmission of the change to a smartphone via Bluetooth technology. This notification informs caregivers that it is time to change the diaper.
“That application was actually born out of personal experience,” explained Huanyu “Larry” Cheng, PhD, James L. Henderson, Jr. Memorial Associate Professor of Engineering Science and Mechanics at Penn State, one of the authors of the study and father to two young children. “There’s no easy way to know how wet is wet, and that information could be really valuable for parents. The sensor can provide data in the short-term, to alert for diaper changes, but also in the long-term, to show patterns that can inform parents about the overall health of their child.”
Do Consumers Want Smart Diapers?
Research into such wearable sensors has been gaining momentum in the scientific community as a novel way to detect and deal with several medical conditions. The Penn State team hopes that devices such as their smart diaper can be used in the future to alert caregivers about the overall health of their children and clients.
“Our team has been focused on developing devices that can capture vital information for human health,” Cheng said. “The goal is early prediction for disease conditions and health situations, to spot problems before it is too late.”
Previous research teams have had similar smart diaper goals.
However, these types of products have yet to gain significant popularity with consumers. Regardless, sales projections for smart diapers remain positive.
According to a MarketsandMarkets report, the smart diaper market, estimated to be $646 million (US) in 2021, is expected to surpass $1.5 billion by 2026. The demand for smart diapers, the report notes, is increasing due to:
Growing elderly populations,
Rising disposable incomes,
Increasing personal hygiene awareness,
Growing populations in emerging countries, and
Expanding preference for advanced technology when it comes to health.
So, it’s uncertain if consumers are now ready for a device in their baby’s diaper telling them it’s time for a change. Regardless, researchers will likely continue developing tools that combine new diagnostics with existing products to help people better understand and monitor their health and the health of their loved ones.
Meanwhile, clinical laboratory managers and pathologists can remain on the alert for future published studies and press releases announcing new wearable items containing sensors, such as smart diapers. The unanswered question is whether both consumers and healthcare professionals will consider these novel inventions useful devices in the care of young and old alike.
NIH program could lead to new diagnostic biomarkers for clinical laboratory tests across a more diverse segment of US population
In another milestone in the US National Institutes of Health’s (NIH) plan to gather diverse genetic information from one million US citizens and then use that data to inform clinical care in ways consistent with Precision Medicine, the NIH’s All-of-Us Research Program announced in a news release it has “begun returning personalized health-related DNA results” to more than 155,000 study participants.
In addition, those participants who request them will receive genetic reports that detail whether they “have an increased risk for specific health conditions and how their body might process certain medications.”
The All-of-Us program, which began enrolling people in 2018, is one of the world’s largest—if not the largest—project of its kind. It could result in more than a million human whole genome sequences to drive medical research and speed discoveries. Study findings, for example, may produce new biomarkers for clinical laboratory tests and diagnostics.
In 2020, the All-of-Us program “had begun releasing genetic results for ancestry and a small number of nonclinical genetic traits,” according to GenomeWeb. Now, the program is taking on the greater challenge of sharing health-related genetic test results directly with its participants.
“We really wanted to make sure that we are providing a responsible return to our participants,” Anastasia Wise, PhD, All-of-Us Program Director for the Genetic Counseling Resource, told GenomeWeb. “They might get information that’s unexpected,” she explained.
So far, about 10,000 people received the NIH’s invitation and 56% have shown interest in receiving their genetic test results, GenomeWeb noted.
“Knowledge is powerful,” said Josh Denny, MD (above), Chief Executive Officer, NIH All-of-Us Research Program, in an NIH news release. “By returning health-related DNA information to participants, we are changing the research paradigm, turning it into a two-way street—fueling both scientific and personal discovery that could help individuals navigate their own health,” he added. The NIH’s research could lead to new clinical laboratory precision medicine diagnostics for chronic diseases across a more diverse segment of the US population. (Photo copyright: National Institutes of Health.)
Two Types of Genetic Health Reports
Study participants who provided a blood sample and gave their consent to receiving genomic information may also receive a Hereditary Disease Risk report that includes 59 genes and genetic variants linked to serious and “medically actionable” health conditions.
About 3% to 5% of participants will have findings suggesting a high risk for a genetic disease such as breast and ovarian cancers as indicated by BRCA1 and BRCA2 genes, Medical Xpress reported.
“I kind of shudder to think about what could happen if I hadn’t known this [finding that she has the BRCA2 gene],” said Rachele Peterson, All-of-Us Chief of Staff, who spoke to the Associated Press about her receiving own Hereditary Disease Risk report.
Participants can also choose to receive an All-of-Us Medicine and Your DNA report with insights on seven genes that affect how specific medications are metabolized. This pharmacogenetics report is important for those who could learn, for example, that they have a 50% to 60% greater risk of a second heart attack when they continue to take the standard medication, as opposed to a different medication, Medical Xpress noted.
“The information on metabolizing medication can be particularly important for people who need treatment after a heart attack,” Josh Denny, MD, Chief Executive Officer, NIH All-of-Us Research Program, told Medical Xpress.
“Such transparency of genetic information about a massive group—as well as the genetic information on individuals—can be used to improve patient care and clinical outcomes,” said Robert Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report.
“The program provides a roadmap for other healthcare organizations to follow. And this is useful strategic knowledge for clinical laboratory leaders to understand and incorporate into their plans to support precision medicine with genetic testing and whole human genome sequencing,” Michel added.
Rich Genetic Data Across a More Diverse Population
As to its goal to reflect national diversity, NIH reported about 80% of All-of-Us participants reside in communities that have been unrepresented in medical research, and that 50% are part of a racial or ethnic minority group.
By combining this information into a single database, the MVP promises to advance knowledge about the complex links between genes and health, according to an MVP news release.
Researchers tapping All-of-Us and MVP data may ultimately produce enlightening and impactful study findings, which could enable clinical laboratories to perform new diagnostic precision medicine tests that identify diseases early and save lives.
Encouraging patients—even children—to be more directly involved in their own medical care may reduce the burden on healthcare workers and might even help those clinical laboratories struggling to hire enough phlebotomists to collect specimens
Researchers at Emory University School of Medicine have concluded a study which found that school-aged children can successfully use a nasal swab to obtain their own SARS-CoV-2 test specimens. This may come as a surprise to hospital and clinical laboratory personnel who have performed nasal swabbing for COVID-19 tests. Some people, adults included, find the procedure so uncomfortable it brings tears.
And yet, after being shown a 90-second how-to video and given a handout with written instructions and pictures, 197 Atlanta children who had COVID-19 symptoms between July and August of 2021 performed their own self-swabbing. A healthcare worker then collected a second swabbed sample. All samples were submitted to a clinical laboratory for PCR analysis.
The Emory study provides another example of how the healthcare system is engaging patients to be directly involved in their own medical care. Results of the study could positively impact clinical laboratories facing a shortage of personnel, as well as schools where children have to take repeated COVID-19 tests with the assistance of trained professionals.
In a study with 197 school-age children, researchers at Emory University School of Medicine found that children could self-swab themselves for COVID-19 testing after watching a 90-second instructional video. Clinical laboratory leaders who are short on personnel may find these results intriguing. (Photo copyright: Emory University.)
How Did the Children Do?
The self-collected swabs and those collected by a healthcare worker agreed 97.8% of the time for a positive result and 98.1% of the time for a negative result. The analysis showed that both collection methods identified the 44% of symptomatic kids who were positive for COVID-19.
“Seeing how closely the results line up between the children and trained healthcare workers is a strong indicator that these age groups are fully capable of swabbing themselves if given proper instruction,” said Jesse Waggoner, MD, an Assistant Professor of Infectious Diseases with the Emory University School of Medicine and one of the lead authors on the study, in an Emory University press release.
A higher percentage of children age eight and under needed assistance, such as more instruction before correctly completing self-collection—21.8% compared to 6.1% for children older—but SARS-CoV-2 detection among the two age groups did not differ.
Does FDA Approve of Self-Swabbing?
The US Food and Drug Administration (FDA) has not authorized COVID-19 tests that include self-swabbing by children under age 14. However, data from the Emory study, published in JAMA, is now available to test manufacturers seeking authorization for pediatric self-collection.
“Pediatric self-swabbing will support expanded testing access and should make it even easier to test school age populations with fewer resources,” said Tim Stenzel, MD, PhD, Director of the Office of In Vitro Diagnostics at the FDA, in the Emory statement. “This study furthers our knowledge of test accuracy with these types of samples and provides test manufacturers with data to support their EUA (Emergency Use Authorization) requests to the FDA.”
Self-swabbing versus Clinical Laboratory Worker
While it has been longstanding medical practice to have healthcare workers collect samples for respiratory tract infection testing, the Emory researchers suggest that allowing children to collect their own COVID-19 samples could be one way to reduce the burden of a shortage of healthcare workers.
The researchers also believe pediatric self-swabbing would expand access to diagnostic tests and make it easier to test school-age populations.
“Every minute of a healthcare worker’s time is at a premium,” said senior study author Wilbur Lam, MD, Professor of Pediatrics and Biomedical Engineering, Emory University and Georgia Tech, in a National Institutes of Health (NIH) press release. “Why not allow a kid to self-swab? It’s a win-win! They would rather do it themselves and it frees up the healthcare worker to do other things,” he added.
In 2020, a Stanford University School of Medicine study published in JAMA showed test samples collected by adults who swabbed their own nasal passages were as accurate as those collected by healthcare workers. This study involved 30 participants who had previously tested positive for COVID-19.
Though the Emory University and Stamford University studies were small, they agreed in their findings which is significant. Clinical laboratory executives and pathologists should expect this trend toward direct-to-consumer and other forms of self-testing to continue, even among young patients.
Although there are healthcare providers who see the potential in microbiome testing, many clinical laboratories are not yet ready to embrace microbiome-based testing
In an unlikely string of events, no less than Nordstrom, the national department store chain, announced in September that it would offer microbiome-based test claimed to “check gut health.” Apparently, its customers were interested in this clinical laboratory test, as the Nordstrom website currently indicates that the “Health Intelligence Test Kit by Viome” is already sold out!
What does it say about consumer interest in clinical laboratory self-testing that Nordstrom has decided to offer at-home microbiome tests to its store customers? Can it be assumed that Nordstrom conducted enough marketing surveys of its customers to determine: a) that they were interested in microbiome testing; and b) they would buy enough microbiome tests that Nordstrom would benefit financially from either the mark-up on the tests or from the derived goodwill for meeting customer expectations?
Whatever the motivation, the retail giant recently announced it had partnered with Viome Life Sciences to sell Viome’s microbiome testing kits to its customers online, and in 2022, at some Nordstrom retail locations. These tests are centered around helping consumers understand the relationship between their microbiome and nutrition.
Pathologists and clinical laboratories will want to track Nordstrom’s success or failure in selling microbiome-based assays to its consumers. Microbiomics is in its infancy and remains a very unsettled area of diagnostics. Similarly, Viome, a self-described precision health and wellness company that conducts mRNA analysis at scale, will need to demonstrate that its strategy of developing precision medicine diagnostics and therapeutics based on the human microbiome has clinical relevance.
Helping Consumers with ‘Precision Nutrition’
In a September news release, Viome founder and CEO Naveen Jain, a serial entrepreneur, said, “Both Viome and Nordstrom believe that true health and beauty start from within. There is no such thing as a universal healthy food or healthy supplement. What is right for one person can be wrong for someone else, especially when it comes to nutrition which is key to human longevity and vitality. Precision nutrition is the future!”
“Precision medicine seeks to improve the personalized treatment of diseases, and precision nutrition is specific to dietary intake. Both develop interventions to prevent or treat chronic diseases based on a person’s unique characteristics like DNA, race, gender, health history, and lifestyle habits. Both aim to provide safer and more effective ways to prevent and treat disease by providing more accurate and targeted strategies.
“Precision nutrition assumes that each person may have a different response to specific foods and nutrients, so that the best diet for one individual may look very different than the best diet for another.
“Precision nutrition also considers the microbiome, trillions of bacteria in our bodies that play a key role in various daily internal operations. What types and how much bacteria we have are unique to each individual. Our diets can determine which types of bacteria live in our digestive tracts, and according to precision nutrition the reverse is also true: the types of bacteria we house might determine how we break down certain foods and what types of foods are most beneficial for our bodies.”
Medical Laboratory Testing, not Guessing
Viome Life Sciences is a microbiome and RNA analysis company based in Bellevue, Wash. The test kit that Nordstrom is selling is called the Health Intelligence Test. It is an at-home mRNA test that can provide users with some insights regarding their health. Consumers use the kit to collect blood and fecal samples, then return those samples to Viome for testing.
In a press release announcing its collaboration with Nordstrom, Viome said, “In a world overwhelmed by information relating to diet and supplement advice, Viome believes in testing, not guessing and empowering its users with actionable insights. To date, Viome has helped over 250,000 individuals improve their health through precision nutrition powered by microbial and human gene expression insights.”
Nordstrom began offering Viome’s Health Intelligence Test kit for $199 on its website starting in September. As of this writing and noted above, the kits are sold out. Nordstrom plans to stock the kit in select stores starting in 2022.
Viome’s Health Intelligence Test kit (above) looks at the microbiome to determine gut health, cellular health, healthy aging, immune health, and stress responses. Test results offer consumers personalized nutritional suggestions and recommendations for supplements, probiotics, and prebiotics based on an individual’s biology. Test are performed by Viome’s own clinical laboratories and results sent directly to Nordstrom’s customers. (Photo copyright: Viome Life Sciences.)
Individuals who purchase the test submit blood and stool samples to Viome’s lab which performs an analysis of gene activity patterns in the user’s cells and microbiome. Viome provides the results to consumers within two to three weeks.
“This partnership is a giant step towards making our technology more accessible, so people can understand what’s right for their unique body,” Jain said in the news release. “We are inspired each day by the incredible changes our customers are seeing in their health including improvements in digestion, weight, stress, ability to focus, and more.”
According to the news release, Viome conducted blind studies earlier this year that revealed significant successes based on their precision nutritional approach to wellness. Study participants, Viome claims, improved their outcomes to four diseases through nutrition:
Is Microbiome Diagnostics Testing Ready for Clinical Use?
Microbiomics is a relatively new field of diagnostics research. Much more research and testing will be needed to prove its clinical value and efficacy in healthcare diagnostics. Nevertheless, companies are offering microbiomics testing to consumers and that has some healthcare providers concerned.
In the GeekWire article, David Suskind, MD, a gastroenterologist at Seattle Children’s Hospital and Professor of Pediatrics at the University of Washington, described Viome’s study methodology as “questionable,” adding, “I think this is a very interesting and exciting space and I do think there are definite potential implications, down the road. [However] we are not there in terms of looking at microbiome and making broad recommendation for individuals, as of yet.”
Will at-home clinical laboratory testing kits that analyze an individual’s microbiome someday provide data that help people lead healthier lives and ward off diseases? That’s Jain’s prediction.
In an article published in Well+Good, Jain said, “COVID-19 has, of course, been such a dark time, but one positive that did come from it is that more people are taking control of their own health. I really believe that the future of healthcare will be delivered not at the hospital, but at home.”
If this collaboration between Nordstrom and Viome proves successful, similar partnerships between at-home diagnostics developers and established retail chains may become even more common. And that should be on the radars of pathologists and clinical laboratories.
