Dec 8, 2017 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Digital Therapeutics combined with clinical laboratory oversight testing could help chronic disease patients avoid surgeries and expensive drug therapies
One area of technology that has fundamentally changed the healthcare industry involves mobile devices. But those early “wellness” tools have evolved. Today’s modern mobile health devices feature software applications (apps) designed to remotely treat chronic conditions by helping modify patient behavior, as well as monitoring drug intake and physical condition biomarkers. These devices are dubbed “Digital Therapeutics,” and they present opportunities for anatomic pathology groups and clinical laboratories.
For if mobile apps are going to be used to monitor patients’ adherence to therapy—including prescription drugs—there will be a need for clinical laboratory tests that work in harmony with these apps. Otherwise, how will providers and insurers know for certain patients’ biomarkers have improved or regressed?
Massive Investments in Digital Therapeutics Companies
Today’s digital therapeutics (AKA, software for drugs) can be tailor to specific treatments of chronic conditions, such as:
· diabetes mellitus;
· cardiovascular disease;
· hypertension; and,
· chronic obstructive pulmonary disease (COPD).
Forbes states that the “future of healthcare will be app based.” That seem likely given the massive influx of capital being directed at the mobile healthcare industry.
The graphic above is taken from a 2015 report by PricewaterhouseCoopers Health Research Institute (PwC), which sourced the data from the 2014 clinician workforce and consumer surveys. Since then, the demand for mHealth products has increased exponentially. Today’s digital therapeutics market includes clinical laboratory and pathology group treatments and drug therapies. (Graphic copyright: PwC.)
The global digital therapeutics market is projected to grow to about $9 billion by 2025. That’s up from $1.7 billion last year, according to a report by Grand View Research. Driving the popularity of digital therapeutics are the benefits it affords patients, explained the report’s summary. They include:
· Continuous monitoring of vital signs;
· Medication management; and,
· Current healthcare reminders.
This is where pathologists and clinical laboratories come in. The medical laboratory can be the source for baseline blood tests before apps are used. And then, ongoing testing can determine if patients are taking drugs according to treatment guidelines and making the appropriate lifestyle changes.
Start-ups Raise Millions, Define Digital Therapeutics Space
One unique aspect of digital therapeutics is its ability to promote health improvements through behavioral changes alone. And millions are being invested in the concept.
For example, Virta Health Corp. raised $37 million in funding for an app that coaches diabetics on a diet to reverse their condition without drugs or surgery, according to MIT Technology Review.
“[Digital therapeutics] is still a fluid space that everyone is trying to categorize,” Peter Hames, co-founder and Chief Executive Officer of Big Health noted in the MIT Technology Review article. Among other programs, Big Health developed Sleepio, a sleep improvement program or insomnia app. Hames says most apps fall into two categories: “medication augmentation” or “medication replacement.”
Omada Health secured $127 million to conduct a clinical trial with Humana that investigates prediabetes, noted Forbes.
The study findings, which appeared in the Journal of Aging and Health, suggest that Omada Health’s digital behavior change program can help people to reduce chronic disease risk, noted a Humana news release.
The study involved Humana Medicare Advantage insurance members, who were enrolled in Omada Health’s Diabetes Prevention Program. The app enabled them to partake in online courses, use wireless scales, and tap other digital health tools as they worked to improve health and reduce risk of type 2 diabetes. Human coaches also were accessible.
“Few efforts have explored the feasibility and effectiveness of using technology to deliver diabetes prevention programs specifically for older adults,” the study researchers wrote.
According to the researchers:
· 501 people with average weight of 208 pounds participated;
· Hour-long lessons were made available and expected to be completed by smartphone, laptop, or tablet;
· Coaches monitored the information participants provided and their requests for counseling;
· 92% of participants completed at least nine of the 16 core online courses, which focused on topics such as changing food habits and increasing physical activities;
· People lost 7.5% of body weight after 12 months, or 13 to 14 lbs.;
· A subsample (69 individuals) who had lab tests performed improved glucose control as evidenced by a -0.14% reduction in glycosylated hemoglobin, and a decrease of -7.08 mg/dL in total cholesterol.
“These results support the clinical validity of the program with Medicare-eligible, at risk older adults. They are added evidence that chronic disease risk reduction is achievable through a variety of modalities, including digital-based programs with human coaching,” the researchers noted.
And because digital therapeutics amasses data that can be leveraged, Omada Health’s program acts as a “continuous learning system,” Sean Duffy, Omada Health’s co-founder and Chief Executive Officer, noted in Undark.
App Tracks People After Heart Attack
Johns Hopkins Medicine’s Corrie Health app is aimed at helping patients recover from heart attacks. A study at Johns Hopkins Bayview Medical Center in Baltimore explored the effectiveness of app-enabled information and resources made available to patients early in the heart attack recovery process, according to Corrie Health’s Website.
Results from the clinical study of 50 patients show no one was readmitted to hospital in the first 30 days, Undark reported.
“We can actually enroll patients who are six or seven hours out of having a stent placed in the ICU. We’re giving [the Corrie Health app] to patients when they have the time to spend watching the videos and asking questions about their medications … We’re getting them to buy-in and learn the skills while they care the most,” Francoise Marvel, MD, an internist affiliated with Johns Hopkins Bayview Medical Center, told Undark.
A Role for Medical Laboratories
So, is there a role for medical laboratories where digital therapeutics are being used? We think so. Pathologists and lab leaders may even want to reach out to venture capitalists working on mobile apps that combine adherence to therapies with medical lab tests.
As our population ages and the shortage of physicians becomes more evident, digital therapeutics may be a smart way to address select patient needs in a quality and cost-effective manner.
—Donna Marie Pocius
Related Information:
Digital Therapeutics: The Future of Health Care Will Be App-Based
Digital Therapeutics Market by Application, End User, and Segment Forecasts 2014 – 2025
Can Digital Therapeutics Be as Good as Drugs?
Digital Therapeutics Market 2017: Omada Health, WellDoc, Livongo Health, Noom Inc., 2Morow, Inc., Canary Health
Prevention Program Resulted in 7.5% Weight Loss in Humana Medicare Advantage Population
Outcomes of a Digital Health Program with Human Coaching for Diabetes Risk Reduction in a Medicare Population
Putting Digital Health Monitoring Tools to the Test
Dec 6, 2017 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Laboratory Testing, Management & Operations
Proof-of-concept research investigates whether photoacoustic imaging can be used in place of traditional tissue staining procedures during cancer surgery to determine if all of the tumor has been removed
Determining where breast cancer ends and healthy tissue begins is a critical part of breast cancer surgery. Surgeons are used to working closely during surgery with anatomic pathologists who generate pathology reports that specify the surgical or tumor margin, an area of healthy tissue surrounding a tumor that also must be excised to ensure none of the tumor is left behind. This helps prevent the need for follow-up surgeries and involves quick work on the part of medical laboratories.
Thus, any technology that renders such a pathology report unnecessary, though a boon to surgeons and patients, would impact labs and pathology groups. However, such a technology may soon exist for surgeons to use during breast cancer surgery.
Assessing Tumor Margin with Light During Surgery
A proof-of-concept study undertaken by researchers at Washington University School of Medicine in St. Louis (WUSTL) and California Institute of Technology (Caltech) has been looking at ways photoacoustic and microscopy technologies could enable surgeons to quickly and accurately assess the tumor margin during breast cancer surgeries. The research suggests it could be possible for surgeons to get answers about critical breast tumor margins without employing a clinical laboratory test.
This new technique based on light and sound uses photoacoustic imaging. The researchers scanned a tumor sample and produced images with enough detail to show whether the tumor was completely removed during surgery, a WUSTL news release explained.
The researchers scanned slices of tumors secured from three breast cancer patients. They also compared their results to stained specimens.
The photoacoustic images matched the stained samples in key features, according to the WUSTL news release. And the new technology produced answers in less time than standard analysis techniques. But more research is needed before photoacoustic imaging is used during surgeries, researchers noted.
“This is proof of concept that we can use photoacoustic imaging on breast tissue and get images that look similar to traditional staining methods without any sort of tissue processing,” Novack added.
A new imaging technique based on light and sound produces images doctors can use to distinguish cancerous breast tissue (below the dotted blue line) from normal tissue more quickly than is currently possible. The new technique (right) produces images as detailed and accurate as traditional methods (left) but in less time, according to the researchers. If such technology were eventually approved for clinical use, it would reduce the need for pathologists to analyze frozen sections while a patient was still in surgery. (Caption and photo copyright: WUSTL/Terence T. W. Wong.)
Once ready, this technology may well change how surgeons and pathologists collaborate to treat breast cancer patients and those with other chronic diseases that include growths that must be excised from the body.
Current Pathology Procedures Take Time, Not Always Useful During Cancer Surgery
At present, standard breast cancer operation procedures involve surgical and pathology teams working simultaneously while the breast cancer patient is in surgery.
Excised tissue is frozen (surrounded by a polyethylene glycol solution), sliced into wafers, stained with a dye, and microscopically analyzed by the pathologist in the clinical laboratory to determine if all cancerous tissue has been removed by the surgeon.
“The procedure takes about 10 to 20 minutes. However, freezing of tissue can result in some distortion of cells and some staining artifact. That is why frozen sections are often preliminary—with a final diagnosis based on routine processing of tissue,” according to LabTestsOnline.
Additionally, fatty breast specimens do not make good frozen sections, which requires surgeons to complete procedures uncertain about whether they removed all of the cancer, the researchers noted.
“Right now, we don’t have a good method to assess margins during breast cancer surgeries,” stated Rebecca Aft, MD, PhD, Professor of Surgery at WUSTL and co-senior study author.
Up to 60% of Breast Cancer Patients Require Follow-up Surgeries
More than 250,000 people in the US are diagnosed with breast cancer each year, and about 180,000 elect to undergo surgery to remove the cancer and preserve healthy breast tissue, WUSTL reported. However, between 20% to 60% of patients learn later they need more surgery to have additional tissue removed when follow-up lab analyses suggest tumor cells were evident on the surface of a tissue sample, Caltech noted in a news release.
“What if we could get rid of the waiting? With three-dimensional photoacoustic microscopy, we could analyze the tumor right in the operating room and know immediately whether more tissue needs to be removed,” noted Lihong Wang, PhD, Professor of Medical Engineering and Electrical Engineering in Caltech’s Division of Engineering and Applied Science. Wang conducted research when he was a Professor of Biomedical Engineering at University of Washington’s School of Engineering and Applied Science.
“Currently, no intraoperative tools can microscopically analyze the entire lumpectomy specimen. To address this critical need, we have laid the foundation for the development of a device that could allow accurate intraoperative margin assessment,” the study authors penned in Science Advances.
What is Photoacoustic Imaging and How Does it Work?
Photoacoustic imaging’s laser pulses create acoustic waves within tissue, which make way for intraoperative images with enough detail to expose cancerous tissue as compared to healthy tissue, explained a Medgadget article.
The graphic above shows elements of the photoacoustic microscopy system for surgical margin imaging developed by researchers at University of Washington School of Medicine in St. Louis and California Institute of Technology. (Photo Credit: Science Advances)
According to the Caltech news release:
· Photoacoustic imaging (also called photoacoustic microscopy or PAM by the researchers) employs a low energy laser that vibrates a tissue sample;
· Researchers measure ultrasonic waves emitted by the vibrating tissue;
· Photoacoustic microscopy reveals the size of nuclei, which vibrate more intensely than nearby material;
· Larger nuclei and densely packed cells characterize cancer tissue.
“It’s the pattern of cells—their growth pattern, their size, their relationship to one another—that tells us if this is normal tissue or something malignant,” said Deborah Novack, MD, PhD, WUSTL Associate Professor of Medicine, Pathology, and Immunology, and co-senior author on the study.
Whether in surgical suites or emergency departments, technological advancements continue to bring critical information to healthcare providers at the point of care, bypassing traditional medical laboratory procedures that cost more and take longer to return answers. Successful development of this technology would create new clinical collaborations between surgeons and anatomic pathologists while improving patient care.
—Donna Marie Pocius
Related Information:
New Imaging Technique Aims to Ensure Surgeons Completely Remove Cancer
Understanding Anatomic Pathology
Cutting Down on Cancer Surgeries
Fast Label-Free Multilayered Histology-Like Imaging of Human Breast Cancer by Photoacoustic Microscopy
Optoacoustics May Allow Surgeons to See Tumor Margins, Accurate Incisions
Nov 22, 2017 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Laboratory Testing, Management & Operations
Industry analysts speculate that Apple might be planning to enter the EHR and healthcare related markets by transforming mobile technologies into gateway devices connected to providers’ EHR systems and patient data
Imagine a mobile device that monitors vitals while connected in real-time to healthcare providers, electronic health records (EHR), and clinical laboratories. One that measures the physical condition and emotional state of the user by casting light onto skin, and then records and transmits it with a swipe of the touch screen. Would such an innovation change how patients expect to interact with their providers? And how physicians, anatomic pathologists, and medical laboratories receive data from their patients? Certainly.
This is why US patents recently granted to Apple have caught the attention of industry analysts. Some speculate that the tech giant is planning to enter the mobile healthcare monitoring device, EHR, and healthcare data storage markets, as reported at Becker’s Health IT and CIO Review and Patently Apple.
How this would affect medical laboratories and anatomic pathology groups remains to be seen. But where Apple goes, industries follow. Thus, it’s worth following the company’s activities in the healthcare market.
Bringing Clinical Data, Medical Laboratory Test Results, to iPhone
Mobile devices launched the era of consumer-grade fitness wearables. It’s not uncommon for a smart phone or watch to capture and store a range of health data generated by users. This can include everything from heart rate and sleeping patterns to dietary logs and fertility tracking. But, to date, much of that healthcare data is user generated and does not integrate in any meaningful way with the majority of EHR systems. Nor does it enable communications with primary care providers or diagnostic services—such as medical laboratories or pathology groups.
This may soon change.
According to a CNBC report, a unit at Apple is “in talks with developers, hospitals, and other industry groups about bringing clinical data—such as detailed lab results and allergy lists—to the iPhone, according to a half-dozen people familiar with the team.”
The report states that Apple:
· “Wants the iPhone to become the central bank for health information;
· “Is looking to host clinical information, such as labs and allergy lists, and not just wellness data; and,
· “Is talking with hospitals, researching potential acquisitions, and attending health IT industry meetings.”
Christina Farr, the report’s author, predicts that Apple could be preparing to apply its music industry model to the healthcare industry by, “Replacing CDs and scattered MP3s with a centralized management system in iTunes and the iPod—in the similarly fragmented and complicated landscape for health data.”
Former National Coordinator of Health IT for the Department of Health and Human Services, Farzad Mostashari, MD, ScM, rather enthusiastically noted the significance of the move, stating, “If Apple is serious about this, it would be a big f—ing deal.”
At a special event in September, Apple COO Jeff Williams (above) announced Stanford Medicine’s Apple Heart Study, which uses “data from Apple Watch to identify irregular heart rhythms, including those from potentially serious heart conditions like atrial fibrillation,” and, according to Williams, “notify users.” This is just one of several healthcare-related study collaborations Apple is exploring. It is not known if Apple is looking to collaborate with medical laboratories. (Photo copyright: Apple.)
Apple’s History with Healthcare Related Technology
Taken as a single event, these speculations might not convince industry leaders. However, Apple’s long-term investments and acquisitions show a clear trend toward integrating healthcare data into the Apple ecosystem.
Healthcare IT News noted that from 2014 to 2017 Apple:
· Unveiled three different APIs—HealthKit, ResearchKit, and CareKit—designed to help capture, analyze, communicate, and integrate healthcare data with the Apple iOS and watchOS ecosystems;
· Hired several MDs, including: Stephen Friend, MD; Rajiv Kumar, MD; Mike Evans, MD; Ricky Bloomfield, MD; and Sumbul Ahmad Desai, MD; and,
· Engaged with the Argonaut Project and Health Gorilla (a centralized hub of healthcare data and information) suggesting a shift from wearables and basic device-based biometrics toward in-depth reporting, interoperability, and access to third-party healthcare data repositories—such as those in a person’s EHR or medical laboratory portal.
The Future of EHRs or Another Failed Attempt at Innovation?
Apple isn’t the only company to attempt such a system. Other efforts include Microsoft’s Health Vault and Google’s now shuttered Google Health. Another CNBC article notes that Amazon is also researching healthcare related options. “The new team is currently looking at opportunities that involve pushing and pulling data from legacy electronic medical record systems,” stated Farr. “The group is also exploring health applications for existing Amazon hardware, including Echo and Dash Wand.”
However, where most services fail to gain traction is user engagement. After all, if a system isn’t widely used or fails to offer benefits over existing systems, patients and service providers are not likely to go through the process of switching systems. Speaking with CNBC, Micky Tripathi, President and CEO of the Massachusetts eHealth Collaborative notes, “At any given time, only about 10% to 15% of patients care about this stuff. If any company can figure out engagement, it’s Apple.”
According to comScore, 85.8-million people over the age of 13 already own an iPhone in the US. The upcoming facial recognition features on Apple’s iPhone X might also provide the added security needed for those questioning the safety of their data. Should Apple succeed, communicating data between clinical laboratories, physicians, and patients might be both convenient and fast. More importantly, it might be the universal platform that finally provides health data access across the entire care continuum, while simultaneously improving access to providers and empowering healthcare consumers.
Of course, this is a few years from reality. But, we can speculate … would innovative medical laboratories have their patients’ lab test data hosted in the Cloud in such a way that patients and providers could access it securely, along with other protected clinical records?
Imagine how this would enable patients to have their complete medical record traveling with them at all times.
—Jon Stone
Related Information:
Could Apple Be Taking a Bite Out of EHRs?
Could Amazon or Apple Actually Make a Dent In the EHR Market?
Apple Extends Its Reach into Healthcare
Electronic device that computes health data
Apple Is Quietly Working on Turning Your iPhone Into the One-Stop Shop for All Your Medical Info
Wait! What? Amazon and Apple Eye Building EHRs
Apple Is Working with This Small Start-Up to Change How We Track Our Health
Timeline: How Apple Is Piecing Together Its Secret Healthcare Plan
Amazon Has a Secret Health Tech Team Called 1492 Working on Medical Records, Virtual Doc Visits
With Apple Consulting Argonaut Project on Health Records, Interoperability Could Get the Push It Needs
Apple Enlists Help of Startup Health Gorilla to Add Diagnostic Data to iPhones
Nov 15, 2017 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Management & Operations
Onboard cooling system ensures samples remain viable for medical laboratory analysis after three-hour flight across Arizona desert
Clinical laboratories and anatomic pathology groups could soon be receiving blood samples and tissue specimens through the air by medical drone. The technology has been tested successfully in Europe, which Dark Daily reported in July. Now, Johns Hopkins University Medicine (JHUM) has set a record in America for the longest distance drone delivery of viable medical specimens.
In a project to demonstrate the viability of using drones to transport medical laboratory specimens, the Johns Hopkins University team flew a drone with specimens more than 161 miles across the Arizona desert. The goal is to bring autonomous medical delivery drones a step closer to transforming how specimens get transported across long distances, according to a Johns Hopkins press release.
A previous Johns Hopkins study in 2015 proved common and routine blood tests were not affected when medical laboratory specimens were transported in up to 40-minute flights on hobby-sized drones. This latest research provides evidence that unmanned aircraft may be able to successfully and quickly shuttle medical specimens even longer distances between remote hospitals and medical laboratories.
Transporting Clinical Laboratory Samples by Air Can Save Lives
In conducting its most recent study, Johns Hopkins researchers obtained paired chemistry and hematology samples from 21 adults (84 samples in total). One sample from each pair was held at a drone test range in a car with active cooling. Remaining samples were flown for three hours in a drone with a Johns Hopkins-designed onboard payload-cooling system to maintain temperature control in the hot desert environment.
A temperature-controlled specimen transport container (above) designed by the Johns Hopkins University research team ensured the blood samples remained cooled and were viable for testing after the three-hour drone flight in the Arizona heat. The project demonstrated the viability of using drones to transport medical laboratory specimens. (Photo copyright: Johns Hopkins Medicine.)
After the 161-mile flight, all samples were transported 62 miles by car to the Mayo Clinic in Scottsdale, Ariz., for testing. Flown and not-flown paired samples showed similar results for red blood cell, white blood cell and platelet counts, and sodium levels, among other results. Only glucose and potassium levels revealed minor but statistically significant differences in results.
Pathologist Timothy Amukele, MD, PhD (above), led a team of researchers at Johns Hopkins University School of Medicine that set a new distance delivery record for medical drones after successfully transporting human blood samples 161 miles across the Arizona desert. The test flight adds to the growing evidence that unmanned aircraft may be the most effective way to quickly transport blood and other medical samples to clinical laboratories. (Photo copyright: Johns Hopkins Medicine.)
In a report of the findings published in the American Journal of Clinical Pathology (AJCP), the research team concludes that long drone flights at high temperature “do not appear to affect the accuracy of 17 of the 19 test types in this study.” However, they note, “Time- and temperature-sensitive analytes such as glucose and potassium will require good pre-planning and stringent environmental controls to ensure reliable results.”
The John Hopkins team believes their achievement adds to mounting evidence that drone transportation can transform the delivery of clinical laboratory specimens.
“We expect that in many cases, drone transport will be the quickest, safest, and most efficient option to deliver some biological samples to a laboratory from rural or urban settings,” stated Timothy Kien Amukele, MD, PhD, Assistant Professor of Pathology at Johns Hopkins University School of Medicine and the paper’s senior author, in a Johns Hopkins Magazine article.
“Getting diagnostic results far more quickly under difficult conditions will almost certainly improve care and save more lives,” Amukele added.
Full Drone Delivery Network Operating Over Switzerland
Medical drones are rapidly moving from demonstration projects to active use. As Dark Daily previously reported, Switzerland is establishing a delivery network of medical drones in the city of Lugano. In March 2017, drone logistics system developer Matternet, based in Menlo Park, Calif., received authorization from the Swiss Federal Office for Civil Aviation (FOCO) for full operation of drone logistics networks over densely populated areas in Switzerland. Working in partnership with Swiss Post (Switzerland’s postal service) and the Ticino EOC hospital group, Matternet successfully completed roughly 100 drone transport test flights between two of Ticino EOC’s hospitals in Lugano.
Another major player in medical drone delivery is Zipline, a Silicon Valley-based drone delivery company that since October 2016 has flown more than 14,000 flights in Rwanda, delivering 2,600 units of blood. The company’s foothold in Africa expanded in August when Tanzania announced it was partnering with Zipline to launch the “world’s largest drone delivery service to provide emergency on-demand access to critical and life-saving medicines.” Tanzania will establish four distribution centers that will use more than 100 drones to make up to 2,000 flights a day.
The emergence of medical drones not only could speed up diagnoses for patients in remote regions of the world and rural communities, but also could revolutionize anatomic pathology specimen deliveries to clinical laboratories in urban areas by providing a faster, more reliable and lower-cost delivery option than third-party couriers using ground transportation.
—Andrea Downing Peck
Related Information:
Study Sets New Distance Record for Medical Drone Transport
Drone Transport of Chemistry and Hematology Samples Over Long Distances
Using Drones to Transport Blood Samples Could Speed Diagnosis, Treatment
Drone Carrying Blood Samples Travels 160 Miles in Arizona Desert to Set New Record
Matternet Unveils the Matternet Station
Tanzania Announces World’s Largest National Drone Delivery Network Partnering with Zipline
Drones Used to Deliver Clinical Laboratory Specimens in Switzerland
Oct 27, 2017 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory Pathology, Laboratory Testing
Is gut microbiota the fabled fountain of youth? Researchers at Valenzano Research Lab in Germany found it works for killifish. Could it work for other vertebrates as well?
Research into the microbiomes of humans and other animals is uncovering tantalizing insights as to how different microbes can be beneficial or destructive to the host. It is reasonable to expect ongoing research will eventually give microbiologists and clinical laboratories useful new medical laboratory tests that assess an individual’s microbiome for diagnostic and therapeutic purposes.
Human microbiota (AKA, microbiome) have been identified as having a key role in several different health conditions. In previous ebriefings, Dark Daily reported on several breakthroughs involving the microbiome that bring the promise of precision medicine ever closer. Research and clinical studies are contributing to more accurate diagnoses, identification of best drugs for specific patients, and, enhanced information for physician decision-making, to name just a few benefits.
Now, researchers at Valenzano Research Lab at the Max Planck Institute for Biology of Aging in Cologne, Germany, are looking into whether gut microbiota could potentially increase life spans in all vertebrates, a group of species that includes humans.
Valenzano Lab published its study online in August. The team of scientists and researchers led by Dario Valenzano, PhD, focused on the longevity of the turquoise killifish (Nothobranchius furzeri), a tiny fish native to the African countries of Mozambique and Zimbabwe. They found that when older killifish ate the fecal matter of younger killifish they lived longer. The fecal matter carried the microbiota to the older fish and extended their lifespans.
Moving Microbiome from One Gut to Another
To perform the research, Valenzano and his team first treated killifish that were nine and a half weeks old (considered middle-aged) with antibiotics to cleanse their gut flora. The fish were then placed in a sterile aquarium containing the gut contents of young adult killifish that were just six weeks old. Although killifish won’t typically eat feces, they would nip at the gut contents in the water and swallow some of the microbes from the younger fish in the process. The researchers discovered that the transplanted microbes were able to successfully colonize the stomachs of the older fish.
Dario Valenzano, PhD (above), gazes at an older Killifish, the subject in his research into increased aging at the Valenzano Research Lab in Cologne, Germany. Studies of the microbiomes of different species is expected to eventually give microbiologists new and useful clinical laboratory tests. (Photo copyright: Max Planck Institute for Biology of Aging.)
When the middle-aged killifish reached the age of 16 weeks—considered elderly—their gut microbiomes were still similar to that of a six-week-old fish. The process had a noticeable effect on the lifespan of the killifish that received the microbiome transplants from the young fish. They lived 41% longer than killifish that received microbes from middle-aged fish and their longevity increased by 37% over fish that were not exposed to any treatment at all. In addition, at 16 weeks, the killifish who had received the transplants were much more active than fish of the same age who had not received the transplants.
“These results suggest that controlling the composition of the gut microbes can improve health and increase life span,” the study paper noted. “The model system used in this study could provide new ways to manipulate the gut microbial community and gain key insights into how the gut microbes affect aging. Manipulating gut microbes to resemble a community found in young individuals could be a strategy to delay the onset of age-related diseases.”
Transferring Fecal Microbiota to Save/Extend Human Lives
Previous research has indicated there may be a connection between microbiomes and aging in some animals, and that the diversity of gut microbes decreases with age. This study proved that this same pattern is true in turquoise killifish.
However, Valenzano does not know how the microbes are affecting the lifespans of the older killifish. “It is possible that an aging immune system is less effective at protecting the micro-organisms in the intestines, with the result that there is a higher prevalence of pathogens in older guts. The gut microbiota in a young organism could help to counter this and therefore support the immune system and prevent inflammation. This could lead to longer life expectancy and better health,” he stated in a press release.
“You can really tell whether a fish is young or old based on its gut microbiota,” Valenzano told Nature. He noted, however, that it is too early to determine if fecal transplants can be used in humans to extend life. “I wouldn’t go that far. This is really early evidence that this has a potential positive effect.”
There is, however, a similar procedure used in humans called Fecal Microbiota Transplant or FMT that has demonstrated promising results in treating certain illnesses.
In a fecal transplant, fecal matter is collected from an approved donor, treated, and placed in a patient during a colonoscopy, endoscopy, sigmoidoscopy, or enema. The purpose of the transplant is to replace good bacteria in a colon that has undergone an event that caused the colon to be inundated with bad bacteria, such as Clostridium difficile, resulting in C. diff. infection, a life-threatening illness that, according to the Centers for Disease Control and Prevention (CDC), kills tens of thousands of people each year.
“The challenge with all of these experiments is going to be to dissect the mechanism. I expect it will be very complex,” stated Heinrich Jasper, PhD, in the Nature article. Jasper is a professor at the Buck Institute for Research on Aging in Novato, California. His lab is working on similar research with microbiome transplants in fruit flies. He predicts this type of longevity research will be performed on other animals in the future.
Valenzano’s and Jasper’s research may eventually create new diagnostic tools for microbiologists to assess the microbiome of individual patients. This technology may also enable microbiologists to advise pathologists and clinical laboratories regarding what specific microbes may be harmful and what microbes may be therapeutically beneficial to patients.
—JP Schlingman
Related Information:
‘Young Poo’ Makes Aged Fish Live Longer
Gut Bacteria Affect Aging
Killifish Project Sheds Light on the Genetic Basis for Aging
National Project to Harness Microbes for Health, Environment
Effort to Map Human Microbiome Will Generate Useful New Clinical Lab Tests for Pathologists
Mayo Clinic and Whole Biome Announce Collaboration to Research the Role of the Human Microbiome in Women’s Diseases Using Unique Medical Laboratory Tests
Expanding Knowledge about the Human Microbiome Will Lead to New Clinical Pathology Laboratory Tests
Oct 25, 2017 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology
Researchers demonstrated it was feasible to encode digital malware onto a strand of synthesized DNA and infect the gene sequencers and computer networks used by medical laboratories
As if anatomic pathology groups and clinical laboratory leaders don’t already have enough to think about, here comes a security vulnerability right out of a sci-fi thriller. Researchers at the University of Washington (UW) have used synthesized DNA to encode digital malware into a physical strand of DNA capable of establishing a remote connection to the computer network on which the sequenced DNA is read!
Stated differently, researchers have now demonstrated that is possible for bad guys to hack into a medical laboratory’s instrument systems and computer network using a physical strand of synthesized DNA that is encoded with digital malware.
Another Threat to Clinical Laboratories, Pathology Groups?
Does this translate into an immediate security issue for medical laboratories? For now, the threat is only theoretical. While researchers did succeed, their study findings should provide some comfort to pathology groups or medical laboratories worried about the implications of DNA-based malware. The UW researchers published their findings at the 2017 USENIX Security Symposium.
Synthetic DNA Malware Exploit is More Proof-of-Concept than Immediate Threat
At its core, computer code (AKA source code) is similar to DNA in that it is composed of a set number of states—with binary, zeroes, and ones. This led UW researchers to question whether they could translate the AGCT elements (adenine, guanine, cytosine, and thymine) of DNA into binary code capable of hacking DNA sequencers and accessing the information they contain.
In an article in The Atlantic, Tadayoshi Kohno, PhD, Short-Dooley Professor in the Department of Computer Science and Engineering at UW, who led the research team, noted that, “The present-day threat is very small, and people don’t need to lose sleep immediately. But we wanted to know what was possible and what the issues are down the line.”
Complexity of Engineering a DNA-Powered Computer Virus
To begin the process, researchers needed to create a specific DNA strand encoded with the exact proteins that would later convert into their exploit. An article in ArsTechnica suggests this would be a challenge due to the physical properties of DNA’s double-helix design.
In the article, John Timmer, PhD, wrote, “DNA with Gs and Cs forms a stronger double-helix. Too many of them, and the strand won’t open up easily for sequencing. Too few, and it’ll pop open when you don’t want it to.”
The study shows it took multiple attempts to find a DNA sequence that would both carry the malware code and withstand the synthesizing and sequencing processes. Even then, researchers needed an exploit for the software used on sequencers in clinical laboratories and other diagnostics providers to prove their theory. Study authors used their own modified version of an open-source sequencing software, adding an exploit they could target, instead of a version of the software already publicly in use.
Lee Organick (above left), Karl Koscher (center), and Peter Ney (right) worked with Luis Ceze and Tadayoshi Kohno, PhD, at the University of Washington to develop the DNA sequence containing the malware code. The researchers determined that it was feasible for the gene instruments used by clinical laboratories to be infected with the malware, which could then move to infect a clinical lab’s computer network. (Photo copyright: University of Washington.)
With their proteins synthesized and customized software in place, researchers still faced challenges getting the code to trigger. “With reads randomly appearing in an FASTQ file,” the researchers noted, “we would expect the modified program to be exploited 37.4% of the time.”
As with genetic code, the binary code of a program is highly sensitive to errors. Any misread bases or splitting of the code resulted in failure. When sequencers only read a few hundred bases at a time, ensuring the code doesn’t hit one of these splits is a challenge.
One unique difference between binary and genetic code also caused trouble—genetic sequences aren’t direction dependent, while binary sequences are. If the code is read in reverse, it won’t execute properly.
Future Concerns for Clinical Laboratories and Genetic Researchers
Today, the threat to medical laboratories and the sensitive data generated by sequencing is minor. However, tomorrow that threat could be more common.
In a WIRED article on the subject, Jason Callahan, Chief Information Security Officer for Illumina stated, “This is interesting research about potential long-term risks. We agree with the premise of the study—that this does not pose an imminent threat and is not a typical cyber security capability.”
Don Rule, founder of Translational Software, agrees. When asked about the threat posed to clinical laboratories, he said, “… if you have to pre-introduce the hack in the analytics program, this is a pretty circuitous way to take over a computer. I can see how it is feasible and right now Norton Antivirus is not looking for viruses encoded in the AGCT code set, but we are right not to lose a lot of sleep over it.”
However, as genetic sequencing becomes a common part of medicine, attackers might have increased reason to disrupt services or intercept data. The UW researchers cite “important domains like forensics, medicine, and agriculture” as potential targets.
While their successful attack was highly engineered, their research into open-source sequencing software revealed a range of common security weaknesses. Many clinical laboratories and anatomic pathology groups also run proprietary analysis software or use hardware with embedded software.
They recommend that medical laboratories work to centralize software updates and create ways to verify data and patches through digital signatures or other secure measures.
Already, genetic researchers take care to avoid synthesizing potentially dangerous sequences, and to contain tests and data. But this study shows that not all threats come from within the research or clinical laboratory environment. Both engineers of sequencing technology and hardware—and the medical laboratories using them—will need to optimize operations and monitor trends closely to see how security issues evolve alongside sequencing capabilities.
—Jon Stone
Related Information:
These Scientists Took Over a Computer by Encoding Malware in DNA
Computer Security and Privacy in DNA Sequencing
Computer Security, Privacy, and DNA Sequencing: Compromising Computers with Synthesized DNA, Privacy Leaks, and More
This Speck of DNA Contains a Movie, a Computer Virus, and an Amazon Gift Card
Researchers Encode Malware in DNA, Compromise DNA Sequencing Software
Biohackers Encoded Malware in a Strand of DNA
The Ultimate Virus: How Malware Encoded in Synthesized DNA Can Compromise a Computer System
Researchers Hacked into DNA and Encoded It with Malware
