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University of Illinois Study Concludes Regular Physical Exercise Improves Human Microbiome; Might Be Useful Component of New Treatment Regimens for Cancer and Other Chronic Diseases

Mar 16, 2018 | Digital Pathology, Laboratory News, Laboratory Pathology, Laboratory Testing

Exercise contributes to improving the human microbiome in ways that fight disease and clinical labs might eventually provide tests that help track beneficial changes in a patient’s microbiome

With growing regularity, new discoveries about the human Microbiome have been reported in scientific journals and the media. Some of these discoveries have led to innovations in clinical laboratory tests over the past few years. Dark Daily reported on these breakthroughs, which include: improved cancer drugs, life extension, personalized medical treatments (AKA, precision medicine), genetic databases, and women’s health.

Now, a study from the University of Illinois at Urbana-Champaign (UI) has linked exercise to beneficial changes in the makeup of human microbiota. The researchers identified significant differences in the gut bacteria of obese and lean individuals who underwent the same endurance training. The lean individuals developed healthy gut bacteria at a much higher rate than the obese participants. And they retained it, so long as the exercise continued.

Thus, researchers believe weight loss and regular exercise could become critical components of new treatment regimens for many chronic diseases, including cancer.

Regular Exercise Increases Good Gut Bacteria in Humans and Mice

The UI researchers published the results of their study in Medicine and Science in Sports and Exercise, a journal of the American College of Sports Medicine. To perform their study, they analyzed the impact six weeks of endurance training had on the gut bacteria of 32 adults:

  • Eighteen of the subjects were lean and the remaining 14 were obese;
  • Eleven of the obese and nine of the lean participants were female; and,
  • All 32 were sedentary before the study began.

The subjects participated in six weeks of supervised exercise three days/week. They started at 30-minutes/day and progressed to 60-minutes/day. Fecal samples were collected from the participants before and after the six weeks of training. The subjects were instructed to not change any of their dietary habits during the study.

Upon completion of the initial six-week exercise program, participants returned to a sedentary lifestyle for another six weeks and then researchers took more fecal samples.

Jacob Allen, PhD-Candidate (left), and Jeffrey Woods, PhD

In a University of Illinois study, Jacob Allen, PhD-Candidate (left), and Jeffrey Woods, PhD (right), et al, concluded that regular exercise increased production of beneficial gut bacterial (microbiome) more in lean individuals than in obese participants. This finding could alter how anatomic pathologists and medical laboratories view exercise and weight loss for patients undergoing treatment regimens for chronic diseases. (Photo copyright: University of Illinois/L. Brian Stauffer.)

As a result of the study, the researchers found the gut bacteria of the subjects did change, however, those changes varied among the participants. Fecal concentrations of short chain fatty acids (SCFAs), particularly butyrate, increased in the guts of the lean participants but not in the guts of the obese subjects.

SCFAs have been shown to improve metabolism and reduce inflammation in the body, and they are the main source of energy for the cells lining the colon. However, nearly all of the beneficial changes in the participants’ gut bacteria disappeared after six weeks of non-exercise.

“The bottom line is that there are clear differences in how the microbiome of somebody who is obese versus somebody who is lean responds to exercise,” Jeffrey Woods, PhD, Professor, Department of Kinesiology and Community Health, College of Applied Health Sciences, University of Illinois at Urbana-Champaign and co-leader of the study, told UI’s News Bureau. “These are the first studies to show that exercise can have an effect on your gut independent of diet or other factors.”

Reduced Inflammation Promotes Healing

The researchers had previously performed a related study using lab mice and found similar results. For that experiment, mice were separated into two groups where some were permitted to run around and be active while the others were sedentary. The gut material from all of the mice was then transplanted into gnotobiotic (germ-free) mice where their microbiomes were exposed to a substance that was known to cause irritation and inflammation in the colon. The animals with the gut bugs from the active mice experienced less inflammation and were better than the sedentary mice at resisting and healing tissue damage.

“We found that the animals that received the exercised microbiota had an attenuated response to a colitis-inducing chemical,” Jacob Allen, PhD Candidate, co-leader of the study and former doctoral student at UI, now a postdoctoral researcher at Nationwide Children’s Hospital in Columbus, Ohio, told the UI News Bureau. “There was a reduction in inflammation and an increase in the regenerative molecules that promote a faster recovery.”

Exercise Added to Growing List of Benefits from Health Gut Bacteria

Similar research in the past has found that healthy gut bacteria may have many positive effects on the body, including:

  • Improved immune health;
  • Improved mood and mental health;
  • Boosting energy levels;
  • Improved cholesterol levels;
  • Regulated hormone levels;
  • Reduction of yeast infections;
  • Healthy weight support;
  • Improved oral health; and,
  • Increased life expectancy.

Other ways to improve gut bacteria include: dietary changes, taking probiotics, lowering stress levels, and getting enough sleep. Now regular exercise can be added to this growing list.

Once further research confirms the findings of this study and useful therapies are developed from this knowledge, clinical laboratories should be able to provide microbiome testing that would help physicians and patients track the benefits of exercise on enhancing gut bacteria.

—JP Schlingman

Related Information:

Exercise Alters Our Microbiome. Is That One Reason It’s So Good for Us?

Exercise Training-induced Modification of the Gut Microbiota Persists After Microbiota Colonization and Attenuates the Response to Chemically-induced Colitis in Gnotobiotic Mice

Exercise Alters Gut Microbiota Composition and Function in Lean and Obese Humans

Exercise Changes Gut Microbial Composition Independent of Diet, Team Reports

Exercise Can Beneficially Alter the Composition of Your Gut Microbiome

Researchers Discover Link between Gut Bacteria and the Effectiveness of Certain Cancer Drugs; Knowledge May Lead to New Types of Clinical Laboratory Tests

Researchers in Two Separate Studies Discover Gut Microbiome Can Affect Efficacy of Certain Cancer Drugs; Will Findings Lead to a New Clinical Laboratory Test?

Attention Microbiologists and Medical Laboratory Scientists: New Research Suggests an Organism’s Microbiome Might Be a Factor in Longer, More Active Lives

Get the Poop on Organisms Living in Your Gut with a New Consumer Laboratory Test Offered by American Gut and uBiome

Mayo Clinic and Whole Biome Announce Collaboration to Research the Role of the Human Microbiome in Women’s Diseases Using Unique Medical Laboratory Tests

Flu Season Brings Shut Down of Elective Surgeries and Procedures in United Kingdom’s National Health Service Hospitals

Mar 14, 2018 | Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations

Mounting financial and patient-care problems in UK show NHS may not provide a quality blueprint for fixing US healthcare system flaws

Patients scheduled for elective surgeries—such as hip replacements or penciled in for routine outpatient appointments—have been turned away this winter from National Health Service (NHS) hospitals as the United Kingdom’s (UK’s) public healthcare system suffers another care emergency.

This latest crisis in the UK should provide further evidence to anatomic pathologists and medical laboratory leaders that the United States healthcare system is not alone in facing mounting financial and patient care questions. While an NHS-like single-payer healthcare system in the US is the goal of many reformers, the UK’s current crisis indicates such a system has serious flaws.

UK News Organizations Disagree with Government Leaders as to Cause of Crisis

NHS officials estimate as many as 55,000 elective operations and outpatient procedures were cancelled as hospitals attempted to free up capacity for the sickest patients. The Telegraph reported that the bed shortfall is blamed on a spike in winter flu, with budget cuts to social services for home healthcare, staff shortages, and an aging population further pressuring the healthcare system.

In late January, the NHS’ National Emergency Pressure Panel (NEPP) announced that planned operations, such as elective surgeries, that had been “suspended because of pressure on the NHS in January,” would be able to resume in February, Sky News reported.

Meanwhile, in response to the original decision in January to have hospitals stop performing elective surgeries and similar procedures, an editorial in The Guardian challenged Prime Minister Theresa May’s suggestion that the current crisis was primarily due to the flu epidemic.

“This is not the flu: it is a system-wide crisis brought about by seven years of mounting austerity,” The Guardian’s editors wrote. “Oh, and that is getting worse, too. The official defense is that this is not a crisis because there is a plan … But planning can’t magic up highly trained doctors and nurses. Plans do not make hospital beds. And while vaccination helps, you can’t entirely plan your way out of the impact of flu.”

Doctors Report ‘Intolerable Conditions’ at 68 Hospitals

The crisis reached new heights when specialists in emergency medicine from 68 hospitals sent a letter to the prime minister stating the “current level of safety compromise is at times intolerable, despite the best efforts of staff.” The letter, published in The Guardian, also pointed out media coverage reporting anecdotal accounts of “appalling” situations in many emergency departments “are not outliers.” According the doctors, conditions include:

  • Over 120 patients a day managed in corridors, some dying prematurely;
  • An average of 10-12 hours from decision to admit a patient until they are transferred to a bed;
  • Over 50 patients at a time awaiting beds in the emergency department; and,
  • Patients sleeping in clinics as makeshift wards.

One doctor, Richard Fawcett, MD, drew media attention when he used Twitter to apologized for “third world conditions” caused by overcrowding in the hospital where he works, The Telegraph reported.

Richard Fawcett, MD

Richard Fawcett, MD (above), a consultant in emergency medicine for University Hospitals of North Midlands NHS Trust, drew widespread media attention in England when he apologized to patients on Twitter for the “third world conditions” this winter at the hospital where he works. A Lieutenant Colonel in the British Royal Army, Fawcett has done three deployments to Afghanistan. (Photo copyright: Midlands Air Ambulance Charity.)

NHS officials acknowledged staff criticism but attempted to paint the crisis as temporary. University of North Midlands NHS Trust (UHNM) told BBC News that area hospitals had been under “severe and sustained pressure over the Christmas period,” which had “continued into the new year.”

“Our staff want the very best for our patients and at times they find the situation frustrating, which can be reflected on social media. However, we are a leading trauma, stroke, and cardiac center and have been regularly praised by external independent commentators for the quality of compassionate care provided at our hospitals despite all our pressures,” Dr. John Oxtoby, Consultant Radiologist and Deputy Medical Director, UHNM, told BBC News.

“We have to keep going and turn up in a fit state to do the best job that we can. But it’s been really tough, particularly on more junior staff,” one hospital staff member told The Guardian. “And when they ask me, ‘Will it always be like this and will it get better?’ I cannot say it will improve as the truth is it won’t unless the NHS gets the resources and investment it needs.”

Basic Elements of Care Neglected

This is not the first time the NHS has come under fire for substandard patient care.

Between 400 and 1,200 patients are estimated to have died as result of poor care between January 2005 and March 2008 at Stafford Hospital, reported The Guardian. A 2010 report into care at the hospital, now named County Hospital and run by UHNM, found a litany of problems.

“For many patients, the most basic elements of care were neglected,” inquiry Chairman Sir Robert Francis, QC, told The Guardian. “Some patients needing pain relief either got it late or not at all. Others were left unwashed for up to a month … The standards of hygiene were at times awful, with families forced to remove used bandages and dressings from public areas and clean toilets themselves for fear of catching infections.”

Reports of substandard patient care within the United Kingdom’s National Health Service are not new. British barrister Sir Robert Francis, QC (above), led investigations into the Stafford Hospital scandal, which uncovered that an estimated 400 to 1200 patients died between 2005 and 2008 at the facility due to appalling conditions and lax procedures. (Photo copyright: The Telegraph.)

Why not this crisis in US? Because, even if our system of healthcare has flaws, it is responsive to consumer/patient demand. Whereas, in the UK, the NHS is always budget short and so is always struggling to invest in expanding hospital/physician capacity to meet the steady increase in patient demand.

Dark Daily’s goal in reporting on this story is to help anatomic pathologists and clinical laboratory leaders in the United States understand that every country’s health system—like ours—has its share of unique problems and is not perfect.

—Andrea Downing Peck

Related Information:

NHS Patients Dying in Hospital Corridors, A/E Doctors Tell Theresa May

The Guardian View on the Crisis: It’s Not Just the Flu

Mid Staffs Hospital Scandal: The Essential Guide

NHS Crisis: ‘I Live in Fear I’ll Miss a Seriously Ill Patient and They Will Die’

Hospitals to Delay Non-Urgent Operations

NHS to Lift Suspension of Elective Surgery as Hospital Pressures ‘Ease’

Potential New Clinical Laboratory Urine Test for TB Could Speed Up Diagnosis and Treatment of Disease That Kills 1.7 Million People Each Year

Mar 12, 2018 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing

Public health agencies and physicians would gain access to accurate, rapid dip-stick test that could give results similar to a pregnancy test

Tuberculosis is a major killer that ranks alongside HIV/AIDS as a leading cause of death worldwide. This deadly disease takes the lives of more than a million people each year. And, unfortunately, traditional medical laboratory testing using X-rays, blood/skin/sputum specimens, or the new molecular diagnostic systems can be time consuming and expensive.

Now, scientists at George Mason University (GMU) in Virginia have developed a urine test for tuberculosis (TB) that could lead to a dip-stick technology that would accurately and rapidly diagnose the deadly lung disease. Similar to a pregnancy test, if successfully developed for use in clinical settings, the dip-stick could not only enable public health agencies to test for TB more effectively, but also allow primary care physicians and other doctors to easily test their patients for TB at the point of care. However, it also could mean clinical laboratories might find their participation.

Nearly All TB Deaths Occur in Resource Strapped Areas

Such a breakthrough would certainly be a boon to public health and global healthcare, especially in resource strapped areas of the world. According to the World Health Organization (WHO), more than 95% of the 1.7 million TB deaths each year occur in low- and middle-income countries. This is one reason why an inexpensive and easy-to-use detection method for diagnosing the lung disease has long been sought. TB is curable, particularly if diagnosed early.

With that goal in mind, an international team led by Alessandra Luchini, PhD, Associate Professor at GMU, and Lance Liotta, PhD, MD, co-director and co-founder of the GMU Center for Applied Proteomics and Molecular Medicine, developed the potentially revolutionary urine test that uses nanotechnology to measure a sugar molecule in urine that identifies TB with a high degree of accuracy. The scientists published their results in Science Translational Magazine.

George Mason University scientists Alessandra Luchini, PhD

George Mason University scientists Alessandra Luchini, PhD (above left), and Lance Liotta, MD, PhD (above right), head an international team that has developed a nanotechnology that may lead to a simple dipstick urine test to detect tuberculosis. Such a test could greatly impact medical laboratories by reducing the need for traditional lab tests. (Photo copyrights: George Mason University.)

While past attempts at developing an accurate urine test for TB failed to reliably detect low concentrations of the sugar entity lipoarabinomannan (LAM) in HIV-negative, TB-infected patients, the GMU team developed a technology capable of doing so.

According to New Scientist, the GMU team’s test “uses tiny molecular cages embedded with a special dye that can catch and trap these sugar molecules. This makes the test capable of detecting the sugar at low concentrations, making the technique as much as 1,000 times more accurate [than] previous methods for detecting TB in urine.”

“We can measure now what could never be measured before,” Liotta noted in a news release.

World Health Organization Recommends Not Using Serodiagnostic Blood Tests

Common methods to detect TB currently include microscopy of sputum samples—a fast and accurate but expensive detection method (that also can diagnosis drug resistant disease)—or a skin test. A third test for TB, an Interferon-Gamma Release Assay, provides results in less than 24 hours but cannot distinguish between active and latent infection. In 2011, the WHO issued a Policy Recommendation urging countries to stop using serodiagnostic blood tests to diagnose TB, calling these tests unreliable and inaccurate. X-rays, meanwhile, detect only advanced lung damage.

In the GMU study, 48 Peruvian patients were chosen, all with active pulmonary TB, none of whom was infected with HIV or previously had received treatment for TB. According to the research, TB infections were detected with greater than 95% sensitivity, with TB-positive, HIV-negative patients having detectably higher concentrations of LAM in their urine compared to the controls. Patients who had more advanced disease also had elevated LAM concentrations. Eight of nine patients who were smear-negative and culture-positive for TB tested positive for urinary LAM.

“The technology can be configured in a variety of formats to detect a panel of previously undetectable very-low-abundance TB urinary analytes … This technology has broad implications for pulmonary TB screening, transmission control, and treatment management for HIV-negative patients,” the study’s authors told Science.

While The Scientist reports the GMU urine test gives results in about 12 hours, Luchini’s goal is for that timeframe to be dramatically shortened as the test is refined.

“We showed that our technology could be used to measure several different kinds of markers for TB in the urine and could be configured as a rapid test similar to a pregnancy test,” Luchini said in a GMU news release.

According to the university, GMU researchers will continue their work in Peru, where students will begin testing hundreds of patients as part of a research study. Grants from the National Institutes of Health and the Bill and Melinda Gates Foundation are funding their work. Luchini told New Scientist her goal is to make their TB urine test easier to use and to test it on thousands more people.

If successful, she predicts the test could be commercially available for physicians and clinical laboratories to use within three years. GMU’s biotechnology partner Ceres Nanosciences will be commercializing the technology, with the aim of making the test available worldwide, the university said in a statement.

—Andrea Downing Peck

Related Information:

TB, or Not TB? At Last, a Urine Test Can Diagnose It Quickly

Urine Lipoarabinomannan Glycan in HIV-Negative Patients with Pulmonary Tuberculosis Correlates with Disease Severity

Mason Scientists Develop Nanotechnology-based Urine Test that Could Lead to Early TB Detection

Urine Test for TB Yields Results in 12 Hours

Tuberculosis Serodiagnostic Tests Policy Statement 2011

Tuberculosis Mortality Nearly Halved Since 1990

Tuberculosis Fact Sheet

Severe Lack of Volunteers for Clinical Laboratory Studies Has US Alzheimer’s Researchers Employing Innovative Methods to Recruit Participants

Mar 9, 2018 | Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations

Low interest and a lack of diversity among study participants hinders research into one of America’s most fatal and costly chronic diseases

Finding enough people to participate in clinical laboratory trials for Alzheimer’s disease can be a daunting task for researchers. The shortage of participants has compelled scientists to develop innovative ways to locate volunteers for their studies. That includes “Swab-a-Palooza” events to make it easy for individuals to provide samples for this research and get speedy feedback about their ApoE.

“It’s all about recruitment now,” Stephen Salloway, MD, Director of Neurology and the Memory and Aging Program at Butler Hospital in Providence, R.I., and Professor of Clinical Neurosciences and Psychiatry at Brown Medical School, said in an article on the Biomedical Research Forum (BRF) website.

Some researchers are hunting online and offering free genetic testing to interested individuals to ensure they obtain the number of participants needed for their trials. Both the Alzheimer’s Prevention Registry (APR) and the Brain Health Registry (BHR) are using the Internet to compile listings of suitable participants.

The APR is dedicated to uniting Alzheimer’s researchers with individuals interested in participating in clinical trials. The Phoenix-based non-profit organization also educates the public on Alzheimer’s and prevention of the disease. The Brain Health Registry is a web-based research study led by medical researchers at the University of California, San Francisco. Participants complete online questionnaires and tests that provide researchers with information regarding an individual’s health, lifestyle, and cognitive function. The collected data is used to create a listing of potential participants for Alzheimer’s studies.

Using Genetic Testing to Recruit Alzheimer’s Study Participants

GeneMatch is a program led by the Banner Alzheimer’s Institute in the Phoenix area that is part of the APR. The purpose of this national program is to recruit participants for research on Alzheimer’s disease by using genetic testing to match qualified volunteers with research studies. According to their website, 80% of research studies on the disease aren’t completed on time due to a lack of volunteers.

Anyone can register to be part of GeneMatch as long as they live in the United States and are between the ages of 55 and 75. In addition, participants cannot have a diagnosis of cognitive impairment, Alzheimer’s, or dementia.

“We hold local swabbing parties, where the GeneMatch sign-up rate is 95%,” Pierre Tariot, MD, Internal Medicine and Psychiatry, and Director of Banner Alzheimer’s Institute, said in the BRF article. “Jeffrey Cummings calls them Swab-a-Paloozas.”

GeneMatch screens individuals for the Apolipoprotein E (ApoE) and the ApoE-e4 allele which increases the risk for Alzheimer’s disease and is associated with earlier onset of memory loss and other symptoms. At this time, it is not known how this allele is related to the risk of getting the disease, but researchers have discovered the brain tissue of affected individuals have an increased number of protein clumps called amyloid plaques. A buildup of these plaques may lead to the death of neurons and the presence of Alzheimer’s symptoms.

“I spend a lot of time in my community doing outreach. People are very interested and receptive,” said Salloway, who recently hosted a swabbing party for GeneMatch. “At events, I ask everyone to tell five other people about what they learned, and to host swabbing parties themselves.”

The DNA samples obtained by GeneMatch are analyzed by a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory. Over the past two years, GeneMatch has tested over 45,000 individuals for the ApoE-e4 allele and were able to identify 1,000 homozygote and 9,000 heterozygote carriers.

Lack of Diversity Among Study Participants

A paper published in September 2017 by Jeffrey Cummings, MD, Director of the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, estimated the number of participants currently needed for Alzheimer’s research is over 55,000. Clinical trials for Alzheimer’s need volunteers who have little or no symptoms of the illness and locating such interested individuals can be complicated.

Jeffrey-Cummings-MD

Jeffrey Cummings, MD (above), is Medical Director at Lou Ruvo Center for Brain Health in Las Vegas. In an interview with Drug Discovery and Development, Cummings said, “There is a huge problem of recruitment for many diseases throughout the nation. The problem goes beyond Alzheimer’s disease; there is a general lack of awareness by the public of either the availability or the importance of clinical trials.” (Photo copyright: Jerry Henkel/Las Vegas Review-Journal.)

Additional obstacles that face Alzheimer’s researchers are the lack of diversity among volunteers for their studies. The participants in GeneMatch are 78% female and there is little representation of African-American and Latino minorities.

“It’s not easy to get healthy individuals to join, and those who do are predominantly highly educated, white, and female,” Jessica Langbaum, PhD, Principal Scientist at Banner Alzheimer’s Institute, said in the BRF article. “That’s okay if the women are the health-info gatherers and send their men for trials, but it will be a problem if we cannot get men into studies.”

Delivering ApoE Genotype Results at Events

Technology that could help locate participants for Alzheimer’s research at open “Swab-a-Palooza” events include a small ApoE analyzer called the Spartan Cube. The small molecular diagnostic device, manufactured by Ottawa-based Spartan Bioscience, Inc., can deliver an ApoE genotype result in less than an hour. The gadget is perfect for outreach gatherings, as people can learn their ApoE genotype while at an event. At this time, the Spartan Cube is used only for research purposes and is not CLIA approved.

The paper by Cummings was a topic of discussion at the Clinical Trials on Alzheimer’s Disease (CTAD), which was held in November in Boston. The CTAD is an annual conference for Alzheimer’s disease researchers to meet and share information about the disease with each other. The 11th CTAD conference will take place in Barcelona, Spain, in October of this year.

More than five million people are living with Alzheimer’s disease in the United States and this number could reach 16 million by 2050, according to the Alzheimer’s Association. It is the sixth leading cause of death in the US and cost the nation $259 billion in 2017. It’s estimated that the costs associated with the disease could reach $1.1 trillion by 2050, which makes finding volunteers for research studies an important endeavor.

—JP Schlingman

 

Related Information:

Don’t Be an Enrollment Loser: Throw Your Own Swab-a-Palooza!

Alzheimer’s Disease Drug Development Pipeline: 2017

A Cure for Alzheimer’s by 2025? An Interview with Jeff Cummings, MD

California Company Creates ‘Uber for Blood’ to Speed the Transport of Life-Saving Medical Laboratory Supplies and Blood Products in Rwanda

Mar 7, 2018 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory Pathology

High-flying service expected to take flight in other African countries this year, as Tanzania announces launch of ‘world’s largest’ drone network for medical supply and clinical laboratory specimen deliveries

Anatomic pathologists and medical laboratories know that blood is a scarce and life-saving commodity. This is especially true in developing countries. Rising to that need, a California-based logistics company is using drones to provide on-demand access to vital blood supplies in Rwanda and Tanzania, creating a so-called “Uber for blood” delivery service that is poised for deployment to other regions in Africa as well.

Silicon Valley Start-up Zipline is an American automated logistics company based in California that transported more than 5,500 units of blood in 2017 to 12 regional hospitals from a base in the east of Rwanda, reported The Guardian.

The high-flying Silicon Valley startup began operating in the African nation in October 2016 and has cut blood delivery time from four hours to an average of about 30 minutes! Shipments arrive by parachute, dropping within a narrow target landing zone.

Though the Rwandan government, which is funding the project, has not officially released data quantifying the drones’ impact, the fixed-wing drones (called Zips) have been credited with reducing deaths due to malaria, childbirth, and other medical emergencies.

World’s Largest Drone Delivery Network

In August, Zipline announced plans to launch what it claims is the world’s largest drone delivery network in partnership with the government of Tanzania, a country of 56 million people. Zipline will open four distribution centers in the country during the next four years, with the first drones taking to the air in the first quarter of 2018 from the Tanzanian capital city of Dodoma, according to Cargo Forwarder Global (CFG), a cargo and logistics industry news website.

“Every life is precious. The government of Tanzania through the Ministry of Health, Community Development, Gender, Elderly and Children, has made great achievements in improving health services including the availability of medicines in all public health facilities,” Mpoki Ulisubisya, MD, Permanent Secretary of the Tanzania Ministry of Health, stated in a press release. “Our vision is to have a healthy society with improved social well-being that will contribute effectively to personal and national development; working with Zipline will help make that vision a reality.”

Zipline co-founder and CEO Keller Rinaudo (above) speaking at a 2017 TEDTalk on partnering with Rwanda and Tanzania to deliver life-saving medical supplies—including blood and medical laboratory products—by drone up to 500 times each day. Click on image above to view video. (Photo copyright: TEDTalk.)

Zipline co-founder and CEO Keller Rinaudo (above) speaking at a 2017 TEDTalk on partnering with Rwanda and Tanzania to deliver life-saving medical supplies—including blood and medical laboratory products—by drone up to 500 times each day. Click on image above to view video. (Photo copyright: TEDTalk.)

Each of the four distribution centers will be equipped with up to 30 drones, capable of making 500 on-demand delivery flights per day. Drones will provide access to more than 1,000 clinics, many of which lack well-functioning supply chains due to surface roads that “become increasingly bumpy and eventually impassable, particularly during the rainy season,” the CFG website reported.

“We strive to ensure that all 5,640 public health facilities have all the essential medicines, medical supplies, and laboratory reagents they need, wherever they are—even in the most hard-to-reach areas,” Laurean Bwanakunu, Director General of Tanzania’s Medical Stores Department, said in a news release. “But that mission can be a challenge during emergencies, times of unexpected demand, bad weather, or for small but critical orders. Using drones for just-in-time deliveries will allow us to provide health facilities with complete access to vital medical products no matter the circumstance.”

According to Zipline, health workers at remote clinics and hospitals text orders to Zipline for the medical products they need, which are stored in distribution centers. Within minutes, a Zipline Distribution Center can pack and prepare blood and other stored medical products for the 60-mph flight to any delivery site within a 93-mile round trip.

A Zipline worker technician launches a drone in Muhanga. (Photo copyright: Stephanie Aglietti/AFP/Getty Images. Caption copyright: The Guardian.)

A Zipline worker technician launches a drone in Muhanga. (Photo copyright: Stephanie Aglietti/AFP/Getty Images. Caption copyright: The Guardian.)

In a CFG statement, Keller Rinaudo, Zipline’s co-founder and Chief Executive Officer, said the expansion to Tanzania will make East Africa a world leader in drone logistics.

“Millions of people across the world die each year because they can’t get the medicine they need when they need it,” noted Rinaudo. “It’s a problem we can help solve with on-demand drone delivery. Now African nations are showing the world how it’s done.”

Rinaudo told IEEE Spectrum that Zipline expects to expand its operations to several other countries in 2018, though he did not specify where Zips will be flying next. He said the next generation of Zips will be able to fly longer distances, carry larger payloads, and make more deliveries per day.

“Rwanda has shown such remarkable success that a lot of other countries want to follow in its footsteps,” noted Rinaudo. “The problems we’re solving in Rwanda aren’t Rwanda problems, they’re global problems—rural healthcare is a challenge everywhere.”

Drones Delivering Medical Laboratory Specimens Globally

Africa is not the only part of the world where drones are taking flight to deliver blood and medical laboratory specimens. Johns Hopkins University Medicine researchers set a record in America for the longest distance drone delivery of viable medical specimens when its test drone traveled 161 miles across the Arizona desert, an event that Dark Daily reported on in November.

And in Switzerland, an eight-hospital medical group in Lugano partnered with Swiss Post (Switzerland’s postal service) and transportation technology manufacturer Matternet of Menlo Park, Calif., to successfully use drones to transport medical laboratory samples between hospitals, as noted in another Dark Daily report.

As drone technology improves, use of UAVs to transport blood and medical supplies and clinical laboratory specimens from point A to point B will likely become commonplace. They soon could be overflying a neighborhood near you!

—Andrea Downing Peck

 

Related Information:

‘Uber for blood’: How Rwandan Delivery Robots Are Saving Lives

Tanzania Announces World’s Largest National Drone Delivery Network Partnering with Zipline

Tanzania on Way to Becoming Drone Champion

Zipline Expands its Medical Delivery Drones Across East Africa

Johns Hopkins Test Drones Travels 161 Miles to Set Record for Delivery Distance of Clinical Laboratory Specimens

Drones Used to Deliver Clinical Laboratory Specimens in Switzerland

Former Hershey Medical Technologist Floyd Benko Sentenced to 15 Months in Prison for Failing to Follow Procedures when Performing Clinical Laboratory Tests

Mar 5, 2018 | Compliance, Legal, and Malpractice, Laboratory Hiring & Human Resources, Laboratory News, Laboratory Pathology, Laboratory Testing

The indicted medical laboratory technician will also be required to pay back more than $69,000 to Hershey Medical Center

It what may be a unique first for the clinical laboratory industry, a medical technologist in Pennsylvania has been found guilty of a criminal felony for failing to perform certain cancer genetic tests according to approved protocols. The judge has sentenced the medical technologist to 15 months in prison and repayment of almost $70,000 in restitution.

Dark Daily reported on earlier developments in this case in 2017. Medical technologist Floyd Benko was indicted in 2015 after pleading guilty to false statement charges stemming from his work with genetic testing at Hershey Medical Center (HMC) between November 2014 and April 2015. Now, Benko has been sentenced to nearly 15 months in prison after pleading guilty to false statement charges.

US Middle District Judge Yvette Kane sentenced Benko to 15 months in prison with three years of supervised release following his prison term. He must also make restitution to HMC in the amount of $69,742 related to retesting of the gene mutation tests he previously performed in which the results were found to be inaccurate.

The sentence required Benko to report to the Pennsylvania Bureau of Prisons on January 22, 2018.

Failure to Follow Protocols Leads to Faulty Results and Eventual Sentencing

The charges levied against Benko relate to DNA gene mutation tests performed by him on behalf of HMC for 124 advanced-stage cancer patients. According to a Department of Justice press release, the genetic testing included:

“Benko failed to perform the assays in the manner called for by Hershey’s standard operating procedures,” the press release states. “Subsequent retesting of the patients during summer 2014, revealed that 60 of the 124 patients had assay results discordant with results obtained by two outside medical laboratories.”

Unusual Application of Federal Fraud Statute

Dark Daily’s previous coverage provides a detailed timeline of events leading up to Benko’s guilty plea.

Court filings state that in late 2013, a treating physician at HMC noted discordant results for tests when compared to a patient’s clinical profile. The physician resubmitted the test to an outside lab and received results that differed from those of Benko’s test.

This led to a request from HMC supervisors for Benko to repeat the test. Again, results differed from the outside laboratory. When supervisors asked for access to the tissue samples used for the test, Benko could not provide them.

Penn State Milton S. Hershey Medical Center (above) where in 2013 to 2014 Floyd Benko, a 60-year-old research technologist, improperly conducted 124 gene mutation clinical laboratory tests and then lied about it to cover up his lack of following standard operating procedures. (Photo copyright: PennLive/Paul Chaplin.)

Standard operating procedures (SOPs) for the tests in question—procedures Benko himself helped to create in conjunction with HMC—required preservation of all tissue samples. They also required the use of a Thermo Scientific NanoDrop 2000 spectrophotometer—a piece of equipment that Benko did not acknowledge using.

With Benko unable to provide samples, HMC triggered an FBI investigation into testing practices by Benko. The investigation yielded 125 tests for which samples were not preserved. Repeat testing by two outside medical laboratories—at HMC’s expense—resulted in 60 assay results returned that were discordant with Benko’s original findings.

Benko eventually resigned from HMC. He later attempted to explain the discordant results in two separate letters to HMC supervisors. However, in July 2015, a federal grand jury returned an indictment: one count of healthcare fraud and two counts of making false statements in healthcare matters to HMC.

Copies of court filings available at Leagle show that Benko initially disputed the charges using four primary arguments and requested case dismissal. These arguments were eventually denied by Kane. “In refusing to dismiss the charges against Benko, Kane rejected his arguments that his alleged actions don’t constitute a crime, especially since he didn’t profit financially,” noted PennLive. “The judge did, however, characterize the Benko case as an ‘unusual application of the federal healthcare fraud statute.’”

After denial of his dismissal, Benko entered a guilty plea to false statement charges in July 2017. Follow-up coverage from PennLive explained that Benko’s plea agreement included a stipulation that advised a sentence of up to 18 months—of which he received 15 months. At the time of sentencing, the final charge appears to be one count of making false statements.

Establishing Protocols and Ensuring Accuracy in Medical Laboratory Testing

Anatomic pathology and medical laboratory testing is an increasingly important part of the modern healthcare system. Both value-based care models and personalized medicine rely on lab results to help improve outcomes and tailor treatments to the individual patient profile.

By failing to follow SOPs when performing these clinical laboratory tests, Benko potentially jeopardized the treatment outcomes and health of more than 100 patients and also created liability concerns for the laboratory in which he was employed.

As highlighted by Benko’s sentence, the impact from this case was not limited to the lives of more than 100 patients. It also affected both the reputation of HMC and their financials—requiring nearly $70,000 in additional spending for the flawed assays—and to confirm the results of suspect tests performed by Benko. And, this does not account for the time and monetary costs related to the investigation and prosecution of the case, or public relations work surrounding the case.

As test volumes continue to increase and lab liability continues to take the spotlight, it is essential that clinical laboratories, anatomical pathology groups, and other diagnostic service providers maintain effective protocols and procedures to ensure the accuracy of test results. And they must establish comprehensive documentation and compliance programs that create accountability and highlight concerns quickly to ensure both patient and laboratory safety.

—Jon Stone

Related Information:

U.S. v. BENKO No. 1:15-cr-00159

Former Hershey Medical Center Worker Pleads Guilty to Lying About Cancer Testing Procedure

Judge Won’t Dismiss Charges That Hershey Med Tech Fudged Genetic Tests for Cancer Patients

Former Hershey Medical Center Research Technologist Sentenced for Making False Statements About Cancer Tests

Penn State University College of Medicine (COM); The Penn State Hershey Medical Center (PSHMC): Standard Operating Procedures (SOPs) Regarding Review and Management of Conflict of Interest

Hershey, Pennsylvania, Clinical Laboratory Technician Indicted in 2015 for Fraudulent Cancer Test Results Pleads Guilty to False Statement Charges

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