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University College London Study Shows Direct-to-Consumer DNA Tests Not Reliable in Assessing Disease Risk

Regulatory agencies in UK and US have yet to address dangers inherent in customer misunderstanding of DTC medical laboratory genetic test results

Direct-to-consumer (DTC) medical laboratory genetic tests are gaining popularity across the globe. But recent research out of the United Kingdom questions the reliability of these tests. The study, according to The Guardian, found that “Over the counter genetic tests in the UK that assess the risk of cancer or heart problems fail to identify 89% of those in danger of getting killer diseases.”

Researchers at University College London (UCL) examined 926 polygenic scores for risk of 310 different diseases from details retrieved from the Polygenic Score (PGS) Catalog. This catalog is an open-access database of published polygenic scores.

According the PGS website, “each PGS in the catalog is consistently annotated with relevant metadata; including scoring files (variants, effect alleles/weights), annotations of how the PGS was developed and applied, and evaluations of their predictive performance.”

However, the researchers told The Guardian, “Polygenic risk scores performed poorly in population screening, individual risk prediction, and population risk stratification. Strong claims about the effect of polygenic risk scores on healthcare seem to be disproportionate to their performance.”

The UCL researchers published their findings in the journal BMJ Medicine titled, “Performance of Polygenic Risk Scores in Screening, Prediction, and Risk Stratification: Secondary Analysis of Data in the Polygenic Source Catalog.”

“Strong claims have been made about the potential of polygenic risk scores in medicine, but our study shows that this is not justified,” Aroon Hingorani, PhD (above), Professor of Genetic Epidemiology at UCL and lead author of the study, told The Guardian. “We found that, when held to the same standards as employed for other tests in medicine, polygenic risk scores performed poorly for prediction and screening across a range of common diseases.” Consumer misunderstanding of DTC medical laboratory genetic tests is a real danger. (Photo copyright: University College London.)

Polygenic Scores Not Beneficial to Cancer Screening

To complete their study, the UCL researchers compared PGS genetic risk data to conventional clinical laboratory testing methods and discovered some troubling results. They include:

  • On average, only 11% of individuals who developed a disease had been identified by the tests.
  • A 5% false positive rate where people were informed that they would get a disease within 10 years but did not.
  • PGS only identified 10% of people who later developed breast cancer.
  • PGS only identified 12% of individuals who later developed coronary artery disease.

The researchers state in their BMJ Medicine paper that polygenic risk scores are not the same as testing for certain gene mutations, which could be critical in screening for some cancers. They also wrote that discovering genetic variants associated with the risk for disease is still crucial for drug development.

“It has been suggested that polygenic risk scores could be introduced early on to help prevent breast cancer and heart disease but, in the examples we looked at, we found that the scores contributed little, if any, health benefit while adding cost and complexity,” research physician and epidemiologist Sir Nicholas Wald, FRS, FRCP, FMedSci, Professor of Preventive Medicine at UCL Institute of Health Informatics and co-author of the study, told the Jersey Evening Post

“Our results build on evidence that indicates that polygenic risk scores do not have a role in public health screening programs,” Wald added.

“This research study rightly highlights that for many health conditions genetic risk scores alone may have limited usefulness, because other factors such as deprivation, lifestyles, and environment are also important,” clinical epidemiologist Raghib Ali, MD, CEO, Chief Investigator and Chief Medical Officer, Our Future Health UK, told The Guardian

Our Future Health is a collaboration between public, non-profit, and private sectors to create the UK’s largest health research program. The researchers in this endeavor intend to recruit over five million volunteers and use polygenic risk scores to develop innovative ways to prevent, detect, and treat disease. This program is funded by the UK’s National Health System (NHS).

“[Our] research program will be developing integrated risk scores that will take in all the important risk factors,” Ali explained. “We hope these integrated risk scores can identify people more likely to develop diseases, but this is a relatively new area of science and there are still unanswered questions around it.”

Danger of Misunderstanding DTC Genetic Tests

Here in the US, there have been news stories in recent years about the unreliability of certain genetic tests. Dark Daily covered these stories in previous ebriefs. News stories about the unreliability of genetic tests, particularly those marketed directly to consumers, reveal the problems that existing regulatory schemes have yet to address.

In “Consumer Reports Identifies ‘Potential Pitfalls’ of Direct-to-Consumer Genetic Tests,” we covered CR’s findings that though clinical laboratory and pathology professionals understand the difference between a doctor-ordered genetic health risk (GHR) test and a direct-to-consumer (DTC) genetic test, the typical genetic test customer may not. And that, misunderstanding the results of a DTC at-home genetic test can lead to confusion, loss of privacy, and potential harm.

Scientific American also covered the dangers of DTC testing in “The Problem with Direct-to-Consumer Genetic Tests,” in which the author notes that “despite caveats in ads and on packages, users can fail to understand their limitations,” and that “consumer-grade products are easily misconstrued as appropriate medical tests and create false reassurances in patients who could be at legitimate risk.”

Most clinical laboratory managers and pathologists are probably not surprised that the research performed at UCL shows that there are still issues surrounding genetic tests, particularly those marketed directly to consumers. While direct-to-consumer DNA tests can have some benefits, at this time, they are not always the best option for individuals seeking information about their personal risk for hereditary diseases.

—JP Schlingman

Related Information:

Over the Counter Genetic Tests in UK ‘Fail to Identify 89%’ of Those at Serious Risk

Performance of Polygenic Risk Scores in Screening, Prediction, and Risk Stratification: Secondary Analysis of Data in the Polygenic Score Catalog

3 Things to Know about At-home DNA Testing Kits

What Can At-home Genetic Tests Tell Me about My Health?

What are the Benefits and Risks of Direct-to-consumer Genetic Testing?

Genetic Risk Scores ‘Do Not Have a Place in Public Health Screening’

Consumer Reports Identifies ‘Potential Pitfalls’ of Direct-to-Consumer Genetic Tests

The Problem with Direct-to-Consumer Genetic Tests

University of Ghent Belgium Research Team Finds Stool Transplants Improve Motor Symptoms in Early-stage Parkinson’s Disease Patients

Findings could lead to clinical laboratory tests that help physicians identify microbes lacking in the microbiomes of their Parkinson patients

Microbiologists and clinical laboratory scientists know that gut microbiome can be involved in the development of Parkinson’s disease, a progressive neurological disorder that affects the nervous system due to damage caused to nerve cells in the brain. There is no cure for the illness. But a new treatment developed by researchers at the VIB Center for Inflammation Research at the University of Ghent in Belgium, may help to alleviate the symptoms.

During a clinical trial, VIB Center for Inflammation Research (VIB-IRC) scientists discovered that fecal microbiota transplantation (FMT), also known as a stool transplant, can improve motor skills in some Parkinson’s patients, according to Neuroscience News.

Parkinson’s disease (PD) develops when a protein called alpha-synuclein misfolds and forms into bundled clusters damaging nerve cells in the brain that produce dopamine. These formations, which are believed to appear in the gastrointestinal wall in the early stages of PD, then reach the brain via the vagus nerve leading to typical PD symptoms in patients.

Dopaminergic medication, deep brain stimulation, and speech and occupational therapy are some of the treatments currently available to people with Parkinson’s disease, but researchers are constantly on the lookout for more and better treatments,” Medical News Today reported.

The scientists published their findings in eClinicalMedicine titled, “Safety and Efficacy of Fecal Microbiota Transplantation in Patients with Mild to Moderate Parkinson’s Disease (GUT-PARFECT): A Double-Blind, Placebo-Controlled, Randomized, Phase 2 Trial.”

“Our study provides promising hints that FMT can be a valuable new treatment for Parkinson’s disease,” Roosmarijn Vandenbroucke, PhD (above), Principal Investigator, VIB-UGent Center for Inflammation Research and full professor, UGent Department of Biomedical molecular biology, Faculty of Sciences, told Neuroscience News. “More research is needed, but it offers a potentially safe, effective, and cost-effective way to improve symptoms and quality of life for millions of people with Parkinson’s disease worldwide.” Clinical laboratories will likely be involved in identifying the best microbes for the FMT treatments. (Photo copyright: University of Ghent.)

Correlation between Gut Microbiome and Neurogenerative Disease

To perform their clinical study—referred to as GUT-PARFECT—the IRC researchers first recruited patients with early-stage PD and healthy donors who provided stool samples to the Ghent Stool Bank. The PD patients received the healthy stool via a tube inserted into the nose which led directly into the small intestine.

The FMT procedures were performed on 46 patients with PD between December 2020 and December 2021. The participants in this group ranged in ages from 50 to 65. There were 24 PD patients in the placebo group, and a total of 22 donors provided the healthy stool. Clinical evaluations were performed at baseline, three, six, and 12 months.

After 12 months, the group that received the transplants showed a reduction in symptoms compared to the placebo group. Their motor score on the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) improved by a mean of 5.8 points. The improvement registered on the same scale for the placebo group was 2.7 points.

Developed in the 1980s, the MDS-UPDRS is a scale utilized to evaluate various aspects of PD by measuring patient responses via a questionnaire rating several issues (such as cognitive impairment, apathy, depression, and anxiousness) common in PD patients from normal to severe. It is divided into four parts:

  • Part I: Non-motor experiences of daily living.
  • Part II: Motor experiences of daily living.
  • Part III: Motor examination.
  • Part IV: Motor complications.

During the final six months of the research, the improvement in motor symptoms became even greater. To the VIB-IRC researchers this implied that an FMT may have long-lasting effects on PD patients. The FMT study group also experienced less constipation, a condition that can be bothersome for some PD patients.

“Our results are really encouraging!” said the study’s first author, Arnout Bruggeman, MD, PhD student, VIB-UGent Center for Inflammation Research, in a UGent News release. “After twelve months, participants who received the healthy donor stool transplant showed a significant improvement in their motor score, the most important measure for Parkinson’s symptoms.”

Findings Could Lead to Other Targeted Therapies for PD

The VIB-IRC researchers believe there is a correlation between the gut microbiome and Parkinson’s disease.

“Our findings suggested a single FMT induced mild, but long-lasting beneficial effects on motor symptoms in patients with early-stage PD. These findings highlight the potential of modulating the gut microbiome as a therapeutic approach and warrant a further exploration of FMT in larger cohorts of patients with PD in various disease stages,” the IRC researchers wrote in eClinicalMedicine.  

“Our next step is to obtain funding to determine which bacteria have a positive influence. This could lead to the development of a ‘bacterial pill’ or other targeted therapy that could replace FMT in the future,” Debby Laukens, PhD, Associate Professor, Ghent University, told Neuroscience News.

According to the Parkinson’s Foundation website, nearly one million people in the US live with PD. It is second only to Alzheimer’s disease in the category of neurodegenerative diseases.

More research and studies are needed before the VIB-IRC’s stool transplant treatment can be used in clinical care. As researchers learn more about which specific strains of bacteria are doing the beneficial work in PD patients, that data could eventually lead to clinical laboratory tests performed to help physicians identify which microbes are lacking in the microbiomes of their PD patients, and if fecal transplants could help those patients.

—JP Schlingman

Related Information:

Fecal Bacteria Transplant May Improve Parkinson’s Symptoms

Safety and Efficacy of Fecal Microbiota Transplantation in Patients with Mild to Moderate Parkinson’s Disease (GUT-PARFECT): A Double-Blind, Placebo-Controlled, Randomized, Phase 2 Trial

Stool Transplantation Shows Promise For Parkinson’s Disease

Fecal Microbiota Transplant Eases Parkinson’s Symptoms in Trial

Stool Transplant Could Improve Motor Symptoms in Parkinson’s Disease

In Conversation: Why Parkinson’s Research is Zooming in on the Gut

New Zealand Blood Service Workers and Junior Doctors Hit the Picket Line Once Again to Fight against Pay Disparities and Poor Working Conditions

As before, the ongoing strikes continue to cause delays in critical clinical laboratory blood testing and surgical procedures

After seven months of failed negotiations, New Zealand’s blood workers, clinical laboratory technicians, and medical scientists, are once again back on strike. According to Star News, hundreds of lab workers walked off the job on May 31, 2024, with another longer walkout planned for June to protest pay disparities.

New Zealand Blood Service (NZBS) workers, who are represented by the Public Service Association or PSA (Māori: Te Pūkenga Here Tikanga Mahi), collect and process blood and tissue samples from donors to ensure they are safe for transfer.

“Our colleagues at Te Whatu Ora [Health New Zealand] are being paid up to 35% more than us and we want to be paid too. We want fair pay,” Esperanza Stuart, a New Zealand Blood Service scientist, told Star News.

“The stall in negotiations is largely attributed to a lack of movement from NZBS on the principal issue of parity with Te Whatu Ora laboratory workers rates of pay. There is currently a 21-28% pay differential between NZBS and Te Whatu Ora laboratory workers, despite both groups of workers performing essentially the same work,” NZ Doctor noted.

Health New Zealand is the country’s government-run healthcare system.

The first strike took place on May 31 from 1-5 pm. A second 24-hour strike is planned for June 4. The strikers outlined the rest of their strike schedule as follows:

  • No work outside paid hours (5/29-6/6)
  • Refusal to conduct duties associated with processing AHF [antihemophilic factor] plasma (5/29-6/6)
  • No overtime or extra shifts (6/6-6/19)

The PSA union claims that the pay disparity workers are experiencing is pushing veteran workers out and complicating recruitment of new workers.

New Zealand Blood Service workers and junior doctors are once again back on the picket line to protest wage cuts and pay disparities. “I think it should be a signal that things are not right in our health system when there are multiple groups of workers going on strike simultaneously,” said PSA union organizer Alexandra Ward. Clinical laboratory workers in the US are closely monitoring the goings on in New Zealand as pressure over staff shortages and working conditions continue to mount in this country as well. (Photo copyright: RNZ.)

Clinical Laboratory Worker Strikes Ongoing in New Zealand

This is far from the first time New Zealand lab workers have hit the picket line.

In “Medical Laboratory Workers Again on Strike at Large Clinical Laboratory Company Locations around New Zealand,” Dark Daily reported on a medical laboratory workers strike that took place in 2023 in New Zealand’s South Island and Wellington regions. The workers walked off the job after a negotiated agreement was not reached between APEX, a “specialist union representing over 4,000 allied, scientific, and technical health professionals,” according to the union’s website, and Awanui Labs, one of the country’s largest hospital and clinical laboratory services providers.

And in “Four Thousand New Zealand Medical Laboratory Scientists and Technicians Threatened to Strike over Low Pay and Poor Working Conditions,” we covered a series of walkouts in 2022 sparked by an unprecedented surge in PCR COVID-19 testing that pushed the country’s 10,000 healthcare workers—including 4,000 medical laboratory scientists and technicians—to the breaking point.

This latest strike is likely to cause delays in vital surgeries and risk the nation’s critical blood supply. All of these strikes were spurred on by low pay, negative working conditions and worker burnout. Similar issues have caused labor actions in the United Kingdom’s National Health Service in recent years.  

Junior Doctors Join Blood Service Workers on Picket Line

Blood service workers aren’t the only healthcare employees in New Zealand’s medical community taking action. In May about half of the nation’s junior doctors walked off the job for 25 hours to protest proposed pay cuts, NZ Herald reported.

In a letter to the nation’s public hospitals, Sarah Morley, PhD, NZBS’s Chief Medical Officer, “warned [that] even high priority planned surgeries should be deferred because they did not meet the definition of a ‘life-preserving service,’” and that “only surgeries where there is less than a 5% risk that patients may need a transfusion should be carried out,” RNZ reported.

According to an internal memo at Mercy Ascot, NZBS “did not consider cancers and cardiac operations in private hospitals to be a life-preserving service,” RNZ noted.

The situation may be more dangerous than officials are letting on, NZ Herald noted. A senior doctor at Waikato Hospital told reporters, “There are plenty of elective services cancelled today—clinics, surgery, day stay procedures etc. … And although I can only speak for my department, we are really tight for cover from SMO [senior medical officers] staff for acute services and pretty much all elective work has been cancelled. So, it’s actually pretty dire, and if next week’s planned strike goes ahead it’s going to be worse. I’d go as far as to say that it’s bordering on unsafe.”

The strike did take place, and the junior doctors went back on strike at the end of May as well, according to RNZ.

Support from Patients

Eden Hawkins, a junior doctor on strike at Wellington Hospital told RNZ that patient wellbeing is a top concern of striking workers and that patients have shown support for the doctors.

“When patients have brought it up with me on the wards or in other contexts there seems to be a bolstering sense of support around us, which is really reassuring and heartening because there’s obviously a conflict within ourselves when we strike, we don’t want to be doing that,” she said. Hawkins also makes the argument that striking workers can improve patient wellbeing in the long run. Improvement of pay and conditions could lessen staff turnover and overall improve the standard of care.

New Zealand healthcare workers haven’t been shy when it comes to fighting for the improved working conditions and fair pay. And their problems are far from unique. American healthcare workers have been struggling with worker burnout, pay disparities, high turnover as well. Clinical laboratory and other healthcare professionals in the US would be wise to keep an eye on their Kiwi counterparts.

—Ashley Croce

Related Information:

Fed-Up Blood Service Workers Go on Strike

NZ Blood Workers Plan 24-Hour Strike for Pay Parity

New Zealand Blood Service Laboratory Workers to Strike after 7 Months of Stalled Pay Negotiations

Significant Risk to Blood Supply as Blood Service Lab Workers Strike

Junior Doctors to Strike for 25 Hours, May Postpone Treatments

‘Pretty Dire’ Situation for Patients as Junior Doctors Strike Over Pay Cuts

Junior Doctors Go on Strike Again, More Surgeries Deferred

Medical Laboratory Workers Again on Strike at Large Clinical Laboratory Company Locations around New Zealand

Four Thousand New Zealand Medical Laboratory Scientists and Technicians Threatened to Strike over Low Pay and Poor Working Conditions

Measles Cases in the US, Europe, and Other Countries are Increasing, Slowing Progress on Efforts to Eliminate the Disease

Clinical laboratory managers should prepare for an increase in demand for measles testing, especially for children

Clinical laboratory managers should be on the alert for new cases of measles. The US Centers for Disease Control and Prevention (CDC) has reported a surge in the highly infectious disease. Public health experts pointed to declining vaccination coverage as the primary cause. Officials in other countries have also reported outbreaks.

In 2000, the US declared that measles had been eliminated, meaning it “is no longer constantly present in this country,” the CDC stated on its website. However, the agency noted travelers can still bring the disease into the country and that there have been sporadic outbreaks since then.

In a new study, published April 11, 2024, in the CDC’s Morbidity and Mortality Weekly Report (MMWR), the agency reported that it was notified of 97 confirmed cases in the first quarter of 2024. That compares to an average of five cases during the first quarters of 2020 through 2023, the agency stated. In total, 338 cases were reported to the CDC between Jan. 1, 2020, and March 28, 2024, so the latest outbreaks amount to 29%—nearly a third—of the total.

“While the risk for measles for the majority of the US population still remains low, it’s crucial that we take the necessary steps now to prevent the continued spread of measles and maintain elimination in the US,” Adria D. Mathis, MSPH, lead author of the CDC report, told Healthline. Mathis is affiliated with the CDC’s Division of Viral Diseases at the National Center for Immunization and Respiratory Diseases (NCIRD).

“We have seen, in the region, not only a 30-fold increase in measles cases, but also nearly 21,000 hospitalizations and five measles-related deaths. This is concerning,” Hans Henri P. Kluge, MD (above), WHO Regional Director for Europe, told BBC News. “Vaccination is the only way to protect children from this potentially dangerous disease.” Clinical laboratories in the US that identify a case of measles from a positive test must report that result to public health labs. Thus, wise lab managers will track the rise in measles cases and prepare for increased demand for measles testing. (Photo copyright: World Health Organization.)

Renewed Threat to the US, Other Countries

The recent cases “represent a renewed threat to the US elimination status,” and “underscore the need for additional efforts to increase measles, mumps, and rubella (MMR) vaccination coverage, especially among close-knit and under-vaccinated communities,” Mathis told Healthline.

The MMWR report notes that most of the new cases were in persons under age 20, and that almost all were “in persons who were unvaccinated or whose vaccination status was unknown.” Most of the importations, the report states, were “among persons traveling to and from countries in the Eastern Mediterranean and African WHO [World Health Organization] regions; these regions experienced the highest reported measles incidence among all WHO regions during 2021–2022.”

In the US, vaccination coverage has been below 95% for three consecutive years. That is the “estimated population-level immunity necessary to prevent sustained measles transmission,” according to the federal agency. In 12 states and the District of Columbia, the coverage rate is below 90%. In total, “approximately 250,000 kindergarten children [are] susceptible to measles each year,” the CDC report states.

Measles vaccination coverage has declined globally, “from 86% in 2019 to 83% in 2022.” This left nearly 22 million children under the age of one susceptible to the disease, the report notes.

Earlier Measles Outbreaks in the US

The CDC performed its latest analysis following two larger measles outbreaks in 2019 among under-vaccinated populations in New York state.

The Associated Press (AP) reported that the 2019 epidemic, which totaled 1,274 cases nationwide, “was the worst in almost three decades and threatened the United States’ status as a country that has eliminated measles by stopping the continual spread of the measles virus.”

A vaccine for the disease first became available in 1963. Prior to its availability, “there were some three million to four million cases per year,” AP reported. Most people recover, but “in the decade before the vaccine was available, 48,000 people were hospitalized per year. … About 1,000 people developed dangerous brain inflammation from measles each year, and 400 to 500 died,” AP noted, citing CDC data.

US Not Alone in Fight against Measles

Other countries also are reporting spikes in measles cases. In a recently published rapid risk assessment, the Canadian government reported a total of 29 cases as of March 15, 2024, of which 21 were reported since Feb. 28.

“That’s already the largest annual total since 2019 and more than double the number of cases reported last year, as medical experts fear the number will rise while more Canadians travel in and out of the country this month for March break,” CBC News reported.

“New projections from a team at Simon Fraser University (SFU) in British Columbia show the grim possibilities,” CBC News reported. “The modelling suggests that vaccine coverage of less than 85% can lead to dozens of cases within small communities—or even hundreds if immunization rates are lower.”

Numbers are far worse in parts of Europe. In a February 2024 news release, the World Health Organization reported that in 2023, more than 58,000 people in its European region were infected by the disease, “resulting in thousands of hospitalizations and 10 measles-related deaths.”

According to WHO epidemiological data, countries in Central Asia, which is part of WHO’s European region, reported some of the highest numbers:

  • 15,111 in Kazakhstan,
  • 13,735 in Azerbaijan, and
  • 7,044 in Kyrgyzstan.

The Russian Federation reported 12,723 cases and Turkey reported 4,559.

A WHO European Region Measles and Rubella Monthly Update notes that more than half of the regionwide cases—31,428—were reported in the last three months of 2023. More than 15,000 cases were reported in December. That compares to just 163 cases reported in 2021 and 942 in 2022. Nearly half of the cases were among children under the age of five.

Lack of Vaccinations among Children Blamed for Outbreaks

One factor that has led to the increase in measles cases was the disruption to immunization services caused by the COVID-19 pandemic. “This has resulted in a significant accumulation of susceptible children who have missed their routine vaccinations against measles and other vaccine-preventable diseases,” the WHO reported.

Among the region’s 53 member states, 33 had eliminated measles, WHO reported, but “this achievement remains fragile. To retain this status, a country must ensure that transmission of the virus following any importation is stopped within 12 months from the first reported case.”

In the UK, which reported 231 cases last year, the National Health Service has launched a campaign to improve vaccination rates, the BBC reported, noting that “more than 3.4 million children aged under 16 are unprotected and at risk of becoming ill.”

However, a public health campaign built on vaccination is successful only if a high rate of individuals get vaccinated. The Baby Boomer and Gen X generations had high rates of vaccination for smallpox, polio, etc. because the parents saw individuals in their family and neighborhood who became infected and suffered lifechanging consequences. They recognized that vaccination was a simple thing to provide protection from a potentially deadly infection.

Clinical laboratory managers and pathologists will want to follow the CDC’s ongoing reports of the number of cases of measles in this country. Today, the absolute number of new measles cases is relatively small. At the same time, in communities experiencing an outbreak of even a few measles cases, physicians may want to increase the volume of measles tests they order for their patients.

—Stephen Beale

Related Information:

Canada Heading Toward Major Measles Outbreak without Vaccine Boost, New Modelling Suggests

A Review of the Resurgence of Measles, a Vaccine-Preventable Disease, as Current Concerns Contrast with Past Hopes for Measles Elimination

Alarming 45-Fold Rise in Measles in Europe-WHO

US Declared Measles Gone in 2000—New Outbreaks May Change That

US Measles Cases Are Up in 2024. What’s Driving the Increase?

CDC Warns That Measles Spike Poses A ‘Renewed Threat’ To the Disease’s Elimination

Measles Vaccine Campaign Targets Unprotected Millions

Pennsylvania’s WellSpan Health Announces New Medical Drone Delivery Service

Drone company Zipline delivers medical supplies and clinical laboratory specimens on four continents and is used in the US by several major healthcare networks and retail organizations

Unmanned aerial vehicles (UAVs), commonly referred to as drones, continue to demonstrate their value in the medical industry. In February, WellSpan Health announced it will soon begin using drones to deliver prescriptions to patients and to transport medical supplies and clinical laboratory specimens between its facilities located in Pennsylvania.

WellSpan Health, one of the leading healthcare systems in Southern Pennsylvania and Northern Maryland, is partnering with Zipline, a supplier of drone logistic services, in the endeavor.

“We’re making our [healthcare] system lower cost, faster, and more sustainable by bringing this exceptional technology to South Central Pennsylvania,” said Roxanna Gapstur, PhD, RN, President and CEO, WellSpan Health, in a news release. “We know the easier it is to access care the healthier people can be. With Zipline, we’re connecting healthcare straight to your front door.”

Zipline’s Platform 2 (P2 Zip) drone will be used for the venture. The drone is designed to fly in almost all weather conditions. If true, this would be a boon to the drone delivery service industry.

Previous attempts to implement drone delivery services have been hampered by a typical drone’s low performance in bad weather such as heavy rain and high winds. This seems to be what has held back wide adoption of drone delivery in the US.

“WellSpan continues to reimagine what healthcare can look like for our patients. With Zipline, we’re creating a future for our patients, where getting a prescription filled is as simple as pressing a button,” said Roxanna Gapstur, PhD, RN (above), President and CEO, WellSpan Health, in a news release. WellSpan Health’s drone delivery customers will be able to receive text notifications tracking the progress of their medical supplies and clinical laboratory specimens on their smartphones. (Photo copyright: WellSpan Health.)

Delivery of Medical Supplies Direct to Patients’ Front Door

ABC27 reported that “WellSpan will be the first health service in the state of Pennsylvania that will introduce this type of technology and delivery system.”

According to the drone company’s website, Zipline:

  • Serves more than 4,000 health centers worldwide and more than 45 million people.
  • Has completed more than one million deliveries.
  • Plans to operate more flights annually than almost all the major US airlines by next year.
  • Delivers 75% of Rwanda’s blood supply outside Kigali, the country’s capital city.

Additionally, Zipline’s all-electric, zero-emission drones reduce carbon emissions by an average of 97% when compared to gas-driven vehicles. 

Each P2 Zip drone features Zipline’s autonomous airspace Detect and Avoid (DAA) deconfliction technology and contains fully redundant flight systems.

“This acoustic system is composed of a series of small, lightweight acoustic microphones and onboard processors used to navigate airspace and grant 360-degree awareness with a range of up to 2,000 meters,” DRONELIFE reported. “This innovative onboard system enables the aircraft to autonomously detect and maneuver around other aircraft and obstacles in real-time, making large scale autonomous commercial operations more feasible.”

According to a fact sheet, the P2 Zip drone can carry loads up to eight pounds and has a cruising speed of 70 miles/hour. It’s service range is either a 10-mile radius or a one-way trip of 24 miles. It only requires two feet of open space to execute a delivery and can hover at more than 300 feet above the ground while delivering a package.

“Zipline has been improving access to healthcare for eight years. Together with WellSpan Health we will bring prescriptions and medical products right to patients’ doorsteps with fast, sustainable, and convenient delivery,” stated Keller Rinaudo Cliffton, co-founder and CEO of Zipline, in the news release. 

Other Healthcare Drone Delivery Services

Dark Daily has published many ebriefs about drones being used for medical supply and clinical laboratory specimen deliveries.

In “Dr. Risch Laboratory Group in Switzerland Partners with Drone Company to Deliver Medical Laboratory Specimens in a Unique Way,” we reported how the medical laboratory group was testing drone delivery of specimens to 14 clinical laboratories and eight sample collection locations throughout Switzerland. What makes this service unique is that the Jedsy drone they used can deliver packages directly to windows, regardless of where the window is located on the building.  

In “Oregon-based Interpath Laboratory Launches Pilot Program to Explore Delivering Biological Specimens by Drone from Yellowhawk Tribal Health Center,” we covered how Interpath Laboratory in the Pacific Northwest launched a drone delivery pilot program for delivering clinical laboratory test specimens from Yellowhawk Tribal Health Center to Interpath’s medical laboratory in Pendleton, Ore.

And in “California Company Creates ‘Uber for Blood’ to Speed the Transport of Life-Saving Medical Laboratory Supplies and Blood Products in Rwanda,” we reported how Zipline drones were being used in Rwanda and Tanzania for the transportation of medical supplies and blood products, and how delivery times had been reduced from four hours to just 30 minutes.

As drone delivery technology continues to improve, UAVs are more likely to be used in healthcare situations. If the issue of bad weather has been resolved, it’s reasonable to assume that within a short period of time clinical laboratories may begin receiving many more samples to test via drones.

—JP Schlingman

Related Information:

WellSpan Will Bring Innovative Medical Drone Delivery to PA with Logistics Leader Zipline

WellSpan Health to Bring Medical Drone Delivery to Pennsylvania

The Essential Guide to Implementing Drone Delivery in Healthcare

Dr. Risch Laboratory Group in Switzerland Partners with Drone Company to Deliver Medical Laboratory Specimens in a Unique Way

Oregon-based Interpath Laboratory Launches Pilot Program to Explore Delivering Biological Specimens by Drone from Yellowhawk Tribal Health Center

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

American Cancer Society Annual Report Shows Cervical Cancer Rate Increasing, but Only among 30- to 40-Year-Olds

Lack of regular clinical laboratory screenings in this age group at least partially to blame, researchers say

While cervical cancer rates have seen a 50-year decline overall, that trend is shifting among 30- to 40 year-olds who have experienced a near 2% increase from 2012-2019. This finding comes from a 2024 American Cancer Society (ACS) report that is eyeing the timeline of the human papillomavirus (HPV) vaccines and the lack of clinical laboratory cancer screenings as possible contributors to this new trend.

Though a 2% increase is significant, the study, which was published in CA: A Cancer Journal for Clinicians, titled “Cancer Statistics, 2024,” noted that these cancers were “mostly early, curable tumors,” epidemiologist Ahmedin Jemal DVM, PhD, Senior Vice President Surveillance and Health Equity Science at ACS, and senior author of the new report, told NBC News.

To understand how the increase in cancer rates impacts this age group, consider the numbers: “About 13,800 American women are diagnosed with cervical cancer each year and 4,360 die from the disease,” NBC reported.

US vaccination programs for youths have lagged behind nations that have embraced HPV vaccination to positive results.

Australia, for example, has vaccinated a high proportion of its youth since the vaccine was first released in 2006. In 2023, the nation created its National Strategy for the Elimination of Cervical Cancer in Australia program and expects cervical cancer to be fully eliminated there by 2035.

For lab professionals, this demonstrates how new technologies like the HPV test and vaccine can alter how individuals are screened for diseases, and how vaccines can reduce and even eliminate diseases that were once common.

“We need to make sure we are not forgetting about that generation that was a little too old for HPV vaccination,” Jennifer Spencer, PhD (above), Assistant Professor, Department of Population Health and Department Internal Medicine, Dell Medical School, University of Texas at Austin, told NBC News. “The onus is on the healthcare system to think about who is slipping through the cracks,” she added. Lack of clinical laboratory screenings among the 30-40 age group may be contributing to the increase in cervical cancer rates. (Photo copyright: Dell Medical School.)

Lack of Clinical Laboratory Screenings

Research points to a lag in cervical cancer screenings as a possible cause for the recent rise in cases. Timely screening allows doctors to both identify and remove any worrisome lesions before they become cancerous, Jennifer Spencer, PhD, Assistant Professor of the Department of Population Health, Dell Medical School, University of Texas at Austin, told NBC News.

Spencer was not involved in the American Cancer Society study, but rather had her own study published in the American Journal of Preventative Medicine in 2023 titled, “Racial and Ethnic Disparities in Cervical Cancer Screening from Three US Healthcare Settings.”

Screenings for women ages 21-65 have fallen 15% since 2000, according to data from the National Cancer Institute. Also, more than half of women with cervical cancer have “either never been screened or haven’t been screened in the past five years, according to the Centers for Disease Control and Prevention,” NBC reported.

The US Preventative Services Task Force recommends that women 21-29 years of age should receive Pap smears every three years. Women 30-65 years of age should do the same, or every five years with an HPV test or combo test.

Despite a decrease in cervical cancer, 29% of women in their 20s are overdue to get screening, NBC noted. This was the age group most likely to be lagging on getting screened. Spencer says that this delay in screening could explain the resulting increase in cervical cancer among the 30-40 age group.

Causes for Lack in Screenings

Regardless of age group, women who were uninsured, in a rural area, non-white, or identifying as lesbian, bisexual, or gay were also more likely to be overdue on screenings, according to Spencer’s study.

In addition, women who just moved to the United States may have missed their screenings, thus increasing risk, epidemiologist Nicholas Wentzensen, MD, PhD, Deputy Director, Senior Investigator, and Head of the Clinical Epidemiology Unit at the National Cancer Institute, told NBC News.

Additionally, Spencer found in her research that confusion exists by both patients and doctors on when cervical screening should take place. Some participants in her study did not have screening recommended by their doctors, while others simply did not recognize it was necessary.

“When women in one of Spencer’s studies were asked why they hadn’t been screened recently, they commonly said that they didn’t know they needed to be screened or that a health provider hadn’t recommended it. Only 1% [of] women ages 21 to 29 said they had skipped screening because they had received the HPV shot,” NBC News reported.

A 2022 Journal of American Medicine (JAMA) report also looked at screenings as a possible cause. Those researchers found that “only 73% of women with abnormal screening results received follow-up care,” NBC reported.

“If the increase (in cases) is real, it could be a result of missed screening opportunities at earlier ages, as suggested by the increase in squamous cell carcinoma and localized disease. It may also stem from a decrease in screening at younger ages,” the JAMA study authors wrote.

HPV Vaccine and Cervical Cancer Prevention

The HPV vaccine is another important area of research to be considered. Approved in 2006, HPV vaccines were beneficial because HPV “causes six types of cancer, including cervical cancer,” NBC reported.

Women in their early 20s at that time were the first generation to benefit from HPV vaccines, NBC noted. It may be that they continue to benefit in a decrease in cervical cancer among their cohort.

Countries that have emphasized HPV vaccines and stringent screenings in their cancer prevention efforts are reaping the benefits of that policy.

In “Australia Moves to Fully Eliminate Cervical Cancer by 2035, Especially in Underserved and Diverse Populations,” Dark Daily reported how Australia was one of the first nations to implement HPV vaccination programs. By 2010, Australia was working to vaccinate every child. Now, 14 years later, the pool of adults vaccinated against HPV in that nation is causing the rates of cervical cancer to fall.

Follow-through is Key for Patients

Though cancer screening and the HPV vaccine are important first steps women should take to prevent cervical cancer, follow-through clinical laboratory testing and diagnosis is crucial, Spencer added. This would include additional testing and treatment for any abnormal results of the cancer screening.

However, according to Spencer, “only 73% of women with abnormal screening results received follow-up care,” NBC reported.

Healthcare policymakers today are emphasizing the need for providers to identify and close gaps in care as a way to improve patient outcomes and help control the cost of care. Women who are overdue for a cervical cancer screening test—whether an HPV test or Pap smear—have this care gap. This creates an opportunity for clinical labs to add value.

Clinical laboratories could be helpful during this period by looking at patient files to note which patients are overdue for screenings and then alerting their doctors. Medical labs also could work directly with doctors to establish a program to reach out to patients. Labs would thus be adding value as well as benefitting patients.

—Kristin Althea O’Connor

Related Information:

Cervical Cancer Increasing in Women in Their 30s and 40s, New Report Finds

Cervical Cancer Incidence among US Women, 2001-2019

Cancer Statistics, 2024

Racial and Ethnic Disparities in Cervical Cancer Screening from Three US Healthcare Settings

Australia Moves to Fully Eliminate Cervical Cancer by 2035, Especially in Underserved and Diverse Populations

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