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UK’s NHS to Distribute New Clinical Laboratory Test for Women Suspected of Having Pre-Eclampsia

Based on clinical trials of the medical laboratory test, pregnant women can expect a reduced risk for experiencing complications associated with the dangerous blood disorder

Clinical pathology laboratories and obstetricians in the UK may soon have a new blood test that can help provide earlier diagnoses of pre-eclampsia, a hypertensive disorder of pregnancy that can cause liver and kidney disfunctions and, if untreated, can lead to eclampsia and deadly seizures.

Following a clinical trial conducted by scientists at King’s College London (King’s College), the National Health Service (NHS) in the United Kingdom (UK) announced it would be making the new test widely available.

The researchers published their findings in The Lancet medical journal. Their paper explains that the clinical trial took place in 11 maternity units in the UK from June 2016 through October 2017. And that 1,023 women were divided into two groups:

  • 576 (56%) were in the “intervention group,” meaning they had PGF test results made available to their maternity teams;
  • 447 (44%) did not have PGF test results made available.

The researchers, the Independent reported, wanted to determine the impact, if any, the new test’s results would have on diagnoses.

Significantly Reduced Time to Diagnosis

Trial results indicated that measuring the placental growth factor (PGF) in women who are suspected of having pre-eclampsia can increase speed to diagnosis. “PGF testing was shown to reduce the average time to pre-eclampsia diagnosis from 4.1 days to 1.9 days, and serious complications before birth (such as eclampsia, stroke, and maternal death) [dropped] from 5% to 4%,” a King’s College press release stated.

“Complications like stroke, seizures and maternal death fell by 20% when doctors had access to PGF testing,” the Independent reported.

The researchers stated in their study, “Our trial has shown that, in women presenting with suspected pre-eclampsia, PGF measurement, incorporated into a management algorithm based on national guidelines, significantly reduces the time taken for treating clinicians to diagnose pre-eclampsia. This improvement was associated with a significant reduction in maternal adverse outcomes, with no detected difference in gestational age at delivery or adverse perinatal outcomes.”

The King’s College press release states, “Pre-eclampsia is suspected in around 10% of UK pregnancies, affecting approximately 80,000 women annually. If untreated, it can progress to cause complications in the woman, including damage to vital organs, fits, and can be fatal for the woman and baby. Globally, 100 women die as a result of the condition every day.”

The release also noted that “doctors were able to diagnose pre-eclampsia on average two days sooner. This was associated with significant improvements in outcomes for women without causing health problems for babies.”

Tony Young, PhD (above), National Clinical Lead for Innovation at NHS, stated in the King’s College press release that “This innovative blood test helps determine the risks of pre-eclampsia in pregnancy, enabling women to be directed to appropriate care or reduce unnecessary worry more quickly.” (Photo copyright: LinkedIn.)

Measuring PGF in Clinical Laboratory Study

PGF is a molecular marker for inflammation associated mostly with the mother’s placenta. The King’s College researchers wanted to find out if a quicker diagnosis of pre-eclampsia was possible. And, if so, could it reduce adverse outcomes in the mother and baby?

“For the last hundred years, we have diagnosed pre-eclampsia through measuring blood pressure and checking for protein in a woman’s urine. These are relatively imprecise and often quite subjective,” said Lucy Chappell, PhD, NIHR Research Professor in Obstetrics at King’s College, and lead author of the study, in the news release.

“We knew that monitoring PGF was an accurate way to help detect the condition, but [we] were unsure whether making this tool available to clinicians would lead to better care for women. Now we know that it does,” she concluded.

Pre-eclampsia can lead to stroke, seizures, and even death of expectant mothers and unborn children. It is usually diagnosed after 20 weeks of gestation through blood pressure tests and urine tests that show hypertension and elevated protein levels.

“We found that the availability of PGF test results substantially reduced the time to clinical confirmation of pre-eclampsia. Where PGF was implemented, we found a lower incidence of maternal adverse outcomes,” the researchers wrote in their study.

Similar Study in the US

In the UK, pre-eclampsia affects about one in 20 pregnancies or 80,000 women each year, New Scientist explained. While in the US, data compiled from the Centers for Disease Control and Prevention (CDC) indicate that pre-eclampsia affects one in 25 pregnancies or about 154,220 women annually.

Researchers in Ohio also recently reported on a test and a piloted clinical study for rapid diagnosis of pre-eclampsia.

Scientists at Ohio State University’s College of Medicine and Wexner Medical Center (OSU), and at Nationwide Children’s Hospital, have developed a non-invasive red-dye-on-paper urine test to identify pre-eclampsia at the point-of-care, a Wexner press release announced.

“This is the first clinical study using the point-of-care, paper-based Congo Red Dot (CRD) diagnostic test, and the mechanism proved superior in establishing or ruling out a diagnosis of pre-eclampsia,” Kara Rood, MD, a maternal-fetal medicine physician at Wexner Medical Center and first author of the study said in the Wexner press release. “Our findings will have a huge impact on the health of women and children.”

The researchers published their findings in EClinicalMedicine, a Lancet Journal.

“Pre-eclampsia is often described as ‘mysterious’ because it’s difficult to diagnose. Our researchers show that there’s an easy, non-invasive test that will help diagnose this condition and maintain the health of pregnant women and their babies,” K. Craig Kent, MD, OSU Dean of the College of Medicine, said in the press release.

Clinical laboratory tests such as these being developed in the US and abroad could help pregnant women worldwide experience happy pregnancies and give birth to healthy babies. Medical laboratory leaders in this country may want to stay abreast of the development of these simple blood and urine tests.

                                                                        —Donna Marie Pocius

Related Information:

Pre-Eclampsia: NHS to Roll Out Breakthrough Test Which Speeds Up Diagnosis and Can Save Lives

Blood Test Helps Accurate, Rapid Diagnosis for Pre-eclampsia

Blood Pressure in Pregnancy

Placental Growth Factor Testing to Assess Women with Suspected Pre-eclampsia: a Multi-Centre, Pragmatic, Stepped-wedge Cluster Randomized Controlled Trial

Pre-Eclampsia Blood Test Could Help Diagnose the Condition Earlier

Research Finds Simple Urine Test Allows for Rapid Diagnosis of Pre-eclampsia

Medical Laboratory Testing Company uBiome Raided by FBI for Alleged Insurance Fraud and Questionable Business Practices

Following the raid, the company’s co-founders resigned from the board of directors

Microbiome testing company, uBiome, a biotechnology developer that offers at-home direct-to-consumer (DTC) test kits to health-conscious individuals who wish to learn more about the bacteria in their gut, or who want to have their microbiome genetically sequenced, has recently come under investigation by insurance companies and state regulators that are looking into the company’s business practices.

CNBC reported that the Federal Bureau of Investigation (FBI) raided the company’s San Francisco headquarters in April following allegations of insurance fraud and questionable billing practices. The alleged offenses, according to CNBC, included claims that uBiome routinely billed patients for tests multiple times without consent.

Becker’s Hospital Review wrote that, “Billing documents obtained by The Wall Street Journal and described in a June 24 report further illustrate uBiome’s allegedly improper billing and prescribing practices. For example, the documents reportedly show that the startup would bill insurers for a lab test of 12 to 25 gastrointestinal pathogens, despite the fact that its tests only included information for about five pathogens.”

Company Insider Allegations Trigger FBI Raid

In its article, CNBC stated that “company insiders” alleged it was “common practice” for uBiome to bill patients’ insurance companies multiple times for the same test.

“The company also pressured its doctors to approve tests with minimal oversight, according to insiders and internal documents seen by CNBC. The practices were in service of an aggressive growth plan that focused on increasing the number of billable tests served,” CNBC wrote.

FierceBiotech reported that, “According to previous reports, the large insurers Anthem, Aetna, and Regence BlueCross BlueShield have been examining the company’s billing practices for its physician-ordered tests—as has the California Department of Insurance—with probes focusing on possible financial connections between uBiome and the doctors ordering the tests, as well as rumors of double-billing for tests using the same sample.”

Becker’s Hospital Review revealed that when the FBI raided uBiome they seized employee computers. And that, following the raid, uBiome had announced it would temporarily suspend clinical operations and not release reports, process samples, or bill health insurance for their services.

The company also announced layoffs and that it would stop selling SmartJane and SmartGut test kits, Becker’s reported.

uBiome Assumes New Leadership

Following the FBI raid, uBiome placed its co-founders Jessica Richman (CEO) and Zac Apte (CTO) on administrative leave while conducting an internal investigation (both have since resigned from the company’s board of directors). The company’s board of directors then named general counsel, John Rakow, to be interim CEO, FierceBiotech reported.

John Rakow (center) is shown above with uBiome co-founders Jessica Richman (lower left) and Zac Apte (lower right). In a company statement, Rakow stressed that he believed in the company’s products and ability to survive the scandal. His belief may be based on evidence. Researchers have been developing tests based on the human microbiome for everything from weight loss to predicting age to diagnosing cancer. Such tests are becoming increasingly popular. Dark Daily has reported on this trend in multiple e-briefings. (Photo copyrights: LinkedIn/uBiome.)

After serving two months as the interim CEO, Rakow resigned from the position. The interim leadership of uBiome was then handed over to three directors from Goldin Associates, a New York City-based consulting firm, FierceBiotech reported. They include:

Four testing products remain available for in-home testing on the uBiome website:

What Went Wrong?

Richman and Apte founded uBiome in 2012 with the intent of marketing a new test that would prove a link between peoples’ microbiome and their overall health. The two founders initially raised more than $100 million from venture capitalists, and, according to PitchBook, uBiome was last valued at around $600 million, Forbes reported.

Nevertheless, as a company, uBiome’s future is uncertain. Of greater concern to clinical laboratory leaders is whether at-home microbiology self-test kits will become a viable, safe alternative to tests traditionally performed by qualified personnel in controlled laboratory environments.

Dark Daily reported on the controversy surrounding this trend in “At-Home Microbiology Tests Trigger Concerns about Scientific Value and Impact from Microbiologists and Clinical Laboratory Scientists,” October 16, 2017.

It’s a trend worth watching.

—JP Schlingman

Related Information:

Insiders Describe Aggressive Growth Tactics at uBiome, the Health Start-up Raided by the FBI Last Week

FBI Investigating uBiome’s Billing Practices

Turmoil Persists at uBiome with New Management Overhaul Amid FBI Probe: Reports

uBiome Appoints John Rakow as Interim Chief Executive Officer

Another Shakeup at uBiome: Interim CEO Quits

Seven Updates on the Ongoing uBiome Investigation

Microbiome Startup uBiome Cofounders on Administrative Leave after Reports of FBI Raid

Microbiome Testing Startup Under Scrutiny for Billing Practices

At-Home Microbiology Tests Trigger Concerns about Scientific Value and Impact from Microbiologists and Clinical Laboratory Scientists

Researchers at Emory University School of Medicine Develop Technology That Makes Urine Fluorescent When Transplanted Organs Are Rejected

This new technology could replace needle biopsies and allow physicians to detect rejection of transplanted organs earlier, saving patients’ lives

Anatomic pathologists may be reading fewer biopsy reports for patients with organ transplants in the future. That’s thanks to a new technology that may be more sensitive to and capable of detecting organ rejection earlier than traditional needle biopsies.

When clinicians can detect organ transplant rejection earlier, patients survive longer. Unfortunately, extensive organ damage may have already occurred by the time rejection is detected through a traditional needle biopsy. This led a group of researchers at Emory University School of Medicine to search for a better method for detecting organ rejection in patients with transplants.

The Emory researchers describe the method and technology they devised in a paper published in Nature Biomedical Engineering, titled, “Non-Invasive Early Detection of Acute Transplant Rejection Via Nanosensors of Granzyme B Activity.” The new technology could make it easier for clinicians to detect when a patient’s body is rejecting a transplanted organ at an earlier time than traditional methods.

This technology also provides a running measure of processes, so clinicians have more powerful tools for deciding on the most appropriate dosage of immunosuppressant drugs.

“Right now, most tests are aimed at organ dysfunction, and sometimes they don’t signal there is a problem until organ function is below 50 percent,” Andrew Adams, MD, PhD Co-Principal Investigator and an Associate Professor of Surgery at Emory University School of Medicine, in a Georgia Institute of Technology news release.

How the Technology Works

The method that Adams and his colleagues tested involves the detection of granzyme B, a serine protease often found in the granules of natural killer cells (NK cells) and cytotoxic T cells. “Before any organ damage can happen, T cells have to produce granzyme B, which is why this is an early detection method,” said Gabe Kwong, PhD, Assistant Professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University, in the news release.

The new technology is made up of sensor nanoparticles in the shape of a ball with iron oxide in the middle. Amino acids stick out of the ball like bristles. Each amino acid has a fluorescent molecule attached to the tip.

The nanoparticles are injected into the patient. Their size prevents them from gathering in the patient’s tissue or from being flushed out through the kidneys. They are designed to accumulate in the tissue of the transplanted organ.

If the T cells in the transplanted organ begin to produce granzyme B, the amino acids break away from the nanoparticles, releasing the fluorescent molecules attached to their tips. Those molecules are small enough to be processed through the kidneys and can be detected in the patient’s urine.

Pathologists Play Crucial Role on Transplant Teams

Anatomical pathologists (histopathologists in the UK) are key members of transplant teams for many reasons, including their ability to assess biopsies. The current method for detecting organ transplant rejection involves needle biopsies. It is considered the gold standard.

However, according to a paper published in the International Journal of Organ Transplantation Medicine: “Although imaging studies and laboratory findings are important and helpful in monitoring of the transplanted liver, in many circumstances they are not sensitive enough. For conditions such as rejection of the transplant, liver histology remains the gold-standard test for the diagnosis of allograft dysfunction. Therefore, histopathologic assessments of allograft liver biopsies have an important role in managing patients who have undergone liver transplantation.”

There are two main problems with needle biopsies. The first, as mentioned above, is that they don’t always catch the rejection soon enough. The second is that the needle may cause damage to the transplanted organ.

“The biggest risk of a biopsy is bleeding and injury to the transplanted organ,” noted Andrew Adams, MD, PhD (above), Co-Principal Investigator and an Associate Professor of Surgery at Emory University School of Medicine, in the Georgia Tech news release. “Then there’s the possibility of infection. You’re also just taking a tiny fraction of the transplanted organ to determine what’s going on with the whole organ, and you may miss rejection or misdiagnose it because the needle didn’t hit the right spot,” he added.

And, according to Kwong, even though biopsies are the gold standard, the results represent one moment in time. “The biopsy is not predictive. It’s a static snapshot. It’s like looking at a photo of people in mid-jump. You don’t know if they’re on their way up or on their way down. With a biopsy, you don’t know whether rejection is progressing or regressing.”

Future Directions of Emory’s Research

The research conducted by Adams and Kwong, et al, is in its early stages, and the new technology they created won’t be ready to be used on patients for some time. Nevertheless, there’s reason to be excited.

Nanoparticles are not nearly as invasive as a needle biopsy. Thus, risk of infection or damaging the transplanted organ is much lower. And Emory’s technology would allow for much earlier detection, as well as giving clinicians a better way to adjust the dose of immunosuppressant drugs the patient takes.

“Adjusting the dose is very difficult but very important because heavy immunosuppression increases occurrence of infections and patients who receive it also get cancer more often,” said Kwong. The new technology provides a method of measuring biological activity rates, which would give clinicians a clearer picture of what’s happening.

The Emory team’s plan is to enhance the new sensors to detect at least one other major cause of transplant rejection—antibodies. When a patient’s body rejects a transplanted organ, it produces antibodies to neutralize what it sees as a foreign entity.

“Antibodies kill their target cells through similar types of enzymes. In the future, we envision a single sensor to detect both types of rejection,” said Kwong.

Adams adds, “This method could be adapted to tease out multiple problems like rejection, infection, or injury to the transplanted organ. The treatments for all of those are different, so we could select the proper treatment or combination of treatments and also use the test to measure how effective treatment is.”

This line of research at Emory University demonstrates how expanding knowledge in a variety of fields can be combined in new ways. As this happens, medical laboratories not only get new biomarkers that can be clinically useful without the need for invasive procedures like needle biopsies, but these same biomarkers can guide the selection of more effective therapies.

—Dava Stewart

Related Information:

Non-Invasive Early Detection of Acute Transplant Rejection Via Nanosensors of Granzyme B Activity

Role of Histopathologist in Liver Transplantation

Urine Test Detects Organ Transplant Rejection, Could Replace Needle Biopsies

Researchers at Princeton University Develop Tiny Biosensor Chip That Can Be Manufactured Cheaply and Possibly Perform Diagnostics Inside the Human Body

Miniaturization of clinical laboratory testing continues to intrigue pathology researchers, medical scientists, and diagnostics developers who see the technology as a way to bring pathology diagnostics to resource deficient areas

Can useful, fast, and cheap medical laboratory tests be performed using the million-pixel cameras found in today’s smartphones, in combination with microchips and other technologies? A team of researchers at Princeton University believe they are on the path to achieving those goals.

Dark Daily has covered the development of “lab-on-a-chip” miniature diagnostic technologies for many years. Through these diminutive devices, clinical laboratory testing has been brought to remote regions of the world where even basic resources like electricity and adequate clean water are in short supply.

The Princeton researchers are developing their own tiny biosensor microchip. The device reads fluorescent light and could, they say, be used to diagnose disease from inside the human body.

The researchers published their findings in ACS Photonics, a journal of the American Chemical Society (ACS), and Biomedical Optics Express, an online journal published by The Optical Society. Both peer-reviewed scientific journals specialize in the fields of photonics and optics.

Revolutionary Use of Standard Microchip Technology

The device developed by the Princeton University researchers uses silicon chip technology to perform various types of clinical laboratory assays.

“The key idea is to allow complex optical systems in modern-day chips,” said Kaushik Sengupta, PhD, Assistant Professor of Electrical Engineering at Princeton and one of the project leaders, in a press release. “All smartphones carry a million-pixel camera. How do we turn this into a device that allows laboratory-quality diagnostics?”

The miniature device (above) uses standard microchip technology consisting of tiny metal layers. It’s those layers that serve as the biosensor. The chip measures a mere four millimeters (approximately 5/32 of an inch) per side, and according to the University of Princeton scientists, it can be mass produced in a cost-effective manner using standard manufacturing techniques and does not require detailed assembly. (Photo copyright: Lingyu Hong/University of Princeton.)

The researchers discovered that existing microchip technology can be adapted to “take advantage of light’s unusual behavior when interacting with structures smaller than wavelength of light,” the press release noted. 

“We show these complex optical biosensor systems can also be realized in the same technology with absolutely no change in manufacturing the microchip,” Sengupta said.

Employing existing manufacturing would make mass producing the chips highly cost effective compared to other lab-on-a-chip technologies. And, if the diagnostics are accurate as well, clinical laboratories could have a remarkable new tool to aid physicians in the diagnosis of disease.

How It Works

The Princeton scientists say light harnessed by the fluorescence-based biosensor can detect and differentiate biological substances ranging from bacterial Deoxyribonucleic acid (DNA) to hormones present in humans.

They also claim their sensor can detect tiny molecules, such as DNA and proteins, in liquid samples as small as one microliter. By comparison, a single drop of water holds about 50 microliters. The researchers say the sensitivity of their microchip in analyzing this tiny sample is comparable to results achieve by diagnostic laboratories.

“We show for the first time that this level of optical field manipulation is possible in a silicon chip. By eliminating all classical optics, the system is now small enough that you could start thinking about putting it in a pill,” said Kaushik Sengupta, PhD, Assistant Professor of Electrical Engineering at Princeton. He’s shown above with Haw Yang, PhD (on right), Professor of Chemistry and Principle Investigator at the Haw Yang Laboratory at Princeton University. “You could start thinking about diagnostics inside the body in a way you could not think about before,” Sengupta concluded. (Photo copyright: Frank Wojciechowski/Princeton University.)

Like a traditional lab setup, the chip uses chemical antibodies to target certain molecules. These antibodies are then altered to propagate a specific light wavelength when they are exposed to a distinct molecule. Exposure to ultraviolet light causes the antibodies to glow a faint red color when they come into contact with the targeted substance.

Cheaper Diagnostics for the Developing World

The researchers hope that their miniature chip will someday be used as a mainstream diagnostic technology, and that it may lead to the development of other, similar diagnostic products. 

“Once we make the diagnostics cheaper, we can enable diagnostics in the developing world,” stated Sengupta. “And it’s not just diagnostics. What we have come up with here is just a low-cost, tiny fluorescent sensor and you can use fluorescent sensing in many different things: for food and water-quality monitoring, environmental monitoring, and industrial applications.”

More research is required to ensure the effectiveness of the new technology. And it will need to receive clearance from the federal Food and Drug Administration (FDA) before going into widespread production. Nevertheless, this newest miniature lab-on-a-chip technology could prove beneficial to clinical laboratories in the future, as a cost-effective tool to diagnose disease and better serve medical professionals and patients in resource-strapped regions of the world. 

—JP Schlingman

Related Information:

New Technology Marks Key Step Toward Shrinking a Medical Lab to Fit on Fingertip

Integrated Angle-Insensitive Nanoplasmonic Filters for Ultraminiaturized Fluorescence Microarray in a 65 nm Digital CMOS Process

Nano-plasmonics and Electronics Co-integration in CMOS Enabling a Pill-sized Multiplexed Fluorescence Microarray System

Lab-on-a-Fiber Technology Continues to Highlight Nano-Scale Clinical Laboratory Diagnostic Testing in Point-of-Care Environments

IBM and Mount Sinai Researchers Develop Innovative Medical Lab-on-a-Chip Solution

Lab-on-a-Chip Diagnostics: When Will Clinical Laboratories See the Revolution?

Sleek ‘Lab in a Needle’ Is an All-in-One Device That Detects Liver Toxicity in Minutes during a Study, Showing Potential to Supplant Some Medical Laboratory Tests

Implantable Medical Laboratory-on-a-Chip Continuously Monitors Key Chemicals in Chemotherapy and High-Risk Patients

UPS and WakeMed Now Use Aerial Drone for Daily Transport of Clinical Laboratory Specimens; In Australia, Google Wing Initiates Drone Delivery Service

Drone delivery of goods, including medical laboratory specimens, gains popularity around the world and FAA licensing in the US

In April, Dark Daily’s sister publication The Dark Report was first to report WakeMed Health and Hospitals’ use of a quadcopter drone to deliver patients’ medical laboratory specimens. The drone flew roundtrip between a complex of physicians’ offices on WakeMed’s Raleigh, N.C. campus and the central clinical laboratory.

The flight was the culmination of a multi-year drone-delivery pilot program during which a team at WakeMed collaborated with the United Parcel Service (UPS), the Federal Aviation Commission (FAA), and the North Carolina Department of Transportation (NCDOT). Matternet of Menlo Park, Calif., manufactured the drones used for the flights.

The April flight was the first time a drone transport of medical laboratory specimens in the US generated revenue.

Google Drone Delivery?

Not to be outdone, Alphabet (NASDAQ:GOOG), Google’s parent company, appears to be getting in on the trend. In April, the FAA issued an Air Carrier Certification to Wing Aviation LLC, an air delivery developer and subsidiary of Alphabet. Wing has recently launched a drone delivery service in Canberra, Australia and is testing a similar drone delivery service in the US.

“Our service allows customers to order a range of items such as fresh food, hot coffee, or over-the-counter chemist items on our mobile app, and have them delivered directly to their homes by drone in minutes,” Wing stated in a press release.

The photo above shows a Virginia family receiving breakfast delivered by a Wing drone, part of an FAA validation flight. (Photo copyright: Wing Aviation.)

The FAA’s Air Carrier Certification allows Wing to deliver goods from local businesses to private homes in the US. Their vertical take-off drones weigh about 11 pounds, are equipped with a hover propeller to reduce noise, and have wings that allow the devices to fly further and faster while using less energy.

The FAA certification restricts drone deliveries to daylight hours only with no flying in the rain. The devices are allowed to fly over people but cannot hover above them, nor can they carry any hazardous materials.  

The company plans to launch a trial delivery service later this year in the Blacksburg and Christiansburg areas of Southwest Virginia. Wing hopes to add other markets to its drone delivery service in the future. 

“This is an important step forward for the safe testing and integration of drones into our economy. Safety continues to be our number one priority as this technology continues to develop and realize its full potential,” said U.S. Secretary of Transportation, Elaine L. Chao, in a press release.

Wing Drones Deliver Over Australia Too!

Wing has been testing its drone delivery service in Australia since 2014. Over the past 18 months, Wing has flown over 70,000 test flights and made more than 3,000 successful deliveries—including food, small household items, and over-the-counter drug store items—as part of the Australia project.

In April, the company launched a commercial air delivery service in the North Canberra area of Australia after receiving approval from the Civil Aviation Safety Authority (CASA).

Drone Delivery Could Reshape Healthcare

Unmanned aerial vehicles (UAVs, but commonly called drones) continue to gain in popularity around the world. As more drones appear in the sky, more practical functions are being discovered for them, including medical uses.

According to an article penned by Jeremy Tucker, DO, for Drones in Healthcare, numerous potential medical uses exist for drones. In addition to transport and delivery services, they may also be helpful in search and rescue missions and providing medical care and telemedicine services. Tucker is Executive Director for Patient Safety Solutions at US Acute Care Solutions.

“Drones are going to decrease the reliance on human beings that provide care and decrease the cost of assisting people,” he predicted. “Being able to cross long distances at faster speeds to deliver blood products and lab samples also is a huge benefit. Now transporting blood products between hospitals, for example, involves vehicles on the ground that are prone to accidents and delays. Drones can help decrease those incidents.”

Prior to using drones for clinical laboratory specimen deliveries, WakeMed relied on courier cars and trucks to transport specimens within the campus. The ground delivery service could take up to an hour to complete. By comparison, drones can make the same delivery in minutes, ensuring lab specimens remain viable, and getting test results to patients faster.

Drone Delivery Around the World!

Dark Daily previously covered the use of drones to deliver laboratory specimens in Switzerland and laboratory supplies and blood products in Rwanda. And in 2017, Dark Daily reported that a team of researchers from Johns Hopkins University had successfully flown a drone carrying lab specimens more than 161 miles across the Arizona desert. 

Might we soon see a Google drone delivery service for clinical laboratory specimens as well?

The utilization of drones represents another market trend that is creating opportunities for clinical laboratories. Using drones to transport lab specimens could be a potential source of revenue and presents labs with a pathway for providing value-added, timely service to healthcare networks.

—JP Schlingman

Related Information:

Google’s Wing Kicks off First Drone Delivery Service in Australia

UPS Partners with Matternet to Transport Medical Samples via Drone Across Hospital System in Raleigh, N.C.

Matternet Partners with UPS as It Launches First Regular Drone Delivery Service in U.S.

UPS Launches First Revenue Drone Delivery Service in U.S.

FAA and NCDOT Launch Drone Pilot Over WakeMed

UAS Integration Pilot Program

NCDOT Launches ‘First Flight’ in Drone Pilot Program

Chairman and CEO David Abney Explains UPS’ Drive Toward Drone Technology

WakeMed Used Drone to Deliver Patient Specimens

Drones Used to Deliver Clinical Laboratory Specimens in Switzerland

UTSA Researchers Create Leukemia Proteome Atlases to Assist in Leukemia Research and Personalized Medicine Treatments

This new atlas of leukemia proteomes may prove useful for medical laboratories and pathologists providing diagnostic and prognostic services to physicians treating leukemia patients

Clinical pathology laboratories, hematopathologists, and medical technologists (aka, medical laboratory scientists) have a new tool that aids in leukemia research and helps hematologists and other medical practitioners treat patients with acute myelogenous leukemia (aka, acute myeloid leukemia or AML).

Researchers at the University of Texas at San Antonio (UTSA) and the University of Texas MD Anderson Cancer Center created the online atlases—categorized into adult and pediatric datasets—to “provide quantitative, molecular hallmarks of leukemia; a broadly applicable computational approach to quantifying heterogeneity and similarity in molecular data; and a guide to new therapeutic targets for leukemias,” according to the Leukemia Atlases website.

In building the Leukemia Proteome Atlases, the researchers identified and classified protein signatures that are present when patients are diagnosed with AML. Their goal is to improve survival rates and aid scientific research for this deadly disease, as well as develop personalized, effective precision medicine treatments for patients.  

The researchers published their findings in Nature Biomedical Engineering, titled, “A Quantitative Analysis of Heterogeneities and Hallmarks in Acute Myelogenous Leukaemia.” A link to a downloadable PDF of the entire published study is below.

 Leukemia: One or Many Diseases?

To perform the study, the scientists looked at the proteomic screens of 205 biopsies of patients with AML and analyzed the genetic, epigenetic, and environmental diversity in the cancer cells. Their analysis “revealed 154 functional patterns based on common molecular pathways, 11 constellations of correlated functional patterns, and 13 signatures that stratify the outcomes of patients.”

Amina Qutub, PhD, Associate Professor at UTSA and one of the authors of the research, told UTSA Today, “Acute myelogenous leukemia presents as a cancer so heterogeneous that it is often described as not one, but a collection of diseases.”

“To decipher the clues found in proteins from blood and bone marrow of leukemia patients, we developed a new computer analysis—MetaGalaxy—that identifies molecular hallmarks of leukemia,” noted Amina Qutub, PhD (above), UTSA Professor of Biomedical Engineering and one of the UTSA study’s authors. “These hallmarks are analogous to the way constellations guide navigation of the stars: they provide a map to protein changes for leukemia,” she concluded. (Photo copyright: UTSA.)

To better understand the proteomic levels associated with AML, and share their work globally with other scientists, the researchers created the Leukemia Proteome Atlases web portal. The information is displayed in an interactive format and divided into adult and pediatric databases. The atlases provide quantitative, molecular hallmarks of AML and a guide to new therapeutic targets for the disease. 

Fighting an Aggressive and Lethal Cancer

AML is a type of cancer where the bone marrow makes an abnormal type of white blood cells called myeloblasts, red blood cells, or platelets. It is one of the most lethal forms of leukemia and only about one in four patients (28.3%) diagnosed with the disease will survive five years after their initial diagnosis, according to Cancer Stat Facts on Leukemia posted by the National Cancer Institute (NCI) at the National Institutes of Health (NIH).

The NCI predicts there will be approximately 21,540 new cases of AML diagnosed this year. They will account for about 1.2% of all new cancer cases. The disease will be responsible for approximately 10,920 deaths in 2019, or 1.8% of all cancer deaths. In 2016, there were an estimated 61,048 people living with AML in the US. 

“Our ‘hallmark’ predictions are being experimentally tested through drug screens and can be ‘programmed’ into cells through synthetic manipulation of proteins,” Qutub continued. “A next step to bring this work to the clinic and impact patient care is testing whether these signatures lead to the aggressive growth or resistance to chemotherapy observed in leukemia patients.

“At the same time, to rapidly accelerate research in leukemia and advance the hunt for treatments, we provide the hallmarks in an online compendium [LeukemiaAtlas.org] where fellow researchers and oncologists worldwide can build from the resource, tools, and findings.”

By mapping AML patients from the proteins present in their blood and bone marrow, the researchers hope that healthcare professionals will be able to better categorize patients into risk groups and improve treatment outcomes and survival rates for this aggressive form of cancer.  

The Leukemia Proteome Atlases are another example of the trend where researchers work together to compile data from patients and share that information with other scientists and medical professionals. Hopefully, having this type of data readily available in a searchable database will enable researchers—as well as clinical laboratory scientists and pathologists—to gain a better understanding of AML and benefit cancer patients through improved diagnosis, treatment, and monitoring. 

—JP Schlingman

Related Information:

Computational Researchers and Oncologists Develop Protein Cancer Atlas to Accelerate Personalized Medicine for Leukemia Patients

Leukemia Protein Atlas Holds Power to Accelerate Precision Medicine

A Quantitative Analysis of Heterogeneities and Hallmarks in Acute Myelogenous Leukaemia

Downloadable PDF: A quantitative analysis of heterogeneities and hallmarks in acute myelogenous leukaemia

Cancer Stat Facts: Leukemia – Acute Myeloid Leukemia (AML)

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