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.”
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.
“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.
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.
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:
SmartFlu: a nasal microbiome swab that detects bacteria and viruses associated with the flu, the common cold, and bacterial infections.
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.
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.
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.
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.
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 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.
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.
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 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 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.
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.
This new atlas of leukemia proteomes may prove useful for medical laboratories and pathologists providing diagnostic and prognostic services to physicians treating leukemia patients
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.
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 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.
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.