Clinical laboratories may soon find opportunities to assist retail pharmacists who are doing genetic test counseling, as employers’ support of genetic testing advances
In another market example of acceptance of genetic tests by major employers, a new pilot program is underway by Kroger Prescription Plans that offers GeneSight by Myriad Genetics as a benefit. GeneSight is an LDT, a laboratory-developed pharmacogenomic test, used to treat psychiatric disorders, such as depression.
As part of the agreement with Myriad Genetics, Inc. (NASDAQ:MYGN), pharmacists at more than 2,300 Kroger stores will offer counseling about GeneSight to eligible employees and coordinate the testing with referring healthcare providers, according to a news release.
Clinical laboratory leaders and clinical pathologists will want to observe these early steps by Kroger to offer genetic tests and genetic test counseling in a retail pharmacy setting. If the GeneSight benefit option and in-store pharmacy interventions prove popular, Kroger Prescription Plans may soon offer other genetic tests, as well.
Kroger Not the Only Pharmacy to Offer Genetic Tests and
Counseling
Headquartered in Cincinnati, Ohio, Kroger (NYSE:KR) is the largest supermarket chain in the US and the country’s fourth-largest employer. Kroger Prescription Plans—a pharmacy benefit manager (PBM)—provides pharmacy management services and clinical programs to employers, including Kroger, in 32 states. But it’s not the only pharmacy company to offer genetic tests and genetic counseling.
Last year Albertsons Companies and Genomind, a personalized medicine platform, launched Genecept Assay (now known as Professional PGx)—a genetic test designed to help doctors make informed treatment decisions for their mental health patients—as well as pharmacy-based genetic counseling at select Albertsons and its subsidiaries, according to Supermarket News.
Participating locations include:
21 Sav-On pharmacies at Albertsons in Boise,
Idaho;
Five Jewel-Osco pharmacies in the Chicago area;
and
Two Sav-On pharmacies at Acme supermarkets in
the Philadelphia area.
The Albertsons-Genomind partnership is aimed at patients who
may be struggling with a medication for depression, anxiety,
obsessive-compulsive disorder, or other mental illnesses. Patients can receive
counseling from “specially trained pharmacists” who work with referring
clinicians to offer [Professional PGx], noted Supermarket News.
Pharmacists as Genetic Test Counselors?
Pathologists and medical laboratory leaders may be intrigued
by the concept of putting pharmacists into the role of a genetic test
counselor. However, pharmacists may need to increase their knowledge of
pharmacogenomics, reported Drug
Topics.
“The science advances in the field are just making it more
critical that pharmacists have a really strong understanding of how to blend [pharmacogenomics]
into their training,” Kathleen Jaeger,
National Association of Chain Drug Stores
(NACDS) Senior Vice President of Pharmacy Care and Patient Advocacy, told Drug
Topics.
However, some see pharmacists as the natural experts in the space. “In my opinions, [pharmacists] should be the people who own pharmacogenetics. It’s a relatively new field, and who better than pharmacists to optimize drug therapy?” Daniel Dowd, PharmD, Vice President of Medical Affairs at Genomind, told Drug Topics.
Pharmacists will need to be proactive in working with companies that provide genetic testing, according to a Managed Health Care Connect Pharmacy Learning Network analysis, which also indicated billing for pharmacists’ informational services would need to be addressed.
“These opinions about this type of role for pharmacists will not be what pathologists want to hear,” stated Robert L. Michel, Editor-In-Chief of The Dark Report, Dark Daily’s sister publication. “Pathologists have had the role of the ‘doctor’s doctor’ for decades. Pathologists are trained in how to recognize disease, how to determine which medical laboratory tests are appropriate for the symptoms displayed by a patient, and how to interpret the results to select the best therapies.
“Additionally, pathologists are trained to understand the
technical performance of clinical laboratory tests, such as whether the sample
was of acceptable quality to produce a reliable result, whether the analyzer
that produced a result was performing within specifications, and what factors
should be considered in tandem with the lab test results when making a
diagnosis,” he explained. “It is easy to see why the pathology profession would
argue that pharmacists lack this depth of knowledge and experience when
ordering and interpreting medical laboratory tests. How the pathology
profession will respond to these developments involving pharmacists,
interpretation of genetic test results, and counseling patients is not yet
clear.”
Opportunities for Clinical Laboratories to Assist
Pharmacies
Additionally, we suggested, clinical laboratory leaders and
pathologists could find opportunities helping others understand the results of
the genetic tests.
The recent partnerships between genetic test companies and
corporate retail pharmacies suggest that clinical laboratories could benefit
from reaching out to pharmacists who are now at a point-of-care and who may be
looking to improve their knowledge of pharmacogenomics.
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.
Methods that target the causes of acidity could become part of precision medicine cancer treatments and therapies
Researchers at Massachusetts
Institute of Technology (MIT) have found that acidic environments enable
tumor cells to strengthen through protein production. And that when acidic surfaces
extend beyond a tumor’s interior, and come into contact with healthy tissue,
cancer can spread.
The results of their study will interest anatomic
pathologists who review tissue biopsies to diagnose cancer and help identify
the most effective therapies for cancer patients. Currently, there are no new clinical
laboratory tests under development based on MIT’s research.
The researchers published their findings in the journal Cancer Research. Their paper also
shared how tumor acidity can be identified and reversed.
Acidity is a Tumor Cell’s
Friend
Acidity results from lack of oxygen in tumors and enables
tumor cell growth. “Acidification of the microenvironment plays established roles
in tumor progression and provides a hostile milieu that advantages tumor cell
survival and growth compared to non-cancerous cells,” the researchers wrote in Cancer Research.
In their study, the MIT scientists sought to learn:
What areas of a tumor are actually acidic?
How does acidosis propel cells to
invade surrounding healthy tissues?
They used a nanotechnology platform
called pHLIP (pH Low
Insertion Peptide) to sense pH at the surface of cancer cells and then insert a
molecular probe into the cell membranes. “This brings nanomaterial to close
proximity of cellular membrane,” noted a research study
conducted at the University of Rhode Island by scientists who developed the
pHLIP technology.
Medical News Today reported that the MIT scientists
used pHLIP to map the acidity in human breast cancer tumors implanted in mice.
When it detected a cell in an acidic environment, pHLIP sent a small protein
molecule into the cell’s membrane. The scientists found that acidosis was not
confined to the oxygen-rich tumor core. It extended to the stroma, an important boundary
between healthy tissue and malignant tumor cells.
“We characterized the spatial characteristics of acidic
tumor microenvironments using pHLIP technology, and demonstrated that
tumor-stroma interfaces are acidic, and that cells within the acidic front are
invasive and proliferative,” the scientists wrote in Cancer Research.
What Stimulates
Acidity and How to Reverse It?
The MIT researchers sought the reasons, beyond hypoxia, for
high acidity in tumor tissue.
“There was a great deal of tumor tissue that did not have
any hallmarks of hypoxia that was quite clearly exposed to acidosis. We started
looking at that, and we realized hypoxia probably wouldn’t explain the majority
of regions of the tumor that were acidic,” Gertler pointed out in the MIT news
release.
So what did explain it? The researchers pointed to aerobic
glycolysis, a “condition in which glucose is converted to lactate in the presence
of oxygen,” according to an article published by StatPearls. “Cancer
stem cells (CSC) within a tumor are notorious for aerobic glycolysis. Thus,
extensive aerobic glycolysis has been indicative of aggressive cancer,” the
paper’s authors noted.
During their study, the MIT scientists found:
Cells at the tumor surface shifted to aerobic
glycolysis, “a type of metabolism that generates lactic acid, making way
for high acidity,” and
“Tumor acidosis gives rise to the expression of molecules
involved in cell invasion and migration. This reprogramming, which is an
intracellular response to a drop in extracellular pH, gives the cancer cells
the ability to survive under low-pH conditions and proliferate,” said Nazanin Rohani, PhD, former
postdoctoral researcher in the MIT Koch Institute for Integrative Cancer
Research, and Lead Author of the study, in the news release.
Could a Reduction in Acidity Reverse Tumor Growth?
In another experiment, the researchers fed sodium
bicarbonate (baking soda) to mice with breast or lung tumors. The tumors became
less acidic and metastatic.
“It adds to the sense that this pH dynamic is not permanent.
It’s reversible. I think that’s an important addition to an ongoing discussion
about the role of pH in tumor behavior,” said Ian Robey, PhD, in an
MITblog
post. Robey is a Research Assistant Professor, Department of Medicine
at the University of Arizona, and Full Investigator at the Arizona Cancer Center. He was not
involved in the MIT research.
Spreading the Word on
How Cancer Spreads
The MIT study is important—not only to anatomic pathologists—but
also to oncologists and cancer patients worldwide. Cancer is not simple to
diagnose and treat. The MIT study may provide important insights into targeting
cancer care and precision
medicine treatments.
Prior (2018) price reporting cycle offers lessons that can help clinical laboratory benefit administrators and personnel take an informed approach to meeting the requirements of the Protecting Access to Medicare Act of 2014 (PAMA)
With the PAMA Private Payor Price Reporting period under way, some clinical laboratories may be grappling with questions about the new requirements.
Under PAMA, applicable labs must report private payer data on
selected Clinical Diagnostic Laboratory Tests (CDLTs) to CMS every three years. For the current
cycle, data must be collected from Jan. 1 through June 30.
A six-month review period follows so that laboratories can
assess whether the applicable lab thresholds are met. Data must be reported to
the Centers for Medicare & Medicaid Services (CMS) during a three-month
window starting Jan. 1, 2020, with data due by March 31, 2020.
To help clinical laboratories
meet PAMA’s new requirements, CMS defines an applicable laboratory as one that answers
yes to the following questions:
1) Does the lab
have CLIA certification?
2) Does the lab
meet the majority of Medicare threshold, which is either greater than 50
percent of Medicare payments received on CLFS and PFS (Physician Fee Schedule)
by National Provider Identifier (NPI) or a hospital lab with a shared NPI bills
any Type of Bill (TOB) 14x to Medicare during the six-month reporting timeframe.
3) Does the lab
have a minimum of $12,500 payments received from Medicare during the six-month
reporting period.
Failure to file, or filing late, incomplete, or
inaccurate data can result in federal fines for laboratories—up to
$10,000 a day.
Sarah Simonson, Director of Laboratory Client Management for Change Healthcare, outlines ways labs can avoid those fines and best prepare for this cycle of private payer reporting.
“Begin with the end in mind,” Simonson said. “Understand what is required and prepare for data extraction.” Simonson is one of several pros who will offer insights during a special post-Executive War College workshop geared to private payer price data reporting under PAMA.
Labs should allow
ample time to review extracted data, Simonson said, as well as evaluate the
data for quality assurance. It’s also important to understand login
requirements and the format required to deliver the data. That
means getting your IT team involved.
Having learned many lessons from the previous reporting cycle, Trish Hankila, Chief Financial Officer of the South Bend Medical Foundation, recommends talking with your internal IT or vendor to ensure that accounts receivable (A/R) reports capture the required data. Review available data to ensure accuracy and completeness of data, and review the A/R report that will be used to transmit that data, she says.
Hankila, who will also speak at the 24th Annual Executive War College post-conference workshop encourages a visit to the CMS website to obtain documents regarding the data, registration, and submission requirements.
“The Center for
Medicare Management, CLFS User Manual explains in detail how to log in to the
CMS portal, register the data submitter and data certifier, and the process for
submitting and certifying the data,” Hankila said.
CMS will use the
data collected to calculate 2021 fees for each individual laboratory Current
Procedural Terminology (CPT) code.
“CMS is trying to establish fees
that reflect the market value of the tests being performed, using a weighted
average of the various amounts paid per CPT code by third-party payers,”
Hankila said.
How to structure your
data when working with your internal IT team or third-party billing will be one
focus of the PAMA workshop, in addition to how to avoid the pitfalls when
gathering, analyzing, and reporting lab test price data. The post-conference workshop will
benefit administrators and personnel responsible for reporting PAMA data.
“What Hospital and
Health Network Labs Must Know to Comply with PAMA Private Payer Price
Reporting,” will take place from 8 a.m. to 5 p.m., May 2, in New Orleans.
“The takeaways include
understanding PAMA, lessons learned from the prior (2018) cycle, and how to
structure your request to your IT/billing department,” Simonson said.
To help attendees prepare to
participate in the PAMA workshop, Hankila previewed what South Bend Medical
Foundation has learned:
Get
started early with data gathering and the reconciliation process;
Reconcile
the data by using other reports from your A/R system;
Ensure
you have enough time to modify programs; and
Do
not wait until the last minute to transmit the data.
“There may be issues with
registration of the submitter and certifier in the CMS portal, the CMS website,
or with your data file that you have prepared for submission,” Hankila said.
More Upcoming PAMA Workshop
Highlights
Elizabeth Sullivan, JD, will cover “Compliance and Regulatory Issues Associated with the PAMA Statute and the CMS Final Rule for Reporting Private Payer Lab Test Prices: Risks, Consequences, and Often-Overlooked Requirements.”
Diana Voorhees, MA, CLS, MT, SH, CLCP, CPCO, will cover “Understanding the Requirements for Reporting PAMA Private Payer Lab Test Price Data: Who Reports, What Is Reported, How to Report, When Penalties Apply, and More.”
Kyle C. Fetter, MBA, BA, will present “Key Recommendations for Reporting Your Lab’s Private Payer Price Data: Identifying Data Sources, Using Informatics Tools, Understanding Where Data is Missing or Inaccurate, and Transmitting Your Data.”
Crash into Lake Zurich of American-made drone carrying blood specimens is first setback for pioneering Swiss Post medical drone program
Medical drones shuttling clinical laboratory specimens across open terrain is an exciting reality that Dark Daily has reported on in previous e-briefings. However, the medical drone revolution experienced a setback in January when drone-pioneer Swiss Post (Switzerland’s postal service) saw one of its American-made Matternet drones crash into Lake Zurich, Switzerland.
According to a Swiss Post news release, the drone went down carrying a “non-vital” blood sample (one that had been previously analyzed). The flight was part of a recently launched pilot program transporting blood samples between Zurich’s central laboratory and the Hirslanden Klinik Im Park, a private clinic on the opposite side of Lake Zurich.
A drone can cover the 5.8-kilometres across the water in seven minutes—five times faster than an on-the-road courier, according to Swiss Post.
Zurich city police recovered the drone from the lake on
January 28. However, until the cause of the accident is determined, Swiss Post has
grounded all drone flights, the news release noted.
This was the first accident involving Swiss Post drones,
which have successfully completed more than 3,000 flights in Lugano, Berne, and
Zurich.
Christian Hegner, Director General of Switzerland’s Federal Office of Civil Aviation, is proud of his country’s contribution to the development of performance-based regulatory models for the drone industry, which are detailed in the World Economic Forum (WEF) Advanced Drone Operations Toolkit. “The goal of this toolkit is to enable regulators to learn from the innovative policy experiments occurring around the world and empower them to adopt these governance models that accelerate the promise of drones for all,” he states in the toolkit.
“We have learned a lot in the last few years,” Hegner told SWI swissinfo.ch (SWI), the international reporting service of the Swiss Broadcasting Corporation (SBC). “Sharing our expertise and learning from other countries will help speed up and extend drone security around the world.”
Might Medical Drones
in the US Carry Clinical Laboratory Samples?
Now that the World Economic Forum has issued its “toolkit,” which is aimed at helping countries replicate the pioneering success of Switzerland and Rwanda in transporting blood and other medical specimens using unmanned aerial vehicles (drones), could the use of medical transport drones to deliver clinical laboratory specimens throughout the US could take off as well?
Maybe. Creation of such a medical transport network using
drones faces headwinds from aviation industry regulators.
“We haven’t seen the [FAA] be interested in a one-off approach,” Susan Roberts, PhD, told NPR. Roberts is Global Commercial Head of Innovation and Sales Excellence for Panasonic Avionics, and founder and former policy leader at AiRXOS, a General Electric subsidiary focused on drone infrastructure technology. “It doesn’t do anybody any good for a delivery company to be able to fly from two specific points if they can’t then scale that over and over again,” she noted.
Nevertheless, in its Advanced Drone Operations Toolkit, the WEF
argues a “unique opportunity exists today to harness the revolutionary power of
drones and autonomous aerial mobility,” and it provides a regulatory framework
to do so.
The crash of the Swiss Post drone carrying clinical
laboratory samples is a setback. However, it is also a learning experience. As Swiss
Post and other nations gain experience, and as regulatory models become established,
anatomic pathology groups and medical laboratories worldwide may finally have a
solution for delivering specimens over long distances while maintaining the
integrity of samples.
Human microbiota is linked to many diseases but could hold the key for advanced clinical laboratory tests and targeted precision medicine therapies
Study of the human microbiome continues to provide understanding and knowledge regarding gut bacteria and its many benefits, and incites development into new clinical laboratory tests. However, a new study reveals that our bodies might also put gut bacteria under stress leading to better health.
Traditionally, scientists believe the human gut is a hospitable environment that allows bacteria to thrive. However, microbiologists may be interested in a study by Duke University School of Medicine (Duke) that suggests the relationship between humans and their microbiomes may be adversarial as well.
In fact, the study found that human hosts are starving their microbes of nutrients and forcing them to compete for food for the benefit of the host.
“There appears to be a natural pecking order to the bacteria and us,” noted Lawrence A. David, PhD, Assistant Professor, Department of Molecular Genetics and Microbiology at Duke University School of Medicine, in an article Duke posted on Phys.org. “In a way it’s not surprising that we, the host, should hold more of the cards.”
Duke researchers published the results of their study in Nature Microbiology, an online peer-reviewed scientific journal.
Could Nitrogen Impact Gut Bacteria?
The human microbiome consists of hundreds of different types of bacteria and other various tiny organisms, such as viruses and fungi. When combined, the microbes in the human gut weigh approximately three pounds or about the same as the brain.
The theory behind Duke’s study was that the human microbiome is an ecosystem comprised of various entities that compete for resources, and which are often constricted by nutrients, such as nitrogen or phosphorus.
To perform the study, Aspen Reese, PhD, a PhD candidate at Duke during the study and now a Junior Fellow researcher at Harvard University, procured stool samples from more than 30 types of mammals. She then ground the individual samples and tabulated the number of nitrogen and carbon atoms contained within those samples.
The animals used for the study included wild zebras, giraffes and elephants from Kenya, domestic sheep, cattle and horses from New Jersey, and humans from North Carolina. The graphic above shows how “carbon-to-nitrogen ratios in poop vary between animals as a result of diet and physiology. These ratios also govern the abundance of microbes in their guts.” (Image copyright: Aspen Reese/Harvard University.)
Reese discovered that the bacteria in the human gut had access to only one nitrogen atom for every 10 carbon atoms. The bacteria in other mammals’ guts had access to one nitrogen atom for every four carbon atoms. The question arose: Could nitrogen levels in the human gut impact the microbiome?
Reese performed tests on mice to determine if nitrogen levels could help regulate the microbiome. She fed the mice a diet packed with protein, which naturally contains a large amount of nitrogen. When she increased the amount of protein fed to the mice, the amount of their gut bacteria also increased. Reese then injected nitrogen directly into the bloodstream of the mice and found that some of that nitrogen ended up in their gut bacteria.
This discovery suggests the host can help save microbes in the gut by secreting nitrogen through the cells.
“Our findings support the idea that we’ve evolved a way to keep our bacteria on a leash by leaving them starving for nitrogen,” David noted on Phys.org. “It also explains why the Western diet might be bad for us. When people eat too much protein, it swamps the host’s ability to take up that nitrogen in the small intestine, and more of it ends up making its way to the large intestine, eliminating our ability to control our microbial communities.” (Photo copyright: Duke University School of Medicine.)
Antibiotics and Gut Bacteria
The team also performed a previous study regarding the effects of antibiotics on gut bacteria, which they published in June on eLife, an online open-access journal.
In that study, the researchers gave mice a five-day treatment of antibiotics. By analyzing their stool samples daily, the scientists discovered that many of the energy sources needed by microbes in the gut accumulated as bacteria was depleted. Some species of valuable gut bacteria are eliminated by antibiotics and may never return.
The researchers found that the mice had to eat each other’s stools in order for those essential microbes to return.
“People probably won’t want to do that,” David told Phys.org.
The trillions of microbes that reside in the human gut help manage almost every function of the human body. Poor gut health can contribute to a wide variety of health problems, including allergies, arthritis, dementia, diabetes, cardiovascular disease, leaky gut syndrome, and some cancers and autoimmune diseases.
Factors such as diet, sleep habits, stress levels, and the number of bacteria an individual is exposed to on a regular basis can negatively affect the microbiome.
Continuing research into the mysteries contained in the human microbiome provide valuable data about our gut bacteria. This type of information could eventually help microbiologists and clinical laboratory professionals more accurately identify diseases and health conditions and guide physicians to appropriate, and possibly targeted, precision medicine therapies for patients.