Jun 13, 2018 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Access to vast banks of genomic data is powering a new wave of assessments and predictions that could offer a glimpse at how genetic variation might impact everything from Alzheimer’s Disease risk to IQ scores
Anatomic pathology groups and clinical laboratories have become accustomed to performing genetic tests for diagnosing specific chronic diseases in humans. Thanks to significantly lower costs over just a few years ago, whole-genome sequencing and genetic DNA testing are on the path to becoming almost commonplace in America. BRCA 1 and BRCA 2 breast cancer gene screenings are examples of specific genetic testing for specific diseases.
However, a much broader type of testing—called polygenic scoring—has been used to identify certain hereditary traits in animals and plants for years. Also known as a genetic-risk score or a genome-wide score, polygenic scoring is based on thousands of genes, rather than just one.
Now, researchers in Cambridge, Mass., are looking into whether it can be used in humans to predict a person’s predisposition to a range of chronic diseases. This is yet another example of how relatively inexpensive genetic tests are producing data that can be used to identify and predict how individuals get different diseases.
Assessing Heart Disease Risk through Genome-Wide Analysis
Sekar Kathiresan, MD, Co-Director of the Medical and Population Genetics program at Broad Institute of MIT/Harvard and Director of the Center for Genomics Medicine at Massachusetts General Hospital (Mass General); and Amit Khera, MD, Cardiology Fellow at Mass General, told MIT Technology Review “the new scores can now identify as much risk for disease as the rare genetic flaws that have preoccupied physicians until now.”
“Where I see this going is that, at a young age, you’ll basically get a report card,” Khera noted. “And it will say for these 10 diseases, here’s your score. You are in the 90th percentile for heart disease, 50th for breast cancer, and the lowest 10% for diabetes.”
However, as the MIT Technology Review article points out, predictive genetic testing, such as that under development by Khera and Kathiresan, can be performed at any age.
“If you line up a bunch of 18-year-olds, none of them have high cholesterol, none of them have diabetes. It’s a zero in all the columns, and you can’t stratify them by who is most at risk,” Khera noted. “But with a $100 test we can get stratification [at the age of 18] at least as good as when someone is 50, and for a lot of diseases.”
Sekar Kathiresan, MD (left), Co-Director of the Medical and Population Genetics program at Broad Institute at MIT/Harvard and Director of the Center for Genomics Medicine at Massachusetts General Hospital; and Amit Khera, MD (right), Cardiology Fellow at Mass General, are researching ways polygenic scores can be used to predict the chance a patient will be prone to develop specific chronic diseases. Anatomic pathology biomarkers and new clinical laboratory performed genetic tests will likely follow if their research is successful. (Photo copyrights: Twitter.)
Polygenic Scores Show Promise for Cancer Risk Assessment
Khera and Kathiresan are not alone in exploring the potential of polygenic scores. Researchers at the University of Michigan’s School of Public Health looked at the association between polygenic scores and more than 28,000 genotyped patients in predicting squamous cell carcinoma.
“Looking at the data, it was surprising to me how logical the secondary diagnosis associations with the risk score were,” Bhramar Mukherjee, PhD, John D. Kalbfleisch Collegiate Professor of Biostatistics, and Professor of Epidemiology at U-M’s School of Public Health, stated in a press release following the publication of the U-M study, “Association of Polygenic Risk Scores for Multiple Cancers in a Phenome-wide Study: Results from The Michigan Genomics Initiative.”
“It was also striking how results from population-based studies were reproduced using data from electronic health records, a database not ideally designed for specific research questions and [which] is certainly not a population-based sample,” she continued.
Additionally, researchers at the University of California San Diego School of Medicine (UCSD) recently published findings in Molecular Psychiatry on their use of polygenic scores to assess the risk of mild cognitive impairment and Alzheimer’s disease.
The UCSD study highlights one of the unique benefits of polygenic scores. A person’s DNA is established in utero. However, predicting predisposition to specific chronic diseases prior to the onset of symptoms has been a major challenge to developing diagnostics and treatments. Should polygenic risk scores prove accurate, they could provide physicians with a list of their patients’ health risks well in advance, providing greater opportunity for early intervention.
Future Applications of Polygenic Risk Scores
In the January issue of the British Medical Journal (BMJ), researchers from UCSD outlined their development of a polygenic assessment tool to predict the age-of-onset of aggressive prostate cancer. As Dark Daily recently reported, for the first time in the UK, prostate cancer has surpassed breast cancer in numbers of deaths annually and nearly 40% of prostate cancer diagnoses occur in stages three and four. (See, “UK Study Finds Late Diagnosis of Prostate Cancer a Worrisome Trend for UK’s National Health Service,” May 23, 2018.)
An alternative to PSA-based testing, and the ability to differentiate aggressive and non-aggressive prostate cancer types, could improve outcomes and provide healthcare systems with better treatment options to reverse these trends.
While the value of polygenic scores should increase as algorithms and results are honed and verified, they also will most likely add to concerns raised about the impact genetic test results are having on patients, physicians, and genetic counselors.
And, as the genetic testing technology of personalized medicine matures, clinical laboratories will increasingly be required to protect and distribute much of the protected health information (PHI) they generate.
Nevertheless, when the data produced is analyzed and combined with other information—such as anatomic pathology testing results, personal/family health histories, and population health data—polygenic scores could isolate new biomarkers for research and offer big-picture insights into the causes of and potential treatments for a broad spectrum of chronic diseases.
—Jon Stone
Related Information:
Forecasts of Genetic Fate Just Got a Lot More Accurate
Polygenic Scores to Classify Cancer Risk
Association of Polygenic Risk Scores for Multiple Cancers in a Phenome-Wide Study: Results from the Michigan Genomics Initiative
Polygenic Risk Score May Identify Alzheimer’s Risk in Younger Populations
Use of an Alzheimer’s Disease Polygenic Risk Score to Identify Mild Cognitive Impairment in Adults in Their 50s
New Polygenic Hazard Score Predicts When Men Develop Prostate Cancer
Polygenic Hazard Score to Guide Screening for Aggressive Prostate Cancer: Development and Validation in Large Scale Cohorts
UK Study Finds Late Diagnosis of Prostate Cancer a Worrisome Trend for UK’s National Health Service
Jun 11, 2018 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
Plans by large-scale employers to self-insure brings into question how clinical laboratories would submit claims and get reimbursed from inside and outside of a corporate provider/payer network
Clinical laboratories and anatomic pathology groups serving the nation’s hospitals and health systems may get increased network access to patients due to new developments in the health insurance marketplace. In recent months, both large corporate players and a number of smaller hospital systems have decided to form their own health insurance companies.
For example, six New Jersey hospital health systems announced they have taken steps to self-insure their employees by forming the Healthcare Transformation Consortium (HTC). This follows a similar joint agreement by Amazon, Berkshire Hathaway, and JPMorgan Chase to self-insure their employees as well. Inhouse medical laboratories and anatomic pathology groups that service these entities will likely find themselves part of new private provider/payer networks, which will impact how and when they get reimbursed for their services.
Both groups hope to slow skyrocketing healthcare costs, improve outcomes, and avoid having to navigate the increasingly complex insurance industry. Between the two groups, nearly one million employees will be insured directly by their companies.
Another reason these two events could be good news for the hospitals, doctor’s groups, and medical laboratories involved is they will no longer have to deal with narrow networks and mandates required of health plans subject to the federal Employee Retirement Income Security Act (ERISA) of 1974. This also may include regulations in the Health Insurance Portability and Accountability Act (HIPAA), which amended ERISA in 1996.
Local clinical laboratories will likely automatically become part of the combined provider group as well, which is good. But will they have to alter how they submit claims and get reimbursed for services rendered to a private corporate payment system?
Goals of Corporate Healthcare
In a press release, Amazon, JPMorgan Chase, and Berkshire Hathaway stated they are “partnering on ways to address healthcare for their US employees, with the aim of improving employee satisfaction and reducing costs.” A not-uncommon healthcare goal, these days.
One of the few concrete details in the release stated, “The initial focus of the new company will be on technology solutions that will provide U.S. employees and their families with simplified, high-quality and transparent healthcare at a reasonable cost.”
The six N.J. healthcare providers in the HTC include:
Together, they employ approximately 50,000 individuals who all will be enrolled in a single health plan, scheduled to go live January 1, 2019.
Kevin Slavin (above), President and CEO of St. Joseph’s Health in Syracuse, N.Y., told HealthLeaders Media. “Each of us have had our different strategies to reduce costs and improve care for our beneficiaries, but now we have six systems that can share those ideas and harness power together.” He added that they expect to see immediate cost savings per enrollee for hospital, outpatient, and medical laboratory services. (Photo copyright: St. Joseph’s Healthcare System.)
Stocks Fall in Response to Announcements
On the day that Amazon (NASDAQ:AMZN), JPMorgan Chase (NYSE:JPM), and Berkshire Hathaway (NYSE:BRK.A, BRK.B) made their announcement, UnitedHealth Group (NYSE:UNH), Anthem (NYSE:ANTM), and other healthcare companies saw their stocks fall. This demonstrates how disruptive such partnerships and coalitions can be in the healthcare marketplace, the New York Times reported.
They can be disruptive in more immediate ways, as well. For example, companies may use collected patient data to devise wellness programs they then offer their employees for free—even going as far as providing a financial incentive to participate. A healthier employee workforce means lower healthcare costs, but also less revenue to surrounding hospitals, physician’s practices, and medical laboratories.
What’s good for one group is not so good for the other, even though people are getting healthier in the long run.
And, to be fair, removing a million people from health insurance plans surely will negatively impact those companies’ finances, as well. The six HTC entities spend approximately $250 million annually for health benefits.
Kevin Joyce, VP of Insurance Networks at Atlantic Health System, a six-hospital health system in Morristown, N.J., told Healthcare Finance that, because the organizations involved in the HTC are healthcare providers themselves, the consortium has a particularly intimate knowledge of the issues causing the ever-rising cost of care.
“This is one of the ways to try to bend the cost curve,” he noted. “I honestly believe with the rise in high-deductible plans, trying to make healthcare more affordable should be the mission of both payer and provider. What makes us different from Amazon is that we as competitors came together to do this. This should have a ripple effect across all of our membership.”
Kevin Lenahan, CPA, Senior Vice President, Chief Financial and Administrative Officer, at Atlantic Health System agrees, adding, “It’s like-minded organizations that came together. We know each other. We all felt that we have a responsibility to improve quality, help transparency.”
Huge Obstacles on All Sides
In a CNBC interview covered by Inc. Magazine, Berkshire Hathaway CEO Warren Buffett emphasized that the obstacles such coalitions face are enormous.
“You talk about something that has $3.3 trillion in revenues presently going to people, and most people that are on the receiving end of the $3.3 trillion are happy with things.” He added, “If it was easy, it’d have been done.”
Nevertheless, both coalitions hope to serve as models for others. “By working closely with like-minded organizations, we can share best practices, learn from one another, and lead the transition from fee-for-service to value-based care, using our own benefit plans as proving grounds,” Joyce told Healthcare Finance.
As the trend to self-insure employees gains steam across corporate America, it will be interesting to see how the inhouse medical laboratories, and independent clinical laboratories and pathology groups that service these entities, are affected by the change.
—Dava Stewart
Related Information:
New Jersey Beats Amazon to the Punch on Self-Insured Health Plan
Amazon, Berkshire Hathaway, and JPMorgan Chase to Partner on US Employee Healthcare
Amazon, Berkshire Hathaway, and JPMorgan Team Up to Try to Disrupt Health Care
Six New Jersey Health Systems Borrow a Page from Amazon
Jun 8, 2018 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory Pathology, Laboratory Testing
As standard masks are used they collect exhaled airborne pathogens that remain living in the masks’ fibers, rendering them infectious when handled
Surgical-style facial masks harbor a secret—viruses that could be infectious to the people wearing them. However, masks can become effective virus killers as well. At least that’s what researchers at the University of Alberta (UAlberta) in Edmonton, Canada, have concluded.
If true, such a re-engineered mask could protect clinical laboratory workers from exposure to infectious diseases, such as, SARS (Severe Acute Respiratory Syndrome), MERS (Middle East Respiratory Syndrome), and Swine Influenza.
“Surgical masks were originally designed to protect the wearer from infectious droplets in clinical settings, but it doesn’t help much to prevent the spread of respiratory diseases such as SARS or MERS or influenza,” Hyo-Jick Choi, PhD, Assistant Professor in UAlberta’s Department of Chemical and Materials Engineering, noted in a press release.
So, Choi developed a mask that effectively traps and kills airborne viruses.
Clinical Laboratory Technicians at Risk from Deadly Infectious Diseases
The global outbreak of SARS in 2003 is a jarring reminder of how infectious diseases impact clinical laboratories, healthcare workers, and patients. To prevent spreading the disease, Canadian-based physicians visited with patients in hotel rooms to keep the virus from reaching their medical offices, medical laboratory couriers were turned away from many doctors’ offices, and hospitals in Toronto ceased elective surgery and non-urgent services, reported The Dark Report—Dark Daily’s sister publication. (See The Dark Report, “SARS Challenges Met with New Technology,” April 14, 2003.)
UAlberta materials engineering professor Hyo-Jick Choi, PhD, (right) and graduate student Ilaria Rubino (left) examine filters treated with a salt solution that kills viruses. Choi and his research team have devised a way to improve the filters in surgical masks, so they can trap and kill airborne pathogens. Clinical laboratory workers will especially benefit from this protection. (Photo and caption copyright: University of Alberta.)
How Current Masks Spread Disease
How do current masks spread infectious disease? According to UAlberta researchers:
- A cough or a sneeze transmits airborne pathogens such as influenza in aerosolized droplets;
- Virus-laden droplets can be trapped by the mask;
- The virus remains infectious and trapped in the mask; and,
- Risk of spreading the infection persists as the mask is worn and handled.
“Aerosolized pathogens are a leading cause of respiratory infection and transmission. Currently used protective measures pose potential risk of primary and secondary infection and transmission,” the researchers noted in their paper, published in Scientific Reports.
That’s because today’s loose-fitting masks were designed primarily to protect healthcare workers against large respiratory particles and droplets. They were not designed to protect against infectious aerosolized particles, according to the Centers for Disease Control and Prevention (CDC).
In fact, the CDC informed the public that masks they wore during 2009’s H1N1 influenza virus outbreak provided no assurance of infection protection.
“Face masks help stop droplets from being spread by the person wearing them. They also keep splashes or sprays from reaching the mouth and nose of the person wearing the face mask. They are not designed to protect against breathing in very small particle aerosols that may contain viruses,” a CDC statement noted.
Pass the Salt: A New Mask to Kill Viruses
Choi and his team took on the challenge of transforming the filters found on many common protective masks. They applied a coating of salt that, upon exposure to virus aerosols, recrystallizes and destroys pathogens, Engineering360 reported.
“Here we report the development of a universal, reusable virus deactivation system by functionalization of the main fibrous filtration unit of surgical mask with sodium chloride salt,” the researchers penned in Scientific Reports.
The researchers exposed their altered mask to the influenza virus. It proved effective at higher filtration compared to conventional masks, explained Contagion Live. In addition, viruses that came into contact with the salt-coated fibers had more rapid infectivity loss than untreated masks.
How Does it Work?
Here’s how the masks work, according to the researchers:
- Aerosol droplets carrying the influenza virus contact the treated filter;
- The droplet absorbs salt on the filter;
- The virus is exposed to increasing concentration of salt; and,
- The virus is damaged when salt crystallizes.
“Salt-coated filters proved highly effective in deactivating influenza viruses regardless of [influenza] subtypes,” the researchers wrote in Scientific Reports. “We believe that [a] salt-recrystallization-based virus deactivation system can contribute to global health by providing a more reliable means of preventing transmission and infection of pandemic or epidemic diseases and bioterrorism.”
Other Reports on Dangerous Exposure for Clinical Laboratory Workers
This is not the first time Dark Daily has reported on dangers to clinical laboratory technicians and ways to keep them safe.
In “Health of Pathology Laboratory Technicians at Risk from Common Solvents like Xylene and Toluene,” we reported on a 2011 study that determined medical laboratory technicians who handle common solvents were at greater risk of developing auto-immune connective tissue diseases.
And more recently, in “Europe Implements New Anatomic Pathology Guidelines to Reduce Nurse Exposure to Formaldehyde and Other Toxic Histology Chemicals,” we shared information on new approaches to protect nurses from contacting toxic chemicals, such as formalin, toluene, and xylene.
The UAlberta team may have come up with an inexpensive, simple, and effective way to protect healthcare workers and clinical laboratory technicians. Phlebotomists, laboratory couriers, and medical technologists also could wear the masks as protection from accidental infection and contact with specimens. It will be interesting to follow the progress of this special mask with its salty filter.
—Donna Marie Pocius
Related Information:
Researcher Turns “SARS Mask” into a Virus Killer
Universal Reusable Virus Deactivation System for Respiratory Protection
Understanding Respiratory Protection Options in Healthcare
H1N1 Flu and Masks
Arming Surgical Masks to Kill Viruses
New Surgical Mask Designed to Kill Viruses
SARS Challenges Met with New Technology
Toronto Hospital Labs Cope with SARS Impact
Europe Implements New Anatomic Pathology Guidelines to Reduce Nurse Exposure to Formaldehyde and Other Toxic Histology Chemicals
Health of Laboratory Technicians at Risk from Common Solvents Like Xylene and Toluene
Jun 6, 2018 | Digital Pathology, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
In what could be a major boon to clinical laboratories and healthcare providers, researchers found that fears of rampant testing and ballooning spending due to results of whole-genome sequencing may be less of a concern than opponents claim
Clinical laboratory testing and personalized medicine (AKA, precision medicine) continue to reshape how the healthcare industry approaches treating disease. And, whole-genome sequencing (WGS) has shown promise in helping in vitro diagnostic (IVD) companies develop specific treatments for specific patients’ needs based on their existing conditions and physiology.
At first blush, this would seem to be a good thing. However, there has been controversy over cost and unintended consequences after patients who received their test results experienced negative encounters with physicians and genetic counselors. The impact on their lives and on their caregivers have not always been positive. (See Dark Daily, “Consumers Buying Genealogy Gene Sequencing Tests in Record Numbers; Some Experts Concerned Data Could Be Misinterpreted,” May 14, 2018.)
Nevertheless, WGS development and the ensuing controversy continues. This has motivated researchers at Brigham and Women’s Hospital (BWH) in Boston to engage in a study that compares the upfront costs of WGS to the downstream costs of healthcare, in an attempt to determine if and how whole-genome sequencing does actually impact the cost of care.
Are Doctors Acting Responsibly?
The MedSeq Project study, published in Genetics in Medicine, a journal of the American College of Medical Genetics and Genomics, involved 200 people—100 of them healthy, the other 100 diagnosed with cardiomyopathy. Roughly half of each group underwent whole-genome sequencing, while the other half used family history to guide treatments and procedures. The project then collected data on downstream care costs for the next six months for each group to compare how whole-genome sequencing might impact the final totals.
“Whole genome sequencing is coming of age, but there’s fear that with these advancements will come rocketing healthcare costs,” lead author Kurt Christensen, PhD, Instructor of Medicine in the Division of Genetics at BWH, stated in a press release.
“Our pilot study is the first to provide insights into the cost of integrating whole-genome sequencing into the everyday practice of medicine,” noted Kurt Christensen, PhD, lead author of the Brigham and Women’s Hospital study. “Our data [provides] reassurance that physicians seem to be responding responsibly and that we’re not seeing evidence of dramatically increased downstream spending.” (Photo copyright: ResearchGate.)
Within the healthy volunteer group, patients who based treatment decisions solely on their family medical history averaged $2,989 in medical costs over the next six months. Those who received WGS incurred $3,670 in costs.
Services also remained relatively consistent between both groups. The WGS group averaging 5.5 outpatient lab tests and 8.4 doctor visits across the period, while the family history group averaged 4.4 outpatient lab tests and 6.9 doctor visits.
Within the cardiology patient group, however, the dynamic flipped. WGS recipients averaged $8,109 in spending, while the family history group averaged $9,670. Study authors attribute this to the possibility of treatments while being hospitalized for concerns unrelated to the study.
When removing hospitalizations from the data set, the WGS group averaged $5,392, while the family history group averaged $4,962—a result similar to that of the healthy group.
Utilization of services was also similar. The WGS group averaged 7.8 doctor visits, while the family history group averaged 7.2 visits. However, the outpatient lab testing spread was wider than any other group in the study. WGS patients averaged 9.5 tests compared to the 6.5 of the family history group.
Unanswered Questions
In their report, the study’s authors acknowledged a range of questions still unanswered by their initial research.
First, the project took place at a facility in which physicians were educated in genetics, had contacts familiar with genetics, and had the support of a genome resource center. The level of experience with genetics may also have prevented additional spending by tempering responses to results.
Although the whole-genome sequencing that took place during the project uncovered genetic variants known to or likely to cause disease within the healthy population, this did not trigger the wave of testing or panic many opponents of genetic sequencing predicted.
Authors also acknowledge that a longer, larger study would offer more conclusive results. Researchers are planning for a longer 5-year study to verify their initial findings. However, study co-author Robert Green, MD, Director of the Genomes2People Research Program at BWH told STAT, “… downstream medical costs of sequencing may be far more modest than the common narrative suggests.”
Further Research Needed
The BWH researchers acknowledged that monetary cost is only one facet of the impact of genetic sequencing results. “Patient time costs were not assessed,” the study authors pointed out. “Nor were the effects of disclosure on participants’ family members, precluding a complete analysis from a societal perspective.”
Lastly, they noted that while the sample size sufficed to verify their results, diversity was lacking. In particular, they mentioned that the participant pool was “more educated and less ethnically diverse than the general population.”
The cost of genetic sequencing and similar technologies continue to drop as automation and innovation make the process more accessible to clinicians and healthcare providers. This could further impact longer studies of the overall cost of sequencing and other genetics-based tools.
For medical laboratories, these results offer proof to both payers and physicians on the value of services in relation to the overall cost of care—a critical concern, as margins continue to shrink and regulations focus on efficiency across a broad spectrum of healthcare-related service industries.
—Jon Stone
Related Information:
Genetic Sequencing: Low Rate of Downstream Costs Demonstrate It’s Worth the Investment
Getting Your Genome Sequenced Might Not Make You Spend More on Health Care
Sequencing Patients’ Genomes Might Not Break the Health Care Bank, Study Finds
Studies Show How Clinical Whole-Exome Sequencing May Forever Change the Future Practice of Medicine while Giving Pathologists a New Opportunity to Deliver Value
Consumers Buying Genealogy Gene Sequencing Tests in Record Numbers; Some Experts Concerned Data Could Be Misinterpreted
Jun 4, 2018 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Management & Operations
New scientific insights from these studies represent progress in the effort to develop a clinical laboratory test that would enable physicians to diagnose Alzheimer’s Disease earlier and with greater accuracy
Most medical laboratory professionals are aware that, for more than 30 years, in vitro diagnostic (IVD) developers and pharmaceutical researchers have sought the Holy Grail of clinical laboratory testing—an accurate test for Alzheimer’s disease that is minimally-invasive and produces information that is actionable by clinicians at a reasonable cost. Such a test could spark a revolution in the diagnosis and treatment of this debilitating disease and would improve the lives of tens of thousands of people each year.
Now, two different research studies being conducted in Germany and Japan may have developed such tests that use blood samples. The tests detect specific biomarkers found in Alzheimer’s patients and one day could enable physicians to diagnose the disease in its preclinical stages.
German Test Identifies Amyloid-Beta Biomarker
The test under development at Ruhr University in Bochum, Germany, detects the presence of amyloid-beta, a component of amyloid plaque (AKA, amyloid-β plaques), which has consistently been found in Alzheimer’s patents, according to United Press International (UPI).
A healthy brain has amyloid-beta plaques, too. However, in a person with Alzheimer’s disease, the amyloid-beta is misfolded, formed like a sheet, and toxic to nerve cells, the researchers explained in a press release.
The test works with small amounts of blood plasma and employs an immuno-infrared-sensor, also developed at Ruhr University. The sensor measures the amounts of both pathological (the misfolded kind) and healthy amyloid-beta in the blood.
Amyloid plaques can start to form decades prior to the onset of Alzheimer’s symptoms, making them identifiable biomarkers that can be used as a “preselection funnel in two‐step diagnostics,” the researchers noted.
“The use of the immuno‐infrared‐sensor as an initial screening funnel to identify people who should undergo further diagnostics and eventually take part in clinical trials on therapeutics targeting Aβ misfolding might already be an important step forward because subjects with early AD stages are hard to identify,” the researchers note. “To our knowledge, there is today no other plasma test available, which has been tested both in an AD research cohort and in the general population.”
Klaus Gerwert, PhD, (left) Chair of Biophysics at Ruhr University in Bochum, Germany, and Dr. Katsuhiko Yanagisawa, PhD, (right) molecular biologist and Director of the Center for Development of Advanced Medicine for Dementia in Obu City, Japan, both lead research teams that developed tests for identifying amyloid-β biomarkers in early onset Alzheimer’s patients. More research must be conducted before these assays could be offered by clinical laboratories. (Photo copyrights: International Max Planck Research School in Chemical and Molecular Biology/Nagoya University School of Medicine.)
Another Blood Test Finds Amyloid-Beta
Interestingly, just a few months ahead of the German researchers’ paper, scientists at the Center for Development of Advanced Medicine for Dementia (CAMD) in Obu City, Japan, published their own paper on a similar blood test they developed that also identifies high levels of amyloid-beta in patients with Alzheimer’s.
However, according to a news release, the Japanese study involved the use of immunoprecipitation and mass spectrometry to measure amyloid-beta related fragments in the blood.
The study, which was published in Nature, involved 373 people: 121 Japanese in the discovery cohort set and 252 Australians in the validation data set. The test found amyloid-beta levels in the brain with 90% accuracy, The Scientist reported.
“These results demonstrate the potential clinical utility of plasma biomarkers in predicting brain amyloid-β burden at an individual level. These plasma biomarkers also have cost-benefit and scalability advantages over current techniques, potentially enabling broader clinical access and efficient population screening,” the researchers wrote in their paper.
Previous Alzheimer’s Research
These studies are not the first to seek biomarkers that could detect the early-onset of Alzheimer’s disease. In 2016, Dark Daily reported on two other studies: one conducted at Rowan University School of Osteopathic Medicine (RowanSOM) and another by IVD company Randox Laboratories. (See Dark Daily, “Two Different Research Teams Announce Tests for Alzheimer’s Disease That Could Be Useful for Clinical Laboratories after Clearance by the FDA,” November 30, 2016.)
Nevertheless, as of 2018, Alzheimer’s disease has impacted the lives of approximately 5.7 million Americans of all ages, according to the Alzheimer’s Association. And yet, doctors currently only have expensive positron emission tomography (PET) brain scans and invasive cerebrospinal fluid (CSF) analysis to identify the disease, generally in the latter stages of its development.
Thus, a less invasive, inexpensive test that accurately identifies biomarkers found in the majority of people during the early stages of the disease would be a boon to physicians who treat chronic neurodegenerative disease, medical laboratories that perform the tests, and, of course, the thousands of people each year who are diagnosed and suffer with this debilitating condition.
—Donna Marie Pocius
Related Information:
Blood Test Can Detect Alzheimer’s Years Before Symptoms
New Blood Test Useful to Detect People at Risk of Developing Alzheimer’s Disease
Blood Test Detects Alzheimer’s Before Symptoms Appear
Blood Test May Detect Very Early Alzheimer’s
Simple Blood Test Spots Dementia Protein
High Performance Plasma Amyloid-Beta Biomarkers for Alzheimer’s Disease
Researchers Develop Potential Blood Test for Alzheimer’s Disease
Japan Researchers Develop Cheap and Easy Way to Diagnose Alzheimer’s
Two Different Research Teams Announce Tests for Alzheimer’s Disease That Could Be Useful for Clinical Laboratories After Clearance by the FDA
Jun 1, 2018 | Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Ascension’s refocus exemplifies challenges facing healthcare systems as shrinking reimbursement rates, stagnant inpatient admissions, and changing care models put a financial squeeze on traditional hospitals
Hospital-based medical laboratories and anatomic pathology groups are adapting rapidly to both external and internal forces in the healthcare continuum. Efforts to shift clinical care from hospitals to ambulatory settings is a trend that impacts how, where, and when ordering physicians request testing.
Further, healthcare consumers are responding positively to the growth in local urgent care and walk-in clinics, even as hospital support for in-home healthcare treatments for chronic diseases is increasing. This is why even large-scale health systems are seeking ways to bring caregiving to patients, wherever they may be. (See Dark Daily, “Consumer Trend to Use Walk-In and Urgent Care Clinics Instead of Traditional Primary Care Offices Could Impact Clinical Laboratory Test Ordering/Revenue,” May 25, 2018.)
One good marker for this trend is the year-over-year change in hospital admissions. Data given to Congress in the latest MedPac (Medicare Payment Advisory Commission) report on Medicare payment policy show that, between the years 2006 and 2016, the cumulative percent change in the number Medicare inpatient discharges per beneficiary declined by 21.8%. During these same years, the cumulative percent change in the number of outpatient visits per Medicare beneficiary increased by 49%!
Now, Ascension Healthcare of St. Louis—reportedly the nation’s largest nonprofit healthcare system—also appears to be shifting its focus from hospital-based care to less expensive outpatient settings and services. It is doing this by using new staffing models and external businesses.
The move highlights an industry trend. Driven by continued economic, regulatory, and care delivery challenges, hospitals and health systems have been forced to consider different business/clinical models that better serve the evolving needs of their patients.
However, fewer hospitals and shrinking budgets also could impact hospital-based medical laboratories’ revenue, as hospitals seek new formulas for profitability.
In a video message, Ascension President and CEO Anthony R. Tersigni (above), EdD, FACHE, told 165,000 employees that Ascension would be reducing its hospital footprint and administrative costs, while exploring telemedicine and other outpatient care delivery models. This is potentially a major shift in how the nation’s largest nonprofit healthcare system does business, which could impact in-hospital and local independent medical laboratories. (Photo copyright: Ascension.)
New Strategic Direction
According to Modern Healthcare, Ascension President and CEO Anthony Tersigni, EdD, FACHE, outlined the company’s “advanced strategic direction” via video message to his 165,000 employees on March 23. He told his employees a new strategy was needed, due to dwindling reimbursements from both federal and private insurers, increasing regulatory complexity, skyrocketing pharmaceutical costs, and a shift from inpatient to outpatient care and from fee-for-service to value-based care.
“We are in the midst of major transitions, not only in how we provide care, but in how we are reimbursed for the services we provide,” Tersigni revealed in the video message.
Tersigni stated that the world’s largest Catholic health system needs a “dual transformation,” a process that would both “transform current healthcare delivery and operations to meet the challenges presented by the rapidly changing environment” and “safeguard a sustainable presence in its communities that responds to the changes in how people are accessing care.”
In his remarks, Tersigni outlined changes Ascension already had made to reduce administrative costs by $400 million. Further leadership and organizational restructuring is expected to net $61 million of additional savings in fiscal 2019.
In addition, he noted, the health system would save $57 million a year by “aligning its pay practices” to eliminate inconsistencies and follow common benchmarks.
Reducing Hospital Footprint and Controlling Patient Experience
Modern Healthcare also noted that the health system had “implemented new staffing models and productivity standards for nurses and other caregivers, as well as for nonclinical positions that align with other Ascension facilities.”
Ascension recently signed a letter of intent to sell St. Vincent Medical Center in Bridgeport, Conn., to Hartford Healthcare. The deal, according to a St. Vincent’s press release, includes a:
- 473-bed community teaching hospital;
- 76-bed inpatient psychiatric facility;
- Vincent’s Special Needs Services; and
- Multi-specialty provider group.
“There has always been a need for hospitals in our country, but not as many as we have today,” Tersigni told Modern Healthcare. “We don’t need to control everything. What we need to do is collectively control the patient experience along the continuum.”
In addition to selling off hospitals in cities where it is not the market leader, Ascension is looking for partners that will enable it to expand its reach in outpatient settings, such as:
- Urgent care;
- Skilled nursing;
- Home healthcare; and,
- Telemedicine.
Ascension’s plans also include minimizing business travel to reduce costs and hiring a Chief Digital Officer, whose job will include improving price transparency, Modern Healthcare reported.
Are the Days of Large Hospital-based Health Systems Numbered?
Healthcare Dive reported that admission rates for many health systems are declining as expenses are rising. That double-edge sword is causing the healthcare industry to question “whether the days of large hospital-based health systems are numbered.” The article also noted Tenet Healthcare (a network of 69 acute care and specialty hospitals in 11 states) and Community Health Systems (operator of 126 hospitals in 20 states) both are shedding hospitals in an effort to reduce debt. Tenet’s restructuring also includes laying off 2,000 employees.
According to Ascension’s website, the healthcare system operates more than 2,600 sites of care—including 153 hospitals and more than 50 senior living facilities—in 22 states and the District of Columbia. Nevertheless, it has not been immune from the multi-faceted pressures facing the healthcare industry.
Becker’s Hospital Review reported that Ascension’s operating income dropped 78% to $84.7 million in the first half of fiscal 2017, while operating revenue fell to $11.3 billion from $11.4 billion during the same period one year ago. The decline in revenues was largely attributed to the 2017 sale of Ministry Saint Joseph Hospital in Marshfield, Wis., and the divestiture of Door County Medical Center in Sturgeon Bay, Wis., in 2016.
Gwen MacKenzie, former Senior Vice President, Ascension Healthcare, and Ministry Market Executive, Ascension Michigan, oversaw Ascension Health in Michigan’s employee layoffs and management restructuring, which saw the 14-hospital system lay off 500 workers, including 20 executives and managers.
Concerning Ascension’s new direction, she told Modern Healthcare, “We think this is our new normal. The landscape we are navigating here is the new reality.”
If Ascension’s restructuring of its operations away from hospital-centric care is a harbinger of things to come, hospital-based and independent clinical laboratory leaders may be forced to revamp their business models as well, to survive the changes.
—Andrea Downing Peck
Related Information:
Ascension Could Shift Away from Hospital Focus, Modern Healthcare Video Finds
2018 Report to the Congress: Medicare Payment Policy
Ascension Revamps to Enter New Era
Ascension Layoffs in Michigan Total 500 So Far
As Ascension Restructures, it Hints at Smaller Hospital Footprint
Ascension’s Operating Income Dips 78% in First Half of FY 2018
Ascension Michigan’s Market Leader Leaving Post
Ascension, Hartford HealthCare Sign Letter of Intent for Hartford to Acquire St. Vincent’s Medical Center
