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High School Students in Upstate New York Learn 60 Critical Medical Laboratory Skills

Program launched by a Rochester-area technical center is intended to provide early study for students interested in a career in clinical laboratory medicine

Acute shortages of clinical laboratory staff across all types of skills is one of the big stories of this new year. It is also triggering unconventional approaches to reach students in high school and interest them in careers as medical technologists (MTs). One such example is a high school in New York that now offers a top-level medical laboratory program designed to create interest—then train—high school students for a career in laboratory medicine.

A recent CLP podcast, titled, “Has a High School Found the Solution to the Laboratorian Shortage?” outlined the Medical Laboratory Assisting and Phlebotomy program that is offered to students at Western Monroe and Orleans Counties (WEMOCO) Career and Technical Center in Spencerport, New York, a suburb of Rochester.

“With the acute shortage of medical technologists, this effort by one high school to reach students early and encourage them to pursue a career in clinical laboratory medicine should be of interest to all laboratory professionals,” said Robert Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report.

Jim Payne

“Our juniors and seniors in high school will learn about 60 employable laboratory skills,” said Jim Payne (above), a Medical Laboratory Assisting and Phlebotomy program instructor at WEMOCO. “They learn not only medical laboratory skills, but [the skills] are transferable to biotechnology, to chemical labs, food labs, environmental labs, research, forensics, and so on. The goal is each individual student comes out skilled in all 60 skills.” Clinical laboratories may want to explore creating similar programs with high schools in their own areas. (Photo copyright: Twitter.)

Dynamic Curriculum of Clinical Laboratory Skills

During the first year of the WEMOCO program, students learn skills that Jim Payne, a Medical Laboratory Assisting and Phlebotomy program instructor at WEMOCO, stated he learned in college. These include:

The students also learn the theories and techniques behind phlebotomy and how to perform blood draws (venipuncture).

Students spend 40 hours drawing blood samples from real patients in local medical laboratories and can earn a certification as a Phlebotomy Technician after completing the necessary coursework.

During the second year of the program, students learn college-level:

They also receive their certifications in American Red Cross CPR/AED and First Aid and spend 80 hours actually working in local clinical laboratories. Upon completion of the second year of coursework, students can earn a certification as a Certified Medical Laboratory Assistant.

“In both cases, they can get jobs straight out of the program,” said Payne in the CLP podcast. “But a lot of our grads go on to college for medical laboratory careers.”

Overcoming Vocational School Stigma

Recruiting students into the program was initially challenging as some of the negative stigma surrounding non-traditional coursework had to be overcome. Vocational education is now referred to as career and technical education and the WEMOCO program is more academically focused than previous vocational studies. Students can obtain some college credits when completing the two-year program.

“With my students, when we are teaching them how to do the math around making laboratory solutions, for example, that requires algebra,” Payne explained. “And they have to actually make something with the algebra and suddenly it starts to make a lot more sense than the way that they were taught in a traditional high school.”

In addition, some students interested in the program struggled in a typical high school environment due to lack of direction, according to Payne. However, when those same students found their focus, discovered a passion, and were motivated and challenged, they flourished. 

Originally, Payne gave a talk to potential enrollees. But he found there was more interest if students were given a hands-on experience at their first exposure to the program. He also lets current students interact with interested students and allows them to answer any questions in a student-friendly manner. 

“Students who are interested in the program come in, they get lab coats on, they get gloves on, and they are then told a story about a case and have to perform a few experiments to try to determine what is wrong with a patient. They actually do things,” Payne explained.

Multiple Career Paths in Clinical Laboratories upon Graduation

One advantage to completing the two-year WEMOCO program is that students can explore all the different careers in clinical laboratory medicine and are offered opportunities to work in medical laboratory situations. Phlebotomy students perform 40 hours of work in a blood lab with a goal of performing 50 successful sticks, although many students perform more than that.

“I have students who are under the age of 18 drawing blood on real patients with real samples with these companies’ trainers. It’s like they have been hired,” Payne said. The medical laboratory assistant work is broken up into increments of two hours a day over the course of several months.

Another benefit to the WEMOCO program is that students are prepared for a job right out of high school, which pleases both the students and the parents. Many graduates of the program go on to college to study different fields within the clinical laboratory profession.

Attracting Young Students to the Clinical Laboratory Profession

Payne believes it is important to get young kids interested in the medical laboratory profession in the lower grade levels. His suggestions for stoking that level of interest include:

  • Developing programs that are age-appropriate but contain medical laboratory concepts.
  • Outreach programs where clinicians talk to students in the lower grades to spark interest.
  • Outreach programs where kids can perform simple experiments like staining onions and seeing results.
  • Telling stories and explaining the roles labs play in helping patients.
  • Holding field trips where students visit local clinical laboratories and observe medical laboratory professionals.
  • Opportunities for students to shadow medical laboratory technicians so the kids can imagine themselves in the profession.
  • Participating in local activity day/career day events.

He also believes that clinical laboratory professionals should promote their field at every opportunity.

“The biggest thing is actively advocating for the profession. Any chance I get, I’m going out and trying to talk to anyone about the clinical laboratory. Try to have some statistics in your back pocket or other things that can be a good talking point and make a powerful statement to people,” Payne suggested.

Determining unique ways to garner interest in the medical laboratory profession is a crucial step in mitigating staffing shortages. Clinical laboratory leaders may want to participate in community outreach programs and serve as advocates for their profession.

JP Schlingman

Related Information:

Has a High School Found the Solution to the Laboratorian Shortage?

Medical Laboratory Assisting and Phlebotomy

Forbes Senior Contributor Covers Reasons for Growing Staff Shortages at Medical Laboratories and Possible Solutions

Critical Shortages of Supplies and Qualified Personnel During the COVID-19 Pandemic is Taking a Toll on the Nation’s Clinical Laboratories says CAP

Study Comparing Data from Hospitals and Insurers Finds Major Hospitals Still Not Complying with Price Transparency Law

But insurers are complying under the Transparency in Coverage regulations and that is where discrepancies in the disclosure of prices to the public have been found

Despite federal regulations requiring hospitals to publicly post their prices in advance of patient services, some large health systems still do not follow the law. That’s according to a new Transparency in Coverage Report from PatientRightsAdvocate.org (PRA), which found that some hospitals are “flouting” the federal Hospital Price Transparency Rule.

By cross-referencing price disclosures by hospitals and insurance companies, which are required to publish the amounts they pay for hospital services under federal Transparency in Coverage regulations, PRA, a 501(c)(3) nonprofit, nonpartisan organization, discovered the healthcare providers’ noncompliance with federal transparency regulation.

“Prices revealed in newly released health insurance company data files show some major American hospitals are omitting prices from their required price disclosures in violation of the federal hospital price transparency rule,” according to the PRA report.

Sally C. Pipes

Hospitals conceal their prices because they don’t want people to know how much rates for the same procedure vary,” Sally C. Pipes (above), President and CEO of Pacific Research Institute, wrote in the Washington Examiner. “A lack of price transparency benefits hospitals but not patients or payers. The federal government should not let providers get away with flouting the law,” she added. Clinical laboratories are also required under federal law to publish their prices. (Photo copyright: The Heartland Institute.)

Prices Paid by Insurers Missing in Hospital Files

PRA analysts compared publicly available Standard Charge File (SCF) data from seven Ascension Health and HCA Healthcare hospitals in Texas and Florida, and Transparency in Coverage disclosures from Blue Cross Blue Shield, Cigna, and UnitedHealthcare.

“PatientRightsAdvocate.org discovered several instances in which prices were omitted from the hospital files but appeared in the insurance company files,” noted the PRA report. “These discrepancies indicate that some large hospitals are not posting their complete price lists as required by the hospital price transparency rule.”

The federal Centers for Medicare and Medicaid Services (CMS) says hospitals must post standard charges in a single machine-readable digital file, and display in a consumer-friendly way, “300 shoppable services with discounted cash prices, payer-specific negotiated charges, and de-identified minimum and maximum negotiated charges.”

But according to the PRA report and news release, the study team discovered that this was not always the case. Below are examples from the report of some of the discrepancies between prices on a hospital’s website and what payers’ websites showed as prices involving those same hospitals:

Ascension Seton Medical Center, Austin, Texas:

  • The hospital SCF for shoppable services showed “N/A” (not available).
  • UnitedHealthcare files included 16 rates it negotiated by plan and BCBS shared 12 prices by plan.

Ascension St. Vincent’s Clay County Hospital, Middleburg, Florida:

  • The hospital’s SCF “did not contain negotiated rates” for services by Current Procedural Terminology (CPT) codes.
  • UnitedHealthcare showed negotiated rates for 69 CPT codes.

HCA Florida Northside Hospital, St. Petersburg, Florida:

  • PRA analysts found in the hospital SCF file “a range of 300 codes” and “one single negotiated rate.”
  • The insurer, meanwhile, displayed “many different rates corresponding to 300+ codes in the range.”

HCA Houston Healthcare Clear Lake, Webster, Texas:

HCA Medical City, Fort Worth, Texas:

  • The provider displayed in its SCF “one distinct dollar price for all 62 MS-DRG codes that appeared as a group.”
  • BCBS of Texas Blue Premier plan displayed 58 distinct negotiated rates for the codes in that group.

The report also summarized findings for:

PRA’s report casts light on inconsistencies between what insurers and providers share with the public on prices.

“Today’s report confirms that hospitals are hiding prices from patients and [this] calls into question their public assertions that individual prices don’t exist for many of the services they provide,” said PRA Founder and Chairman Cynthia Fisher in the news release.

“The data made possible by the [federal] Transparency in Coverage (TiC) rule reveals prices negotiated with insurers that hospitals did not disclose in the machine-readable files required by law. Our report is just the tip of the iceberg of what the staggering amount of data in TiC disclosures will reveal,” she added.

Ascension, HCA Note Compliance with CMS Rule

For its part, Ascension, in a statement to Healthcare Dive, confirmed it is complying with the CMS rule and offers consumers tools to estimate costs.

“We’re proud to be a leader in price transparency,” Ascension said.

HCA told Healthcare Dive it has “implemented federal transparency requirements in January 2021 and provides a patient payment estimator in addition to posting third-party contracted rates.”

Advice for Clinical Laboratories Sharing Test Prices

Hospitals flouting the federal transparency rule is not new. Dark Daily has covered other similar incidences.

In “Two Georgia Hospitals First to Be Fined by CMS for Failure to Comply with Hospital Price Transparency Law,” we reported how CMS had issued its first penalties to two hospitals located in Georgia for violating the law by not updating their websites or replying to the agency’s warning letters.

And in “Wall Street Journal Investigation Finds Computer Code on Hospitals’ Websites That Prevents Prices from Being Shown by Internet Search Engines, Circumventing Federal Price Transparency Laws,” we covered the Wall Street Journal’s report on “hundreds of hospitals” that had “embed code in their websites that prevented Alphabet Inc.’s Google and other search engines from displaying pages with the price lists.”

Clinical laboratory leaders who oversee multiple labs in healthcare systems may benefit from advice about CMS rule compliance shared in HealthLeaders.

  • Post a separate file for each provider.
  • Be “cognizant” of different sets of standard charges for multiple hospitals under one license.

“Today’s healthcare consumer wants to know prices in advance of service. That’s because many have high deductible health insurance plans of, say, $5,000 for an individual or $10,000 for a family as the annual deductible,” said Robert Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report.

Clinical laboratory tests may not be the most expensive healthcare service. But they are critical for high-quality hospital care and outcomes. Increasingly, patients want to know in advance how much they will cost. This is true of patients of all generations, from Baby Boomers to Generations X, Y, and Z.

Donna Marie Pocius

Related Information:

PRA New Report: Insurance Pricing Files Reveal That Hospitals are Hiding Prices

Transparency in Coverage

Hospitals Are Still Hiding Costs

Hospitals Are Hiding Prices from Patients, Advocacy Report Says

Large Health Systems Are Being Called Out for Lack of Price Transparency

Two Georgia Hospitals First to Be Fined by CMS for Failure to Comply with Hospital Price Transparency Law

HHS Office of Inspector General Report Finds ‘Steep Decreases’ in Medicare Beneficiaries Receiving Clinical Laboratory Testing During COVID-19 Pandemic’s Early Months

OIG warns that without adequate clinical laboratory testing healthcare organizations could see more deaths and increased spending

Clinical laboratory leaders and pathologists know that lab test volume decreased dramatically during the early months of the COVID-19 pandemic. That was primarily because community lockdowns stopped people from seeing their doctors for the standard range of chronic health conditions, many of which require clinical laboratory tests for diagnosis and chronic disease management.

This early and substantial drop in the volume of medical laboratory testing done in the early months of the pandemic has been confirmed and quantified in a recently published report by US Department of Health and Human Services (HHS) Office of Inspector General (OIG). The report describes the  “steep decreases” in the number of Medicare beneficiaries receiving Medicare Part B lab tests in early 2020, by month, as follows:

• 24% reduction in Medicare Part B test volumes in March
• 53% in April
• 30% in May

The decline of Medicare patients visiting clinical laboratories continued through the balance of 2020. During the first 10 months of the pandemic—March through December 2020—Medicare beneficiaries who pursued lab testing decreased by about 9% compared to the same 10-month period in 2019, according to a news release.

This is a strong indicator that the government’s response to the pandemic had a measurable effect on clinical laboratory testing volume among all age groups, especially among the elderly.

Kyle Fetter

“The cumulative decline in lab test volume across all client labs for [March 9 to April 12] was just over 40%. But in that time, some of our lab customers were hit with a decline of maybe 50% to 60% in test volume,” Kyle Fetter (above), COO, XIFIN, told The Dark Report in 2020. Clinical laboratory testing that originates from a routine patient visit to a doctor—such as blood testing—may have been affected the most, Fetter explained. (Photo copyright: XIFIN.)

Clinical Laboratory Tests Key to Well-being of Patients with Chronic Conditions 

The OIG study was limited to Medicare beneficiaries and thus did not provide information about testing fall-off among people who have private health insurance. But in “From Mid-March, Labs Saw Big Drop in Revenue,” Dark Daily’s sister publication The Dark Report reported early in 2020 on a 40% decline in test volumes and the pandemic’s varying effects on clinical labs, anatomic pathology (AP) groups, and AP subspecialties.

The OIG’s Report in Brief on its study recognized that medical laboratory testing is critical to helping healthcare providers manage chronic conditions that affect patients’ well-being and increase their healthcare costs.

“Lab tests are important for beneficiaries with chronic medical conditions, which are associated with hospitalizations, billions of dollars in Medicare costs, and deaths,” the OIG said.

The OIG audit collected data on the numbers of Medicare beneficiaries receiving all lab tests as well as specific lab tests for Type 2 diabetes mellitus, Chronic kidney disease, and Chronic ischemic heart disease during the period March through December 2020, as compared to the same months in 2019.

According to the OIG’s report:

  • Beneficiaries receiving clinical laboratory tests in general decreased 9%.
  • Beneficiaries with type 2 diabetes receiving lab tests declined 14%.
  • Beneficiaries with chronic kidney disease getting lab tests fell 11%.
  • Beneficiaries with chronic ischemic heart disease receiving lab tests decreased 19%.

“The information may be useful to stakeholders involved in ensuring that beneficiaries avoid the potential bad outcomes that may result from missing or delaying appropriate care,” the report noted.

Overall, 23.7 million Medicare beneficiaries received medical laboratory tests during the first 10 months of the pandemic, down 2.4 million from 26.1 million in 2019, the OIG reported.

Overall Medicare lab test volume and spending also declined during the reported period:

  • Part B clinical laboratory tests for Medicare beneficiaries decreased 15% from 419.9 million tests in 2019 to 358.4 million tests in the first 10 months of the pandemic.
  • Medicare spending for these tests decreased 16% from $6.6 billion in 2019 to $5.5 billion during the first 10 months of the pandemic.

“OIG’s audit of Part B clinical laboratory tests, reimbursed under the Clinical Laboratory Fee Schedule (CLFS) is a useful benchmark for how Medicare beneficiaries received fewer lab tests during the pandemic, especially during the early months,” said Robert Michel, Editor-in-Chief of Dark Daily and The Dark Report.

Medical Laboratory Tests That Were Down Most During COVID-19

The following 10 clinical laboratory tests experienced a 10% or more decline in Medicare beneficiaries seeking them during the pandemic period as compared to pre-pandemic, according to the OIG report:

  • Basic metabolic panel down 18% to 4.8 million Medicare patients.
  • Urinalysis with microscope analysis down 13% to 4.6 million Medicare recipients.
  • Automated urinalysis down 16% to 3.4 million Medicare beneficiaries.
  • Vitamin B12 decreased 11% to 3.4 million Medicare patients.
  • Complete blood count (CBC) down 13% to 3.2 million Medicare beneficiaries.
  • Comprehensive urine culture test fell 16% to three million Medicare patients.
  • Uric acid level blood down 13% to 1.9 million Medicare beneficiaries.
  • Evaluation of antimicrobial drug decreased 17% to 1.74 million Medicare patients.
  • Folic acid level down 12% to 1.73 million Medicare beneficiaries.
  • Urinalysis manual test plunged 28% to 1.4 million Medicare patients.

Beyond Medicare, Clinical Laboratory Test Volume Dropped 40%

OIG was not the only organization to analyze medical laboratory testing volume during the pandemic’s early phase.

The Dark Report correlated data tracked by XIFIN, a San Diego-based health information technology (HIT) company providing revenue cycle management services to clinical laboratories and pathology groups. XIFIN’s collected data showed a steep drop in routine test volume as COVID-19 testing ramped up.

“Starting in the third week of March, we saw medical laboratories suffer a sharp drop in routine testing. But at about the same time, many labs began to offset those revenue losses with testing for the novel coronavirus,” Kyle Fetter, XIFIN’s then Executive Vice President and General Manager of Diagnostic Services told The Dark Report in 2020. Fetter is now XIFIN’S Chief Operating Officer.

“Over four weeks beginning March 9, we saw a cumulative drop of over 40% in test volume from all of our lab clients,” he added.

According to XIFIN’s data, lab specialty organizations experienced the following drop in routine testing during the period March 9 to April 16, 2020:

  • 58% at clinical laboratories.
  • 61% at hospital outreach laboratories.
  • 52% at molecular and genetic testing laboratories.
  • 44% at anatomic pathology (AP) groups.
  • 70% to 80% at AP dermatology and other AP subspecialties.

Many medical laboratories are still recovering from the COVID-19 pandemic’s effects on testing volume.

Notably, the OIG’s report acknowledges the importance of adequate clinical laboratory testing and declares that—without these essential lab tests to manage some healthcare conditions—the healthcare industry could see increased morbidity, deaths, and Medicare spending.   

Donna Marie Pocius

Related Information:

Full Report: The Number of Beneficiaries Who Received Medicare Part B Clinical Laboratory Tests Decreased During the First 10 Months of the COVID-19 Pandemic

Press Release: The Number of Beneficiaries Who Received Medicare Part B Clinical Laboratory Tests Decreased During the First 10 Months of the COVID-19 Pandemic 

Report-in-Brief: The Number of Beneficiaries Who Received Medicare Part B Clinical Laboratory Tests Decreased During the First 10 Months of the COVID-19 Pandemic

From Mid-March Labs Saw Big Drop in Revenue

2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management Announced for April 25-26

New Orleans will once again host the 28th annual gathering for clinical laboratory, pathology, and in vitro diagnostics (IVD) leaders

Clinical laboratory leaders keen on gaining a competitive edge amid a difficult business environment will want to attend the 28th Annual Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management, which returns to New Orleans on April 25-26, 2023.

The 2023 conference comes as clinical laboratories, diagnostics companies, and anatomic pathology practices wrestle with budgets that are strained by inflation, supply chain woes, and the faltering financial performance of parent hospitals and health systems. Meanwhile, lab hiring managers continue to face a severe staffing shortage of diagnostics employees.

For example, in “Medical Technologist Demand Exceeds Supply by Large Margin Across the United States as Clinical Laboratories Scramble to Stay Fully Staffed,” Dark Daily reported how medical technologists and clinical laboratory scientists are in particularly short supply and that some experts do not see this critical shortage waning anytime soon.

“The current twin trends of hospitals losing money and labs struggling to maintain adequate staffing is without parallel in my 30 years of covering the clinical laboratory, diagnostics, and pathology sectors,” said Robert Michel, Founder of the Executive War College and Editor-in-Chief at Dark Daily. “This is a perfect storm that threatens the ability of labs to sustain high-quality testing services in a financially-sustainable manner. At the 2023 Executive War College, we are going to help participants get through this predicament by giving them innovative insights and best-in-class expertise they can take back and implement in their clinical labs and pathology groups.”

“Super early bird” pricing for the 2023 Executive War College ends on Dec. 31.

Robert Michel

“Staffing and supply chain difficulties are not the only burdens facing clinical laboratories,” said Robert Michel (above), Founder of the Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management. “Equally stressful forces are altering how providers, payers, and healthcare consumers access medical laboratory testing and pay for those services.” (Photo copyright: The Dark Intelligence Group.)

Earning New Revenue Will Take Center Stage at 2023 Executive War College

The full agenda for the 2023 Executive War College has not yet been released, but attendees can expect to see keynote presentations and sessions devoted to pressing topics in the diagnostics and laboratory industries. Among them is how to best position the clinical lab as a growing revenue source.

“With financial pressures mounting, we intend to present cutting-edge advice from innovative clinical laboratories, diagnostics companies, and pathology practices about how they earn new revenue—whether that be through creating business opportunities in the community, uncovering new test reimbursements, or using technology to improve existing processes,” Michel explained.

Last spring’s gathering of the Executive War College featured 10 keynotes, 55 sessions, and three post-conference workshops. Participants at the upcoming 2023 Executive War College conference can expect a similar bonanza of educational and professional development options, as well as collaborative networking breaks, luncheons, and receptions.

“The chance to meet innovative peers from across the country, share lab-related challenges with them, and compare effective solutions makes the Executive War College a cost-effective investment for any laboratory administrator, executive, or business-minded pathologist,” Michel added.

Diagnostics Services Will Be Better Reflected at 2023 Conference

For the first time, the conference’s moniker directly reflects the diagnostic work associated with clinical laboratories and pathology groups.

“Long-time attendees will notice that we tweaked the Executive War College’s full title to emphasize ‘diagnostics.’ That term is an important addition,” Michel noted.

“In the recent past, ‘clinical laboratory’ and ‘anatomic pathology’ were terms that sufficiently described the profession of laboratory medicine,” he continued. “However, a subtle but significant change has occurred in recent years. The term ‘diagnostics’ has become a common description for medical testing, along with other diagnostic areas such as radiology and imaging.”

Keep an eye on the conference’s website, ExecutiveWarCollege.com, for updates about the upcoming program and to see the session topics and speakers as they are confirmed and announced.

“The Executive War College is the top gathering for lab leaders to learn from the profession’s best innovators and gain insights they will need to keep their laboratories at the cutting edge of clinical excellence in a financially sustainable manner,” Michel concluded.

Register today to ensure places for you and your management team at the 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management. Click here for early registration discounts.

Scott Wallask

Related Information:

Executive War College to Be Held April 25-26 in New Orleans

Medical Technologist Demand Exceeds Supply by Large Margin Across the United States as Clinical Laboratories Scramble to Stay Fully Staffed

Hospitals Will Lose Billions of Dollars in 2022

New Research Challenges Long-Held Theory about Causes of Alzheimer’s Disease, Creating the Possibility of Useful New Biomarkers for Clinical Laboratory Tests

University of Cincinnati researchers hypothesize that low levels of amyloid-beta protein, not amyloid plaques, are to blame

New research from the University of Cincinnati (UC) and Karolinska Institute in Sweden challenges the prevailing theory about the causes of Alzheimer’s disease, suggesting the possibility of new avenues for the development of effective clinical laboratory assays, as well as effective therapies for treating patients diagnosed with Alzheimer’s.

Scientists have long theorized that the disease is caused by a buildup of amyloid plaques in the brain. These plaques are hardened forms of the amyloid-beta protein, according to a UC news story.

However, in their findings published in the Journal of Alzheimer’s Disease, titled “High Soluble Amyloid-β42 Predicts Normal Cognition in Amyloid-Positive Individuals with Alzheimer’s Disease-Causing Mutations,” the researchers advanced an alternative hypothesis—that Alzheimer’s is instead caused by “depletion” of a soluble form of that same amyloid-beta protein.

“The paradox is that so many of us accrue plaques in our brains as we age, and yet so few of us with plaques go on to develop dementia,” said Alberto Espay, MD, one of the lead researchers of the study, in another UC news story. Espay is Professor of Neurology at the UC College of Medicine and Director and Endowed Chair of the Gardner Center for Parkinson’s Disease and Movement Disorders.

“Yet the plaques remain the center of our attention as it relates to biomarker development and therapeutic strategies,” he added.

Alberto Espay, MD

“It’s only too logical, if you are detached from the biases that we’ve created for too long, that a neurodegenerative process is caused by something we lose, amyloid-beta, rather than something we gain, amyloid plaques,” said Alberto Espay, MD (above), in a University of Cincinnati news story. “Degeneration is a process of loss, and what we lose turns out to be much more important.” The UC study could lead to new clinical laboratory diagnostics, as well as treatments for Alzheimer’s and Parkinson’s diseases. (Photo copyright: University of Cincinnati.)

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High Levels of Aβ42 Associated with Lower Dementia Risk

In their retrospective longitudinal study, the UC researchers looked at clinical assessments of individuals participating in the Dominantly Inherited Alzheimer Network (DIAN) cohort study. DIAN is an ongoing effort, sponsored by the Washington University School of Medicine in St. Louis, to identify biomarkers associated with Alzheimer’s among people who carry Alzheimer’s mutations.

The researchers found that study participants with high levels of a soluble amyloid-beta protein, Aβ42, were less likely to develop dementia than those with lower levels of the protein, regardless of the levels of amyloid plaques in their brains or the amount of tau protein—either as phosphorylated tau (p-tau) or total tau (t-tau)—in their cerebral spinal fluid. P-tau and t-tau are proteins that form “tau tangles” in the brain that are also associated with Alzheimer’s.

One limitation of the study was that the researchers were unable to include Aβ40, another amyloid-beta protein, in their analysis. But they noted that this “did not limit the testing of our hypothesis since Aβ40 exhibits lower fibrillogenicity and lesser depletion than Aβ42, and is therefore less relevant to the process of protein aggregation than Aβ42.” Fibrillogenicity, in this context, refers to the process by which the amyloid-beta protein hardens into plaque.

While the presence of plaques may be correlated with Alzheimer’s, “Espay and his colleagues hypothesized that plaques are simply a consequence of the levels of soluble amyloid-beta in the brain decreasing,” UC news stated. “These levels decrease because the normal protein, under situations of biological, metabolic, or infectious stress, transform into the abnormal amyloid plaques.”

The UC News story also noted that many attempts to develop therapeutics for Alzheimer’s have focused on reducing amyloid plaques, but “in some clinical trials that reduced the levels of soluble amyloid-beta, patients showed worsening in clinical outcomes.”

New Therapeutics for Multiple Neurodegenerative Diseases

Eisai, a Japanese pharmaceutical company, recently announced phase three clinical trial results of lecanemab, an experimental drug jointly developed by Eisai and Biogen, claiming that the experimental Alzheimer’s drug modestly reduced cognitive decline in early-stage patients, according to NBC News.

Espay noted that lecanemab “does something that most other anti-amyloid treatments don’t do in addition to reducing amyloid: it increases the levels of the soluble amyloid-beta.” That may slow the process of soluble proteins hardening into plaques.

Beyond their findings about Alzheimer’s, the researchers believe similar mechanisms could be at work in other neurodegenerative diseases such as Parkinson’s disease, where the soluble alpha-synuclein protein also hardens into deposits.

“We’re advocating that what may be more meaningful across all degenerative diseases is the loss of normal proteins rather than the measurable fraction of abnormal proteins,” Espay said. “The net effect is a loss not a gain of proteins as the brain continues to shrink as these diseases progress.”

Espay foresees two approaches to treating these diseases: Rescue medicine, perhaps based on increasing levels of important proteins, and precision medicine, which “entails going deeper to understand what is causing levels of soluble amyloid-beta to decrease in the first place, whether it is a virus, a toxin, a nanoparticle, or a biological or genetic process,” according to UC News. “If the root cause is addressed, the levels of the protein wouldn’t need to be boosted because there would be no transformation from soluble, normal proteins to amyloid plaques.”

Clinical Laboratory Impact

What does this mean for clinical laboratories engaged in treatment of both Alzheimer’s and Parkinson’s patients? A new understanding of the disease would create “the opportunity to identify new biomarkers and create new clinical laboratory tests that may help diagnose Alzheimer’s earlier in the disease progression, along with tests that help with the patient’s prognosis and monitoring his or her progression,” said Robert Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report.

Given the incidence of Alzheimer’s disease in the population, any clinical laboratory test cleared by the FDA would be a frequently-ordered assay, Michel noted. It also would create the opportunity for pathologists and clinical laboratories to provide valuable interpretation about the test results to the ordering physicians.

Stephen Beale

Related Information:

High Soluble Amyloid-β42 Predicts Normal Cognition in Amyloid-Positive Individuals with Alzheimer’s Disease-Causing Mutations

UC Study: Decreased Proteins, Not Amyloid Plaques, Tied to Alzheimer’s Disease

US News: Scientists Propose New Mechanism Driving Alzheimer’s

Scientists Propose New Mechanism Driving Alzheimer’s Disease

Alzheimer’s: Lack of Beta-Amyloid, Not Plaque Buildup, May Be the Culprit

Better Cognitive Predictor in People at High Risk of Alzheimer’s Disease

UC Study: Researchers Question Prevailing Alzheimer’s Theory with New Discovery

ABPP Amyloid Plaques’ Role in Onset of Alzheimer’s Questioned by Cincinnati University: GlobalData Reveals That ABPP Targeted by a Tenth of All Alzheimer’s Drugs

Blots on a Field? A Neuroscience Image Sleuth Finds Signs of Fabrication in Scores of Alzheimer’s Articles, Threatening a Reigning Theory of the Disease

WVXU: Does a Key Alzheimer’s Study Contain Fabricated Images?

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