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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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University of California San Francisco Study Finds Both High and Low Levels of High-Density Lipoprotein Cholesterol Associated with Increased Dementia Risk

If validated, study findings may result in new biomarkers for clinical laboratory cholesterol tests and for diagnosing dementia

Researchers continue to find new associations between biomarkers commonly tested by clinical laboratories and certain health conditions and diseases. One recent example comes from research conducted by the University of California San Francisco. The UCSF study connected cholesterol biomarkers generally used for managing cardiovascular disease with an increased risk for dementia as well.

The researchers found that both high and low levels of high-density lipoprotein (HDL)—often referred to as “good” cholesterol—was associated with dementia in older adults, according to a news release from the American Academy of Neurology (AAN).

UCSF’s large, longitudinal study incorporated data from 184,367 people in the Kaiser Permanente Northern California health plan. How the findings may alter cholesterol biomarker use in future diagnostics has not been determined.

The researchers published their findings in the journal Neurology titled, “Low- and High-Density Lipoprotein Cholesterol and Dementia Risk over 17 Years of Follow-up among Members of Large Health Care Plan.”

Maria Glymour, ScD

“The elevation in dementia risk with both high and low levels of HDL cholesterol was unexpected, but these increases are small, and their clinical significance is uncertain,” said epidemiologist Maria Glymour, ScD (above), study author and Professor of Epidemiology and Biostatistics at UCSF School of Medicine, in a news release. This is another example of how researchers are associating common biomarkers tested regularly by clinical laboratories with additional health conditions and disease states. (Photo copyright: University of California San Francisco.)

HDL Levels Link to Dementia Risk

The UCSF researchers used cholesterol measurements and health behavior questions as they tracked Kaiser Permanente Northern California health plan members who were at least 55 years old between 2002 and 2007, and who did not have dementia at the time of the study’s launch.

The researchers then followed up with the study participants through December 2020 to find out if they had developed dementia, Medical News Today reported.

“Previous studies on this topic have been inconclusive, and this study is especially informative because of the large number of participants and long follow-up,” said epidemiologist Maria Glymour, ScD, study author and Professor of Epidemiology and Biostatistics at UCSF School of Medicine, in the AAN news release. “This information allowed us to study the links with dementia across the range of cholesterol levels and achieve precise estimates even for people with cholesterol levels that are quite high or quite low.” 

According to HealthDay, UCSF’s study findings included the following:

  • More than 25,000 people developed dementia over about nine years. They were divided into five groups.
  • 53.7 milligrams per deciliter (mg/dL) was the average HDL cholesterol level, amid an optimal range of above 40 mg/dL for men and above 50 mg/dL for women.
  • A 15% rate of dementia was found in participants with HDL of 65 mg/dL or above.
  • A 7% rate of dementia was found in participants with HDL of 11 mg/dL to 41 mg/dL.

“We found a U-shaped relationship between HDL and dementia risk, such that people with either lower or higher HDL had a slightly elevated risk of dementia,” Erin Ferguson, PhD student of Epidemiology at UCSF, the study’s lead study author, told Medical News Today.

What about LDL?

The UCSF researchers found no correlation between low-density lipoprotein (LDL)—often referred to as “bad” cholesterol”—and increased risk for dementia. But the risk did increase slightly when use of statin lipid-lowering medications were included in the analysis.

“Higher LDL was not associated with dementia risk overall, but statin use qualitatively modified the association. Higher LDL was associated with a slightly greater risk of Alzheimer’s disease-related dementia for statin users,” the researchers wrote in Neurology.

“We found no association between LDL cholesterol and dementia risk in the overall study cohort. Our results add to evidence that HDL cholesterol has similarly complex associations with dementia as with heart disease and cancer,” Glymour noted in the AAN news release.

Australian Study also Links High HDL to Dementia

A separate study from Monash University in Melbourne, Victoria, Australia, found that “abnormally high levels” of HDL was also associated with increased risk for dementia, according to a Monash news release.

The Monash study—which was part of the ASPREE (ASPpirin in Reducing Events in the Elderly) trial of people taking daily aspirin—involved 16,703 Australians and 2,411 Americans during the years 2010 to 2014. The researchers found:

  • 850 participants had developed dementia over about six years.
  • A 27% increased risk of dementia among people with HDL above 80 mg/dL and a 42% higher dementia risk for people 75 years and older with high HDL levels.

These findings, Newsweek pointed out, do not necessarily mean that high levels of HDL cause dementia. 

“There might be additional factors that affect both these findings, such as a genetic link that we are currently unaware of,” Andrew Doig, PhD, Professor, Division of Neuroscience at University of Manchester, told Newsweek. Doig was not involved in the in the Monash University research.

Follow-up research could explore the possibility of diagnosing dementia earlier using blood tests and new biomarkers, Newsweek noted.

The Australian researchers published their findings in The Lancet Regional Health-Western Pacific titled, “Association of Plasma High-Density Lipoprotein Cholesterol Level with Risk of Incident Dementia: A Cohort Study of Healthy Older Adults.”

Cholesterol Lab Test Results of Value to Clinical Labs

If further studies validate new biomarkers for testing and diagnosis, a medical laboratory’s longitudinal record of cholesterol test results over many years may be useful in identifying people with an increased risk for dementia.

Clinical pathologists and laboratory managers will want to stay tuned as additional study insights and findings are validated and published. Existing laboratory testing reference ranges may need to be revised as well.

As well, the findings of this UCSF research demonstrate that, in this age of information, there will be plenty of opportunities for clinical lab scientists and pathologists to take their labs’ patient data and combine it with other sets of data. Digital tools like artificial intelligence (AI) and machine learning would then be used to assess that large pool of data and produce clinically actionable insights. In turn, that positions labs to add more value and be paid for that value.

—Donna Marie Pocius

Related Information:

Both High and Low HDL Cholesterol Tied to Increased Risk of Dementia

Low-and High-Density Lipoprotein Cholesterol and Dementia Risk over 17 Years of Follow-up among Members of a Large Health Care Plan

Both High and Low HDL Cholesterol Tied to Slight Increase in Risk of Dementia

How HDL “Good” Cholesterol Might Raise Dementia Risk

HDL vs. LDL Cholesterol

How Levels of “Good” Cholesterol May Increase Dementia Risk

High Levels of “Good Cholesterol” May Be Associated with Dementia Risk, Study Shows

Association of Plasma High-Density Lipoprotein Cholesterol Level with Incident Dementia: A Cohort Study of Healthy Older Adults

Study Claims High Good Cholesterol Levels Linked to Greater Dementia Risk

AdventHealth Gives 10,000 Floridians Free Genetic Tests, Sees Genomics as the Future of Precision Medicine

Many other healthcare systems also are partnering with private genetic testing companies to pursue research that drive precision medicine goals

It is certainly unusual when a major health network announces that it will give away free genetic tests to 10,000 of its patients as a way to lay the foundation to expand clinical services involving precision medicine. However, pathologists and clinical laboratory managers should consider this free genetic testing program to be the latest marketplace sign that acceptance of genetic medicine continues to move ahead.

Notably, it is community hospitals that are launching this new program linked to clinical laboratory research that uses genetic tests for specific, treatable conditions. The purpose of such genetic research is to identify patients who would benefit from test results that identify the best therapies for their specific conditions, a core goal of precision medicine.

The health system is AdventHealth of Orlando, Fla., which teamed up with Helix, a personal genomics company in San Mateo, Calif., to offer free DNA sequencing to 10,000 Floridians through its new AdventHealth Genomics and Personalized Health Program. A company news release states this is the “first large-scale DNA study in Florida,” and that it “aims to unlock the secret to a healthier life.”

The “WholeMe” genomic population health study screens people for familial hypercholesterolemia  (FH), a genetic disorder that can lead to high cholesterol and heart attacks in young adults if not identified and treated, according to the news release.

Clinical laboratory leaders will be interested in this initiative, as well other partnerships between healthcare systems and private genetic testing companies aimed at identifying and enrolling patients in research studies for disease treatment protocols and therapies. 

The Future of Precision Medicine

Modern Healthcare reported that data from the WholeMe DNA study, which was funded through donations to the AdventHealth Foundation, also will be used by the healthcare network for research beyond FH, as AdventHealth develops its genomics services. The project’s cost is estimated to reach $2 million.

“Genomics is the future of medicine, and the field is rapidly evolving. As we began our internal discussions about genomics and how to best incorporate it at AdventHealth, we knew research would play a strong role,” Wes Walker MD, Director, Genomics and Personalized Health, and Associate CMIO at AdventHealth, told Becker’s Hospital Review.

“We decided to focus on familial hypercholesterolemia screening initially because it’s a condition that is associated with life-threatening cardiovascular events,” he continued. “FH is treatable once identified and finding those who have the condition can lead to identifying other family members who are subsequently identified who never knew they had the disease.”

The AdventHealth Orlando website states that participants in the WholeMe study receive information stored in a confidential data repository that meets HIPAA security standards. The data covers ancestry and 22 other genetic traits, such as:

  • Asparagus Odor Detection
  • Bitter Taste
  • Caffeine Metabolism
  • Cilantro Taste Aversion
  • Circadian Rhythm
  • Coffee Consumption
  • Delayed Sleep
  • Earwax Type
  • Endurance vs Power
  • Exercise Impact on Weight
  • Eye Color
  • Freckling
  • Hair Curl and Texture
  • Hand Grip Strength
  • Height
  • Lactose Tolerance
  • Sleep Duration
  • Sleep Movement
  • Sleeplessness
  • Sweet Tooth
  • Tan vs. Sunburn
  • Waist Size

Those who test positive for a disease-causing FH variant will be referred by AdventHealth for medical laboratory blood testing, genetic counseling, and a cardiologist visit, reported the Ormond Beach Observer.

One in 250 people have FH, and 90% of them are undiagnosed, according to the FH Foundation, which also noted that children have a 50% chance of inheriting FH from parents with the condition.

AdventHealth plans to expand the free testing beyond central Florida to its 46 other hospitals located in nine states, Modern Healthcare noted.

Other Genetics Data Company/Healthcare Provider Partnerships

In Nevada, Helix partnered with the Renown Health Institute for Health Innovation (IHI) and the Desert Research Institute (DRI) to sequence 30,000 people for FH as part of the state’s Healthy Nevada Project (HNP).

Helix (above) is one of the world’s largest CLIA-certified, CAP-accredited next-generation sequencing labs. The partnership with AdventHealth offered study participants Exome+: a panel-grade medical exome enhanced by more than 300,000 informative non-coding regions; a co-branded ancestry + traits DNA product for all participants; secure storage of genomic data for the lifetime of the participant; infrastructure and data to facilitate research; and in-house clinical and scientific expertise, according to Helix’s website. (Photo copyright: Orlando Sentinel.)

Business Insider noted that Helix has focused on clinical partnerships for about a year and seems to be filling a niche in the genetic testing market.

“Helix is able to sidestep the costs of direct-to-consumer marketing and clinical test development, while still expanding its customer base through predefined hospital networks. And the company is in a prime position to capitalize on providers’ interest in population health management,” Business Insider reported.

Another genomics company, Color of Burlingame, Calif., also has population genomics programs with healthcare networks, including NorthShore University Health System in Ill.; Ochsner Health System in La.; and Jefferson Health in Philadelphia.

Ochsner’s program is the first “fully digital population health program” aimed at including clinical genomics data in primary care in an effort to affect patients’ health, FierceHealthcare reported.

In a statement, Ochsner noted that its innovationOchsner (iO) program screens selected patients for:

  • Hereditary breast and ovarian cancer due to mutations in BRCA1 and BRCA2 genes;
  • Lynch syndrome, associated with colorectal and other cancers; and
  • FH.

Color also offers genetic testing and whole genome sequencing services to NorthShore’s DNA10K program, which plans to test 10,000 patients for risk for hereditary cancers and heart diseases, according to news release.

And, Jefferson Health offered Color’s genetic testing to the healthcare system’s 33,000 employees, 10,000 of which signed up to learn their health risks as well as ancestry, a Color blog post states.

Conversely, Dark Daily recently reported on two Boston healthcare systems that started their own preventative gene sequencing clinics. The programs are operated by Brigham and Women’s Hospital and Massachusetts General Hospital (MGH).

And a Precision Medicine Institute e-briefing reported on Geisinger Health and Sanford Health’s move to offer genetic tests and precision medicine services in primary care clinics.

“Understanding the genome warning signals of every patient will be an essential part of wellness planning and health management,” said Geisinger Chief Executive Officer David Feinberg, MD, when he announced the new initiative at the HLTH (Health) Conference in Las Vegas. “Geisinger patients will be able to work with their family physician to modify their lifestyle and minimize risks that may be revealed,” he explained. “This forecasting will allow us to provide truly anticipatory healthcare instead of the responsive sick care that has long been the industry default across the nation.”

It will be interesting to see how and if genetic tests—free or otherwise—will advance precision medicine goals and population health treatments. It’s important for medical laboratory leaders to be involved in health network agreements with genetic testing companies. And clinical laboratories should be informed whenever private companies share their test results data with patients and primary care providers. 

—Donna Marie Pocius

Related Information:

It May Be Your DNA: First Large-Scale DNA Study in Florida Aims to Unlock the Secret to a Healthier Life

AdventHealth Offers Free DNA Tests to 10,000 Floridians

How AdventHealth Orlando is Building a Future in Genomics

Helix Partners with AdventHealth to Offer 10,000 Genetic Screenings in Florida

AdventHealth to Launch Large Genetic Study for High Cholesterol

Ochsner Health System Teaming Up with Genetic Testing Company Color in Population Genomics

The Healthy Nevada Project: from Recruitment to Real-World Impact

Ochsner Health System to Pilot Genetic Screening Program in Partnership with Color

North Shore and Color Unlock the Power of Genomics in Routine Care

Jefferson Heath and Color Advancing Precision Health Through Clinical Genomics and Richer Data

Two Boston Health Systems Enter the Growing Direct-to-Consumer Gene Sequencing Market by Opening Preventative Genomics Clinics, But Can Patients Afford the Service

Geisinger Health and Sanford Health Ready to Offer Genetic Tests and Precision Medicine Services in Primary Care Clinics

Winners of the Qualcomm Tricorder XPRIZE for Medical Laboratory Testing Were Announced in April, Five Years After the Competition Began

More than 312 teams applied for the completion and the prize-winning hand-held device uses clinical laboratory assays to diagnose up to 34 different medical conditions

Star Trek fans among clinical laboratory manager and pathologist will be excited to learn that the winners of the Qualcomm Tricorder XPRIZE were announced earlier this year, five years after the contest began. The purpose of the XPRIZE competition was to challenge teams to create a mobile integrated diagnostic device that weighed less than five pounds and had the ability to monitor health metrics and diagnose 13 specific health conditions. The premise for the contest was inspired by the Star Trek medical tricorder that was first conceptualized on the television show “Star Trek” in the 1960s.

In the popular science-fiction show, the tricorder was a multifunctional hand-held device used for sensor scanning, data analysis, and recording data. The name “tricorder” was an abbreviation for the full name of the gadget, “tri-function recorder,” which referred to the three primary functions of the device.

Based in Culver City, Calif, the XPRIZE Foundation is a non-profit organization that creates and oversees prestigious technological competitions for the purpose of prompting innovations that could benefit humanity.

Handheld Device That Can Perform Multiple Clinical Laboratory Assays

The Qualcomm Tricorder XPRIZE competition was launched in January 2012. Participants had until August 2013 to register for the contest. The qualifying round was held the following August. Three hundred and twelve teams entered the competition. Qualifiers had until March 2015 to design and build their prototypes. Consumer testing on the products began in September 2016 and the winners were announced in April 2017.

The top prize of $2.6 million was awarded to Final Frontier Medical Devices, the team led by Basil Harris, MD, an emergency room physician with a PhD in Materials Engineering led the team, along with his network engineer brother, George Harris.

Basil Leaf Technologies, founded by Basil Harris, MD, PhD, FACEP (above center); and his brother George, a Network Engineer (second from left), is a medical technology company headquartered in Paoli, Pa. Their winning entry, called DxtER (pronounced Dexter), is a small FDA-approved group of medical devices that enable consumers to diagnose illnesses at home or remotely and share that data with healthcare providers. (Photo copyright: XPRIZE Foundation.)

The collection of FDA-approved devices that make up the “tricorder” includes sensors designed to gather data about vital signs, body chemistry, and biological functions. The DxtER device walks patients through the self-diagnosis of 34 medical conditions. The instruments include:

·       A compact spirometer that calculates lung strength;

·       A test kit for Mononucleosis;

·       A heart rate monitor;

·       A respiration monitor;

·       The DxtER Orb, a digital stethoscope that also serves as a thermometer; and

·       An artificial intelligence (AI) “engine” that diagnoses medical conditions.

DxtER communicates with a tablet and/or smartphone-based app. Since the components are FDA-approved, diagnostic test results can be taken directly to healthcare professionals.

“You can [receive the] results and take them to the ER or to your physician or whoever’s helping you, and they can build off those results,” George Harris explained in an Engadget article. “They don’t have to start back at square one. They can jump off at that point and move on with their healthcare.”

Basil Leaf Technologies’ DxtER “tricorder” (above) enables the user to self-diagnose up to 34 medical conditions. Each individual component is FDA-approved, so hospital physicians can rely on the accuracy of the test results. (Photo copyright: XPRIZE Foundation.)

According to the contest website, “at the heart of DxtER is an artificially intelligent engine that learned to diagnose by integrating years of experience in clinical emergency medicine with data analysis from actual patients having a variety of medical conditions and outcomes.”

“It is very exciting that our vision of mobile, personalized patient-centric healthcare is getting closer to becoming a reality thanks to the great work of the Qualcomm Tricorder XPRIZE teams,” declared Paul E. Jacobs, PhD, Executive Chairman of Qualcomm Incorporated (NASDAQ:QCOM) in an XPRIZE press release. “Creating technology breakthroughs in an industry as complex as healthcare is quite a milestone, and what these teams accomplished is a great stepping stone to making mobile healthcare a viable option across the world.”

DxtER Functions Like a Mobile Medical Laboratory

In addition to the $2.6-million prize, Qualcomm Foundation is giving the Basil Leaf team $3.8 million to further develop the device. This amount includes a:

·       $2.5 million proposal grant to the University of California San Diego; and a

·       $1.6-million gift from the Roddenberry Foundation to adapt the tricorder for hospital use in the developing world.

The XPRIZE competition required contestants to create a tricorder device that could accurately diagnose 13 health conditions. This included 10 core conditions and a choice of three elective health conditions. The devices also needed to be able to acquire five real-time vital signs:

1.     Blood pressure;

2.     Heart rate;

3.     Oxygen saturation;

4.     Respiratory rate; and

5.     Temperature.

The 10 core conditions the devices had to be able to identify were:

1.     Anemia;

2.     Atrial Fibrillation;

3.     Chronic Obstructive Pulmonary Disease;

4.     Diabetes Mellitus;

5.     Leukocytosis;

6.     Pneumonia;

7.     Otitis;

8.     Sleep Apnea;

9.     Urinary Tract Infection; and

10.  Absence of condition.

The contest also required participants to choose three elective conditions from the following list:

·       Cholesterol screen;

·       Food-borne illness;

·       Human Immunodeficiency Virus (HIV) screen;

·       Hypertension;

·       Hypothyroidism/Hyperthyroidism;

·       Melanoma;

·       Mononucleosis;

·       Pertussis;

·       Shingles, and

·       Strep throat.

It is notable that the TriCorder XPRIZE—with its $2.6 million prize—generated entries from 312 teams. Pathologists and clinical laboratory managers can take this high number of entrants as a sign that the ongoing advances in technology are poised to support a new generation of very small medical lab testing devices. Thus, miniaturized diagnostic technologies, when combined with more sophisticated computing chips and software are making it simpler and more feasible to pack multiple diagnostic instruments into a hand-held package.

—JP Schlingman

Related Information:

Final Frontier Medical Devices

Family-led Team Takes Top Prize in Qualcomm Tricorder XPRIZE Competition for Consumer Medical Device Inspired by Star Trek

The Contest to Build the First Star Trek Tricorder Has a Winner [Infographic]

XPRIZE Winner Says its Tricorder is Better Than ‘Star Trek’

Underdog Team Wins Millions in Competition to Make Real-Life Tricorder

Star Trek’s “Tricorder” Medical Scanner Just Got Closer to Becoming a Reality

Qualcomm Tricorder XPRIZE Goes to US Team for Device Fusing AI, IoT, Health

Tricorder X Prize – Wikipedia

Star Trek’s Tricorder, Realized? This Device Uses AI to Diagnose Medical Conditions

The Race to Build a Real Star Trek Tricorder

Qualcomm TriCorder XPRIZE Selects 10 Finalists: Next Step Is for Devices to Diagnose Patients using Clinical Laboratory Test Technologies and Similar Diagnostic Tools

Consumers Increasingly Purchase Medical Laboratory Self-Test Kits for Blood Glucose, Cholesterol, and Colon Cancer Screening, according to Consumer Reports

The self-monitoring/self-test market is expected to swell to $19 billion by 2019, offering opportunities for pathologists and clinical laboratories to advise patients and ensure the proper use of home tests

Might the future of clinical laboratory tests be sitting on the shelf at your corner pharmacy right now? Patient self-testing and screening kits continue to garner the approvals of Consumer Reports’ medical advisors.

That’s happening because the Food and Drug Administration (FDA) continues to clear many do-it-yourself tests that traditionally were performed in medical laboratories by qualified personnel, much to the chagrin of some doctors.

Empowered healthcare consumers are checking their cholesterol, monitoring their diabetes, and more, using health screening kits that range from $8 to $175, according to a Consumer Reports on Health article, which advised consumers to use self-tests judiciously and share the results with their physicians. (more…)

Can Medical Laboratories Tell Patients There’s No Need for Overnight Fasting before a Cholesterol Test? Denmark’s Experience Says Answer is ‘Yes!’

Comparing results from more than 300,000 individuals, international experts recommend using non-fasting blood screening for most cholesterol and triglyceride tests

Every clinical laboratory offering cholesterol testing across the globe must deal with a common issue: because patients are told to fast overnight before giving a blood specimen, patient service centers (PSCs) and blood collection centers are overcrowded when they first open their doors in the morning. That’s because hungry patients want their sample collected so they then go eat something as soon as possible.

It has long been recognized that the overnight fasting requirement for collecting blood samples used in cholesterol testing is unpleasant for patients. It also adds cost to the healthcare system because labs must staff an adequate number of phlebotomists in their PSCs to handle the predictable early morning rush of hungry patients wanting to be done with this task. Meanwhile, in the afternoons, patient traffic in the same PSCs can dwindle to near nothing, leaving phlebotomists in those PSCs with little to do. (more…)

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