News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
Sign In

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…)

When It Comes to Mining Healthcare Big Data, Including Medical Laboratory Test Results, Optum Labs Is the Company to Watch

Example is a big data-based study involving Optum and Mayo Clinic that indicates diabetes management can be too aggressive for some patients

Mayo Clinic has tapped Optum Labs’ huge data set to fuel research suggesting diabetes management can be too aggressive among those diabetics who don’t have problems controlling their glucose level. Optum Labs’ data is also being mined to investigate dozens of research initiatives, including a major fight against Alzheimer’s disease. These projects provide a glimpse into the growing role of big data in healthcare.

Because more than 70% of a typical patient’s permanent medical record consists of clinical laboratory test data, pathologists and medical laboratory scientists have a stake in the growth of big-data analytics, which are a core component in healthcare’s journey toward personalized medicine. (more…)

ETH Zurich Develops Implantable Molecular Device Capable of Monitoring Blood pH and Regulating Insulin Production in Mice; May One Day Allow Pathologists to Remotely Monitor Patients

Prototype could provide glimpse of radically different future for patient monitoring and present new opportunities for pathologists and medical laboratory scientists

Are pathologists and medical laboratory scientists ready for a new diagnostic paradigm? Instead of specimens transported into a central medical laboratory, how about in vivo real-time monitoring of patients with chronic diseases, where pathologists are able to remotely spot changes in a patient’s condition as they happen and alert physicians to take timely action?

Researchers are combining several technologies to create sensor-based systems for in vivo real-time monitoring of body processes. In Basel, Switzerland, a team at ETH Zurich’s Department of Biosystems Science and Engineering created an implantable sensor for continuous monitoring of blood pH that is paired up with a gene feedback mechanism to produce the necessary amount of insulin. The dual function device has been described as a “molecular prosthesis.” The purpose of this device is to monitor patients with diabetes.

While ETH Zurich’s prototype needs more development before it will be ready for clinical uses, the university’s research shows pathologists and medical laboratory scientists how fast new capabilities are being developed that can eventually support a radically different approach to patient diagnosis and patient monitoring. Use of such real-time in vivo diagnostic devices could allow laboratory professionals to remotely monitor patients and trigger clinical interventions when the biomarkers being tracked indicate such a need.

Device Monitors Blood Acidity: Responds to Diabetic Acidosis by Producing Insulin

What is particularly intriguing about the device created by the Swiss university’s bioengineers is that it is capable of both diagnostic and therapeutic actions. Both modules of the device—the blood pH sensor and insulin production mechanism—are constructed from biological components, such as various genes and proteins. These are incorporated into cultivated renal cells. The researchers then embedded millions of these customized cells in capsules that can be used as implants in the body.

According to an ETH news release, the pH sensor transmits a signal to trigger the production of insulin if pH values fall below 7.35, a low pH value specific for type 1 diabetes. Once blood pH returns to the ideal range, the sensor turns itself off and the reprogrammed cells stop producing insulin.

In tests using mice with type 1 diabetes, the ETH device was able to successfully monitor the blood’s acidity and respond to diabetic acidosis by producing insulin. Mice with capsules implanted produced the amount of insulin appropriate to their individual acid measurements, enabling them to have hormone levels comparable to that of healthy mice. The implant also compensated for larger deviations in blood sugar. The system design and test results were published in an August 7, 2014, Molecular Cell article.

ETH Prototype Shows the Possibility of Creating Applications for Humans

Despite the promising results, Martin Fussenegger, Ph.D., Professor in ETH Zurich’s Department of Biosystems Science and Engineering, says the university will need an industrial partner in order to consider commercial development of the molecular device.

“Applications for humans are conceivable based on this prototype, but they are yet to be developed,” stated Fussenegger in the news release. “We wanted to create a prototype first to see whether molecular prostheses could even be used for such fine adjustments to metabolic processes.”

Martin Fussenegger, Ph.D

Martin Fussenegger, Ph.D., Professor in ETH Zurich’s Department of Biosystems Science and Engineering, says the initial results of studies in mice of ETH Zurich’s implantable molecular device for regulating blood pH levels through a closed loop pH sensing and insulin production mechanism shows promise. (Photo copyright ETH Zurich)

Until recently, most progress in diabetes care focused on improvements to continuous glucose monitors and insulin delivery systems, with implantable, long-lasting sensors for continuous monitoring on the horizon. ETH Zurich’s implantable molecular device would represent a major leap forward.

Diabetes in U.S. Continues to Increase

A 2014 report from the U.S. Centers for Disease Control and Prevention (CDC) shows that diabetes is on the rise, with 29.1 million people (9.3% of the U.S. population) living with diabetes. By comparison, in 2010 there were an estimated 26 million people in the U.S. with diabetes.

The CDC says that nearly 28% of people with diabetes are undiagnosed, which increases risk for heart disease, stroke, blindness, kidney failure, amputation of toes, feet or legs, and early death.

The report also estimates that the total cost in medical bills and lost work and wages due to diabetes and related complications adds up to $245 billion, up from $174 billion in 2010.

“These new numbers are alarming and underscore the need for an increased focus on reducing the burden of diabetes in our country,” said Ann Albright, Ph.D., R.D., Director of the CDC’s Division of Diabetes Translation, in a CDC news release. “Diabetes is costly in both human and economic terms. It’s urgent that we take swift action to effectively treat and prevent this serious disease.”

Ann Albright, Ph.D., R.D

Ann Albright, Ph.D., R.D., Director of the Centers for Disease Control and Prevention’s Division of Diabetes Translation, stresses the importance of continued diabetes research. (Photo copyright CDC)

The need for new methods to control diabetes was underscored in a 2010 study published at PubMed Central (PMC) on the U.S. National Institutes of Health’s National Library of Medicine (NIH/NLM) website. It painted a “sobering picture of the future growth of diabetes.”

“Under an assumption of low incidence and relatively high diabetes mortality, total prevalence is projected to increase to 21% of the U.S. adult population by 2050,” the authors wrote. “On the other hand, if recent increases in diabetes incidence continue (middle incidence projections) and diabetes mortality ratios are relatively low, diabetes prevalence will increase to 33% by 2050.”

The study blames the rise in diabetes in the U.S. in part on demographic changes brought about by an aging population—older adults are more likely to develop diabetes—an increase in minority populations that report higher diabetes rates, and reduced mortality rates for those living with the disease.

In Vivo and In Vitro Diagnostics Continue to Merge

Dark Daily has reported on the evolution of implantable diagnostic tests for some time. As we noted in “In Vivo Pathology Testing Might Use Injectable Microbeads to Detect Excessive Glucose Levels” (Dark Daily, January 1, 2011), pathology researchers continue to find novel ways to integrate in vivo and in vitro diagnostic tests. This trend does not appear to be slowing.

Implantable diagnostic technology continues to develop, which should indicate to clinical laboratories the possibility that disease diagnosis and monitoring is shifting away from centralized laboratories and towards medical communities and patients’ homes. The added twist in the new in vivo device created by researchers at ETH Zurich is that, after the diagnostic component of the device has tracked a change in the biomarker, the device can then automatically produce the appropriate therapy, also in real time and in vivo.

—Andrea Downing Peck

Related Information:

Sensitive Acid Sensor Controls Insulin Production

A Molecular Implant for pH Sensitive Insulin Production

New CDC Diabetes Report

Diabetes Latest

In Vivo Pathology Testing Might Use Injectable Microbeads to Detect Excessive Glucose Levels

Ochsner Becomes First Health System to Interface Apple’s HealthKit App to its Epic EHR; Will It Help Patient’s Monitor Their Medical Laboratory Test Results?

electronic health recordNew products are expected to radically change the wearable fitness device game by allowing physicians and patients and even pathologists to see the same data

If Apple Inc. can succeed with its latest wearable health device, experts predict that physicians may soon begin using it to monitor the health of their patients. This may be auspicious for pathologists and clinical laboratory scientists if physicians ask them to monitor that patient data and provide consultative support.

It was in September when Apple (NASDAQ: AAPL) unveiled its new smartwatch. When combined with Apple’s HealthKit software platform, the Apple watch might well the most powerful wearable health-tracking device to hit the market yet. (more…)

Team at Intermountain Medical Center Research Unveils Cortisol Measurement Tool Via Smartphone Device With Possibilities for Worldwide Use for Clinical Laboratory Testing

After a visit to Uganda, a research team leader was inspired to develop a medical laboratory tool for diagnosing adrenal disorders

Saliva and the smartphone do not appear to be a harmonious pair, particularly as elements of a method to remotely perform a medical laboratory test for cortisol. But new research at Intermountain Medical Center in Murray, Utah, suggests they can work together to help physicians remotely conduct cortisol tests.

Intermountain Healthcare is an internationally recognized, nonprofit healthcare system based in Salt Lake City, Utah, with 22 hospitals, more than 185 physician clinics, and 33,000 employees throughout the state of Utah, as well as an affiliated health insurance company, SelectHealth. (more…)

;