Oct 1, 2018 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
New advancements in mHealth, though encroaching on testing traditionally performed at clinical laboratories, offer opportunity to expand testing to remote locations
Mobile technology continues to impact clinical laboratories and anatomic pathology groups and is a major driver in precision medicine, as Dark Daily has reported. Most of the mobile-test development which incorporates smartphones as the testing device, however, has been for chemistry and immunoassay types of lab tests. Now, a new developer in Monmouth Junction, NJ, has created a Complete Blood Count (CBC) test that runs on devices attached to smartphones.
Such devices enable doctors to order test panels for patients in remote locations that also may lack resources, such as electricity.
The developer is Essenlix and it calls its new testing device iMOST (instant Mobile Self-Testing). According to the company’s website, which is mostly “Under Construction,” iMOST can provide “accurate blood and other healthcare testing in less than 60 seconds by a smartphone and matchbox-size-attachment, anywhere, anytime, and affordable to everyone.”
The company description on the Longitude Prize website states that Essenlix “uses multidisciplinary approaches to develop a new innovative platform of simple, fast, ultrasensitive, bio/chemical sensing and imaging for life science, diagnostics, and personal health.
The Longitude Prize competition was established to promote the invention of “an affordable, accurate, fast and easy-to-use test for bacterial infections that will allow health professionals worldwide to administer the right antibiotics at the right time,” the website states.
The Essenlix iMOST mobile-testing device (above) connects to a smartphone (shown right) and enables clinical laboratory technicians to run tests in remote locations from samples taken at time the test. Though still in trials, iMOST, and other similar devices, promise to expand testing to outside of traditional medical laboratory locations and further promote precision medicine. (Photos copyright: Lydia Ramsey/Business Insider.)
Essenlix’s iMOST mobile testing system consists of:
- a mobile application (app);
- the device attachment, which goes over the phone’s camera; and,
- a cartridge that holds a sample of blood.
So far, there have been two trials with a total of 92 participants, comparing traditional CBC testing with the Essenlix test. The results were within the FDA’s requirements for allowable error, prompting Chou to tell Business Insider, “Our error is clearly smaller than the FDA’s requirement, so the data is very, very good.”
Chou and his team are working toward FDA approval.
Other Testing Devices That Attached to Smartphones
Aydogan Ozcan, PhD, Professor of Electrical Engineering and Bioengineering at UCLA, and Mats Nilsson, PhD, Professor and Scientific Director of the Science for Life Laboratory at Stockholm University, have developed an attachment that they say can transform “a phone into a biomolecular analysis and diagnostics microscope,” according to The Pathologist. Dark Daily has published many e-briefings on Ozcan’s innovations over the years.
Their goal, the researchers said, was to create technology that can be used in low- and middle-income areas (LMICs), as well as in more advanced locations, such as Sweden. “I’ve been involved in other projects where we’ve looked at point-of-care diagnostic approaches,” he said, “and it seems to be very important that the devices [do not] rely on wired electricity or networks to serve not only LMICs, but also modern, developed environments. It’s often difficult to find an available power socket in Swedish hospitals.”
The molecular diagnostic tests that can be done with smartphone attachments—such as those developed by Ozcan and Nilsson—represent another way of using a smartphone in the healthcare arena, The Pathologist points out. Their invention combines the smartphone’s native camera, an app, optomechanical lasers, and an algorithm contained within the attachment to carry out fluorescence microscopy in the field.
Future of Mobile-Testing
An article appearing in the Financial Times describes some of the ways mobile technology is changing healthcare, including diagnostics that have traditionally been performed in the medical pathology laboratories.
“Doctors scan your body to look for irregularities, but they rely on pathologists in the lab to accurately diagnose any infection,” the article notes. “There, body fluids such as blood, urine, or spit are tested for lurking microbes or unexpected metabolites or chemicals wreaking havoc in your body. Now companies are miniaturizing these tests to create mobile pathology labs.”
Apple introduced the first iPhone in 2007. It’s doubtful anyone imagined the innovations in diagnostics and pathology that would soon follow. Thus, trying to predict what may be coming in coming decades—or even next year—would be futile. However, scientists and researchers themselves are indicating the direction development is headed.
Should Essenlix and other mobile-lab-test developers succeed in their efforts, it would represent yet another tectonic shift for medical pathology laboratories. Clinical laboratory managers and stakeholders should be ready, for the words of the ancient Greek philosopher Heraclitus have never been truer: “Change is the only constant in life.”
—Dava Stewart
Related Information:
Mobile Phone Microscopy
How Smartphones Are Transforming Healthcare
This Startup Wants to Make Blood Testing as Easy as Snapping a Photo with an iPhone
Is mHealth an Opportunity or Threat to Medical Laboratories and Pathology Groups?
New FDA Regulations of Clinical Decision-Support/Digital Health Applications and Medical Software Has Consequences for Medical Laboratories
UCLA Device Enables Diagnosis of Antimicrobial Resistance in Any Setting; Could Save Lives Lost to Antimicrobial Resistant Bacteria
Lab-on-a-Chip Diagnostics: When Will Clinical Laboratories See the Revolution?
Tiny, Simple-to-Use Lensless Microscope Might Soon Find a Place in Pathology
Apr 16, 2018 | Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Managed Care Contracts & Payer Reimbursement, Management & Operations
Recent studies exploring the economics behind the high price of US healthcare independently point to the price of labor, goods, services, administrative costs, and pharmaceuticals as primary reason why the US spends almost twice as much as peer countries on healthcare
It is regularly reported that the cost of healthcare in the United States is notably more expensive that in most developed nations. Overutilization of medical services in this country is often given as a reason why this is true. But the findings of a new research study suggest that the reason healthcare in the US is expensive is not due to overutilization. Rather, it is because of the much higher prices American patients pay for services, including clinical laboratory testing.
This recent study contradicts the claims of some experts who say overutilization is to blame for the high cost of healthcare in the United States. The research was conducted by researchers at the Institute for Health Metrics and Evaluation (IHME) in Seattle and the UCLA David Geffen School of Medicine. They attribute the overarching factor in high healthcare costs not to high utilization of services—such as clinical laboratory and anatomic pathology testing—or increased rates of illness.
Instead, the researchers found that it’s simply a matter of higher prices for healthcare delivered in this nation, compared to other healthcare systems around the globe. This is what makes America’s healthcare system so expensive. And, lacking financial incentives for stakeholders to lower prices, these researchers suggest that continued high costs could negatively impact providers’ quality of care.
High Cost of Diagnostic Services, including Medical Laboratory Testing
The IHME/UCLA researchers published their findings in the Journal of the American Medical Association (JAMA), in which they argued that increases in US healthcare cost are independent of increases in:
- Disease prevalence;
- US population age;
- Use of healthcare services; or,
- Overall population size.
Joseph L. Dieleman, PhD, Assistant Professor at IHME and lead researcher on the investigation, stated, “After adjustments for price inflation, annual healthcare spending on inpatient, ambulatory, retail pharmaceutical, nursing facility, emergency department, and dental care increased by $933.5 billion between 1996 and 2013—from $1.2 trillion to $2.1 trillion.”
Data produced by the study identified one overlying factor in increased spending—increased prices. According to Dieleman, health spending in 2015 “reached $3.2 trillion and constituted 17.8% of the US economy.”
In an editorial response to Dieleman’s investigation, also published in JAMA, Patrick H. Conway, MD, MSc (above), President and CEO of Blue Cross Blue Shield of North Carolina in Durham, stated that “the United States is on an unsustainable growth path in terms of healthcare costs and must get costs under control.” He added that data from Dieleman’s study has important implications for quality of healthcare, which may include medical laboratory diagnostics. (Photo copyright: Duke University.)
Price Spirals and Artificial Price Hikes: No Real Incentive for Regulation
Pricing for medical care is notoriously opaque. Patients are often unaware of the cost of services until the bill arrives. This lack of transparency prevents patients from comparing prices between healthcare providers and medical laboratories.
To try and create some cost transparency for consumers, Conway noted that some states, such as Maryland and Vermont, have adopted multi-payer payment models or all-payer rate settings. However, there could be resistance to such reforms, according to some experts.
Health economist Austin Frakt, PhD; and Aaron E. Carroll, MD, MS, Vice Chair for Health Policy and Outcomes Research, and Director of the Center for Health Policy and Professionalism Research at Indiana University School of Medicine, co-authored a New York Times article that agrees with Conway’s assertion. In it, they state that attempts to create regulation for healthcare prices “would be met with resistance from all those who directly benefit from high prices, including physicians, hospitals, pharmaceutical companies—and pretty much every other provider of healthcare in the United States.”
No Incentive to Lower the Prices of Medical Services
An opinion piece in the Wall Street Journal, Keith Lemer, CEO, WellNet Healthcare Group, shared a similar view. He stating that insurers and preferred provider organizations (PPOs) have no “natural incentive to keep provider prices down.” Lemer looks at the Affordable Care Act and its establishment of a medical loss ratio rule, which “requires insurers covering individuals and small businesses to spend at least 80 cents of every premium dollar on medical expenses.”
Lemer uses the cost of a routine blood test as an example, stating that when providers raise costs of such tests, “insurers can charge higher premiums, while also boosting the value of their 20% share,” which goes “towards administrative costs and profits.”
Lemer argues that the deck is stacked against consumers, and that the medical loss ratio “encourages insurers to ignore providers” artificial price hikes,” while attracting customers “with the promise of steep discounts through their PPO plans.” The resulting affect is what Lemer calls a “price spiral” that’s difficult to escape.
Higher Costs Do Not Equate to Better Care
A special JAMA communication from Irene Papanicolas, PhD, and other members of the Department of Health Policy and Management, Harvard T. H. Chan School of Public Health, Harvard Global Health Institute, and Department of Health Policy at the London School of Economics and Political Science, reports that higher US costs do not coincide with better care.
In comparison to 10 other high-income countries the US spends “approximately twice as much,” Papanicolas noted. She added that despite the higher spending in the US, the nation “performs poorly in areas such as healthcare coverage and health outcomes.”
To illustrate the difference in average costs, Papanicolas and colleagues listed “comparison prices” on a series of healthcare services between countries in 2013. For example, the price of a single computed tomography (CT) scan varies widely:
- $896 (US);
- $97 (Canada);
- $279 (Netherlands); and,
- $500 (Australia).
The high prices of clinical laboratory (AKA, pathology laboratory in Australia) diagnostics have already caused a sharp decline in the use of important imaging utilization and are at risk of affecting other aspects of clinical pathology, such as anatomic pathology (histopathology in AU) services.
PricewaterhouseCoopers (PwC) Health Research Institute’s annual medical cost report predicts 2018 medical costs will rise by 6.5% and that “price continues to be a major driver of healthcare costs” that are outpacing the economy. PwC recommends “increasing collaboration across the industry” to address the growing issue of rising medical costs and shift the burden of cost away from patients.
Clinical Laboratories Contribute to High Costs
Although US healthcare cost is a topic of intense conversation, little change may come if there is no incentive to change. Each of the recent JAMA published articles ends on the same repeated note: a plea for active debate among policy makers, healthcare providers, patients, insurers, and politicians, with the goal of decreasing healthcare costs, without sacrificing patient care.
This is also true for clinical laboratory and anatomic pathology stakeholders, which are critical aspects of the healthcare continuum, and therefore, contribute to the overall financial burden on healthcare consumers.
— Amanda Warren
Related Information:
Why the US Spends So Much More Than Other Nations on Healthcare
Healthcare Spending in the United States and Other High-Income Countries
Factors Associated with Increases in US Healthcare Spending, 1996-2013
Factors Associated with Increased US Healthcare Spending: Implications for Controlling Healthcare Costs (Editorial Response)
The Best Healthcare System in the World: Which One Would You Pick?
The Deception Behind Those In-Network Health ‘Discounts’
Medical Cost Trend: Behind the Numbers 2018
Dec 15, 2017 | Instruments & Equipment, Laboratory Hiring & Human Resources, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
As the still-developing pathology profession in China struggles to meet demand, 3rd-party medical laboratory groups, and university/industry arrangements, find opportunities to fill the needs of China’s hospitals
China is currently facing a severe shortage of anatomic pathologists, which blocks patients’ access to quality care. The relatively small number of pathologists are often overworked, even as more patients want access to specialty care for illnesses. Some hospitals in China do not even have pathologists on staff. Thus, they rely on understaffed anatomic pathology departments at other facilities, or they use imaging only for diagnoses.
To serve a population of 1.4 billion people, China has only 29,000 hospitals with seven million beds. Among the healthcare providers, there just 20,000 licensed pathologists, according to the Chinese Pathologist Association. By contrast, recent statistics show that the United States has a population of 326 million people with approximately 18,000 actively practicing pathologists and 5,815 registered hospitals with 898,000 beds.
The largest pathology department in China is at Fudan University Shanghai Cancer Center (FUSCC), a hospital with 1,259 beds in operation and 50 pathologists on staff. News accounts say those pathologists are expected to process 40,000 cases this year, surpassing their 2016 workload by 5,000 cases. The FUSCC pathologists are supported by a small number of supplemental personnel, which include assistants, technicians, and visiting clinicians.
Qifeng Wang, a pathologist at FUSCC, indicated that most leading hospitals in China with average or above-average pathology staffing are experiencing similar barriers as FUSCC. Large hospitals, such as:
· Cancer Hospital at the Chinese Academy of Medical Sciences;
· Beijing Cancer Hospital;
· Peking Union Medical College Hospital;
· West China Hospital; and
· First Affiliated Hospital of Sun Yat-sen University also deal with similar staffing shortages and excessive workloads for their pathology departments.
“The diagnostic skill level at FUSCC is not that different from that in the U.S.,” Wang told Global HealthCare Insights (GHI). He added, however, that the competent skill level of their staffers is not sufficient to handle the internal workload at FUSCC plus the additional workload referred to them from other facilities.
Though not at the top of the list, as the graphic above illustrates, China is preceded only by Uganda, Sudan, and Malaysia for the number of patients per anatomic pathologist. China has approximately one pathologist per 74,000 people. By contrast, the United States has one pathologist for every 19,000 people. Studies indicate that, globally, the number of pathologists each year is shrinking. (Image copyright: Clinical Laboratory Products)
Patients Forced to Migrate to Receive Diagnoses
Because there are so few pathologists in the vast, heavily-populated country, many Chinese patients travel to major cities to increase their chances of obtaining reliable diagnosis and care, which further overwhelms the system.
The 1,530-bed Yunnan Cancer Hospital in the western city of Kunming handles more than 4,000 cases forwarded to them from other institutions annually. The 14 pathologists at the center also sometimes travel to rural communities to provide anatomic pathology services.
“It’s the complex cases that make it hard to keep up with our workload” said Yonglin Wang, an anatomic pathologist at the Yunnan Cancer Hospital, in the GHI article. The pathologists at Yunnan often refer their more demanding cases to larger hospitals to ensure the best analysis and outcomes for the patients.
Workload, Low Pay, and Lawsuits Discourage Pathology Enrollments
A logical solution to the critical shortage of pathologists in China would be to increase the number of people choosing the profession. However, medical students in the country tend to steer clear of surgical pathology due to the excessive workload, lower pay and status, and the threat of lawsuits relating to improper diagnoses.
To address the demand, a private pathology industry is emerging in China. There are currently more than 300 private medical laboratories located throughout the country. The largest of these businesses is KingMed Diagnostics in Guangzhou. According to their website, the 3rd-party medical laboratory group focuses on medical testing, clinical trials, food and hygiene testing, and scientific research. They examine more than 4,000 pathology cases annually, concentrating on:
· Immunohistochemistry;
· Specialized staining; and,
· Ultrastructural and molecular pathological diagnosis.
American Colleges Partnering with Chinese Laboratory Groups
Organizations from other countries, including the United States, also are entering the pathology industry in China.
In 2014, the UCLA Department of Pathology and Laboratory Medicine partnered with Chinese firm Centre Testing International Corporation (CTI) to operate a clinical laboratory in Shanghai. In the endeavor, pathologists from UCLA trained Chinese lab specialists on the proper interpretation of tests at the 25,000 square-foot facility. (See The Dark Report, “UCLA, Centre to Open Lab In China to Offer High Quality Testing,” May 19, 2014.)
“Because pathology has a history of being undervalued in China, the country has a shortage of pathologists trained to diagnose and interpret complex test results in specialized fields of medicine,” said Scott Binder, MD, Senior Vice Chair at UCLA Health in a statement. “Our partnership gives CTI and UCLA the opportunity to save lives by changing that.”
“Our collaboration will offer the people of China oncology, pathology, and laboratory medicine services they can trust. Many of these services are not largely available in China and are needed by physicians and healthcare providers to accurately diagnose and treat their patients,” stated Dr. Sangem Hsu, President of CTI in the UCLA statement.
As the need for pathologists increases worldwide, many countries will struggle to fulfill the demand. This may create even more opportunities for enterprising medical laboratory organizations and anatomic pathology groups who have the wherewithal and determination to make a difference overseas.
—JP Schlingman
Related Information:
China Grapples with a Pathologist Shortage
In China, More Irate Patients Violently Attack Doctors over Wrong Diagnoses and Poor Healthcare
UCLA Launches Joint Venture with Chinese Firm to Open Sophisticated Lab in Shanghai
The Pathologist Workforce in the United States
UCLA, Centre to Open Lab In China to Offer High Quality Testing
Digital Pathology Gives Rise to Computational Pathology
Pathologist Workforce in the United States: I. Development of a Predictive Model to Examine Factors Influencing Supply
Anatomic Pathology in China Is a Booming Growth Industry
Digital Pathology Enables UCLA-China Lab Connection
Lab Testing, Pathology is Fast-growing in China
Oct 9, 2017 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Mobile point-of-care (POC) smartphone-based nucleic acid assay allows for quick turn arounds and accurate information in any healthcare setting, including resource limited and remote environments
DNA detection might soon be accomplished with the use of a smartphone. That’s the goal of a research effort at the University of California Los Angeles (UCLA). If this effort succeeds, it would give medical laboratories a new tool to use in genetic testing.
Clinical laboratory equipment is becoming more effective even as it shrinks in size and cost. One such device has been developed by Ozcan Laboratory Group, headed by UCLA professor Aydogan Ozcan, PhD. It is a portable, smartphone-based mobile lab with sensitivity and reliability on par with large-scale medical laboratory-based equipment.
Ozcan Lab’s portable DNA detection system, according to a UCLA press release, “leverages the sensors and optics of cellphones” and adapts them to read and report the presence of DNA molecules. The sensor uses a new detector dye mixture and reportedly produces a signal that is 10 to 20 times brighter than previous detector dye outputs.
This new system improves upon the optical detection abilities of current point-of-care nucleic acid tests (POCTs) and, according to a study published in the American Chemical Society’s ACS Nano, the device is able to “retain the same robust standards of benchtop lab-based tests.”
Go Anywhere Technology Improves POC Testing
Nucleic acid detecting assays are crucial tools anatomic pathologists use to identify pathogens, detect residual disease markers, and identify treatable mutations of diseases. Due to the need for amplification of nucleic acids for detection with benchtop equipment, there are challenges associated with providing rapid diagnostics outside the clinical laboratory.
The device developed by Ozcan Labs (above) is a “field-portable and cost-effective mobile-phone-based nucleic acid amplification and readout platform [that] is broadly applicable to other real-time nucleic acid amplification tests by similarly modulating intercalating dye performance. It is compatible with any fluorescence-based assay that can be run in a 96-well microplate format, making it especially valuable for POC and resource-limited settings.” (Caption and photo copyright: American Chemical Society.)
In an article published in Future Medicine, Ozcan and Hatice Ceylan Koydemir, PhD, a post-doctoral researcher in electrical engineering at UCLA, comment on the growing interest in mobile POC diagnostics, stating that smartphone-based devices and platforms have the potential “to be used for early detection and prevention of a variety of health problems.”
According to the article, smartphone-based sensing and imaging platforms have been developed to:
- Analyze chemicals and biological specimens;
- Perform advanced cytometry and bright-field/fluorescence microscopy;
- Detect bacterial contamination;
- Image nano-sized specimens;
- Detect antimicrobial drug resistance; and
- Analyze enzyme-linked immunosorbent assay (ELISA)-based testing.
Smartphones, according to Ozcan and Koydemir, have been adapted to a range of biomedical measurement tools, “have the potential to transform traditional uses of imaging, sensing, and diagnostic systems, especially for point-of-care applications and field settings,” and can provide speedy results.
A ‘Highly Stable’ and Sensitive System
The proof-of-concept study of Ozcan Lab’s new smartphone-based detection system and new detector dye mixture was led by Janay E. Kong, PhD in bioengineering at UCLA, with the help of Ozcan and fellow professors Dino Di Carlo, PhD, professor of bioengineering and mechanical and aerospace engineering at UCLA, and Omai Garner, PhD, associate professor of clinical microbiology at the David Geffen School of Medicine at UCLA.
According to an article in Bioscience Technologies, the new smartphone DNA detection system addresses issues with detection of light emitted from intercalator dyes, which are normally “too subtle and unstable for regular cellphone camera sensors.” The new system uses loop-mediated isothermal amplification (LAMP) to amplify DNA in connection with a newly developed dye that uses hydroxynaphthol blue (HNB) as an indicator.
The inclusion of HNB into the dye, according to the original research study, “yields 20 times higher fluorescent signal change over background compared to current intercalating dyes,” making the results bright enough for smartphone camera sensors without “interfering with the nucleic acid amplification process.” The original study reports that the digital LAMP system and use of the HNB intercalating dye, in fact, provided “significantly enhanced performance compared to a benchtop reader with standard LAMP conditions.”
Ozcan labs shows no signs of slowing down their development of mobile POC diagnostic devices. The development of these smartphone-based tools may provide unique and much-needed equipment for clinical pathologists given the rising interest in mobile healthcare worldwide.
— Amanda Warren
Related Information:
UCLA Researchers Make DNA Detection Portable, Affordable Using Cellphones
Mobile Phones Create New Opportunities for Microbiology Research and Clinical Applications
Highly Stable and Sensitive Nucleic Acid Amplification and Cell-Phone-Based Readout
Cellphone System Makes DNA Detection Affordable and Portable
UCLA Device Enables Diagnosis of Antimicrobial Resistance in Any Setting; Could Save Lives Lost to Antimicrobial Resistant Bacteria
UCLA Researchers Develop Lens-Free Smartphone Microscope, Pathologists May Be Able to Take the Clinical Pathology Laboratory Just About Anywhere
Smartphone “Dongle” Achieves Capabilities of Big Clinical Laboratory Analyzers: Diagnoses Three Diseases at Once from Single Drop of Blood
New Fast, Inexpensive, Mobile Device Accurately Identifies Healthcare-Acquired Infections and Communicates Findings to Doctors’ Smartphones and Portable Computers
Pathologists and Researchers Predict Development Trajectory for Biomarker-based Molecular Diagnostics in Support of Translational Medicine
Tiny, Simple-to-Use Lensless Microscope Might Soon Find a Place in Pathology
Apr 14, 2017 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Pathology, Laboratory Testing
In studies, the automated microbial susceptibility testing device for smartphone performed with 98.2% accuracy, meeting FDA criteria
Imagine doing antimicrobial susceptibility testing outside a clinical laboratory. That’s the goal of researchers on the West Coast who are developing a smartphone-based diagnostic device with the capability of performing this type of point-of-care testing (POCT).
This new mobile POCT device is under development at the University of California-Los Angeles (UCLA). It promises to bring antimicrobial susceptibility testing—a routine procedure in the most medical laboratories—to remote, resource-limited areas of the world.
The device, which attaches directly to a smartphone, contains an automated diagnostic test reader that examines the body’s antimicrobial resistance, according to a UCLA news release. (more…)
