Instruments & Equipment Archives

UnitedHealth Group to Launch Electronic Health Records Platform in 2019; Will It Guide Physicians to Preferred Clinical Laboratory Providers?

Jan 11, 2019 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations

Leveraging the user base of its existing Rally mobile wellness platform, UnitedHealth Group plans to expand its new electronic health records system to 50 million benefited members and one million healthcare providers by the end of 2019

Before the end of 2019, UnitedHealth Group plans to introduce an electronic health records (EHR) system that it developed internally. It has a ready market for such a system because of its 50 million beneficiaries and one million providers. But this EHR may raise interesting questions for the clinical laboratory industry if it is designed to guide physicians to UnitedHealth’s preferred clinical laboratories when they use the EHR to order lab tests.

According to Healthcare Dive, UnitedHealth Group (NYSE:UNH) CEO David Wichmann announced plans to roll out a “fully individualized, fully portable” EHR platform in 2019 by leveraging Rally, their existing mobile wellness platform, during their third-quarter earnings call in October. With 20 million registered users already using Rally, this could encourage adoption and use of the new EHR among UnitedHealth Group’s 50 million fully benefited members.

UHC’s IHR Complements EHR Systems

Exact details of the platform’s capabilities are still unclear. However, additional information from a November 27 investors conference indicates that the new platform might function more like Apple’s approach to personal health records (PHRs) and less like a traditional EHR. (See Dark Daily, “Apple’s Update of Its Mobile Health App Consolidates Data from Multiple EHRs and Makes It Easier to Push Clinical Laboratory Data to Patients,” March 21, 2018.)

“UnitedHealth executives offered a few more details on Tuesday, leaving the impression that the new IHR [individual health record] would complement, not replace, existing EHRs,” noted FierceHealthcare in their coverage of the conference.

Coverage from Forbes indicates the UnitedHealth IHR will be available to both patients and healthcare providers, with UnitedHealth Group predicting usage by one million medical care providers by the end of 2019.

“A traditional electronic medical record focuses largely on streamlining internal business processes for facilities and medical groups,” Steve Nelson, CEO of UnitedHealthcare (UHC), explained during the conference. “But the IHR connects numerous EMRs, creating a unified and secure source of truth for both consumers and care providers, and unlocking the value of data that is currently trapped in today’s fragmented healthcare system. That means consumers have a much more complete, personal picture of their health needs.” [Photo copyright: UnitedHealth Group/Business Insider.)

Connecting Data from Multiple EHRs to Provide a Big Picture Look at Care

Forbes quotes Nelson as saying, “[The new IHR] also empowers care providers with connected, credible information at the point of care by enabling them to see a patient’s interactions with other clinicians.”

According to Healthcare Dive, Wichmann noted that the UNH health record platform would be “deeply personal” and suggest “best actions” gleaned from medical data. This would allow UnitedHealth to utilize the strong points of Optum—a UnitedHealth Group venture focused on providing health services and innovations—to leverage analytics capabilities aimed at both encouraging patients to take an active role in managing their health and finding the best providers in their area.

LabCorp, Quest Could Benefit from UnitedHealth’s IHR

FierceHealthcare also outlines other acquisitions made by UnitedHealth and Optum over the past 10 years that might play a role in the new system, including:

• Axolotl: a health information exchange provider bought in 2010;

• Picis: a health IT and analytics company bought in 2010;

• Humedica: a Boston-based analytics company bought in 2013; and,

• CentriHealth: developer of an individual health record system acquired in 2017.

In the medical laboratory market, this might also give LabCorp and Quest Diagnostics an inside track given their in-network status with UnitedHealth. However, the larger trend is that the new IHR stands to position UnitedHealth as the central point between patients, doctors, and the overall care experience.

“You might imagine what that could ultimately lead to in terms of continuing to develop a transaction flow between physicians and us and the consumer and us,” Wichmann told investors in their October earnings call, according to Healthcare Informatics. “And us being the custodian to try to drive better health outcomes for people, but also ensure that the highest level of quality is adhered to.”

According to Becker’s Hospital Review, the IHR system is already in testing at three accountable care organizations (ACOs) as of November 2018.

Helping Patients Manage Their Care

The information released in November supports a prediction referenced in Fierce Healthcare by Matt Guldin, a senior analyst at Chilmark Research, that UnitedHealth is focusing on an “Apple-type strategy” with their new platform. However, unlike Apple, UnitedHealth stands to directly benefit from providing a centralized hub of personal health information for consumers looking for ways to manage their care experience while keeping costs affordable in the face of rising premiums and deductibles.

Whether UnitedHealth’s new offering works to replace or supplement existing EHR platforms, their attempt to use data-driven technologies to both shape the healthcare process of benefited members and optimize costs by positioning the company as a middleman between patients and doctors highlights the importance of communicating value for medical laboratory services.

Having a major health insurer develop and launch an electronic health records system with some number of useful functions is one more example of the potential upheavals happening in healthcare today. It is the latest reminder that clinical laboratories and anatomic pathology groups must have a strategy to stay relevant in a medical marketplace that is being transformed by such technologies as the Internet-of-Things, big data, real-time analytics, and artificial intelligence (AI).

For almost 20 years, innovative clinical lab executives and pathologists have pointed out their respective laboratory organizations are information factories. Yet, as of 2019, only a handful of such medical labs have developed services that leverage their lab test data to convert it into actionable intelligence for physicians, patients, and payers—intelligence for which these labs can be paid. UnitedHealth’s plans for its EHR is the latest warning that it is timely for labs to develop informatics strategies that deliver value to the stakeholders they serve.

—Jon Stone

Related Information:

UnitedHealth to Launch ‘Fully Integrated’ EHR Next Year

EHR, PHR or Something In Between? UnitedHealth’s Tech Venture Prompts Skepticism and Intrigue

UnitedHealth to Roll Out Individual Health Record, Predicts What It Will Look like in 10 Years

UnitedHealth to Launch New EHR Service by End of 2019

UnitedHealth Grows Q3 Revenue, Eyes 2019 Expansion

UnitedHealth Plans to Roll Out a New EHR Offering for Consumers and Providers by the End of 2019

UnitedHealth to Debut EHR in 2019: 8 Things to Know

UnitedHealth Group Plans to Unveil Health Record for Members, Providers in 2019

UnitedHealth’s EHR to Serve 50M Members in 2019

UnitedHealth Rolls Out Beta Individual Health Record to 3 ACOs, Touts Promising Early Results

UnitedHealth’s Individual EMR Tested at 3 ACOs, CEO Says

UnitedHealth Group: 50M to Access New Personal Health Record in 2019

Apple’s Update of Its Mobile Health App Consolidates Data from Multiple EHRs and Makes It Easier to Push Clinical Laboratory Data to Patients

Health Insurers Spending Big Dollars to Be Players in ‘Big Data’; Trend Has Implications for Clinical Pathology Laboratories

FDA Clears AI Device for Diagnosis of Diabetic Retinopathy; Is this Favorable for Use of AI in Digital Pathology?

Jan 2, 2019 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology

FDA clearance of a cloud-based, AI system capable of diagnosing diabetic retinopathy using retinal images highlights the potential for deep learning and algorithmic analysis to assist and, in some cases, replace diagnosticians in medical tests

While clinical laboratories and anatomic pathologists have seen an increasing amount of research and concepts related to artificial intelligence (AI) for diagnostic purposes, few technologies have reached a point where they are ready for clinical applications.

However, the FDA’s recent clearance of the IDx-DR AI diagnostic system from IDx Technologies Inc. of Coralville, Iowa, through the De Novo premarket review pathway, illustrates how image-based AI systems might one day help clinicians, anatomic pathologists, and other care providers diagnose disease and guide therapy decisions.

Already in use at University of Iowa Hospitals and Clinics (UIHC), the device uses cloud computing and algorithms to “autonomously analyze images of the retina for signs of diabetic retinopathy,” according to the IDx website.

This allows IDx-DR to provide a screening decision roughly 20 seconds after image capture.

The IDx-DR system

The IDx-DR system (above) delivers a binary result. When signs of diabetic retinopathy are present, the system recommends a follow-up with an ophthalmologist. If it detects no signs of the condition, the system recommends a follow-up screening in one year. All of this happens without input from a clinician or the services of a medical laboratory. (Photo copyright: Modern Healthcare.)

In a clinical study involving 900 participants published in Nature, a similar AI system achieved 87.2% sensitivity and 90.7% specificity in the detection of diabetic retinopathy, exceeding pre-specified primary endpoint goals.

“AI tools can help physicians handle a lot more data a lot more quickly and help them prioritize,” Susan Etlinger, an industry analyst with the Altimeter Group, told Modern Healthcare. “Theoretically, that could give a family physician a lot more tools in [his/her] toolbox to be able to run an initial diagnostic on somebody and then refer that person for additional treatment.”

Full Integration Shows Promise for Streamlining AI and Diagnostics Workflows

The ability to reach a diagnosis without a clinician already holds potential to drastically impact the workflows and services of medical laboratories and other diagnosticians. However, IDx Technologies also showed how AI might influence data interfacing, while explaining to Modern Healthcare how they have integrated IDx-DR with the electronic health record (EHR) systems of UIHC.

“No one has ever integrated a diagnostic system where there’s no human involved,” noted Michael Abramoff, MD, PhD, Chief Executive Officer and founder of IDx. “We’re ramping up slowly because we want to make sure we work out all the kinks with the EHR and the workflow.”

Once the AI system analyzes images captured by a Topcon TRC-NW400 non-mydriatic retinal camera, results are then automatically communicated to an EHR using Health Level-7 (HL7) interfacing. The entire process is automated once the image is captured.

“The general advantages of AI include automation of certain tasks. This automation allows for increased scale, i.e. increased access, to a service. For systems like IDx-DR, it also allows talent to shift focus to other high priority areas.” Maia Hightower, MD, Chief Medical Information Officer and Chief Population Health Officer for University of Iowa Healthcare, told Digital Journal. “Healthcare is an industry where there is a critical shortage of key talent including medical assistants, nurses, and physicians. AI helps to detect both operational and clinical high-risk areas so that limited resources can be targeted to areas of highest need or greatest return.”

The process used by UIHC highlights potential benefits for medical laboratories as AI continues to impact diagnostic workflows and information processing. The ability to streamline workflows and offload repetitive tasks to automation or AI could allow skilled laboratory workers to further focus on diagnosing complex or difficult cases.

Ryan-Amelon-PhD-IDx

“Due to the highly robotic nature of the camera and the fully autonomous diagnosis, virtually anyone in a healthcare setting can be trained to operate IDx-DR,” Ryan Amelon, PhD, Director of Research and Development at IDx told Digital Journal. “The result is displayed to the user in under a minute or inserted directly into the EMR. The entire patient experience is roughly five minutes.” (Photo copyright: LinkedIn.)

Applying AI to More types of Medical Diagnoses

In an editorial published in NPJ Digital Medicine, Pearse Keane, MD, a clinician scientist at the National Institute for Health Research (NIHR) in the UK, and Eric J. Topol, MD, Director of the Scripps Translational Science Institute (STSI) and Executive Vice President at Scripps Research Institute, posted questions concerning the IDx-DR system and its FDA clearance.

According to Healthcare IT News, key concerns includes:

A relatively small sample size to determine diagnostic accuracy;
The ability of clinics to incorporate retinal screening into their practices; and,
The ability for IDx-DR to detect diabetic neuropathy when patients present other more severe retinal conditions.

Despite these concerns, Keane and Topol note, “While it is always easy to be critical of studies that forge new ground, it is important to applaud the authors for this pivotal work.”

For anatomic pathology laboratories, the IDx-DR system represents a proof of concept that AI and deep learning can analyze medical images—in this case, retinal photographs—and work alongside or in place of trained professionals to make decisions and guide the diagnosis process. How long before similar AI diagnostic systems find their way into clinical laboratories?

“Although deep learning will not be a panacea, it has huge potential in many clinical areas where high dimensional data is mapped to a simple classification and for which datasets are potentially stable over extended periods,” Keane and Topol concluded in their editorial. “As such, it will be incumbent on healthcare professionals to become more familiar with this and other AI technologies in the coming years to ensure that they are used appropriately.”

—Jon Stone

Related Information:

AI Alone Now Making the Diagnosis

Pivotal Trial of an Autonomous AI-Based Diagnostic System for Detection of Diabetic Retinopathy in Primary Care Offices

FDA Permits Marketing of Artificial Intelligence-Based Device to Detect Certain Diabetes-Related Eye Problems

With an Eye to AI and Autonomous Diagnosis

AI Diagnostic Tool Plows through FDA Clearance, But Some Experts Not Convinced

New AI System That Tests for Diabetic Eye Disease

University of Iowa Healthcare Rolls Out First Autonomous AI Diagnostic System Cleared by the FDA

FDA Greenlights Tool for Automated Detection of Diabetic Retinopathy in Primary Care

The FDA Just Opened the Door to Let AI Make Medical Decisions on Its Own

AI Can Deliver Specialty-Level Diagnosis in Primary Care Setting

U.S. FDA Approves AI Device to Detect Diabetic Eye Disease

Singapore University Researchers Unveil Portable $1 Point-of-Care Testing That Speedily Tests for Multiple Diseases

Dec 28, 2018 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations

Hand-held tests developed from the work of the NUS BIGHEART team could help caregivers in remote areas diagnose disease quickly, accurately, and inexpensively

There is great demand in Asia for diagnostic tests that are cheap, accurate, and have a fast time to answer. Especially in Asia’s remote and mobile clinics where caregivers need immediate access to clinical laboratory test results at the time of patients’ visits.

Researchers at the National University of Singapore (NUS) have unveiled just such a test that could eventually be performed at the point-of-care using smartphones for disease detection and analysis.

Dark Daily has reported many times on new clinical laboratory tests that use smartphones in past e-briefings. They are among the most significant developments to impact the pathology industry in our times.

According to the NUS researchers, their test can screen, detect, and analyze multiple diseases through a nucleic acid test platform. Best of all, the test costs less than $1, operates at room temperature, and takes about 30 minutes to an hour to uncover diseases.

NUS published the study in Nature Communications.

Researchers Aim to Simplify Complex Lab Testing

“Rapid, visual detection of pathogen nucleic acids has broad applications in infection management,” the researchers wrote in their study. They found that a screening device using molecular agents to detect disease-specific molecules has implications for a range of diseases: from Zika and Ebola to hepatitis, dengue, malaria, and cancers, according to a news release.

The NUS researchers dubbed their creation enVision (enzyme-assisted nanocomplexes for visual identification of nucleic acids).

2018-0918-enVision-graphic

The enVision microfluidic system (above) consists of a series of enzyme–DNA nanostructures to enable target recognition, target-independent signaling, and visual detection. The common cartridge houses the universal signaling nanostructures, which are immobilized on embedded membranes, for target-independent signaling and visual detection. The platform is designed to complement the modular enVision workflow. (Image and caption copyright: National University of Singapore.)

“Conventional technologies—such as tests that rely on polymerase chain reaction to amplify and detect specific DNA molecules—require bulky and expensive equipment, as well as trained personnel to operate these machines. With enVision, we are essentially bringing the clinical laboratory to the patient,” said Nicholas Ho, PhD, an NUS Biomedical Institute for Global Health Research and Technology (BIGHEART) Research Fellow and study co-first author, in the news release.

Shao-Lab-NUS-BIGHEART-enVision

NUS BIGHEART researchers include Assistant Professor Huilin Shao, PhD, at center holding the enVision cartridge, with Nicholas Ho, PhD, to the left and Lim Geok Soon, PhD, to the right. They tested the performance of enVision on human papillomavirus (HPV), a sexually transmitted infection and primary cause of cervical cancer. HPV has more than 100 subtypes of which 15 are malignant. The researchers studied samples from 35 NUS patients. (Photo copyright: National University of Singapore.)

“HPV is a global epidemic. While mostly benign, some of these infections can progress to cause deadly cervical cancer,” they wrote in Nature Communications. “Point-of-care testing that can distinguish the infection subtypes, and be performed at the patient level, could bring tremendous opportunities for patient stratification and accessible monitoring and is associated with better health outcomes.”

NUS researchers found that the enVision platform had a 95% accuracy rate in screening for HPV, as compared to conventional lab testing, according to Singapore’s Straits Times.

“While laboratory tests can detect one to two HPV strains, the kit is able to detect over 10 strains and has better coverage for each strain,” said Assistant Professor Huilin Shao, PhD, NUS BIGHEART, in the Straits Time article.

How Does it Work?

The test’s steps, according to an NUS News article, include:

The tiny plastic chip holds the sample (blood, urine, or saliva) for analysis, along with a DNA “molecular machine” to recognize genetic sequences;
This sample is channeled to a common signal cartridge containing another DNA molecular machine;
Visual signals are evidence of disease-specific molecules and an assay turns from colorless to brown if disease is present;
Further analysis, potentially using a smartphone app, could delve into the extent of an infection.

“The first machine is a recognition nanostructure which detects specific genetic sequences that relate to different kinds of diseases—the pathogens, bacteria, or viruses for example—and produces a signal,” Ho told NUS News. “It pairs up with what we call an amplifier nanostructure which takes that signal, amplifies it and turns it into a color read-out.”

The researchers note that more studies on other diseases are needed before marketing of the test kit, which they developed over 18 months. The NUS team also sees opportunities to enable better image capabilities and analysis algorithms through smartphone applications (apps).

“Large cohort studies on the detection of pathogen nucleic acids across a spectrum of diseases (e.g., other infections, cancers, inflammatory disorders) using various biological specimens (e.g., tissue, blood, urine) could be performed to validate the clinical utility of the enVision technology for diverse visual detection,” they concluded in Nature Communications.

As healthcare resources become limited and populations continue to grow, studies into portable, low-cost testing become more critical. Clinical laboratories performing tests in rural, outlying areas of the world will especially benefit from the work of researchers like the NUS BIGHEART team at University of Singapore.

—Donna Marie Pocius

Related Information:

New Test Kit Invented by NUS Researchers Enables Quick, Accurate, and Inexpensive Screening of Diseases

Cheap Portable Screening Kit for Multiple Diseases in the Works

Visual and Modular Detection of Pathogen Nucleic Acids with Enzyme-DNA Molecular Complexes

72 Cents Test Screens for Diseases in Less Than an Hour

enVisioning Future Disease Diagnostics

New Fast Inexpensive Mobile Device Accurately Identifies Healthcare-acquired Infections and Communicates Findings to Doctors’ Smartphones and Portable Computers

Multi-channel Smartphone Spectrometer Enables Clinical Laboratory Testing Quickly and Accurately in Remote Regions

Gates Foundation, Chan Zuckerberg Initiative Fund Open-Source Global Disease Tracker; May Be Useful Resource for Microbiology Laboratories

Dec 17, 2018 | Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Management & Operations

Cloud-based platform—IDseq—shows potential to track the causes and spread of infectious diseases worldwide using metagenomic data Here’s the latest example of how big data and related technologies can give physicians—as well as microbiologists and clinical pathologists—a new tool for understanding infectious disease and tracking outbreaks anywhere in the world. This project is being funded and organized by well-known Silicon Valley entrepreneurs. The project is known as IDseq. It was announced recently in a press release issued by Chan Zuckerberg Biohub (CZ Biohub), Chan Zuckerberg Initiative (CZI), and the Bill and Melinda Gates Foundation. IDseq is a platform designed to support global disease surveillance and prevention. It will make use of gene sequencing and analysis of metagenomic data. This data will be made accessible to the global medical community. The system leverages the power of cloud computing to streamline the process of transmitting and analyzing metagenomic data, as well as sharing results with other platform users. “That will be incredibly valuable. Information sharing is one of the most powerful public-health interventions in an outbreak,” Jennifer Gardy, PhD, an epidemiologist at the University of British Columbia, told The Atlantic. Designed by Engineers to Be Easily Used by Healthcare Providers and Medical Laboratory Technicians Coverage in The Atlantic notes that IDseq isn’t the first tool to offer similar features. Joseph DeRisi, PhD, a biochemist at the University of California San Francisco and co-president of CZ Biohub, states, however, that IDseq is one of the first designed by a large team of engineers, security experts, and other tech and medical researchers. Many tools see their origins in academic research and are less friendly to those without advanced academic expertise. The research team’s goal, according to DeRisi, is for IDseq “To enable people in under-resourced areas to do what we’ve been trying to do in San Francisco.”

“It’s easy for us to sit in our labs dreaming up tools and platforms,” Jennifer Gardy, PhD (above), an epidemiologist at the University of British Columbia, told The Atlantic. “But we need to make sure we’re designing them in a way that makes sense to the doctors, nurses, lab techs, and epidemiologists out there in an outbreak.” (Photo copyright: Michelle Thorpe/University of British Columbia.)

Two Trials Show Promise for IDseq Use While the software is already available for free as a collection of open source tools, the IDseq platform is now in a “soft launch” phase. The Bill and Melinda Gates Foundation is funding training for clinicians at CZ Biohub’s labs in San Francisco through its Grand Challenges Explorations Initiative. However, the platform has already achieved success in two noted scenarios—one at Dhaka Shishu Hospital in Dhaka, Bangladesh, and another in Tororo District Hospital in Uganda. Both used the system to analyze the samples of children admitted for fevers for which they found no known cause. In the Dhaka cases, Senjuti Saha, PhD, a microbiologist from Child Health Research Foundation, used the platform to trace unexplained cases of meningitis to an earlier chikungunya virus outbreak. Saha explained to The Atlantic that her colleagues previously thought chikungunya could not cause meningitis. The platform found otherwise, allowing her to analyze a further 478 samples and detect an additional 17 cases of potential chikungunya-related meningitis. In the Uganda cases, the researchers used metagenomic next-generation sequencing (mNGS) data and the IDseq platform to investigate unknown causes of fever in children. “As progress is made toward elimination of malaria in sub-Saharan Africa, it will be increasingly important to understand the landscape of pathogens that account for the remaining burden of morbidity and mortality,” researchers state in their study, currently in early access at bioRxiv. “The use of mNGS can contribute importantly to this understanding, offering unbiased identification of infecting pathogens.” Wide-Spread Use of IDseq Not Without Challenges While an article in Medium by Charles de Bourcy, PhD, Software Engineer at Chan Zuckerberg Initiative, outlines how the IDseq platform can process up to 480GB in approximately 10 minutes, it doesn’t account for the initial data input, which can be daunting. For areas with weak infrastructure and/or slow connection speeds, this could add significant delays as medical laboratories and healthcare workers at remote sites attempt to transfer data to the nearest IDseq-enabled location. Saha told The Atlantic, “If the transfer is too slow or the data too large, we just [ship] hard drives.” Sequencing requirements create additional concerns. Bulky equipment and the skills required to run sequencers could limit the ability to use the IDseq platform to analyze and share results. Clinicians might also face difficulties in sourcing sequencing reagents due to customs and supply chain concerns. Finally, the platform still requires an expert to interpret findings. “IDseq is an excellent tool, but it needs to be paired with people who have substantive knowledge to guide its use,” Saha told The Atlantic. Regardless of these issues, Saha believes IDseq can help remote/resource-challenged medical labs chase diseases. “It doesn’t solve all the problems, but it means that groups like ours don’t have to spend time to build up [sequencing] capacity. And anything is better than nothing.” IDseq might offer an excellent opportunity for microbiology laboratories, clinical laboratories, and medical researchers around the world to share data surrounding outbreaks, track disease on global and community level, and better determine the strains and probable sources of infectious diseases.

—Jon Stone

Why It’s Time for All Clinical Laboratories and Anatomic Pathology Groups to have a Genetic Testing and Gene Sequencing Strategy

Dec 3, 2018 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory Pathology, Laboratory Testing, Management & Operations

As personalized medicine becomes more popular, clinical laboratories, and anatomic pathologists are uniquely positioned to use next-generation sequencing to advance their scope among regulators, insurers, providers and patients, while adding clinical value and generating a new revenue source

By now, most clinical pathologists and medical laboratory scientists recognize that genetics, genetic testing, and gene sequencing will be a major transformative force in this country’s healthcare system. Genetics is the future of modern medicine.

At the same time, most independent labs and health network labs still lack the key resources needed for them to provide accurate and state-of-the-art genetic testing and gene sequencing services in support of clinical care.

The good news is that it is not yet prime time for genetic testing—meaning few genetic tests have become part of routine care, particularly in primary care settings. Today’s limited use of genetic tests creates the opportunity for any medical laboratory and anatomic pathology group to use this time to develop its genetic testing strategy. It also has time to incrementally put in place the resources it will need to offer genetic testing and gene sequencing services to its client physicians.

“Every clinical lab that wants to be a provider of genetic tests needs three basic resources,” stated Robert L. Michel, Editor-in-Chief of The Dark Report and Dark Daily. “First, the lab must have information technology in place that can handle genetic and molecular data. The second thing needed are pathologists, PhDs, and clinical laboratory scientists trained in genetic and molecular diagnostics. Of course, the third resource is to have the lab analyzers, instruments, and automation needed to extract, amplify, and sequence specimens.”

Experts agree that adoption of genetic testing will happen at a rapid pace. “Next-generation sequencing (NGS) is an incredibly powerful, positive force in medical care. We were in the Dark Ages before this. It is the tsunami on our shores, and it’s going to take over all of medicine. It’s not a trend. It’s the future of medicine. There’s no question about it,” predicts Maurie Markman, MD, an oncologist and President of Medicine and Science at Cancer Treatment Centers of America, in an article he penned for Health Connect South.

“As knowledge of genomic medicine has increased, its cost has plummeted,” notes Maurie Markman, MD (above), President of the Cancer Treatment Centers of America, in his Health Connect South article. “Sequencing a human genome [in 2015] costs less than $10,000, compared to more than $100 million in 2001. Not only are the tests more available to patients, but more oncologists are trying their hand at tumor testing and building on the base of knowledge.” (Photo copyright: Cancer Treatment Centers of America.)

“If you agree with Markman’s comments, then your medical lab should have a plan for how it will incorporate NGS technologies and genetic testing into its menu of lab tests,” observed Michel. “Because NGS is the engine powering much of this new genetic information and igniting the potential of personalized medicine, probably the single most important business step clinical labs and pathology groups can take at this point is to begin to create the informatics capabilities needed to support genetic testing.

“This can be done by either adding the needed functions to the existing laboratory information system (LIS) or supplementing that LIS with appropriate middleware solutions,” he continued. “This is true even if a lab plans to outsource both the gene sequencing and the annotation and interpretation of the resulting gene sequences. It will need in-house informatics capabilities to store and report that genetic information.”

NGS, Gene Sequencing, Precision Medicine, and Clinical Laboratories

Purchasing, implementing, and operating NGS technologies can be a costly venture, so it is critical that labs know and understand the needs of their referring clients.

“Knowing who your lab’s customers are and what you do for them today should guide you as a laboratory,” notes Brian Keefe, Vice President of Sales and Customer Innovation at Psyche Systems, a laboratory solutions developer for the medical industry based in Boston. “For example, your pathology group knows it should be offering NGS testing, and the justification for needing to go in this direction is because 90% of your clients are oncologists.”

Using NGS technology and marketing it to clients will be a valuable benefit for clinical laboratories. It will enable labs to participate in personalized medicine and allow them to become the “go to” facility for specific genetic tests.

“If you’re a laboratory that has figured out how to map the genome for nightmare bacteria, it doesn’t matter whether you’re three miles or 3,000 miles away, physicians will send their samples to your lab regardless of the distance,” Keefe notes. “If your lab is first to market, you establish powerful brand recognition and attract positive attention, which justifies your lab’s cost to set up and offer that testing in the first place.”

Learn More by Requesting the Dark Daily NGS White Paper

To help medical laboratories and anatomic pathology groups learn more about the growing role of NGS in clinical care, and how NGS can benefit clinical and molecular laboratories, Dark Daily and The Dark Report have produced a white paper titled, “How Next-Generation Sequencing Helps Molecular Laboratories Deliver Personalized Medicine Services to their Client Physicians.”

Medical laboratory leaders who want to learn how labs can establish NGS services and implement the IT/Informatics needed to be successful in using NGS should request a copy of this important white paper. It reviews how pathologists can help providers select targeted therapies and touches on marketing strategies to use NGS to procure new customers and retain existing customers.

The NGS white paper can be downloaded at no cost by clicking here or placing https://www.darkdaily.com/how-next-generation-sequencing-helps-molecular-laboratories-deliver-personalized-medicine-services-to-their-client-physicians-601/ into your browser.

—JP Schlingman

Related Information:

How Next-Generation Sequencing Helps Molecular Laboratories Deliver Personalized Medicine Services to their Client Physicians

Genomic Medicine: The Future of Cancer Treatment Is Now

Clinical Pathology Labs Are on Track to Get New Genetic Test That Screens for 448 Rare Childhood Diseases

Is Whole-genome Sequencing Reaching a Tipping Point for Clinical Pathology Laboratories?

Innovations in Microsampling Blood Technology Mean More Patients Can Have Blood Tests at Home, and Clinical Laboratories May Advance Toward Precision Medicine Goals

Nov 28, 2018 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing

Clinical laboratory leaders aiming for patient-centered care and precision medicine outcomes need to acknowledge that patients do not want to be in hospitals or travel to physician offices and patient care centers for blood tests. It can be inconvenient, sometimes costly, and often painful.

That’s why disease management methods such as remote patient monitoring are appealing to many people. It’s a big market estimated to reach $1 billion by 2020, according to a Transparency Market Research Report. The study also associated popularity of devices such as heart rate and respiratory rate monitors with economic pressures of unnecessary hospital readmissions.

But can remote patient monitoring be used for more than to check heart rates, monitor blood glucose, and track activity levels? Could such technology be effectively leveraged by medical laboratories for remote blood sampling?

Microsampling versus Dried Blood Collecting

Remote patient monitoring must be able to address a large number of diseases and chronic health conditions for it to continue to expand and gain acceptance as a viable way to care for patients in different settings outside of hospitals. However, as most clinical pathologists and laboratory scientists know, clinical laboratory testing has an essential role in patient monitoring. Thus, there is the need for a way to collect blood and other relevant samples from patients in these remote settings.

One promising approach is the development of new microsampling technology that can overcome past obstacles of dried blood collection. Furthermore, microsampling-enabled devices can make it possible for medical laboratories to reach out to the homebound to secure accurate and volumetrically appropriate samples in a cost-effective manner.

“One well-established fact in today’s healthcare system is that an ever-greater proportion of patients want clinical care that is less invasive and less intrusive,” noted Robert Michel, Editor-in-Chief of Dark Daily and The Dark Report. “Patients want to take more control over their treatment and be more effective at maintaining the stability of their chronic conditions, and often are happier than those who need to travel to have chronic conditions monitored. To meet this need there has been significant innovation, particularly in the area of remote blood sampling using microsampling technology.”

For decades, medical laboratories have tried various methods for acquiring and transporting blood samples from remote locations. One such non-invasive alternative to venipuncture is called dried blood spot (DBS) collecting. It involves placing a fingerprick of blood on filter paper and allowing it to dry prior to transport to the lab.

But DBS collected bio samples often do not contain enough hematocrit (volume percentage of red blood cells) for laboratories and clinical pathologists to provide accurate reports and interpretations. Reported reasons DBS cards have not penetrated a wide market include:

Hematocrit bias or effect;
Costly card punching and automation equipment; and,
Possible disruption to existing lab workflows.

Microsampling Technology Enables Collection of Appropriate Samples

Microsampling has to have the capability to enable labs to deliver quality results from reliable blood samples. This remote sampling technology makes it possible for phlebotomists to offer a comfortable collection alternative for homebound patients and rural residents. It also can be useful for physicians stationed in remote areas. Patients themselves can even collect their own blood samples.

Volumetric Absorptive Microsampling (VAMS) technology enables accurate samples of blood or other fluids from amounts as small as 10, 20, or 30 microliters, according to Neoteryx, LLC, of Torrance, Calif., the developer of VAMS. The technology is integrated into the company’s Mitra microsampler blood collection devices (shown above) in formats for patient use and for medical laboratory microsample accessioning and extraction. Click here to watch a video on the Mitra Microsampler Specimen Collection Device. (Photo copyright: Neoteryx.)

One company developing these types of products is Neoteryx, LLC, of Torrance, Calif. It develops, manufactures, and distributes microsampling products. Patients with the company’s Mitra device use a lancet to puncture their skin and draw a small amount of blood, collect it on the device’s absorptive tip, and then mail the samples to a blood lab for testing (Neoteryx does not perform testing).

“Technologies such VAMS are driving [precision medicine] in an extremely cost-effective manner, while only requiring minimal patient effort. Patients are taking a more active role in their healthcare journeys, and at-home sampling is supporting this shift,” stated Fasha Mahjoor, Chief Executive Officer, Neoteryx, in a blog post. (Photo copyright: Neoteryx.)

Advantages of Microsampling

Patient satisfaction survey data collected by Neoteryx suggest patients are comfortable with their role in blood collection:

70% are comfortable or very comfortable with the process;
86% say it is easy or very easy to use the Mitra device;
92% report it is easy to capture blood on the device’s tip;
55% of Mitra device users are likely or very likely to choose microsampling over traditional venipuncture; and,
93% noted they are likely or very likely to choose the device for child care.

A list of published studies describes certain advantages of VAMS technology that have implications for medical laboratories and clinical pathologists:

Microsampling has benefits and implications for therapeutic drug monitoring, infectious disease research, and remote specimen collection;
Dried blood microsamples from fingerstick can generate reliable data “correlating” to traditional blood collection processes;
Bioanalytical data collected with the Mitra device are accurate and dependable; and,
In a study for a panel of anti-epileptic drugs, VAMS led to optimized extraction efficiency above 86%, which means there was no hematocrit bias.

Learn More by Requesting the Dark Daily Microsampling White Paper

To help medical laboratories and clinical pathologists learn more about microsampling and VAMS devices, Dark Daily and The Dark Report have produced a white paper titled “How to Create a Patient-Centered Lab with Breakthrough Blood Collection Technology: Microsampling Takes Blood Collection Out of the Clinic.” The paper includes sections addressing these topics:

Rise of patient-centered care and remote patient monitoring;
Dried blood collection over the years and the hematocrit effect;
A look at microsampling and how it takes blood collection out of the clinic;
How Volumetric Absorptive Microsampling (VAMS) technology works;
Patient satisfaction data;
Research about microsampling including extensive graphics;
Launching new VAMS technology; and,
Frequently asked questions.

Innovative medical laboratory leaders who want to increase their understanding of how microsampling technology and remote patient monitoring relates to the goal of becoming a patient-centered lab are encouraged to request a copy of the white paper. It can be downloaded at no cost by clicking here, or placing https://www.darkdaily.com/how-to-create-a-patient-centered-lab-with-breakthrough-blood-collection-technology-9-2018/ into your browser.

—Donna Marie Pocius

Related Information:

Remote Patient Monitoring Devices Market

Neoteryx, LLC, and Cedars Sinai Partner to Investigate at Home Blood Sampling Possibilities for Patients with Inflammatory Bowel Disease

Creating a Patient-Centered Lab with Breakthrough Blood Collection Technology Using New Microsampling Methods Provides Reliable, Economic Collection, Shipping and Storage Solutions

How to Create a Patient-Centered Lab with Breakthrough Blood Collection Technology: Microscopy Takes Blood Collection Out of the Clinic

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