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AXIM Biotechnologies Develops Diagnostic Test for Parkinson’s Disease That Uses Tear Drop Specimens and Returns Results in Less than 10 Minutes at the Point of Care

New non-invasive test could replace traditional painful spinal taps and clinical laboratory fluid analysis for diagnosis of Parkinson’s disease

Scientists at AXIM Biotechnologies of San Diego have added another specimen that can be collected non-invasively for rapid, point-of-care clinical laboratory testing. This time it is tears, and the diagnostic test is for Parkinson’s disease (PD).

The new assay measures abnormal alpha-synuclein (a-synuclein), a protein that is a biomarker for Parkinson’s, according to an AXIM news release which also said the test is the first rapid test for PD.

“The revolutionary nature of AXIM’s new test is that it is non-invasive, inexpensive, and it can be performed at a point of care. It does not require a lumbar puncture, freezing, or sending samples to a lab. AXIM’s assay uses a tiny tear drop versus a spinal tap to collect the fluid sample and the test can be run at a doctor’s office with quantitative results delivered from a reader in less than 10 minutes,” the news release notes.

A recent study conducted by the Michael J. Fox Foundation for Parkinson’s Research published in The Lancet Neurology titled, “Assessment of Heterogeneity among Participants in the Parkinson’s Progression Markers Initiative Cohort Using Α-Synuclein Seed Amplification: A Cross-Sectional Study,” found that “the presence of abnormal alpha-synuclein was detected in an astonishing 93% of people with Parkinson’s who participated in the study,” the news release noted.

“Furthermore, emerging evidence shows that a-synuclein assays have the potential to differentiate people with PD from healthy controls, enabling the potential for early identification of at-risk groups,” the news release continues. “These findings suggest a crucial role for a-synuclein in therapeutic development, both in identifying pathologically defined subgroups of people with Parkinson’s disease and establishing biomarker-defined at-risk cohorts.”

This is just the latest example of a disease biomarker that can be collected noninvasively. Other such biomarkers Dark Daily has covered include:

“With this new assay, AXIM has immediately become a stakeholder in the Parkinson’s disease community, and through this breakthrough, we are making possible new paradigms for better clinical care, including earlier screening and diagnosis, targeted treatments, and faster, cheaper drug development,” said John Huemoeller, CEO, AXIM (above), in a news release. Patients benefit from non-invasive clinical laboratory testing. (Photo copyright: AXIM Biotechnologies.)

Fast POC Test versus Schirmer Strip

AXIM said it moved forward with its novel a-synuclein test propelled by earlier tear-related research that found “a-synuclein in its aggregated form can be detected in tears,” Inside Precision Medicine reported.

But that research used what AXIM called the “outdated” Schirmer Strip method to collect tears. The technique involves freezing tear samples at -80 degrees Celsius (-112 Fahrenheit), then sending them to a clinical laboratory for centrifugation for 30 minutes; quantifying tear protein content with a bicinchoninic acid assay, and detecting a-synuclein using a plate reader, AXIM explained.

Alternatively, AXIM says its new test may be performed in doctors’ offices and offers “quantitative results delivered from a reader in less than 10 minutes.”

“Our proven expertise in developing tear-based diagnostic tests has led to the development of this test in record speed, and I’m extremely proud of our scientific team for their ability to expand our science to focus on such an important focus area as Parkinson’s,” said John Huemoeller, CEO, AXIM in the news release.

“This is just the beginning for AXIM in this arena,” he added. “But I am convinced when pharmaceutical companies, foundations, and neurologists see how our solution can better help diagnose Parkinson’s disease in such an expedited and affordable way, we will be at the forefront of PD research, enabling both researchers and clinicians a brand-new tool in the fight against PD.”

AXIM acquired Advanced Tear Diagnostics, Birmingham, Ala., in 2021. As part of this acquisition, it obtained two US Food and Drug Administration-cleared tests for dry eye syndrome, Fierce Biotech reported.

One of those tests was “a lateral flow diagnostic for point-of-care use that measures the level of lactoferrin proteins in tear fluid, which work to protect the surface of the eye. … Axim said that low lactoferrin levels have also been linked to Parkinson’s disease and that the assay can be used alongside its alpha-synuclein test,” Fierce Biotech noted.

Why Tears for PD Test?

Mark Lew, MD, Professor of Clinical Neurology, University of Southern California Keck School of Medicine, published earlier studies about using tear samples as biomarkers for Parkinson’s disease.

“It made sense to try and look at the proteinaceous [consisting of or containing protein] constituents of tear fluid,” Lew told Neurology Live. “Tear fluid is easy to collect. It’s noninvasive, inexpensive. It’s not like when you do a lumbar puncture, which is a much more involved ordeal. There’s risk of contamination with blood (saliva is dirty) issues with blood and collection. [Tear fluid analysis] is much safer and less expensive to do.”

In Biomarkers in Medicine, Lew et al noted why tears make good biomarkers for Parkinson’s disease, including “the interconnections between the ocular [eye] surface system and neurons affected in Parkinson’s disease.”

The researchers also highlighted “recent data on the identification of tear biomarkers including oligomeric α-synuclein, associated with neuronal degeneration in PD, in tears of PD patients” and discussed “possible sources for its release into tears.”

Future Clinical Laboratory Testing for Parkinson’s

Parkinson’s disease is the second most common neurodegenerative disorder after Alzheimer’s. It affects nearly one million people in the US. About 1.2 million people may have it by 2030, according to the Parkinson’s Foundation.

Thus, an accurate, inexpensive, non-invasive diagnostic test that can be performed at the point of care, and which returns clinical laboratory test results in less than 10 minutes, will be a boon to physicians who treat PD patients worldwide.

Clinical laboratory managers and pathologists may want to follow AXIM’s future research to see when the diagnostic test may become available for clinical use.

—Donna Marie Pocius

Related Information:

Parkinson’s Disease Biomarker Found

AXIM Biotechnologies Develops First Non-Invasive, Rapid, Point-of-Care, Diagnostic Test for Parkinson’s Disease

Assessment of Heterogeneity Among Participants in the Parkinson’s Progression Markers Initiative Cohort Using A-Synuclein Seed Amplification: a Cross-sectional Study

Tear Drop Test is First Rapid, Point-of-Care Diagnostic for Parkinson’s Disease

New Test Aims to Spot Signs of Parkinson’s Disease within a Tear Drop

Motivations for Using Tears to Confirm Parkinson’s Disease Diagnosis

Tears—More to Them than Meets the Eye: Why Tears are a Good Source of Biomarkers in Parkinson’s Disease

Nutromics Receives $14M for Development of Lab-on-a-Patch DNA Sensor Platform That Transmits Biometric Data in Real Time from Interstitial Fluid

Similar health monitoring devices have been popular with chronic disease patients and physicians who treat them; this technology may give clinical laboratories a new diagnostic tool

There is an ever-increasing number of companies working to develop lab testing technologies that would be used outside of the traditional clinical laboratory. One such example is Nutromics, an Australia-based medical technology company which recently announced it has raised US $14 million to fund its new lab-on-a-patch platform, according to a company press release.

Nutromics’ lab-on-a-patch device “uses DNA sensor technology to track multiple targets in the human body, including disease biomarkers and hard-to-dose drugs,” according to MobiHealthNews. Notably, Nutromics’ technology uses interstitial fluid as the sample source.

The funding, which is earmarked for clinical trials, research, and continued development of the technology, comes from health technology company Dexcom (through the Dexcom Ventures capital fund), VU Venture Partners, and global investment management firm Artesian Investments.

Nutromics raised $4 million last year to support a manufacturing facility and an initial human clinical trial of its “continuous molecular monitoring (CMM) platform technology that is able to track multiple targets in the human body via a single wearable sensor. The platform provides real-time, continuous molecular-level insights for remote patient monitoring and hospital-at-home systems,” MobiHealthNews reported.

Peter Vranes

“We are aiming to cause a paradigm shift in diagnostic healthcare by essentially developing a lab-on-a-patch. A lack of timely and continuous diagnostic insights can strongly impact outcomes when dealing with critical disease states. With this strategic industry and VC (venture capital) investment in us, we see more confidence in our technology and hope to accelerate our growth,” said entrepreneur and chemical engineer Peter Vranes (above), co-founder and CEO of Nutromics, in a press release. Clinical laboratory leaders have watched similar biometric monitoring devices come to fruition. (Photo copyright: Nutromics.)

.

How Nutromics’ Lab-on-a-Patch Works

“Our technology is, in fact, two technologies coming together—a marker and needle. What that does is give us access to fluid under your skin called interstitial fluid. If you’re going to measure something continuously, that’s a really good fluid [to measure],” Vranes told Outcomes Rocket.

Vranes calls the system’s aptamer-based sensor platform technology the “jewel in the crown.” An aptamer is a short sequence of artificial DNA or RNA that binds a specific target molecule. Nutromics’ aptamer sensor, Vranes said, enables targeting of analytes, unlike continuous glucose monitors (CGMs). 

“[CGMs] are limited to metabolites—things that are already in the body like glucose and lactate. We’re not limited to those. We can do a whole range of different targets. And what that gives us is a ‘blue ocean’ opportunity to go in and solve problems in areas that other technologies just can’t solve,” Vranes said.

Nutromics plans to develop multiple aptamer-based sensors that measure a variety of analytes in interstitial fluid, Medtech Insight noted.

Nutromics' wearable DNA sensor lab-on-a-patch

Nutromics’ wearable DNA sensor lab-on-a-patch technology (above) enables monitoring of multiple targets, including disease biomarkers and some medications, MobiHealthNews explained. The wearable patch contains microneedles that painlessly access interstitial fluid under the skin. Collected data is wirelessly transmitted to a software application and integrates with consumer health software and provider platforms, according to Nutromics. Medical laboratories could have a role in collecting this data and adding it other test results from patients using the wearable patch. (Photo copyright: Nutromics.)

Initial Launch Will Include Antibiotic Monitoring

Nutromics expects to initially launch therapeutic monitoring of vancomycin, a glycopeptide antibiotic medication used to treat various bacterial infections. The company says 60% of doses for this prescription antibiotic are not within therapeutic range.

The smart patch enables clinicians to give patients medicine “at the right dose and at the right time,” Sophie Stocker, PhD, a senior hospital scientist at St. Vincent’s Hospital Sydney and Senior Lecturer, University of Sydney School of Pharmacy in New South Wales, Australia, told MobiHealthNews.

Nutromics also envisions opportunity in acute kidney injury (AKI).

Other Research Using Microneedle Patch to Sample Interstitial Fluid

Nutromics is not alone in its use of a microneedle patch to access interstitial fluid (ISF) for diagnostics. In “Researchers at Washington University in St. Louis Use Microneedle Patch with Fluorescent Nanolabels to Detect Biomarkers in Skin’s Interstitial Fluid,” Dark Daily reported how engineers at the McKelvey School of Engineering at Washington University in St. Louis in Missouri have developed a disposable microneedle patch that one day could be a painless alternative to some blood draws for diagnostics tests and health monitoring.

Scientists at the Georgia Institute of Technology and Emory University in Atlanta have been studying interstitial fluid as a source of biomarkers, as compared to blood, for years.

“Interstitial fluid originates in the blood and then leaks out of capillaries to bring nutrients to cells in the body’s tissues. Because interstitial fluid is in direct communication with the cells, it should have information about the tissues themselves beyond what can be measured from testing the blood,” said Mark Prausnitz, PhD, Regents Professor and J. Erskine Love Jr. Chair, Georgia Tech School of Chemical and Biomolecular Engineering, in a 2020 news release announcing results of human trials of microneedle-based ISF sampling.

The scientists published their findings in the journal Science Translational Medicine titled, “Sampling Interstitial Fluid from Human Skin Using a Microneedle Patch.”

“We sampled interstitial fluid from 21 human participants and identified clinically relevant and sometimes distinct biomarkers in interstitial fluid when compared to companion plasma samples based on mass spectrometry analysis,” the scientists wrote.

Clinical laboratory leaders and pathologists will find it useful to monitor the development of diagnostics for use outside the lab. Nutromics is an example of a company developing wearable health technology that painlessly gathers data for lab tests to be conducted in point-of-care and near-patient settings.     

—Donna Marie Pocius

Related Information:

Nutromics Raises US$14 Million For Its Ground-breaking Wearable Diagnostic Platform

Lab-on-a-Patch Maker Nutromics Scores $14M From Dexcom Ventures, Others

Peter Vranes, Co-founder of Nutromics, Nutromics Smart Patch—The Next Evolution of the Continuous Glucose Monitor

Nutromics Raises $14m as Dexcom Signals Move into Wider Sensing Capabilities

Australian Medtech Start-up Nutromics Bags $4M in Pre-Market Funding for Continuous Monitoring Device

Extraction of Largely Unexplored Bodily Fluid Could be a New Source of Biomarkers

Sampling Interstitial Fluid from Human Skin Using a Microneedle Patch

Researchers at Washington University in St. Louis Use Microneedle Patch with Fluorescent Nanolabels to Detect Biomarkers in Skin’s Interstitial Fluid

Real-time In Vitro Diagnostic Results at the Point of Care? Possible? One San Diego-based IVD Developer Says “Yes!”

Genalyte’s cloud-based Maverick Detection System could potentially change how and when doctors order blood draws, altering long-standing clinical laboratory workflows

Anatomic pathologists and medical laboratory leaders may be aware of efforts in the in vitro diagnostics (IVD) industry to perform clinical laboratory tests with smaller quantities of blood. The most high-profile company to try and fail is Theranos, which both Dark Daily and its sister print publication The Dark Report reported on as events unfolded.

So far, though, continued efforts to dramatically reduce the amount of blood needed for most typical medical laboratory tests have come up dry. But this has not stopped innovative companies from trying to do so.

One such company is San Diego-based Genalyte. The biomedical diagnostics developer has announced it is readying its new Maverick Detection System (Maverick), which, according to the company’s website, “completes a comprehensive battery of blood tests in the physician’s office with results in 15 minutes.”

According to a news release, “Genalyte is laying the groundwork to move the business of biomedical diagnostics online, with the idea of creating an integrated delivery service for test results that can be generated from a drop of blood.” If successful, Maverick may be poised to disrupt the phlebotomy and clinical laboratory industries in a big way.

Fifteen Minutes from Fingerprick to Clinical Lab Test Results

Maverick, according to its developers, “[will] send digital samples to the cloud for quality review before releasing to the physician and patient. Our central lab handles tests that cannot be completed onsite.

“At the core of our cloud-based, diagnostic laboratory offering is revolutionary technology that uses silicon photonic biosensors to perform multiple tests off a single drop of whole blood in 15 minutes,” notes Genalyte’s website.

In a MedCity News article, Cary Gunn, Genalyte’s founder and CEO, said, “There will always be a need for esoteric testing that needs to be referred to a laboratory. But for the vast majority of routine testing, there’s no reason why that can’t be done in the doctor’s office.”

How Maverick Completes Medical Laboratory Tests in Doctor’s Offices

According to Genalyte’s website, “The Maverick Detection System performs real-time detection of macromolecules in crude samples using biologically functionalized silicon photonic biosensors lithographically printed on disposable silicon chips.”

About the width of a pencil erasure, Maverick biosensor chips “are individually functionalized with unique probe molecules and are individually interrogated, making highly multiplexed analysis possible. As a sample flows over the chip, the probes on the sensors bind with their corresponding ligands. This binding results in a localized change in refractive index on the sensor surface; this change is directly proportional to analyte concentration.”

“The silicon chip itself is watching the chemical reactions take place. Anytime two molecules bind, we can see that happen. So, the technology is capable of almost an infinite number of tests,” Gunn explained in the MedCity News article.

According to the developer, test results are available “in 10-30 minutes depending on the type of assay performed.”

Cary Gunn PhD

Cary Gunn, PhD, Genalyte’s Founder and Chief Executive Officer, said in a news release that the San Diego-based biomedical diagnostics company wants “to put a rapid and powerful suite of diagnostic tests in every physician’s office.” (Photo copyright: Genalyte.)

Pilot Studies Show Test Feasibility in Doctor’s Offices

The company also announced completion of two pilot studies of the platform’s effectiveness in performing anti-nuclear antibody (ANA) testing. The purpose of study “one” was to “evaluate the feasibility of using this novel instrument to perform ANA 8 tests in the clinic and to compare those results to the same sample tested in Genalyte’s CLIA registered laboratory.” Study “two” focused on “Detection of anti-nuclear antibodies for the diagnosis of connective tissue diseases (CTD).”

The ANA test is often ordered by physicians for diagnosis of CTDs, including:

• Rheumatoid arthritis;

Systemic lupus erythematosus;

•  Raynaud syndrome; and,

Systemic scleroderma, according to an article in Rheumatoid Arthritis News.

“We are starting with rheumatology, but I call that our entry point,” Gunn told MedCity News. “Our goal is to decentralize the vast majority of diagnostic testing to be near the patient and near the physician.”

The two studies together involved about 750 patients, who were tested by Genaltye’s Maverick system over four months. Results of their blood tests, via fingerprick in the doctor’s office, were compared to traditional medical laboratory procedures and patient diagnoses.

How Maverick Technology Works video

According to the Genalyte video above, “The Maverick Detection System … directly detects the binding of proteins or antibodies to the sensor in real-time and results are analyzed simultaneously with the accompanying Genalyte software. Almost all of the most time consuming and expensive parts of assay development and sample testing are reduced or eliminated.” Click on the image to view the video. (Caption and video copyright: Genalyte.)

According to the news release and the published clinical abstracts, the researchers concluded that:

• Positive and negative results on whole blood tested on the Maverick system highly correlated with serum tested on previously approved devices;

• Multiplex ANA testing on whole blood in physician offices is feasible;

• Venous draw and fingerstick blood samples highly correlated; and

• Maverick has the propensity to improve patients wait times for diagnosis and to enhance their testing convenience.

“There is extremely high correlation for absolute value between venous blood and fingerstick blood, and between positive and negative results seen with whole blood on the Maverick and serum on the FIDIS Connective 10,” noted study “one” researchers.

“I’m impressed,” Patricia Jones, PhD, former President of the American Association for Clinical Chemistry (AACC), told Bloomberg News. “The game-changing part of this would be being able to do testing and potentially make a diagnosis immediately, instead of having to send out lab tests, wait several days, and then call the patient,” she added.

Can One Drop Do It All? Some Researchers Advise Caution

The controversy surrounding point-of-care fingerprick capillary blood draws performed on in-office automated blood analyzers, versus clinical laboratory venous draws performed on high-volume laboratory systems, is not new. Dark Daily has reported on several blood test studies in the past.

One such study involved bioengineers at Rice University. It concluded that fingerpricked capillary blood may not be accurate or reliable enough for clinical decision-making.

Their study acknowledged the value of such capillary blood testing in remote areas. But it also urged caution about use of measurements from a single drop of fingerprick blood.

“Using both a hematology analyzer and POC hemoglobinometer, we found the variability of blood component measures to be greater for successive drops of fingerprick blood than for multiple drops of venous blood,” the researchers wrote in The American Journal of Clinical Pathology (AJCP).

Research will no doubt continue until a viable, accurate, and affordable blood analyzer system that conducts dozens of clinical laboratory tests based on a few drops of blood comes to market. It’s basically inevitable in today’s world where computers can be built from molecules and miniature medical laboratories can be placed in chips, skin patches, and needles.

Pathologists and clinical laboratory leaders would be well advised to monitor the development of these various new diagnostic technologies. For most of the past decade, there has been a steady parade of companies and research teams announcing new discoveries that could revolutionize clinical diagnostics as performed today. However, few disruptive clinical laboratory tests or analyzers based on these technologies have made it into the clinical marketplace.

—Donna Marie Pocius

Related Information:

Can Genalyte Achieve What Theranos Touted?

Genalyte Takes Aim at Lab Testing Giants with Cloud-Based Service

Genalyte Raises $36 Million From Khosla for its One-Drop Blood Test

AACC President Calls Genalyte’s Blood Diagnostic Tests ‘Game-Changing’

Drop-to-Drop Variation in the Cellular Components of Fingerprick Blood: Implications for Point-of-Care Diagnostic Development

Genalyte Diagnostic Tool Shows Potential to Improve Turnaround Time in RA, Other Conditions

Application of a Novel Anti-Nuclear Antibody Multiplex Test Using Finger Stick and Venous Whole Blood in a Rheumatology Clinic—Demonstration of Feasibility

Rice University Researchers Publish Study About Variation in Drop-to-Drop Samples of Capillary Blood Collected by Fingerprick and Used for Clinical Laboratory Testing

After AACC Presentation, Elizabeth Holmes and Theranos Failed to Convince Clinical Laboratory Scientists and the News Media about Quality of Its Technology

Score for Theranos After AACC: Fail

Children’s Study Determines MicroRNA in Saliva Can Accurately Diagnose Acute and Prolonged Concussion Symptoms; Could Lead to New Medical Laboratory Tests and Point-of-Care Diagnostics

Research published in JAMA Pediatrics reports that non-invasive salivary microRNA testing identifies prolonged concussion symptoms with 85% accuracy

Sports-related concussions are always tragic, but doubly so when they involve child athletes. Quick diagnoses and treatments are critical to prevent permanent brain injury. But doctors are often hampered by the pace at which traditional medical imaging modalities and clinical laboratory diagnostic technologies provide crucial feedback.

Now, researchers at Penn State Health Children’s Hospital have determined that microRNA in saliva could be used as biomarkers in point-of-care concussion testing during sports events, according to a Penn State Health news release. Such sideline saliva analyses could provide quick feedback to field doctors on whether a head injury is serious enough to put injured athletes out of play, and how long the effects of such injuries might last. But is it accurate?

Jeremiah J. Johnson, MA, BS, Department of Pediatrics, at Penn State College of Medicine in Hershey, Pa., et al, recently published a study in the Journal of the American Medical Association (JAMA) Pediatrics that evaluated the ability of salivary microRNA to identify concussion in children. The salivary test of microRNA levels, Johnson and colleagues argued, does accurately identify the “duration and character of concussion symptoms.” According to the researchers, the test demonstrated high prognostic potential as a “toolset for facilitating concussion management” and may provide an additional biomarker source for use in clinical laboratory testing.

MicroRNA Offers New Biomarkers for Concussion Diagnosis

The study tested the saliva of 52 adolescents with a clinical diagnosis of mild traumatic brain injury in the form of concussion for specific microRNA expressions. Researchers identified five microRNA molecules which “accurately identify” patients with concussion symptoms. Three of those molecules served to diagnose specific symptoms of headache, fatigue, and memory difficulties up to one month after injury with low false detection rates. Because these microRNA molecules are not specific to children, could the test maintain diagnostic accuracy for patients of all ages?

William P. Meehan III, MD, with the Micheli Center for Sports Injury Prevention at Boston General Hospital, and Rebekah Mannix, MD, MPH, with the Brain Injury Center at Boston Children’s Hospital wrote an editorial responding to the original research article stating that “the use of salivary microRNA in this study is both novel and clinically relevant.” Adding that “using this salivary microRNA panel to diagnose and manage concussions could be a major advancement to the field.”

Meehan and Mannix also remarked on the speed and relative ease of obtaining saliva samples, stating that “salivary microRNAs could also offer insights into the underlying biological mechanisms of injuries, potentially identifying specific targets to modify disease.”

More Accurate than Current Concussion Diagnosis Tools

There has been a marked interest in microRNA analysis and testing in recent years. MicroRNA analysis and testing has found use in cancer prognosis and personalized medicine that help predict responses to specific treatments for individual patients with a variety of chronic diseases. The news that microRNA can be used to predict concussion and duration of symptoms further solidifies the role microRNA may play in medical laboratory testing in the near future.

In an interview with CNN, Steve Hicks, MD, PhD, senior author of the JAMA Pediatrics research article and Assistant Professor of Pediatrics at Penn State College of Medicine, reported that the salivary microRNA test predicted concussion with 85% accuracy in comparison to current clinical survey measures, which are “approximately 65% accurate.” Hicks added that “the technology required to measure saliva RNA is already employed in medicine” as a common means of testing for upper respiratory viruses and that “modifying this approach for patients with concussions could potentially provide a rapid, objective tool for managing brain injury.”

Currently the Standard Concussion Assessment Tool, Third Edition (SCAT 3), which includes a series of cognitive and physical tests, is used on sports sidelines to detect concussion symptoms. Hicks notes that one problem with SCAT 3 is that “an athlete may have a concussion even if [his or her] score is ‘normal.’” Therefore, the microRNA saliva test could provide objective evidence of concussion in patients SCAT 3 fails to accurately diagnose.

Steve-Hicks-MD

Steven D. Hicks, MD, PhD (above), led the research team that studied the use of microRNA in saliva, rather than in blood, as a biomarker to identify concussions symptoms in children, and determine how long effects of the injury might last. (Photo copyright: Penn State Health.)

Too Early to Know How Helpful the Test May Be?   

In the same CNN interview, Neurologist Jeffery Kutcher, MD, head of the Sports Neurology Clinic at The Core Institute in Brighton, Mich., stated that the Penn State study’s findings were “promising” and that “work like this is important because it does provide potential for tests that can be helpful in the clinical setting.” Kutcher cautioned however, that it was “too early to know what this type of tool can do for us.”

In an NPR article, Manish Bhomia, M.Eng., PhD, a brain injury researcher with the Uniformed Services University of the Health Sciences commented that “a saliva test could greatly improve care for young people who don’t have obvious symptoms of a concussion.” Bhomia stated that “micro-RNAs offer a promising way to assess concussions in adults as well as children,” but he is wary to laud saliva tests as the best method of measuring relevant microRNA molecules. Bhomia states that blood samples “which tend to contain greater numbers of the genetic fragments” are perhaps a better option.

Hicks disagrees. In an article from Penn State News, Hicks stated that the novel aspect of this study was that it focused on microRNA levels “in saliva rather than blood.” Thus, a test based on saliva, rather than a phlebotomy stick or more invasive blood testing, requires no need for venous blood.

“The ultimate goal is to be able to objectively identify that a concussion has happened and then predict how long the symptoms will go on for,” Hicks noted in the Penn State News article. “Then, we can use that knowledge to improve the care that we provide for children who have concussions, either by starting medicine earlier or holding them out of activities for longer.”

Quadrant Biosciences, a biotech company in Syracuse, N.Y., that helped fund the study, is hoping to “bring a saliva test for concussion to market in the next 12 to 24 months,” according to Hicks in his CNN interview. If development proceeds as planned, the saliva test could prove a “game changer” for sports medicine diagnostics and possibly open new avenues for related microRNA in clinical laboratory testing.

Amanda Warren

Related Information:

Prolonged Concussion Symptoms Identifiable by Salivary MicroRNA

Association of Salivary MicroRNA Changes with Prolonged Concussion Symptoms

Promise of Salivary MicroRNA for Assessing Concussion

Spit Test May Diagnose, Predict Duration of Concussion in Kids

Molecules in Spit May Be Able to Diagnose and Predict Length of Concussions

Spit Test May Help Reveal Concussion Severity

Meet the Clinical Pathology Laboratory on the Palm of a Hand: Japanese Researchers Announce A Point-Of-Care Testing Device That Detects MicroRNA in 20 Minutes

With Launch of RNAcentral Database, Pathologists Now Have Unprecedented Access to RNA Data

Next-Generation Laboratory Information Management Systems Will Deliver Medical Laboratory Test Results and Patient Data to Point of Care, Improving Outcomes, Efficiency, and Revenue

Moving to market are the newest generation of LIMS products designed to serve clinical laboratories while supporting quality reporting initiatives and new sources of revenue

It was Bob Dylan who made a big hit out of the song, “The Times, They Are A-Changin’.” The same could be said for the next generation of software products designed for use by medical laboratories.

To be fully successful, these next-generation laboratory information management systems (LIMS) must be radically different than the generations that came before. For example, medical laboratories are frustrated with the many limitations of older LIS products that still incorporate software technologies that date back to the 1980s and 1990s, such as MUMPS, which stands for Massachusetts General Hospital Utility Multi-Programming System.

But the newest LIMS products must do more than simply incorporate the latest technologies in software and cloud-based services. They must support all the ways that clinical laboratories and anatomic pathology groups generate increased revenue. More specifically, all medical laboratories will be generating vast quantities of molecular and genetic data. Therefore, an effective LIMS must be capable of capturing that data while also enabling the lab to perform certain healthcare big data analyses in support of the referring physicians and parent hospitals.

There also will be the need for medical laboratories to use their LIMS capabilities to support the data reporting requirements of Medicare and private health insurers. Payers increasingly want providers to report their quality monitoring, patient outcomes, and certain cost-of-care parameters. All these are functions that older LIS (laboratory information systems) products were not developed to provide.

Anatomic pathology group stakeholders and clinical laboratory managers understand the vital importance of their LIMS. Laboratory and healthcare workflows depend on the system’s:

  • efficiency;
  • scalability that supports the growth of the lab and medical practice; and,
  • flexibility to interface with modern, point-of-care telehealth technologies in ways that enable labs and practices to engage in today’s precision medicine healthcare initiatives.

The more immediate need is for a LIMS to be capable of supporting Medicare’s Quality Payment Programs (QPPs), primarily the MACRA Merit-based Incentive Payments System (MIPS). Most physicians, including pathologists, will participate in MIPS. The first Medicare incentives or penalties will be paid next year, based on 2018 metrics and performance.

Given all these changing demands of advanced software technologies and the need for medical laboratories to participate in various value-based revenue programs, how might a LIMS empower labs to ensure success and increased revenue?

Quality Payment Programs and Merit-based Incentives

As part of the shift toward value-based care, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) works to drive down costs and increase quality within both care and laboratory environments. MACRA establishes a data-driven payment system to reimburse service providers based on the outcome of services and care episodes, instead of the volume of services delivered or billed.

Combined with reduced payments, MACRA’s incentives and penalties, and Medicare’s QPP/MIPS payment programs, pressure has been increased on healthcare providers and medical laboratories alike. Thus, technology that gives labs a competitive edge is essential for thriving in an ever-evolving and increasingly competitive marketplace.

Meeting MACRA Goals with a Laboratory Information Management System

While electronic health record (EHR) systems have helped to consolidate patient protected health information (PHI), they do little to address the real-time creation of laboratory data and the accessibility of the massive volume of lab-related data stored in the average patient’s medical files.

A LIMS, however, helps to consolidate all this data in an easily accessible and powerful system. Some LIMS even combine with telehealth technologies to make data actionable and available at the point-of-care.

In this type of LIMS, laboratories, physicians, and other care providers all access the same dataset to ensure information is relayed quickly and efficiently. Interaction takes place using cloud-based interfaces, such as mobile apps or web portals. This ensures access to patient data and laboratory test results in a variety of locations without dependence on proprietary communications systems or hardware.

From bustling ERs and surgical wards to phlebotomists visiting long-term care facilities and mobile clinics, collecting and retrieving data becomes streamlined and accessible virtually anywhere.

The chart above illustrates how a LIMS offers increased potential to automate processes and scale operations while keeping physicians, patients, and other critical parties up to date. This increase in efficiency and access to data empowers providers to reach improved patient outcomes and reduce hospital readmission rates, increasing revenue for both clinicians and clinical laboratories. (Graphic copyright: NetLIMS.)

When implemented properly, a LIMS also helps laboratories and healthcare facilities meet the terms of MIPS. This reduces Medicare penalties and ensures payment adjustments, which improve revenue streams even further.

Understanding LIMS and Cloud-Based Lab Systems

To help outline and explain the benefits of a LIMS for laboratories and healthcare facilities, The Dark Report, in conjunction with NetLIMS, a global provider of laboratory information management systems to hundreds of hospitals and commercial laboratories worldwide, has produced a free white paper titled, “The Path to More Revenue: Cloud-Based LIMS, Mobile Apps, and Point-of-Care Telehealth.”

  • This white paper addresses critical concerns, including:
  • Overviews of new technologies;
  • The impact of value-based programs on the lab market;
  • The importance of MACRA and MIPS adherence;
  • How technology, such as a LIMS, can help labs achieve improved efficiency; and,
  • Tips on choosing a LIMS vendor to maximize ROI.

To download your free copy of the whitepaper click on this link:  Or, copy this URL into your browser: https://www.darkdaily.com/whitepaper/the-path-to-more-revenue-cloud-based-lims-mobile-apps-and-point-of-care-telehealth .

Thanks to advances in LIMS design and development, remote patient digital therapeutics, and cloud-based technology, healthcare providers now have unprecedented opportunities to better manage the health of patients with chronic conditions. In addition, it can help you achieve better efficiency, economics, and compliance with MACRA.

This free white paper is your first step toward significantly reducing hospital readmission rates, bridging the gap between labs, physicians, and other healthcare providers they serve, and positively affecting patient outcomes, improving quality measures, and maximizing reimbursements for all services you provide.

—Jon Stone

Related Information:

The Path to More Revenue: Cloud-Based LIMS, Mobile Apps, and Point-of-Care Telehealth

How Close Is the End of Private Practice Pathology as We’ve Known It?

Attention Anatomic Pathologists: Do You Know Medicare Is Prepared to Change How You Are Paid, Beginning on January 1, 2017?

Innovator Hospitals Bring ICUs into the Info Age, Using New Design Approaches that involve Medical Laboratory Tests

 

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