Oct 16, 2017 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Pathology, Laboratory Testing
As science learns more about the human genome, new companies are being formed to offer consumers at-home microbiology test kits, a development many microbiologists consider worrisome
Can consumers rely on the accuracy of at-home microbiology tests that promise to give them useful information about their microbiome? That’s just one question being asked by clinical laboratory scientists and microbiologists in response to the proliferation of companies offering such tests.
Advances in gene sequencing technology, new insights into the human microbiome, and more sophisticated software to analyze test data are fueling the growth of companies that want to offer consumers at-home microbiology test kits. And no less an authority than the American Academy of Microbiology (ASM) states in a 2017 report, that knowledge of the microbiome can revolutionize healthcare as “insights acquired from NGS [next-generation sequencing] methods can be exploited to improve our health as individuals and the greater public health.”
The move towards more “precision medicine” in terms of diagnostics and treatments, according to the ASM, is based in part on microbial genomic testing, which when combined with a patient’s medical history, clinical signs, symptoms, and human genomic information, can help “create treatment pathways that are individualized and tailored for each patient.”
However, critics worry about overreach given current limitations in the analysis and diagnosis of microbiome data produced by testing, particularly in connection to the rising number of consumer self-testing services aimed at the general public.
No Science to Back Up Claims of Accuracy for At-Home Microbiology Tests
A recent article from the MIT Technology Review, notes that these at-home microbiology testing services, while exciting, can only offer limited information—despite claims. Companies such as Thryve, for example, offer visitors to their website a $99 gut health kit, which they recommend using four times per year. The goal is to use the data to target regimens of supplements and “correct” problems the testing identifies.
Another company, uBiome, offers physician-ordered and customer-requested test kits that the company suggests can determine risk factors for disease. However, critics suggest science cannot currently back up those claims. Concerns about the value of such consumer self-testing, the legitimacy of recommendations based on “diagnoses,” and basic health privacy are leading to serious concerns within the scientific community.
Ethics and Realistic Expectations
One additional criticism of consumer self-testing of microbiomes involves privacy. An NPR article on the American Gut Project (AGP), which Dark Daily reported on in previous e-briefings, notes that those tested may be disclosing quite a bit of information about themselves. The article’s author points out basic privacy and value concerns about the AGP. American Gut Project is a crowd-funded “citizen science project,” and part of the larger global Earth Microbiome Project, described as a “massively collaborative effort to characterize microbial life on this planet.” (See Dark Daily, “Get the Poop on Organisms Living in Your Gut with a New Consumer Laboratory Test Offered by American Gut and uBiome,” September 9, 2015.)
One example of an at-home microbiology test marketed to consumers is the SmartGut by uBiome (above). It is “a microbiome screening test that uses precision sequencing technology to identify key microorganisms in your gut, both pathogenic and commensal.” (Photo copyright: uBiome.)
In her blog post on the Center for Microbiome Informatics and Therapeutics’ website, Tami Lieberman, PhD, claims that “microbiome profiling is messy (and I’m not just talking about the sample collection).” Lieberman submitted samples to American Gut and uBiome for her article. Lieberman’s skepticism of the services is based on two things:
1. There is no “gold standard” for microbiome DNA profiling technology or analysis methods at this time; and,
2. Human microbiomes are in her words, “a moving target, changing with age and diet.”
Thus, the best these services can provide, Lieberman argues, is a snapshot of gut microbes at one period of time. Additionally, she claims there is a danger in trying to interpret personal microbiome data. And, Lieberman is not alone in her criticism.
Science Must Be ‘On Guard’ Against Hype about the Usefulness of Microbiome Tests
Martin Blaser, MD, PhD, Director of the Human Microbiome Project at New York University, also criticizes at-home self-tests of microbiomes. In a New York Times article, Blaser points out that the enormous amount of data generated by microbiome testing is “basically uninterpretable” at this time. According to Blaser, scientists can chart the presence, absence, and levels of specific microbiomes and note correlations, but there is no way to know if changes to microbiomes in a particular patient signal disease risk, progression, or development.
The study of microbiomes is still in its nascent stages, so despite there being significant information correlating the presence or absence of specific microbes to diseases, Blaser states that scientists are currently unsure of what that correlation implies. They simply know the correlations exist.
Although discoveries related to human microbiomes, such as the link between fecal bacteria and infant intellect, insights into the connections between gut microbiome and colorectal cancer, and the tenuous and debatable connection between obesity and microbiome diversity make for interesting news, science must be—as William Hanage, PhD, Director of Harvard’s Department of Epidemiology writes in an article for Nature—on guard against allowing microbiomics to be “drowned in a tsunami of its own hype.”
The “gold rush” of companies offering consumers an at-home microbiology test requires skepticism, notes Hanage. He further urges researchers, press officers, and journalists to remain objective. Hanage writes, “Press officers must stop exaggerating results, and journalists must stop swallowing them whole.” Hanage warns that scientists should be on guard against the “buzz around the field” distorting scientific priorities and misleading the public at large. So, while studies of the human microbiome do carry vast potential for medical laboratories and pathologists to change healthcare and healthcare diagnostics, a healthy dose of skepticism is still the best medicine.
—Amanda Warren
Related Information:
Changing Diagnostic Paradigms for Microbiology, May 2017
Gut Check: Scientists are Wary of At-Home Microbiome Tests
Getting Your Microbes Analyzed Raises Big Privacy Issues
American Gut Project Crowdfunds $1 Million to Study the Human Microbiome
Which Bacteria Are In My Poop? It depends Where You Look
Can I Test the Health of My Gut Microbiota?
Study: Fecal Bacteria Linked with Greater Infant Thinking Skills
Microbiology: Microbiome Science Needs a Healthy Dose of Skepticism
Get the Poop on Organisms Living in Your Gut with a New Consumer Laboratory Test Offered by American Gut and uBiome
Clinical Laboratories Might Soon Be ‘Diagnosing’ Obesity and Guiding Therapies That Utilize Engineered Microbes
Mayo Clinic and Whole Biome Announce Collaboration to Research the Role of the Human Microbiome in Women’s Diseases Using Unique Medical Laboratory Tests
Expanding Knowledge about the Human Microbiome Will Lead to New Clinical Pathology Laboratory Tests
Effort to Map Human Microbiome Will Generate Useful New Clinical Lab Tests for Pathologists
Oct 11, 2017 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Free-standing device eliminates need for special pickups and dangerous disposal of any type of medical waste, including biohazard waste generated by medical laboratories
Clinical laboratories generate a substantial amount of regulated medical waste (RMW) including needles, collection supplies, gloves, sample tubes, and sample storage containers. RMW, also known as biohazardous or infectious medical waste, must be disposed of properly per federal and state regulations, including the Medical Waste Tracking Act of 1988.
There are currently several ways to discard of medical waste, but those methods can be dangerous, costly, and time-consuming. They usually involve chemicals, gases, irradiation, or incineration, and the waste often has to be hauled away in hazardous waste vehicles.
Thus, a revolutionary new machine that enables the disposal of medical waste in a harmless, effective, low-cost, and on-demand basis would be a boon for medical laboratories, pathology groups, blood labs, as well as all other healthcare practices that handle medical waste.
Safe, On-demand, Onsite, Point-of-Care Medical Waste Disposal a Reality
Such a device has been created by Sterilis LLC, a privately-held company headquartered in Boxborough, Mass. The patented, device utilizes steam sterilization and grinding technologies to convert dangerous medical waste into a safe confetti-like material. It is about the size of a large office copier and can handle up to 15 lbs. of biomedical waste at a time. Sterilis is charging $50,000 for the machine or it may be leased for $1,000 per month.
“The regulated medical waste industry has seen little innovation and still operates under an archaic approach of ‘haul and burn.’ Therefore, the industry is ripe for disruption with Sterilis’ new, safer, and more sustainable approach to treat and safely dispose of regulated medical waste, when and where it is generated,” stated Robert Winskowicz, Chief Executive Officer of Sterilis in a Medical Design Technology article.
To operate the Sterilis device (above), users simply place up to 15 lbs. of medical waste (containers and all) into the top compartment of the machine and turn it on. In less than one hour the waste is transformed into a sterile material that is automatically deposited into a proprietary collection bag, which can be placed into a regular trash container. (Photo copyright: Sterilis LLC.)
“Most people in the medical profession would tell you the best way to treat medical waste is as close to the point of generation as possible, and take care of it immediately,” noted Winskowicz in a Fox25News article. “And our machines give you that on-demand capability.”
The free-standing machine is about 36” by 24” by 47” making it similar in size to an office photocopier. It runs on standard electricity, requires no plumbing or set-up, and is completely portable. Depending on usage, the steam reservoir gets refilled with water a few times a week. The device lets users know when it needs water.
“We created the Sterilis device to address a burning need for more sustainable and safer disposal of medical waste,” stated Jeffrey Bell, Sterilis’ founder, President, Chief Financial Officer, and Chairman of the Board of Directors in a Sterilis news release. “The Sterilis method for infectious waste disposal disrupts the RMW industry by allowing facilities to safely remediate waste onsite and at the point-of-care using steam sterilization and grinding technologies, which reduces the waste volume by about 80%. Not only does this create a smaller waste footprint, but it protects the environment by preventing the need for waste incineration, which has been cited by the EPA as a major contributor to climate change.”
Device Designed for All Types of Medical Practices, including Clinical Labs
The apparatus was designed to be used in a variety of settings including medical centers and hospitals, clinics, medical laboratories, nursing facilities, dialysis centers, urgent care centers, dermatology facilities, pathology offices, oral surgery centers, and even corrections facilities, military sites, and veterinary clinics. Sterilis is also experiencing a demand for the device among facilities involved in community needle exchange programs. Among the 40 early adopters of the device are hospitals, HIV treatment centers, community needle-drop facilities, prisons, airports, and nursing homes located throughout the US and Canada.
“The Sterilis device makes handling medical waste safer, protects healthcare professionals, reduces costs, time and labor, and reduces the need to incinerate medical waste. We’re excited by the response and customer demand for the Sterilis device as we enter a more aggressive growth phase and expand our sales and distribution footprint nationwide,” Winskowicz stated in the press release.
The machine also includes software that monitors and captures sterilization parameters for compliance and tracking purposes. That data is automatically transmitted to and stored in the Cloud where it can be easily retrieved and viewed.
The medical waste management market reached $10.3 billion globally in 2015 and is expected to reach $13.3 billion by 2020, according to research firm MarketsandMarkets. Thus, the handling of biomedical waste is becoming a critical issue for medical facilities and clinical laboratories due to limited space, costs, and increasing regulations and requirements. As the medical waste management market continues to grow, it is probable that more technological advances will emerge to better serve laboratory, medical, and research professionals.
—JP Schlingman
Related Information:
Sterilis Introduces Approach to Treating Medical Waste
Sterilis, LLC Named Technology for a Better Future Finalist in MassTLC’s Tech Leadership Awards
This Needle Grinder Can Mash Up Medical Waste in an Hour
Sterilis Device: How It Works
Sterilis, LLC Wins 2017 Top Product of the Year Award for Green Medical Waste Disposal Device by Environmental Leader
New Technology Helps Clean up Areas Littered with Heroin Needles
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
Oct 6, 2017 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Identification of 144 elevated phosphoproteins indicative of cancer shows one possible path forward in the use of liquid biopsies for early detection of cancer and monitoring patients in remission
While precision medicine and a growing menu of medical laboratory assays and diagnostics are increasing the number of treatment methods available to cancer patients, early detection is still key to improving outcomes and increasing the odds of survival.
In February 2017, a Dark Daily ebriefing titled, “British Medical Laboratory Test for Early Screening of Lung Cancer Shows Promising Interim Results in Large Trial; Could Lead to Other Simple Blood Tests for Cancer Detection,” showcased the EarlyCDT-Lung test. In a University of Dundee press release, researchers noted the non-invasive test promised detection of lung cancer “potentially up to five years” earlier than traditional scans.
Now, researchers from Purdue University are testing a non-invasive blood test for detection of all types of cancer using phosphoproteins as biomarkers that could detect cancer even before the onset of any symptoms. This could lead to non-invasive therapies, and ways to monitor them, that could be applied while the patient’s body is still strong and able to respond well to treatment.
Speaking with New Atlas, researcher W. Andy Tao, PhD, Chief Scientific Officer of Tymora Analytical Operations, stated, “This is definitely a breakthrough, showing the feasibility of using phosphoproteins in blood for detecting and monitoring diseases.”
Extracellular Vesicles as the Key to Isolating Phosphoproteins
Protein phosphorylation—particularly mutations in phosphatases and kinases—are already known to play roles in cancer development as noted in the OncLive article “Phosphorylation: The Master Switch of the Cell.”
However, as the liver uses phosphatase to dephosphorylate proteins, identification of phosphoproteins in the blood has remained difficult for researchers.
Isolating phosphoproteins from tissue samples is equally difficult. “Assays of phosphoproteins from tissues face tremendous challenges because of the invasive nature of tissue biopsy and the highly dynamic nature of protein phosphorylation during the typically long and complex procedure of tissue biopsy,” noted I-Hsuan Chen, PhD Candidate, and W. Andy Tao, PhD, in their study published in Proceedings of the National Academy of Sciences of the United States of America (PNAS).
As shown in the illustration above, extracellular vesicles are basically blobs of cellular cytosol that contain microRNA (miRNA) Messenger RNA (mRNA) and proteins, which some researchers believe potentially could compete with stem cell-based therapeutics. (Image copyright: BioProcess Intl.)
In their attempts, researchers instead focused on the biomarker discovery potential of extracellular vesicles (EV)—in particular microvesicles and exosomes—citing strong evidence in the ability to use EV-based disease biomarkers well before symptoms appear.
“The ability to detect the genome output (active proteins, and in particular phosphoproteins) can provide more direct real-time information about the organism’s physiological function and disease progressions, particularly in cancers,” the PNAS study authors noted.
Researchers isolated nearly 2,400 phosphoproteins across 30 samples from breast cancer patients. They then compared these to six control samples and identified 144 specific proteins commonly elevated when cancer was present.
In a Purdue University press release, Timothy Ratliff, PhD, Director of Purdue University Center for Cancer Research expanded on the findings of the study, stating, “The vesicles and exosomes are present and released by all cancers, so it could be that there are general patterns for cancer tissues, but it’s more likely that [W. Andy Tao, PhD] will develop patterns associated with different cancers.”
Monitoring Cancer with a Blood-Based Cartridge Diagnostic
The Purdue University press release highlights the potential of the process, noting, “A simple blood test for cancer would be far less invasive than scopes or biopsies that remove tissue. A doctor could also regularly test a cancer patient’s blood to understand the effectiveness of treatment and monitor patients after treatment to see if the cancer is returning.”
The ability to capture EV phosphoproteins appears to be stable over time. The samples used in the Perdue University study were taken nearly five years ago by the Indiana Biobank.
While the stability of samples is a boon to researchers, they note that there are still many improvements to be made to the methods used before some medical laboratories could attempt to replicate their results.
Current methods require using differential high-speed and ultra-high-speed centrifugation. Study authors note this makes it less than ideal for clinical laboratory use due to lack of access and lower specificity.
However, the Purdue press release also notes plans for future improvements. Tymora Analytical Operations is developing technologies to use the biomarkers in a cartridge-based system. This could mean that pathology groups and medical laboratories might one day add an automated test to their menus for the second leading cause of death in the United States.
Until then, medical laboratories can help further efforts by collecting samples and working with biobanks, such as the one used in the Purdue study. Clinical laboratories already power much of the diagnostic tools driving innovation and discovery in oncological precision medicine. With the addition of a way to detect cancers, both while in remission or before symptoms appear, laboratories could further increase their role in fighting this worldwide killer.
—Jon Stone
Related Information:
Protein Discovery Points to Potential Blood Test for All Cancers
Phosphoproteins in Extracellular Vesicles as Candidate Markers for Breast Cancer
Breakthrough Discovery May Make Blood Test Feasible for Detecting Cancer
Phosphorylation: The Master Switch of the Cell
Overview of Protein Phosphorylation
Extracellular Vesicles Commercial Potential as Byproducts of Cell Manufacturing for Research and Therapeutic Use
Extracellular vesicles: An Introduction
British Medical Laboratory Test for Early Screening of Lung Cancer Shows Promising Interim Results in Large Trial; Could Lead to Other Simple Blood Tests for Cancer Detection
Sep 29, 2017 | Coding, Billing, and Collections, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Managed Care Contracts & Payer Reimbursement
Insurers might use blockchain technology to enable instantaneous verification and interoperability of healthcare records, which could impact clinical laboratory payment systems
Medical laboratories and anatomic pathology groups are keenly aware that connected, secure, interoperable health records are critical to smooth, efficient workflows. However, the current often dysfunctional state of health information technology (HIT) in America’s healthcare system often disrupts the security and functionality of information exchange between hospital and ancillary practice patient record systems.
One solution to this could be blockchain technology. With its big data and abundant touchpoints (typically: insurer, laboratory, physician, hospital, and home care), the healthcare industry could be ripe for blockchain information exchanges. Blockchain might enable secure and trusted linkage of payer, provider, and patient data. But what exactly is blockchain technology and how might it impact your laboratory?
Blockchains Could Transform Healthcare
Blockchain refers to a decentralized and distributed ledger that enables the interface of computer servers for the purpose of making, tracking, and storing linked transactions.
“At its core, blockchain is a distributed system recording and storing transaction records. More specifically, blockchain is a shared, immutable record of peer-to-peer transactions built from linked transaction blocks and stored in a digital ledger,” explained risk-management group Deloitte in a report, which goes on to state:
- “Blockchain technology has the potential to transform healthcare, placing the patient at the center of the healthcare ecosystem and increasing the security, privacy, and interoperability of health data. This technology could provide a new model for health information exchanges (HIE) by making electronic medical records more efficient, disintermediated, and secure.
- “Blockchain relies on established cryptographic techniques to allow each participant in a network to interact (e.g., store, exchange, and view information), without pre-existing trust between the parties.
- “In a blockchain system, there is no central authority; instead, transaction records are stored and distributed across all network participants. Interactions with the blockchain become known to all participants and require verification by the network before information is added, enabling trustless collaboration between network participants while recording an immutable audit trail of all interactions.”
Instant Verifications and Authorizations at Point-of-Care
In a Healthcare Finance News (HFN) article, insurers acknowledged blockchain’s potential for information verification and authorizations in real-time, fast payments, and access to patient databases that could fulfill population health goals.
“Everybody that is part of a transaction has access to the network. There’s no need for an intermediary. Blockchain allows for verification instantly,” noted Chris Kay, JD, Senior Vice President and Chief Innovation Officer at Humana, in the HFN article.
At clinical laboratories, blockchain could enable nearly instantaneous verification of a patient’s health insurance at time of service. Blockchain also could enable doctors to review a patient’s medical laboratory test results in real-time, even when multiple labs are involved in a person’s care.
“Everyone has to have a node on the blockchain and have a server linked to the blockchain. The servers are the ones talking to one another,” explained Kay. “What’s really transformative about this is it takes the friction out of the system. If I see a doctor, the doctor knows what insurance I have because it’s on the network. All this is verified through underlying security software.”
Healthcare Obstacles to Overcome
Breaking down data silos and loosening proprietary holds on information can help healthcare providers prepare for blockchain. However, in our highly regulated industry, blockchain is at least five years away, according to blockchain experts in a Healthcare IT News (HIT News) article.
“We’re hearing that blockchain is going to revolutionize the way we interact with and store data. But it’s not going to happen tomorrow. Let’s find smaller problems we can solve as a starting point—projects that don’t have the regulatory hurdles—and then take baby steps that don’t require breaking down all the walls,” advised Joe Guagliardo, JD, Intellectual Property/Technology Attorney and Chair of the Blockchain Technology Group at Pepper Hamilton, a Philadelphia-based law firm, in the HIT News article.
Healthcoin: Rewarding Patients for Improved Biomarkers
One company has already started to work with blockchain in healthcare. Healthcoin is a blockchain-based platform aimed at prevention of diabetes, heart disease, and obesity. The idea is for employers, insurers, and others to use Healthcoin (now in pre-launch) to reward people based on biomarker improvements shown in medical laboratory tests.
Healthcoin’s Chief Executive Officer Diego Espinosa and Chief Operating Officer Nick Gogerty, founded the company in 2016 after Espinosa, who had been diagnosed with diabetes, made diet changes to reverse it, according to an article in Bitcoin Magazine.
“When I saw my blood labs, the idea for Healthcoin was born—shifting the focus of prevention to ‘moving the needle’ on biomarkers, as opposed to just measuring steps,” Espinosa told Bitcoin Magazine.
Blockchain Provides Security
What does blockchain provide that isn’t available through other existing technologies? According to Deloitte, it’s security and trust.
“Today’s health records are typically stored within a single provider system. With blockchain, providers could either select which information to upload to a shared blockchain when a patient event occurs, or continuously upload to the blockchain,” Deloitte notes. “Blockchain’s security and ability to establish trust between entities are the reasons why it can help solve the interoperability problem better than today’s existing technologies.”
Should Clinical Laboratories Prepare for Blockchain?
It’s important to note that insurers are contemplating blockchain and making relevant plans and strategies. Dark Daily believes the potential exists for blockchain technology to both disrupt existing business relationships, including those requiring access to patient test data, and to create new opportunities to leverage patient test data in real-time that could generate new revenue sources for labs. Thus, to ensure smooth payments, medical laboratory managers and pathology group stakeholders should explore blockchain’s value to their practices.
—Donna Marie Pocius
Related Information:
Blockchain Opportunities for Health Care: A New Model for Health Information Exchanges
Blockchain Will Link Payer, Provider, Patient Data Like Never Before
Old Ways of Thinking Won’t Work for Blockchain, Experts Say
Blockchain-Styled Solutions for Healthcare on the Rise
Can Blockchain Give Healthcare Payers Better Analytical Insight?
Blockchain in Health and Life Insurance: Turning a Buzzword into a Breakthrough
Does Blockchain Have a Place in Healthcare?
Sep 15, 2017 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory Operations, Laboratory Pathology, Management & Operations
Horseshoe crabs have been utilized by the biomedical industry to save millions of lives around the globe for years. But now researchers fear the practice of bleeding them may be threatening their survival
Many medical laboratory scientists are aware that horseshoe crabs are harvested to get their blue blood and the limulus amebocyte lysate, or LAL (pronounce “el-ay-el”), because it can detect bacterial endotoxins. The popular wisdom has been that the collection procedure does not harm the crabs. However, there are growing concerns that indicate the biomedical industry is having a negative impact on the horseshoe crab population.
More than 600,000 horseshoe crabs are harvested annually for their blood in the United States (US). It is estimated that the blood is worth $60,000 per gallon and the global industry of processing the blue blood is valued at over $50-million per year, according to a CNN article.
The blood of the horseshoe crab is bright blue in color because it is rich in copper. Horseshoe crabs are bled in laboratories for a protein contained in their blood that scientists use to make LAL. This protein can detect bacterial endotoxins in clinical laboratory tests by solidifying when it comes in contact with certain bacteria.
LAL is prized by the biomedical industry because it can detect dangerous bacteria in injectable drugs, implantable medical devices, and on instruments and equipment. Federal law mandates that any medical device that is inserted or injected into a human body must pass the LAL test for contamination.
Capture, Bleeding, Leading to Depopulation of the Species
After the crabs are dredged from the ocean floor, or captured as they come ashore for breeding, they are transported to one of a handful of facilities authorized to perform the bleeding process. Once there, the horseshoe crabs are cleaned and sterilized, suspended upside down and inserted with a needle which extracts approximately one third of their blood. The helmet-shaped creatures are then returned to the sea.
Like all animals, horseshoe crabs have an immune system to protect them from infection due to an injury or presence of bacteria. The immune system of a horseshoe crab uses endotoxin as the major chemical signal that the crab is being infected. Even miniscule amounts of endotoxin will spark a clotting reaction. Types of cells in the blood called amebocytes are separated from all the harvested blood and broken open, or lysated, to release the coagulation properties. (Photo copyright: Popular Mechanics.)
An LAL solution is then concocted to test for endotoxins in medications and on medical supplies. After this solution is combined with a sample from a batch of medication or placed on a piece of equipment, the presence or absence of the clotting reaction signifies whether endotoxin is present or not. There are currently no other tests that can analyze the purity of medications with the same accuracy as the LAL test.
Fisherman Regulated but Not Biomedical Laboratories
The Atlantic States Marine Fisheries Commission (ASMFC) regulates how many horseshoe crabs fishermen can collect for use as bait. However, the biomedical industry is not bound to restrictions because the crabs are returned to the water after the blood is extracted. The number of crabs harvested by the US biomedical industry jumped 86% between 2003 and 2014, according to an article in Scientific American.
In “Changing Global Perspectives on Horseshoe Crab Biology, Conservation and Management”, Thomas Novitsky, PhD, Chief Executive Officer of Cape Cod Biosystems of East Falmouth, Mass., wrote, “Evidence is accumulating that mortality of bled horseshoe crabs is higher than originally thought [29% versus 15%]; that females may have an impaired ability to spawn following bleeding and release; and that bled crabs become disoriented and debilitated for various lengths of time following capture, handling, bleeding, and release.”
In 2012, a horseshoe crab subcommittee was created by the International Union for Conservation of Nature (IUCN), an organization that establishes global standards for species extinction. That subcommittee later determined the Atlantic horseshoe crab is “vulnerable to extinction,” which is just one level from its Red List of Threatened Species. Their report also stated that horseshoe crab populations could decrease by 30% over the next 40 years, the Scientific American article noted.
“I wouldn’t be surprised if they weren’t on the Red List very soon. The [Asian] populations are significantly declining,” stated John Dubczak, Director of Operations at LAL facility Charles River Laboratories in Charleston, S.C. “Between pollution, loss of habitat, and the animals being eaten in Asia, their populations are under a tremendous amount of stress.”
The facilities that perform the bleeding assert they are not harming the horseshoe crabs. Dubczak states his company has procedures in place to ensure the creatures will not be harmed during the bleeding process. They also provide economic incentives to their suppliers to help guarantee the crabs are being handled appropriately outside their facility.
“It reduces the injury, it reduces the stress, it’s better for [sustaining] the population, and it’s better for us,” Dubczak said in the Scientific American article, noting that the mortality rate for crabs used in his operation is just 4%. “One of my suppliers built a water slide to put the crabs back into the water. They love it!”
Christopher Chabot, PhD, Professor of Neurobiology, Physiology and Behavior at Plymouth State University in Plymouth, N.H. questions how the overall health of the crabs is affected by the 24- to 72-hours they spend out of the water during the bleeding process.
“As you might imagine, being an aquatic organism, that probably has an impact on their viability, their health, their mortality, perhaps, as well as their ability to bounce back after this bleeding,” said Chabot. It takes about a month for the horseshoe crabs to replenish the blood that was extracted and they are not very active after they are bled.
Horseshoe Crabs Critical to Marine Ecosystems
The biomedical industry isn’t the only threat to the survival of the horseshoe crab. Fishermen use them for bait to catch eel and conch. Many shorebirds, migratory birds, fish, and turtles dine on horseshoe crab eggs. In addition, developments along the shorelines are destroying their natural habitat and breeding grounds.
Since horseshoe crabs have a vital role in the preservation of marine ecosystems, it is crucial that alternatives to the current bleeding procedure are developed. Practical and cost-effective substitutes for the LAL test that do not require horseshoe crab blood are under development. A synthetic version of the clotting factor called recombinant factor C is made from cloned Deoxyribonucleic acid (DNA). A test called the monocyte activation test (MAT) uses human blood and may have the ability to detect endotoxin bacteria that horseshoe crab blood is unable to expose. At this time, however, the LAL test is the only one approved by the Food and Drug Administration.
These news reports about the shrinking population of horseshoe crabs along the Atlantic coast demonstrate how interconnected environmental issues are with society’s use of natural resources. Clinical laboratory managers and pathologists should take note of the fact that researchers determined that the number of horseshoe crabs harvested nearly doubled between 2003 and 2014. That raises the stakes for researchers to find a substitute for the limulus amebocyte lysate that is produced from the blood of horseshoe crabs and has some many essential uses in medicine and healthcare.
—JP Schlingman
Related Information:
Medical Labs May Be Killing Horseshoe Crabs
The Blood of the Crab
Crab Bleeders
As Horseshoe Crab Populations Steadily Decrease, their Indispensable Medical Use is Threatened
Could the Multi-Million Dollar Industry that Bleeds 500,000 Horseshoe Crabs a Year for Medical Research Drive Them to Extinction?
