Oct 20, 2017 | Digital Pathology, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Laboratory Testing, Managed Care Contracts & Payer Reimbursement
New study analyzes the dramatic decline in the utilization of imaging diagnostics between 2008 and 2014 and suggests that reductions in imaging use could be the result of changes in federal policy, increased deductibles, and cost-cutting focuses
Anatomic pathologists have experienced sustained cuts to reimbursements for both technical component and professional component services during the past eight to 10 years. But what has not happened to pathology is a 33% decline in the volume of biopsies referred to diagnosis. Yet that is what some studies say has happened to imaging reimbursement since 2006.
Using Medicare data for Part B imaging procedures covering the years 2001 to 2014, researchers at a major university identified that, beginning in 2006, the total reimbursement for imaging procedures declined at a steady rate throughout the following eight years covered by the study. It is unclear what implications the finding of this study of imaging utilization might predict for the utilization of advance anatomic pathology services.
Routine Use of Imaging in Diagnostics is Slowing Down
The research into imaging utilization was conducted at Thomas Jefferson University and published in the journal Health Affairs. Led by David C. Levin, MD, Emeritus Professor and former Chair of the Department of Radiology at Thomas Jefferson University Hospital, the researchers examined imaging data from Medicare Part B (2001-2014) to determine the reason and rate of “slowdown” in routine use of imaging in diagnostics.
The researchers calculated utilization rates for “advanced” imaging modalities and component relative value unit (RVU) rates for all imaging modalities. They determined that trends in imaging rates and RVU rates rose between 2000 and 2008, but then sharply declined from 2008 to 2014. The researchers theorized that the reduction might have been due to changes in federal policy, increasing deductibles, and focus on cost-cutting by hospitals and healthcare providers.
Levin, along with Thomas Jefferson University associates Vijay M. Rao, MD, FACR, current Chair of Radiology, and Laurence Parker, PhD, Associate Professor of Radiology; and University of Wisconsin-Madison statistics Professor Charles D. Palit, PhD, argue that the decrease in imaging orders might reduce diagnostic costs, but also could negatively impact surgical pathologists, radiologists, medical researchers, and patients themselves.
In a Modern Healthcare article, Levin states that the reduction in utilization of imaging and radiology could be a slippery slope leading to decreased access to life-saving diagnostic tools that could leave patients “not getting the scans they probably need.”
What’s Fueling the Multi-Year Decline in Utilization of Imaging and Radiology?
In the Journal of American College Radiology, Levin, Rao, and Parker, attempt to “assess the recent trends in Medicare reimbursements to radiologists, cardiologists, and other physicians for non-invasive diagnostic imaging (NDI).”
Using data acquired from Medicare part B databases, the authors reported that total reimbursements for NDI peaked at $11.9 billion in 2006, but saw a steep decline of 33% to just over $8 billion in 2015. They attribute some of this decline as a result of the Deficit Reduction Act of 2005, which went into effect in 2007, as well as other cuts to NDI reimbursement funding. Reimbursement to radiologists, according to Levin et al, dropped by more than 19.5%, and reimbursement to cardiologists dropped nearly 45% between 2006 and 2015.
Surgical pathologists may see parallels in the total reimbursement for imaging during the years 2002-2015 compared to pathology technical component and professional component reimbursement during those same years. Taken from the Thomas Jefferson University study, the graphic above shows “total Part B payments for non-invasive diagnostic imaging to all physicians under the Medicare Physician Fee Schedule, 2002 to 2015. Vertical axis shows billions of dollars. The abrupt decline in 2007 was due to the Deficit Reduction Act. The declines in 2009, 2010, and 2011 were due largely to code bundling in, respectively, transthoracic echocardiography, radionuclide myocardial perfusion imaging, and CT of the abdomen and pelvis.” (Caption and image copyright: Thomas Jefferson University.)
In different Journal of American College Radiology article, Levin and Rao outline their concerns over another suspected cause for the decline in imaging utilization—the American Board of Internal Medicine Foundation (ABIMF) Choosing Wisely initiative.
According to Levin and Rao, the Choosing Wisely initiative was intended “to reduce the use of tests and treatments that were felt to be overused or often unnecessary.” Imaging examinations were included in the list of tests that were deemed to be “of limited value” in many situations. Levin and Rao suggested that there might have been a need to curtail testing pushed by payers, policymakers, and physicians at the time, but that the Choosing Wisely initiative could have added to a decline in imaging testing spurred on by the confusion physicians felt when attempting to access unclear scenarios and recommendations for the 124 imaging tests listed.
Imaging Decline Could Have Unintended Consequences for Providers and Patients
In a Radiology Business article, Levin outlined some of the unintended consequences facing healthcare due to the reduction in imaging utilization. He states that “private imaging facilities are starting to close down” and “MRI and other advanced imaging exams are beginning to shift into hospital outpatient facilities.” He predicts that the shift from private facilities to hospital facilities could cause imaging costs to increase for customers and healthcare providers.
Levin suggests that Medicare could “raise the fees a little and make the private offices a little more viable.” The profit margins, Levin argues, “are so low right now that you basically can’t run a business.” Medicare as a program might be seeing huge savings, Levin notes in several articles, but physicians, laboratories, and patients are feeling the pinch as a result.
In an interview with Physicians Practice, Rao echoed Levin’s concerns. “Policy makers lack understanding of the value of imaging and spectrum of the services provided by radiologists,” he declared. “On an institutional level, under the new payment models, radiology is transitioning to a cost center and radiologists often don’t have a seat at the table.”
Rao points out that this devaluing of radiologists’ work affects not only healthcare facilities, but patients themselves. Radiologists provide “major contributions to patient care by making accurate diagnoses, and doing minimally invasive treatments given many technological advances leading to appropriate management and improved outcomes,” he argues. How long before Pathology follows a similar track?
Balancing Cost and Quality in Testing Without Sacrificing Patient Needs
The fear seems to be that the push to lower costs by eliminating unnecessary imaging is inhibiting radiologists and diagnosticians from providing necessary imaging for patients. And that delaying diagnoses affects the ability of healthcare providers to provide adequate and timely patient care. Rao suggests, however, that physicians’ use of medical imaging could simply be evolving.
“There were other factors that also helped limit the rapid growth, such as greater attention by physicians to practice guidelines, concerns about radiation exposure to patients, and the Great Recession of 2007 to 2009,” Rao noted in a Thomas Jefferson University news release. “However, we expect that additional changes, such as the advent of lung cancer and other screening programs, and the use of computerized clinical decision support, will continue to promote and support appropriate use of imaging technology.”
The drive to reduce healthcare expenditures should not be dismissed. We may soon see parallels in the rise and fall of imaging utilization for genetic testing, surgical pathology, and other new and expensive clinical laboratory technologies as policymakers attempt to balance increased spending against the clinical value of these diagnostic tools.
— Amanda Warren
Related Information:
The Overuse of Imaging Procedures on the Decline Since 2008
After Nearly a Decade of Rapid Growth, Use and Complexity of Imaging Declined, 2008–2014
Reducing Inappropriate Use of Diagnostic Imaging Through the Choosing Wisely Initiative
The Recent Losses in Medicare Imaging Revenues Experienced by Radiologists, Cardiologists, and Other Physicians
Five Minutes with David C. Levin, MD: Outpatient Imaging Cuts and Unintended Consequences
Ten Questions with Vijay M. Rao, MD, FACR
Diagnostic Imaging Transitions from Volume to Value
Imaging Use Plunges as Coding, Reimbursement Tightens Up
Has the Time Come for Integration of Radiology and Pathology?
Reference Pricing and Price Shopping Hold Potential Peril for Both Clinical Laboratories and Consumers
Oct 18, 2017 | Compliance, Legal, and Malpractice, Digital Pathology, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
The Joint Commission opposed the Medicare proposal, and patient advocate groups say rescinding it is a setback for hospital transparency
Powerful interests arrayed against greater transparency in the performance of hospitals, physicians, and medical laboratories have stopped a proposed Medicare program that would have allowed the public to see the results of hospital inspections.
Stopped in its tracks was an effort by the Centers for Medicare and Medicaid Services (CMS) to make hospital accreditation inspection reports available for public viewing. Opposition to this program led CMS to withdraw its plan for heightened transparency.
CMS originally called the proposal “groundbreaking” in a National Public Radio (NPR) article. That’s because it would have enabled consumers to view reports that private accreditation organizations, such as The Joint Commission, complete after each inspection. Inspection reports contain information on errors and problems found during hospital surveys. CMS’ push for more transparency in hospital inspections is consistent with the healthcare industry’s trend toward open sharing of healthcare quality, price, and other data.
“We are proposing changes relating to transparency of accrediting organizations survey reports and plans of correction of providers and suppliers,” CMS officials wrote in a proposed rule published on April 28.
CMS Pulls Back Proposal to Make Hospital Survey Reports Public
But it was not to be. After receiving comments, CMS officials stated in early August that the agency had pulled back the proposal.
“CMS is committed to ensuring that patients have the ability to review the findings used to determine that a facility meets the health and safety standards required for Medicare participation. However, we believe further review, consideration, and refinement of this proposal is necessary to ensure that CMS establishes requirements, consistent with our statutory authority, that will inform patients and continue to support high quality care,” noted a CMS fact sheet.
Agencies Find Problems in Hospitals That Accreditors Do Not, CMS Declares
It’s against federal law for CMS to release data related to hospital inspections, Becker’s Hospital Review reported. And, as part of the Clinical Laboratory Improvement Amendments (CLIA), clinical laboratories must participate in inspections to ensure they qualify for Medicare and Medicaid payments. However, the inspection reports of the nation’s medical laboratories are not made public.
So, what motivated CMS to make healthcare organizations’ inspection information public? CMS noted that private accreditation organizations miss serious provider problems that state inspectors find in follow-up visits to hospitals, ProPublica explained.
In fact, state agency reviews of 103 hospitals in 2014 found 41 serious deficiencies, including 39 missed by the accreditors, noted the NPR article.
The chart above based on Johns Hopkins research was compiled by the National Center for Health Statistics and reported by The Washington Post. It shows that medical errors are now the third leading cause of death in the US. (Photo copyright: The Washington Post.)
“Right now, the public has very little information about the places where they’re putting their life on the line, and that’s just not acceptable. If [they are] a good place, what are they afraid of?” Rosemary Gibson, Senior Advisor at The Hastings Center, stated in the NPR article.
Reaction from Accreditors and Consumer Groups Differs
The Joint Commission opposed the CMS proposal. And, now, patient safety advocacy groups are disappointed about the decision by Medicare officials to rescind the proposed program.
“We believe the proposal will have significant detrimental consequences on our nation’s ability to continually improve the delivery of healthcare services,” stated Mark Chassin, MD, FACP, MPP, MPH, Joint Commission President and Chief Executive Officer, in a June letter to CMS published partially in an HCPro blog post.
HCPro, a firm that aids organizations in accreditation, credentialing, and other needs, noted the following Joint Commission concerns about publicly shared survey reports in the blog post:
- Providers may be less likely to be open about opportunities for improvement;
- Accreditors could struggle to create new standards;
- The number of non-accredited facilities may increase;
- Accreditation may be devalued; and,
- Costs to providers and accreditors would likely rise.
The Center for Improvement in Healthcare Quality (CIHQ), another accreditation option for hospitals, also expressed concerns with the CMS proposal, according to the ProPublica report.
“Knowing that survey [inspection] reports are public knowledge will only incentivize hospitals and other healthcare entities to go back to the days of ‘hiding’ quality of care issues from accreditors, rather than working with us to improve the quality and safety of care rendered to patients,” CIHQ advised in the ProPublica article.
The Leapfrog Group, which bills itself as an advocate of hospital transparency, called the reversed proposal “a disappointing setback for healthcare transparency.”
In a statement, Leah Binder, President and Chief Executive Officer of The Leapfrog Group, noted, “We are disappointed to learn that the agency that runs Medicare (CMS) has reversed course on its proposal to require private accrediting organizations, such as the Joint Commission, to publicly release reports of problems they found in hospitals and other healthcare facilities. The public deserves full transparency on how the healthcare industry performs.”
Clearly the public is calling for increased transparency in healthcare. As are many organizations and industry journals, such as the Association of Health Care Journalists (AHCJ), which presented a national award to Ellen Gabler, an investigative reporter for the Milwaukee Journal Sentinel, for her work covering weaknesses in inspections for clinical laboratories. (See Dark Daily, “Journalists Take Home Top National Awards for Their Work Covering Theranos and the Clinical Laboratory Industry,” May 16, 2016.)
Some Accreditation Information Available Online
So, for the time being, it appears that what is found during hospital inspections will stay within the inspection report and will not become available to the general public. However, with consumers expecting greater transparency and higher levels of service in all aspects of healthcare, the interest in public access to the quality performance of hospitals, physicians, clinical laboratories, and anatomic pathology groups will only increase.
Meanwhile, for patients interested in existing resources about provider quality, The Joint Commission has an online “find a gold star healthcare organization” quality check. Also, the American College of Surgeons publishes an online search for accredited facilities. And, the Centers for Disease Control and Prevention (CDC) offers an online search for CLIA accredited labs.
—Donna Marie Pocius
Related Information:
Secret Data on Hospital Inspections May Become Public At Last
Proposed Centers for Medicare and Medicaid (CMS) Rule
Changes to the Application and Reapplication Procedures for National Accrediting Organizations
CMS Backs Off Proposal to Make Hospital Accredited Investigations Public; Five Things to Know
Accreditors Can Keep Their Hospital Inspection Reports Secret, Feds Decide
Joint Commission Comments on Proposed CMS Transparency Rule
Disappointing Setback for Healthcare Transparency
Journalists Take Home Top National Awards for Their Work Covering Theranos and the Clinical Laboratory Industry
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
