Nov 30, 2018 | Laboratory Pathology, Laboratory Testing, Managed Care Contracts & Payer Reimbursement, News From Dark Daily
Studies show medical laboratories may be particularly hit by adjustments to hospital chargemasters as hospitals prepare to comply with Medicare’s New Transparency Rule
Recently, Kaiser Health News (KHN) published a story about a $48,329 bill for allergy testing that cast a spotlight on hospital chargemaster rates just as healthcare providers are preparing to publish their prices online to comply with a new Centers for Medicare and Medicaid Services (CMS) rule aimed at increasing pricing transparency in healthcare. The rule goes into effect January 1, 2019.
The patient—a Eureka, Calif., resident with a persistent rash—had received an invoice for more than $3000 from her in-network provider.
Though this type of allergy skin-patch testing is usually performed in an outpatient setting by a trained professional, such as an allergist or dermatologist, the patient elected to have the testing performed at Stanford Health Care (Stanford), a respected academic medical system with multiple hospitals, outpatient services, and physician practices.
The patient’s insurance plan, Anthem Blue Cross (Anthem), paid $11,376 of the $48,329 amount billed by Stanford Health Care, which was the rate negotiated between the insurer and Stanford, Becker’s Healthcare reported. The patient ultimately paid $1,561 out-of-pocket.
So, where did that $48,329 in total charges come from? Experts pointed to the provider’s chargemaster. A chargemaster (AKA, charge description master or CDM) lists a hospital’s prices for services, suppliers and procedures, and is used by providers to create a patient’s bill, according to California’s Office of Statewide Health Planning and Development (OSHPD).
Chargemasters note high prices beyond hospitals’ costs and may be considered jumping off points for hospitals to use in invoicing payers and patients, RevCycleIntelligence explained.
Hospital representatives will negotiate with insurance companies, asking them to pay a discounted rate off the chargemaster list. A patient with health insurance accesses care at that negotiated rate and perhaps has responsibility for a share of that amount as well.
However, an out-of-network patient, uninsured person, or cash customer who receives care will likely be billed the full chargemaster rate.
In a statement to KHN, Stanford explained that the California woman’s care was customized and, therefore, costly: “We conducted a comprehensive evaluation of the patient and her environmental exposures and meticulously selected appropriate allergens, which required obtaining and preparing putative allergens on an individual basis.”
Johns Hopkins researchers Ge Bai, PhD, CPA (left), and Gerard Anderson, PhD (right), authored a study published in Health Affairs that shows “Hospitals on average charged more than 20 times their own costs in 2013 in their CT scan and anesthesiology departments.” Hospitals with clinical laboratory outreach programs will want to consider how their patients may respond as new federal price transparency requirements make it easier for patients to see medical laboratory test prices in advance of service. (Photo copyright: Johns Hopkins University.)
Now is a Good Time for Clinical Laboratories to Make Chargemaster Changes
Some organizations, such as the Healthcare Financial Management Association (HFMA), are calling for chargemaster adjustments as part of a comprehensive plan to improve transparency and lower healthcare costs. This falls in line with the new CMS rule requiring hospitals to post prices online starting Jan.1, 2019.
In fact, hospital medical laboratories, which cannot distinguish their services from competitors, may be impacted by the new CMS rule perhaps more than other services, the HFMA analysis warned.
“The initial impact for healthcare organizations, if they have not already experienced it, will be on commoditized services such as [clinical] lab and imaging. Consumers do not differentiate between high and low quality on a commoditized service the same way a physician might, which means cost plays a larger role in consumers’ decision making.” That’s according to Nicholas Malenka, Senior Consultant, GE Healthcare Partners, and author of the HFMA report. He advises providers to do chargemaster adjustments that relate charges to costs of services, competitors’ charges, and national data.
Medical laboratory leaders also may want to take another look at the opportunities and risks for labs suggested in an earlier Dark Daily e-briefing on the Medicare requirement. (See, “Latest Push by CMS for Increased Price Transparency Highlights Opportunities and Risks for Clinical Laboratories, Pathology Groups,” August 8, 2018.)
Are Chargemaster Charges Truly Excessive? Johns Hopkins Researchers Say ‘Yes!’
Most hospitals with 50 beds or more have a charge-to-cost ratio of 4.32. In other words, $432 is charged when the actual cost of a service is $100, according a study conducted by Johns Hopkins University and published in Health Affairs.
The researchers also noted in a news release about their findings titled, “Hospitals Charge More than 20 Times Cost on Some Procedures to Maximize Revenue,” that:
- Charge-to-cost ratios range from 1.8 for routine inpatient care to 28.5 for a CT scan; and,
- Hospitals with $100 in CT costs may charge an uninsured patient or out-of-network patient $2,850 for the service.
“Hospitals apparently markup higher in the departments with more complex services because it is more difficult for patients to compare prices in these departments,” lead author Ge Bai, PhD, CPA, Associate Professor at Johns Hopkins Carey Business School, noted in the news release.
“(The bills for high charges) affect uninsured and out-of-network patients, auto insurers, and casualty and workers’ compensation insurers. The high charges have led to personal bankruptcy, avoidance of needed medical services, and much higher insurance premiums,” co-author Gerard Anderson, PhD, Professor of Health Policy and Management at Johns Hopkins Bloomberg School of Public Health, stated in the news release.
Legal Issues Possible for Hospitals, Medical Laboratories, Other Providers
Still another study published in the American Journal of Managed Care (AJMC) explored the legality of “surprising” uninsured and out-of-network patients with bills at the chargemaster rates. It found that contract law supports market-negotiated rates—not chargemaster rates that do not reflect actual costs or the market.
“Patients and payers should know that they are under no obligation to pay surprise bills containing chargemaster rates, and state attorneys generally can use the law to prevent providers from pursing chargemaster-related collection efforts against patients,” the researchers wrote.
Labs Need to Get Involved
Clinical laboratory leaders in hospitals and health systems are advised to reach out to hospital chargemaster coordinators to ensure the chargemaster, as it relates to the lab, is inclusive, accurate, and in sync with competitive market data. Independent medical laboratories may want to similarly check their chargemasters to see how their lab test prices compare to the prices charged by other labs serving the same community.
—Donna Marie Pocius
Related Information:
That’s a Lot of Scratch: The $48,329 Allergy Test
Allergy Tests
Six Things to Know About a Woman’s $48K Allergy Test
The Role of the Hospital Chargemaster in Revenue Cycle Management
Why Your Access Strategy Demands Pricing Transparency
CMS Proposes Changes to Empower Patients and Reduce Administrative Burden
US Hospitals Are Still Using Chargemaster Markups to Maximize Revenue
Hospitals Charge More than 20 Times Costs on Some Procedures to Maximize Revenue
Battling the Chargemaster: A Simple Remedy to Balance Billing for Unavoidable Out-of-Network Care
Latest Push by CMS for Increased Price Transparency Highlights Opportunities and Risks for Clinical Laboratories and Pathology Groups
Sep 24, 2018 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations, News From Dark Daily
It’s the next wave in the long-running trend of hospital laboratory consolidation, as the need to trim costs and support thriving medical laboratory outreach programs continues
There’s an important new development in the hospital/health system sector of the clinical laboratory industry that continues the longstanding trend of consolidating multi-site lab operations. It is to rationalize and standardize medical laboratory operations across all lab sites within the health system. Effectively, this standardization trend represents the next cycle of clinical laboratory consolidation.
One recent example of this trend can be found at Atrium Health, the hospital health network based in Charlotte, N.C. (formerly known as Carolinas HealthCare System until earlier this year). Becker’s Hospital Review states that Atrium Health is the “seventh largest nonprofit system in the country based on number of acute-care hospitals (35).”
Creating Standardized Medical Laboratory Testing Services at Multiple Sites
Over the past four years, the clinical laboratory team at Atrium Health has worked to design, build, and operate a new, state-of-the-art core laboratory. At the same time, there were sequential projects to integrate the lab testing services and operations of nine other medical lab sites within the health system to better align the test menu, lab instruments, and workflow at these sites with the activities of the core laboratory.
According to Modena Henderson, MHA, the Vice President of Laboratory Services at Atrium Health, in an interview with Dark Daily, there were multiple primary goals in this project to rationalize and standardize lab testing at all the participating lab sites. They include:
- Standardizing lab test methodologies, reference ranges, and test menu;
- Standardizing analyzers and test platforms across all labs;
- Using Lean, Six Sigma, and other process improvement methods to streamline workflow and reduce test turnaround time;
- Improve productivity of lab staff;
- Increase quality while reducing or eliminating unproductive activities;
- Using real-time analytics middleware to keep lab management informed on a daily basis, and,
- Collaborating with emergency departments, wards, and outreach physicians to deliver more value with clinical lab testing services.
Using the ‘Three Ps of Project Management’ Approach in Health System Labs
The centerpiece of this program of lab rationalization and consolidation was the design and build-out for a new core clinical laboratory facility. Henderson said her team followed the principals of the “Three Ps of Project Management”—People, Process, Performance—to model the new lab facility, then guide how it was constructed and brought into daily clinical service.
“The Atrium Health laboratory regionalization project is an example of the next step that many innovative hospital laboratories are taking,” stated Robert L. Michel, Editor-in-Chief of The Dark Report. “Every lab has the same double challenge. First is financial. Hospital lab budgets are shrinking as growth in inpatient admissions slows. Outreach revenues are declining as Medicare and private payers slash lab test prices.
“Second, labs must come up with the capital needed to acquire and deploy the expensive and sophisticated new genetic and molecular tests that physicians and patients want,” he continued. “Hospital and health network labs must offer these new tests to keep their parent organizations at the cutting edge of clinical care.
Clinical Labs See Value in Standardizing Test Methodologies, Menus
“Thus, it is logical for the clinical labs of health networks to begin the process of rationalizing and standardizing their test menus, methodologies, and analyzers at every site within the system that performs medical lab testing,” emphasized Michel. “This is a development that we have watched gather momentum.”
Keynote Speaker Robert L. Michel, Editor-in-Chief of The Dark Report and Dark Daily will discuss how clinical laboratories of hospitals and health networks are rationalizing and standardizing their medical laboratory testing services to achieve the goals of managing lab costs, boosting quality, and increasing lab outreach revenue. The 12th annual Lab Quality Confab takes place on Oct. 9-10, 2018, at the Hyatt Regency Atlanta. (Photo copyright: The Dark Report.)
Michel offered two examples of sizable programs to rationalize and standardize clinical lab tests and services across a large health system. One is in Michigan, at Ascension Health. The other is in the Canadian Province of Québec. Both are large and ambitious undertakings, both in the number of lab sites involved and the large geography served by these clinical laboratories.
Consolidation Project in Québec involves 123 Clinical Lab Facilities
Québec’s provincial health system wants to consolidate 123 clinical laboratories in the province into 11 groups (clusters) of labs. Each lab group, or cluster, will have a core lab and rapid response labs. Test menus and methodologies will be standardized throughout the province. In an interview with The Dark Report, Ralph Dadoun, PhD, Project Director for Optilab Québec, plans to accomplish the consolidation without adding costs.
In Michigan, Ascension’s clinical lab leadership is working to integrate and standardize the labs that are operated by seven system organizations. This includes 14 hospitals and 18 existing laboratories located throughout the entire State of Michigan. In an interview with The Dark Report, Carlton Burgess, MSM, Vice President of Laboratory Services at Ascension Health’s St. John Providence Clinical Pathology Laboratory in Grosse Pointe Woods, Mich., stated that the goal is to have all the labs in the state work together in a seamless, integrated fashion.
Regional Lab Integration at North Carolina’s Biggest Health System
“To achieve this, the labs will be linked in four regions—a process we describe as regional integration,” explained Burgess. “Each region has a core lab and rapid response labs and each region will be responsible for building lab volume through increased outreach testing. In addition to changing how labs serve each region, our statewide standardization project has three objectives:
- “Repatriate existing send-out lab testing back into Michigan;
- “Establish standard test menus for each facility; and,
- “Renew each lab’s focus on growing lab outreach business.
“Every lab administrator and pathologist working in hospital and health network laboratories should be tracking this new trend of regionalization and standardization of hospital labs,” observed Michel. “That’s because labs already moving down this path are setting new standards for the entire clinical laboratory industry. This goes beyond cost and productivity, because these labs are putting the systems in place that will allow them to deliver more value to physicians and thus be paid more for that value by private health insurers.”
Innovative Lab Leaders to Speak at Lab Quality Confab in Atlanta
Lab leaders from Ascension Health will be keynote speakers at the upcoming 12th Annual Lab Quality Confab that takes place on October 9-10, 2018, at the Hyatt Hotel in Atlanta. They will also conduct multiple learning sessions to share their successes and lessons learned in building a new core laboratory and using that as a foundation to rationalize and standardize test methods, reference ranges, menus, lab automation, and analyzers at every clinical lab facility in the Ascension Health system. Sessions by Ascension Health lab leaders include:
- Leveraging Lean to become a Best-in-Class Lab Performer: How We Built and Automated a New Core Lab while Integrating Lab Operations and Helping Staff Embrace a New Culture; Modena Henderson, Vice President, Laboratory Services, and, Steven Harris, Assistant Vice President, Atrium Health.
- Achieving Standardized, High-Performance Lab Testing Services at Multiple Hospitals Using Lean Methods and Effective Engagement with Lab Staff and Nurses; Gary Catarella, MBA, MT(ASCP), Assistant Vice President, Hospital Operations, Atrium Health.
- Lessons We’ve Learned in Our Step-by-Step Journey to Transform Lab Operations and Integrate Testing across All Sites: Engaging Staff, Sustaining Change, Working with Vendors and Consultants—Interactive Roundtable Discussion; Modena Henderson, Vice President, Laboratory Services; and, Steven Harris, Assistant Vice President, Atrium Health.
Using Lean, Six, Sigma, ISO 15189 in Clinical Laboratory Operations
Lab Quality Confab this year features 60 speakers and 40 presentations from lab administrators, pathologists, and other lab managers on their successes and innovations using Lean, Six Sigma, ISO 15189, and other process management methods. You can view the full agenda here (or copy and paste this URL into your web browser: https://www.labqualityconfab.com/agenda).
This year’s Lab Quality Confab is on track to be the largest in its 12-year history. Limited spaces are still available. To ensure your place, register today at: https://www.labqualityconfab.com/register (or copy and paste this URL into your web browser: https://www.labqualityconfab.com/register).
Also, you can bring your lab team and make this Lab Quality Confab a group learning opportunity. When you bring four or more from your organization, each can register for $695 for this two-day learning event. One benefit you’ll gain from bringing your team is that it will give them the knowledge, the tools, and the confidence to help your lab reduce costs without compromising quality, while supporting sustained revenue growth from your hospital lab’s successful outreach program.
—Michael McBride
Related Information:
Full Agenda and Other Details for 12th Annual Lab Quality Confab
To Register for 12th Annual Lab Quality Confab
10 Things to Know about Atrium Health, Formerly Carolinas HealthCare System
Québec’s Laboratory Consolidation Plan Aims to Save $13.5 Million: Optilab Québec to move 123 labs into 11 lab groups
Michigan’s Ascension to Standardize Labs Throughout the State: Goals Are Common Test Methods, Menus, Practices
Aug 27, 2018 | Laboratory Management and Operations, Laboratory News, Laboratory Operations, Management & Operations, News From Dark Daily
Data generated by medical laboratories and diagnostic providers takes an increasing role in treatment and precision medicine and allows greater analysis of data and integration of data into the care process
Most anatomic pathologists recognize that the unstructured data that makes up most pathology reports also represents a barrier to more sophisticated use of the information in those pathology reports. One solution is for pathology groups to adopt synoptic reporting as a way to get a pathology report’s essential data into structured fields.
The healthcare marketplace recognizes the value of structured data. In 2012, venture capitalists funded a new company called Flatiron Health. Flatiron’s goal was to access the medical records of cancer patients specifically to extract the relevant—and generally unstructured—data and put it into a structured database. This structured database could then be used to support both research and clinical care for cancer patients.
How valuable is structured healthcare data? Just this February, Roche paid $1.9 billion to acquire Flatiron. At that point, Flatiron had assembled information about the health records of two million cancer patients.
But Roche (ROG.S), recognizing the value of data, was not done. In July, it entered into an agreement to pay $2.4 billion for the remaining shares of cancer-testing company Foundation Medicine that it did not own. Foundation Medicine sequences tumors and uses that genetic data to assist physicians in diagnosing cancer, making treatment decisions, and identifying cancer patients who qualify for specific clinical trials.
Anatomic pathologists play a central role in the diagnosis, treatment, and monitoring of cancer patients. It behooves the pathology profession to recognize that generating, storing, analyzing, and reporting the data generated from examinations of tumor biopsies is a critical success factor moving forward. Otherwise, other players and stakeholders will move past the pathology profession and stake their own claim to capturing, owning, and using that data to add value in patient care.
How Lack of Standards Impact Transfer of Patient Data
DATAMARK Inc., a business process outsourcing (BPO) company headquartered in El Paso, Texas, reports that analysts from Merrill Lynch, Gartner, and IBM estimate unstructured data comprises roughly 80% of the information in the average electronic medical record. This data could be the key to improving outcomes, tailoring precision medicine treatments, or early diagnosis of chronic diseases.
From narrative descriptions of biopsies to dictated entries surrounding preventative care appointments, these entries hold data that might have value but are difficult to collate, organize, or analyze using software or reporting tools.
To further complicate matters, each service provider in a patient’s chain of care might hold different standards or preferred methods for recording data.
“At this point, [standards] are not to a level that helps with the detailed clinical data that we need for the scientific questions we want to ask,” Nikhil Wagle, MD, Assistant Professor of Medicine, Dana-Farber Cancer Institute, Harvard Medical School, and Associate Member, Broad Institute, told the New York Times.
An oncologist at the Dana Farber Cancer Institute in Boston, Wagle and his colleagues are creating a database of metastatic breast cancer patients capable of linking medical records, treatments, and outcomes with their genetic backgrounds and the genetics of their tumors. Despite best efforts, they’ve only collected 450 records for 375 patients in 2.5 years.
Nikhil Wagle, MD (above), Assistant Professor of Medicine, Dana-Farber Cancer Institute, Harvard Medical School, and Associate Member, Broad Institute, is building databases that link patient outcomes and experiences with their EHRs. But sharing that information has proved problematic, he told the New York Times. “Patients are incredibly engaged and excited,” he said, “[But] right now there isn’t a good solution. Even though the patients are saying, ‘I have consented for you to obtain my medical records,’ there is no good way to get them.” (Photo copyright: Dana-Farber Cancer Institute.)
Additionally, once records are obtained, the information—sometimes spanning hundreds of faxed pages—must still be processed into data compatible with Dana-Farber’s database. And updating and maintaining the database requires a full-time staff of experts that must review the information and accurately enter it as required.
When critical concerns arise—such as a cancer diagnosis—information that could yield valuable clues about treatment options and improve outcomes might be held in any number of data silos in any number of formats.
This doesn’t account for the complexity of organizing such information for researchers who are developing new treatments, applying data to less targeted approaches, or dealing with privacy concerns between care providers.
Moving forward, those who can create and interact with data in a way that requires minimal human touch to make it suitable for analysis, further processing, or archiving, could communicate data more effectively and glean value from the growing trove of data silos created by laboratories around the world.
Big Pharma Making Big Bets on Structured Data
These are all the reasons why the recent moves by Roche show the importance and perceived value of structured medical records data as it takes an increasingly important role in precision medicine treatments and diagnosis.
With its acquisition of both Flatiron Health and Foundation Medicine, Roche has secured the ability to generate data, convert said data into a structured format to drive decisions, improve core data-related services, and promote the value of their offerings. This positions Roche to maximize the value of its data for internal use and marketing to researchers and other interested parties.
For clinical laboratories, pathology groups, and other diagnostics providers generating untold amounts of data daily, this highlights a critical opportunity to stay ahead of future trends and position themselves as valuable sources of information as healthcare data continues to play an essential role in modern healthcare.
—Jon Stone
Related Information:
New Cancer Treatments Lie Hidden under Mountains of Paperwork
Unstructured Data in Electronic Health Record Systems: Challenges and Solutions
Pharma Giant Roche Just Made a $2.4 Billion Bet on Cancer Data
Roche to Buy Flatiron Health for $1.9 Billion to Expand Cancer Care Portfolio
Why Drug Giant Roche’s $1.9 Billion Deal to Buy Data Startup Flatiron Health Matters
Roche Acquires the Outstanding Shares of Foundation Medicine for $2.4Bn
New Solutions for Unstructured Data May Help with Clinical Laboratory and Anatomic Pathology Data
Jul 27, 2018 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Management & Operations, News From Dark Daily
Tuft’s proof-of-concept demonstration study shows how changes in saliva can be employed as biomarkers for development of future diagnostic monitoring devices and applications
For years, pathologists and dentists have recognized that the mouth contains many useful biomarkers for a wide range of health conditions and diseases. Now a study by a research team at Tufts University School of Engineering (Tufts) has demonstrated that a tooth-mounted sensor can reliably measure certain target markers.
In this proof-of-concept study, Tufts researchers developed a tooth-mounted sensor that monitors food consumption as it enters the body. This potentially adds behavioral data to the growing list of exploitable biomarkers available to developers of in vitro diagnostics (IVDs) and wearable medical monitoring devices. For that reason, many clinical laboratory managers and anatomic pathologists will want to track further development of this technology, which uses the mouth as the source of the markers to be measured.
A report detailing the device was first published in the scientific journal Advanced Materials in March of this year.
Sensor Reacts to Biomarkers in Saliva
The 2×2-millimeter flexible sensor consists of three layers and adheres to the tooth like a sticker. It has two gold outer rings surrounding an inner layer of bio-responsive material that is highly sensitive to glucose, salt, and alcohol. The presence of any of these substances alters the electrical properties of the sensor and incites it to transmit radio frequency waves that can be received by mobile devices.
Researchers conducting a proof-of-concept study at Tufts University School of Engineering have developed “a materials‐based strategy to add utility to traditional dielectric sensors by developing a conformal radiofrequency (RF) construct composed of an active layer encapsulated between two reverse‐facing split ring resonators,” their paper published in Advanced Materials notes. The sensor is shown above mounted to a tooth, where it reacts to the presence of certain biomarkers in the saliva, triggering the transmission of an RFID signal. This device has the potential to also measure the same biomarkers used in clinical laboratory tests. (Photo copyright: Smithsonian Magazine/Tufts University School of Engineering.)
There are many possible uses for this tooth-mounted sensor. Individuals with medical conditions such as diabetes, celiac disease, or hypertension, which require them to avoid certain substances in their diet, could benefit from utilizing a device that employs the technology under development at Tufts.
Such a gadget might also help those trying to lose weight. The creators hope to enhance the material, so it has the ability to discern additional nutrients and chemicals.
“If you can evolve the sensor and engineer it to have a database of food consumption, then you could think about nutrition management,” Fiorenzo Omenetto, PhD, Professor, Department of Biomedical Engineering at Tufts and one of the authors of the research told Smithsonian Magazine. “That could be reminding us that we’re indulging too much in sugar or something like that.”
It also could potentially detect physiological or chemical changes taking place in the body by detecting certain bio-markers in the saliva.
“In theory we can modify the bio-responsive layer in these sensors to target other chemicals. We’re really limited only by our creativity,” Omenetto noted in a news release. “We have extended common RFID [radio frequency identification] technology to a sensor package that can dynamically read and transmit information on its environment, whether it is affixed to a tooth, to skin, or any other surface.”
Other Food Intake Devices
There have been previous attempts to develop wearable devices that monitors food intake. However, those gadgets usually required the use of mouth guards and head gear, which are too cumbersome for continuous everyday use. The minute size of the Tufts tooth-mounted device renders it more practical for consumers. And, since it can be mounted anywhere on a tooth—front or back—it can be made undetectable while being worn.
“This study is an interesting proof-of-concept demonstration that small, wireless biosensors can detect changes in saliva due to the presence of compounds such as salt, sugar, and alcohol,” Ben Almquist, PhD, a lecturer in the Department of Bioengineering at Imperial College London, told Smithsonian Magazine.
“For instance, for continuous monitoring of food intake, the sensors will need to be robust enough to withstand abrasion during chewing,” Almquist noted. “In addition, foods are complex mixtures of compounds including salts, sugars and proteins, and the relative amounts of each that enter into saliva will depend on factors such as the nature of the food [i.e., cooked versus fresh], the amount of chewing, and the time in the mouth before swallowing.”
The device currently remains in the prototype stage and more testing will be needed to determine its efficacy and durability. However, the emergence of such wearable devices for medical use suggests valuable opportunities for clinical laboratories.
Because data captured from the tooth-mounted device is transmitted wirelessly, clinical laboratories could potentially store and monitor the data, compare the collected data to other medical laboratory test results for the same patient, then communicate that information to clinicians, other caregivers, and even the patients. This would be a new way for clinical laboratories to provide innovative, value-added services to healthcare professionals and consumers.
—JP Schlingman
Related Information:
This Tiny Tooth Sensor Could Keep Track of the Food You Eat
Scientists Develop Tiny Tooth-mounted Sensors That Can Track What You Eat
A New Tooth-mounted Sensor Will Soon Help You Lose Weight
Functional, RF‐Trilayer Sensors for Tooth‐Mounted, Wireless Monitoring of the Oral Cavity and Food Consumption
Jul 16, 2018 | Laboratory News, Laboratory Operations, Laboratory Testing, News From Dark Daily
This potential new source of diagnostic biomarkers could give clinical labs a new tool to diagnose disease earlier and with greater accuracy
Clinical laboratories may soon have a new “omics” in their toolkit and vocabulary. In addition to genomics and proteomics, anatomic pathologists could also be using “interactomics” to diagnose disease earlier and with increased accuracy.
At least that’s what researchers at ETH Zurich (ETH), an international university for technology and natural sciences, have concluded. They published the results of their study in Cell.
“Here, we present a chemoproteomic workflow for the systematic identification of metabolite-protein interactions directly in their native environments,” the researchers wrote. “Our data reveal functional and structural principles of chemical communication, shed light on the prevalence and mechanisms of enzyme promiscuity, and enable extraction of quantitative parameters of metabolite binding on a proteome-wide scale.”
Interactomics address interactions between proteins and small molecules, according to an article published in Technology Networks. The terms “interactomics” and “omics” were inspired by research that described, for the first time, the interactions and relationships of all proteins and metabolites (A.K.A, small molecules) in the whole proteome.
Medical laboratories and anatomic pathologists have long understood the interactions among proteins, or between proteins and DNA or RNA. However, metabolite interactions with packages of proteins are not as well known.
These new omics could eventually be an important source of diagnostic biomarkers. They may, one day, contribute to lower cost clinical laboratory testing for some diseases, as well.
Metabolite-Protein Interactions are Key to Cellular Processes
The ETH researchers were motivated to explore the interplay between small molecules and proteins because they have important responsibilities in the body. These cellular processes include:
“Metabolite-protein interactions control a variety of cellular processes, thereby playing a major role in maintaining cellular homeostasis. Metabolites comprise the largest fraction of molecules in cells. But our knowledge of the metabolite-protein interaction lags behind our understanding of protein-protein or protein-DNA interactomes,” the researchers wrote in Cell.
Leveraging Limited Proteolysis and Mass Spectrometry
The researchers used limited proteolysis (LiP) technology with mass spectrometry to discover metabolite-protein interactions. Results aside, experts pointed out that the LiP technology itself is significant.
“It is one of the few methods that enables the unbiased and proteome-wide profiling of protein conformational changes resulting from interaction of proteins with compounds,” stated a Biognosys blog post.
Biognosys, a proteomics company founded in 2008, was originally part of a lab at ETH Zurich.
The ETH team focused on the E. coli bacterial cell in particular and how its proteins and enzymes interact with metabolites.
“Although the metabolism of E. coli and associated molecules is already very well known, we succeeded in discovering many new interactions and the corresponding binding sites,” Paola Picotti, PhD, Professor of Molecular Systems Biology at ETH Zurich, who led the research, told Technology Networks. “The data that we produce with this technique will help to identify new regulatory mechanisms, unknown enzymes and new metabolic reactions in the cell,” she concluded. (Photo copyright: ETH Zurich.)
More than 1,000 New Interactions Discovered
The study progressed as follows, according to Technology Networks’ report:
- “Cellular fluid, containing proteins, was extracted from bacterial cells;
- “A metabolite was added to each sample;
- “The metabolite interacted with proteins;
- “Proteins were cut into smaller pieces by molecular scissors (A.K.A., CRISPR-Cas9);
- “Protein structure was altered when it interacted with a metabolite;
- “A different set of peptides emerged when the “molecular scissors” cut at different sites;
- “Pieces of samples were measured with a mass spectrometer;
- “Data were obtained, fed into a computer, and structural differences and changes were reconstructed;
- “1,650 different protein-metabolite interactions were found;
- “1,400 of those discovered were new.”
A Vast, Uncharted Metabolite-protein Interaction Network
The research is a major step forward in the body of knowledge about interactions between metabolites and proteins and how they affect cellular processes, according to Balázs Papp, PhD, Principal Investigator, Biological Research Center of the Hungarian Academy of Sciences.
“Strikingly, more than 80% of the reported interactions were novel and about one quarter of the measured proteome interacted with at least one of the 20 tested metabolites. This indicates that the metabolite-protein interaction network is vast and largely uncharted,” Papp stated in an ETH Zurich Faculty of 1000 online article.
According to Technology Networks, “Picotti has already patented the method. The ETH spin-off Biognosys is the exclusive license holder and is now using the method to test various drugs on behalf of pharmaceutical companies.”
The pharmaceutical industry is reportedly interested in the approach as a way to ascertain drug interactions with cellular proteins and their effectiveness in patient care.
The ETH Zurich study is compelling, especially as personalized medicine takes hold and more medical laboratories and anatomic pathology groups add molecular diagnostics to their capabilities.
—Donna Marie Pocius
Related Information:
The New “Omics”—Measuring Molecular Interactions
Map of Protein-Metabolite Interactions Reveals Principles of Chemical Communication
A New Study Maps Protein-Metabolite Interactions in an Unbiased Way
Cell Paper on Protein Metabolite Interactions Recommended in Faculty 1000 Twice
Jul 13, 2018 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations, News From Dark Daily
Popularity of the pocket-sized gene-sequencing device continues to prove that DNA testing away from clinical laboratories in remote clinics and outlying field laboratories is not just possible, but in some cases preferable
Once again, Oxford Nanopore Technologies (ONT) is demonstrating how next-generation gene sequencing technology can make it cheaper, simpler, and faster to sequence without the need for big clinical laboratories. And its successful raising of $180 million to expand development worldwide shows the support it has with capital funding investors.
Dark Daily has repeatedly reported on the development of the UK-based company’s point-of-care DNA sequencer going back to 2011. Called MinION, we predicted in 2015, that once brought to market, the pocket-sized gene sequencing machine “could help achieve the NIH’s goal of $1,000 human genome sequencing and, in remote clinics and outbreak zones, shift testing away from medical laboratories.” (See Dark Daily, “Point-of-Care DNA Sequencer Inching Closer to Widespread Use as Beta-Testers Praise Oxford Technologies’ Pocketsize, Portable Nanopore Device,” November 4, 2015.)
Since then, MinION’s use worldwide “for a number of biological analysis techniques including de novo sequencing, targeted sequencing, metagenomics, epigenetics, and more” has only expanded, according to multiple sources and ONT’s website.
How Does MinION Work as a Gene Sequencer?
The MinION nanopore sequencing device weighs about 100 grams (less than four ounces), is about the size of a standard deck of cards, operates off a laptop USB plug, and can sequence genetic material in a matter of minutes.
To perform the nanopore sequencing, a strand of deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) is pushed through small pores in a membrane. An ionic current is then applied to the material and voltage is implemented to measure any disruptions in the current. The resulting measurement represents an electrical signal that is converted to human-readable sequence.
“It’s like the ultimate barcode,” Gordon Sanghera, PhD, Chief Executive Officer at Oxford Nanopore, told BBC News.
Oxford Nanopore Technologies’ diminutive MinION gene-sequencing device has the capacity to directly recognize epigenetic markers that control gene activity and cellular processes involved in the onset and development of disease. Early detection of cancers, testing for birth defects and infectious diseases, and blood screening are possible future clinical laboratory applications for the MinION. Click on this link to watch video on MinION. (Photo copyright: Oxford Nanopore Technologies.)
Why is MinION Important?
One advantage to this technology is that it has the ability to sequence much longer strands of DNA when compared to existing technologies. The MinION can sequence over a million letters or bases, around 2% of a DNA strand or chromosome with 96% or above accuracy. The device can read remarkably long stretches of consecutive DNA letters. Readouts of several thousand letters are common and the record for the MinION is 882,000 consecutive DNA letters, Technology Review noted.
“One of the most important findings of this research was that, even though the human genome reference was completed or thought to have been completed a while ago, it still contains many missing pieces and we were able to close some of those gaps in the sequence by developing a new method for developing these extremely long reads using nanopore sequencing,” Nick Loman, PhD, Professor of Microbial Genomics and Bioinformatics at the School of Biosciences at the University of Birmingham, UK, told Pharmaphorum. Loman worked on research with Oxford Nanopore on nanopore sequencing.
“We’ve gone from a situation where you can only do genome sequencing for a huge amount of money in well-equipped labs to one where we can have genome sequencing literally in your pocket just like a mobile phone,” Loman told BBC News. “That gives us a really exciting opportunity to start having genome sequencing as a routine tool, perhaps something people can do in their own home.”
Using MinION in the Field
According to the Oxford Nanopore website, the MinION:
- Is pocket-sized and portable;
- Has up to 512 nanopore channels;
- Has a simple 10-minute sample preparation time;
- Allows real-time analysis for rapid and efficient results; and,
- Is adaptable to direct DNA or RNA sequencing.
The MinION Starter Pack is available for purchase on the company’s website with prices starting at $1,000. The kit includes:
- The MinION device;
- Flow cells;
- Sequencing kits;
- Wash kits; and,
- MinION community support.
Researchers at The Kinghorn Center for Clinical Genomics at the Garvan Institute of Medical Research in Darlinghurst, Australia, are currently using the MinION for research purposes.
Members of the Zebra Project (above), an international group of scientists, used Oxford Nanopore Technologies’ MinION to sequence genomes during epidemics in Latin America. With just a laptop computer for power, MinION can run complex gene-sequencing and achieve superior results than other similar technologies. It is in use worldwide bringing clinical laboratory testing to patients in remote, outlying locations. (Photo copyright: Ricardo Funari.)
“I think it’s really expanding the arsenal of tools we have to peer into cell biology and the root causes of cancer and various diseases,” Dr. Martin Smith, Head of Genomic Technologies at the center, told Australian Financial Review. “It’s really just starting to open the lid off the jar and peer more deeply into the genomics of the cell.”
Dr. Sanghera hopes the gadget could be utilized in the future to identify common infections at home and help consumers avoid unnecessary trips to doctors, clinics, and hospitals, and avert the misuse and overuse of prescription medications. He also feels MinION has applications outside the healthcare industry, such as detecting the presence of harmful microbes in food and water supplies.
As gadgets like MinION become more popular, the potential to move DNA sequencing closer to the patient (and out of the core lab) has implications for clinical laboratories and anatomic pathology groups. However, core labs would still be a preferred source to collect the raw data, store that data, then do the annotation of the DNA sequences and report the findings to the referring physician.
—JP Schlingman
Related Information:
How Knowing Your Genetic Code Could Lengthen Your Life
Genome in the Palm of Your Hand
Molecular Machines and the Place of Physics in the Biology Curriculum
Oxford Nanopore’s Hand-Held DNA Analyzer Has Traveled the World
Hostplus Sinks $27m Into Hand-held DNA Sequencing Firm Oxford Nanopore
GIC, Others Invest £100m In Hand-held DNA Sequencing firm Oxford Nanopore
Handheld Device Sequences Human Genome
Breakthrough Leads to Sequencing of a Human Genome Using a Pocket-sized Device
Oxford Nanopore’s Tech Reaches Genome Sequencing Landmark
Point-of-Care DNA Sequencer Inching Closer to Widespread Use as Beta-Testers Praise Oxford Technologies’ Pocketsize, Portable Nanopore Device
$900 Point-of-Care DNA Nanopore Sequencer May Hit Market in Next 12 Months
Is Whole-genome Sequencing Reaching a Tipping Point for Clinical Pathology Laboratories?
