Jan 17, 2018 | Coding, Billing, and Collections, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Laboratory Testing, Management & Operations
Moving to market are the newest generation of LIMS products designed to serve clinical laboratories while supporting quality reporting initiatives and new sources of revenue
It was Bob Dylan who made a big hit out of the song, “The Times, They Are A-Changin’.” The same could be said for the next generation of software products designed for use by medical laboratories.
To be fully successful, these next-generation laboratory information management systems (LIMS) must be radically different than the generations that came before. For example, medical laboratories are frustrated with the many limitations of older LIS products that still incorporate software technologies that date back to the 1980s and 1990s, such as MUMPS, which stands for Massachusetts General Hospital Utility Multi-Programming System.
But the newest LIMS products must do more than simply incorporate the latest technologies in software and cloud-based services. They must support all the ways that clinical laboratories and anatomic pathology groups generate increased revenue. More specifically, all medical laboratories will be generating vast quantities of molecular and genetic data. Therefore, an effective LIMS must be capable of capturing that data while also enabling the lab to perform certain healthcare big data analyses in support of the referring physicians and parent hospitals.
There also will be the need for medical laboratories to use their LIMS capabilities to support the data reporting requirements of Medicare and private health insurers. Payers increasingly want providers to report their quality monitoring, patient outcomes, and certain cost-of-care parameters. All these are functions that older LIS (laboratory information systems) products were not developed to provide.
Anatomic pathology group stakeholders and clinical laboratory managers understand the vital importance of their LIMS. Laboratory and healthcare workflows depend on the system’s:
- efficiency;
- scalability that supports the growth of the lab and medical practice; and,
- flexibility to interface with modern, point-of-care telehealth technologies in ways that enable labs and practices to engage in today’s precision medicine healthcare initiatives.
The more immediate need is for a LIMS to be capable of supporting Medicare’s Quality Payment Programs (QPPs), primarily the MACRA Merit-based Incentive Payments System (MIPS). Most physicians, including pathologists, will participate in MIPS. The first Medicare incentives or penalties will be paid next year, based on 2018 metrics and performance.
Given all these changing demands of advanced software technologies and the need for medical laboratories to participate in various value-based revenue programs, how might a LIMS empower labs to ensure success and increased revenue?
Quality Payment Programs and Merit-based Incentives
As part of the shift toward value-based care, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) works to drive down costs and increase quality within both care and laboratory environments. MACRA establishes a data-driven payment system to reimburse service providers based on the outcome of services and care episodes, instead of the volume of services delivered or billed.
Combined with reduced payments, MACRA’s incentives and penalties, and Medicare’s QPP/MIPS payment programs, pressure has been increased on healthcare providers and medical laboratories alike. Thus, technology that gives labs a competitive edge is essential for thriving in an ever-evolving and increasingly competitive marketplace.
Meeting MACRA Goals with a Laboratory Information Management System
While electronic health record (EHR) systems have helped to consolidate patient protected health information (PHI), they do little to address the real-time creation of laboratory data and the accessibility of the massive volume of lab-related data stored in the average patient’s medical files.
A LIMS, however, helps to consolidate all this data in an easily accessible and powerful system. Some LIMS even combine with telehealth technologies to make data actionable and available at the point-of-care.
In this type of LIMS, laboratories, physicians, and other care providers all access the same dataset to ensure information is relayed quickly and efficiently. Interaction takes place using cloud-based interfaces, such as mobile apps or web portals. This ensures access to patient data and laboratory test results in a variety of locations without dependence on proprietary communications systems or hardware.
From bustling ERs and surgical wards to phlebotomists visiting long-term care facilities and mobile clinics, collecting and retrieving data becomes streamlined and accessible virtually anywhere.
The chart above illustrates how a LIMS offers increased potential to automate processes and scale operations while keeping physicians, patients, and other critical parties up to date. This increase in efficiency and access to data empowers providers to reach improved patient outcomes and reduce hospital readmission rates, increasing revenue for both clinicians and clinical laboratories. (Graphic copyright: NetLIMS.)
When implemented properly, a LIMS also helps laboratories and healthcare facilities meet the terms of MIPS. This reduces Medicare penalties and ensures payment adjustments, which improve revenue streams even further.
Understanding LIMS and Cloud-Based Lab Systems
To help outline and explain the benefits of a LIMS for laboratories and healthcare facilities, The Dark Report, in conjunction with NetLIMS, a global provider of laboratory information management systems to hundreds of hospitals and commercial laboratories worldwide, has produced a free white paper titled, “The Path to More Revenue: Cloud-Based LIMS, Mobile Apps, and Point-of-Care Telehealth.”
- This white paper addresses critical concerns, including:
- Overviews of new technologies;
- The impact of value-based programs on the lab market;
- The importance of MACRA and MIPS adherence;
- How technology, such as a LIMS, can help labs achieve improved efficiency; and,
- Tips on choosing a LIMS vendor to maximize ROI.
To download your free copy of the whitepaper click on this link: Or, copy this URL into your browser: https://www.darkdaily.com/whitepaper/the-path-to-more-revenue-cloud-based-lims-mobile-apps-and-point-of-care-telehealth .
Thanks to advances in LIMS design and development, remote patient digital therapeutics, and cloud-based technology, healthcare providers now have unprecedented opportunities to better manage the health of patients with chronic conditions. In addition, it can help you achieve better efficiency, economics, and compliance with MACRA.
This free white paper is your first step toward significantly reducing hospital readmission rates, bridging the gap between labs, physicians, and other healthcare providers they serve, and positively affecting patient outcomes, improving quality measures, and maximizing reimbursements for all services you provide.
—Jon Stone
Related Information:
The Path to More Revenue: Cloud-Based LIMS, Mobile Apps, and Point-of-Care Telehealth
How Close Is the End of Private Practice Pathology as We’ve Known It?
Attention Anatomic Pathologists: Do You Know Medicare Is Prepared to Change How You Are Paid, Beginning on January 1, 2017?
Innovator Hospitals Bring ICUs into the Info Age, Using New Design Approaches that involve Medical Laboratory Tests
Jan 15, 2018 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Lab-on-skin is the latest concept to join the lab-on-a-chip, lab-in-a-needle, and lab-on-paper field, as researchers continue to seek ways to miniaturize medical laboratory tests
Move over, lab-on-a-chip and lab-on-paper. There’s a new diagnostic technology in research labs that is gaining credibility. It is called lab-on-skin technology and some scientists are quite excited about how it might be used for a variety of clinical purposes.
A recent story published in ACS Nano titled, “Lab-on-Skin: A Review of Flexible and Stretchable Electronics for Wearable Health Monitoring,” reviews the latest advancements in lab-on-skin technology. It provides an overview of different research initiatives incorporating lab-on-skin technologies.
From telehealth to precision medicine to point-of-care mobile devices, anatomic pathologist and clinical laboratories are about to be challenged with new diagnostic technologies. These technologies are intended to streamline the workflow between physicians and medical laboratories while improving access to patient data and medical laboratory test results.
Of all the mobile devices designed to support medical care, no technology may have more potential to change the pathology profession than nanotechnology-based diagnostic devices. Whether lab-on-a-chip, lab-in-a-needle, or lab-on-paper, these miniature laboratories are so small dozens can be carried in a pocket.
Most importantly, for certain diagnostic tests, some of these devices being developed hope to deliver full-size-lab quality results accurately and inexpensively, even in rural regions and areas with little or no resources, such as electricity or water. (See Dark Daily, “Lab-on-a-Chip Diagnostics: When Will Clinical Laboratories See the Revolution?” September 9, 2016.)
Now, researchers have demonstrated that even biomarkers within human skin can be tested by medical wearable devices. “Lab-on-skin” has entered the pathology vernacular.
Lab-on-Skin Constantly Measures Physiological Data
According to ACS Nano, lab-on-skin devices are small electronic patches worn directly on the skin that noninvasively measure a variety of physiological data. These flexible gadgets can interpret information including:
- body temperature;
- blood oxygenation;
- hydration;
- blood pressure;
- glucose;
- potassium;
- sodium; and,
- lactate and pH levels in individuals.
The devices may also be used for wound care, prosthetics and rehabilitation, as well as for optogenetics and human-machine interfaces (HMI).
The image above from the ACS Nano article demonstrates various lab-on-skin devices, including: an NFC tattoo with a bare die chip mounted on an acrylic adhesive film; a soft radio sensor with commercial chips encapsulated in a fluid/ecoflex package; and, a sweat sensor on silicone foam. Each of these devices could be capable of delivering actionable diagnostic data to anatomic pathologists and clinical laboratories. (Image copyright: ACS Nano.)
Lab-on-skin technology can be utilized to read electrophysiological signals typically measured by electrodes placed on various parts of the body, such as:
The direct connection between the patches and the skin allows for continuous and precise data collection without the threat of drying out that comes with traditional electrodes.
Nanotechnology Driving Clinical Laboratory Diagnostic Applications
Because it is the largest organ in the body, skin provides a perfect pathway to convey biological information originating from various parts of the body, such as inner organs, muscles, blood vessels, and the dermis and epidermis.
The ACS Nano article discusses advancements in the designs and materials used for lab-on-skin patches. In addition to the term “lab-on-skin,” these devices may also be referred to as electronic skin, epidermal electronics, and electronic tattoos. They have untapped potential in a variety of clinical applications, including:
For example, researchers at the University of Illinois at Urbana-Champaign have created an epidermal nanotechnology device that utilizes sensors and wireless interfaces to measure ultraviolet (UV) exposure, a risk factor for skin cancers.
“Our goal with this research is to establish a set of foundational materials and device designs for systems that can improve health outcomes by providing information on UV exposure,” John A. Rogers, PhD, and Professor of Materials Science and Engineering and Professor of Chemistry told Nanowerk Spotlight.
Nanotechnology employs extremely small particles performed at the nanoscale (about 1 to 100 nanometers). This field is emerging as a vital element behind cutting-edge innovations in medicine and healthcare.
“We developed new chemistries that yield color changes that quantitatively relate to total exposure dose, separately in both the UV-A and UV-B regions of the solar spectrum,” explained Rogers. “Our formulations have the additional advantage that they provide soft, low modulus mechanics to enhance comfort and biocompatibility with the skin surface.”
Mini-Laboratory Devices Could Push Pathology Data to Clinical Laboratories
The combination of using lab-on-skin devices with nanotechnology can provide researchers and medical professionals a multifunctional and valuable tool for health monitoring and the diagnosis of diseases. However, more research and clinical studies are needed to establish the validity of using lab-on-skin devices in healthcare applications.
Nevertheless, clinical laboratories and pathology groups will be handling more data in the future, generated by these miniature laboratory devices. Their usefulness, especially in challenging healthcare environments, is only beginning to be fully discovered.
—JP Schlingman
Related Information:
A Lab-on-Skin: A Review of Flexible and Stretchable Electronics for Wearable Health Monitoring (downloadable PDF)
Lab-on-Skin: A Review of Flexible and Stretchable Electronics for Wearable Health Monitoring (original ACS Nano article)
Lab-on-Skin: Nanotechnology Electronics for Wearable Health Monitoring
Stick-on Epidermal Electronics Tattoo to Measure UV Exposure
Nanotechnology in Healthcare (Part 1: Fitness Monitoring, Diagnostics and Prevention)
Nanotechnology in Healthcare (Part 2: Nanomedicine Therapy)
Breathable, Wearable Electronics on Skin for Long-term Health Monitoring
Nano-chip Promises to Heal Organs at a Touch
IBM and Mount Sinai Researchers Develop Innovative Medical Lab-on-a-Chip Solution
Lab-on-a-Chip Diagnostics: When Will Clinical Laboratories See the Revolution?
Researchers at University of Rhode Island Unveil Lab-on-Paper Test Capable of Multireagent Diagnostics: Could Enable ‘Diagnostics Without the Lab’ Say Developers
Sleek ‘Lab in a Needle’ Is an All-in-One Device That Detects Liver Toxicity in Minutes during a Study, Showing Potential to Supplant Some Medical Laboratory Tests
Jan 12, 2018 | Laboratory Pathology
Clinical labs and pathology groups know how advances in targeted therapies and genomics far outpace providers’ and patients’ ability to know how best to use and pay for them.
One fascinating development on the road to precision medicine is that many new cancer drugs now in clinical trials will require a companion genetic test to identify patients with tumors that will respond to a specific therapeutic drug.
This implies more genetic testing of tumors, a prospect that challenges both the Medicare program and private health insurers because they already struggle to cope with the flood of new genetic tests and molecular diagnostic assays. However, even as this genetic testing wave swamps payers, some pharmaceutical companies have cancer drugs for rare types of cancers and these companies would like to see more genetic testing of tumors.
Pathologists and clinical laboratory managers will find this to be precisely the dilemma facing specialty pharma company Loxo Oncology (NASDAQ:LOXO), a biopharmaceutical company located in San Francisco and Stamford, Conn.
Loxo is developing larotrectinib (LOXO-101), a “selective TRK inhibitor.” According to a Loxo press release, Larotrectinib is “a potent, oral, and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRK receptors).” In short, the drug is designed to “directly target TRK, and nothing else, turning off the signaling pathway that allows TRK fusion cancers to grow.”
How to Find Patients for This Cancer Drug
While a powerful, new, targeted cancer drug will be a boon to cancer therapy, it is only intended for a relatively small number of patients. Loxo estimates that between 1,500 and 5,000 cases of cancer are caused by TRK mutations in the United States each year. Conversely, according to the National Cancer Institute, the total number of new cancer diagnoses in the US in 2016 was 1,685,210.
An article in MIT Technology Review on larotrectinib notes, “To find patients, Loxo will need to convince more doctors to order comprehensive tests that screen multiple genes at once, including TRK.” And that is where things get complicated.
“These advanced genetic tests, which can cost $5,000 or more, are offered by companies like Foundation Medicine, Caris Life Sciences, and Cancer Genetics. The problem is, insurers still consider the tests ‘experimental’ and don’t routinely cover them, meaning patients are often stuck picking up the bill,” notes MIT Technology Review.
Data for the graph above comes from the National Human Genome Research Institute. The graph illustrates the steep decline in cost for whole genome sequencing over the past 17 years. As the cost of genetic testing drops, development of targeted-drug cancer therapies increases. Clinical laboratories and anatomic pathology groups can expect to be performing more such tests in the future. (Graphic copyright: National Human Genome Research Institute/Simple English Wiki.)
To further confuse the market, the National Cancer Institute states that “Insurance coverage of tumor DNA sequencing depends on your insurance provider and the type of cancer you have. Insurance providers typically cover a DNA sequencing test if there is sufficient evidence to support that the test is necessary to guide patient treatment. Tests without sufficient evidence to support their utility may be considered experimental and are likely not covered by insurance.”
Many reliable sources agree. For example, the US National Library of Medicine Genetics Home Reference states, “In many cases, health insurance plans will cover the costs of genetic testing when it is recommended by a person’s doctor.”
That, however, leads to a different conundrum for drug makers such as Loxo: the majority of doctors are not keeping up with the rapid-fire pace of discovery in the realm of genetics and targeted therapies. Some genes like BRCA1 and BRCA2 are familiar enough to doctors that they know how and why they are important. However, most other genes are less known, and critically, less understood by doctors who must also focus on all the other myriad aspects of patient care.
In an article on the Color Genomics $249 Hereditary Cancer Test, which tests for mutations in 30 genes, Timothy Hamill, MD, Professor Emeritus, University of California San Francisco (UCSF) Department of Laboratory Medicine, and former overall director of UCSF’s clinical laboratories, told Wired, “If you talk to docs, they say ‘BRCA, that’s the only thing I’m interested in because I don’t know what to do with the other information.’ Doctors don’t know what to do with it. Patients don’t know what to do with it.”
More Testing Equals More Knowledge
Further complicating the issue, there is an enormous lack of information on how multipanel screenings will affect individuals, public health, and the cost of healthcare in general. Several studies are underway, but they are so new it could be years before any real results become available.
Five years ago, it cost about $20,000 to sequence the whole human genome. Now the average price is $1,500, though there are more and less expensive types of genetic tests. As the cost continues to decline, however, more people will undergo the testing and scientists will learn more about how to identify the best therapy to treat cancers caused by genetic mutations.
—Dava Stewart
Related Information:
Loxo Oncology Announces Positive Top-Line Results from Independent Review Committee Assessment of Larotrectinib Dataset
National Cancer Institute Statistics
Promising New Cancer Drugs Won’t Go Far Unless Everyone Gets Genetic Testing
Tumor DNA Sequencing in Cancer Treatment
Will Health Insurance Cover the Costs of Genetic Testing?
A Single $249 Test Analyzes 30 Cancer Genes. But Do You Need It?
Personal Genome Test Will Sell at New Low Price of $250
Jan 11, 2018 | Laboratory Hiring & Human Resources, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
At institutions such as University of Texas Medical Branch, Galveston, and Vanderbilt University Medical Center, pathologists are using diagnostic management teams to improve patient outcomes while lowering the medical costs
Diagnostic Management Teams are a hot concept within the medical laboratory profession. In fact, a new annual DMT conference in Galveston, Texas, is the fastest-growing event in the clinical laboratory industry. This year’s Diagnostic Management Team Conference will take place on February 6-7, 2018, and is produced by the Department of Pathology at the University of Texas Medical Branch (UTMB) in Galveston.
In simplest terms, a diagnostic management team (DMT) is described by pathologist Michael Laposata, MD, PhD, as “involving a group of experts who meet daily and focus on the correct selection of laboratory tests and the interpretation of complex test results in a specific clinical field. Typically, DMTs are led by pathologists focusing on the diagnosis of a specific group of diseases, along with physicians and other lab experts involved in the disease or health condition that is the focus of the DMT.”
How Pathologists Use Diagnostic Management Teams
“What differentiates a DMT are two changes from the classic diagnostic pathway,” continued Laposata. “First, the ordering physician gets assistance in selecting the correct tests. This can be done in several ways, such as creating expert-driven algorithms that are updated regularly to manage utilization of laboratory tests and dramatically minimize overuse and underuse. Use of such algorithms with reflex testing makes it easy for treating healthcare providers to order the right tests and only the right tests.
“The second key difference in this new diagnostic pathway is that, within the DMT’s specific clinical context, an expert-driven, patient-specific interpretation of the test results in a specific clinical context is generated by the members of the DMT,” he said. “This requires the knowledge of a true expert—not someone who may have a general idea about the meaning of a particular laboratory test result—and the participation of someone to help that expert search the medical record for relevant data to be included in the interpretation.
DMTs Typically Organized to Support Specific Diseases or Health Conditions
He pointed out that the DMT has a rather simple organization. There is a front-end and a back-end. The front-end starts when “physicians order tests by requesting evaluation of an abnormal screening test or clinical sign or symptom,” explained Laposata. “Upon receiving that request, the expert physician and colleagues in the DMT then synthesize the clinical and laboratory data and provide a narrative interpretation based upon medical evidence. This happens not only when specifically requested by the referring physician, but also for every case handled by the DMT.”
Diagnostic Management Teams are making significant contributions at the University of Texas Medical Branch (UTMB), Galveston. Pictured above, the members of UTMB’s coagulation DMT are (L-R): Jack Alperin, MD; Michael Laposata, MD; Aristides Koutrouvelis, MD; Camila Simoes, MD; Chad Botz, MD; Aaron Wyble, MD: and Jacob Wooldridge, MD. (Photo copyright: University of Texas Medical Branch, Galveston.)
The back-end of the process involves the DMT conducting an “expert-driven, patient-specific interpretation of the test results in a specific clinical context.” Here is where the participating clinical experts—supplemented by staff who conduct an informed search of the medical record to identify and collect data relevant to the diagnosis—sift through this much richer quantity of information to develop the diagnosis.
Overworked Physicians Value the Expertise, Diagnostic Accuracy of DMTs
Laposata points out that individual physicians who already may be overworked in their daily routines generally welcome the help of DMT experts who are up-to-date on the current literature, and who have decades of experience in these diseases and health conditions. He likes to point out that, in coagulation alone, a physician could have as many as 60 to 90 tests that can be ordered. He also notes that typical primary care physicians, for example, are generally not experts in selecting the best coagulation test to order for every group of symptoms, nor do they know how to order the most appropriate reflexive test to continue the diagnostic pathway.
Knowing how to interpret the results of the 60 to 90 different coagulation tests is equally challenging to most physicians.
Over the course of his career, Laposata has signed out more than 50,000 cases in the field of coagulation. “Every positive case that identified a diagnosis resulted in an earlier and more accurate diagnosis,” stated Laposata. “Every case negative for coagulopathy allowed the treating healthcare provider to focus on a diagnosis other than one related to bleeding and thrombosis.”
Using Clinical Laboratory Data to Improve Patient Outcomes, Reduce Costs
There are other reasons why a growing number of medical lab administrators and clinical pathologists believe that DMTs are the right solution at the right time. One reason is the steady reduction in reimbursement from Medicare and private payers. Another is the trend to measure and publish the quality metrics of hospitals and individual physicians.
There are ever more quality metrics that include diagnostic accuracy and total cost per healthcare encounter. Diagnostic Management Teams are proven to improve diagnostic accuracy and ensure the patient gets the right therapy faster. Both of these benefits contribute to substantial reductions in the cost per healthcare encounter.
Pathologists and clinical laboratory professionals interested in learning more about diagnostic management teams have two opportunities.
At the Galveston Island Convention Center on Feb. 6 -7, 2018, the second annual Diagnostic Management Team Conference will take place. Last year, several hundred-people attended. Information can be found at: http://www.dmtconference.com/.
Special Webinar on Diagnostic Management Teams on January 17
For those interested in learning via webinar, Dark Daily is presenting Laposata and his colleagues in a special session on Wednesday, Jan. 17 at 1:00 PM EASTERN. It is titled, “Using Diagnostic Management Teams to Add Value with Clinical Laboratory Tests and Pathologists’ Expertise.”
During this valuable webinar, you’ll hear from three experts. First to speak will be Michael Laposata, MD, PhD. He will provide you with a detailed overview of DMTs, including:
- How to assemble the right team;
- How to engage with referring physicians; and,
- How to work through individual cases.
Laposata will introduce you to the structure and organization of effective diagnostic management teams, organized around a specific disease or health condition and made up of pathologists, other lab scientists, and physicians who are expert in their particular clinical field. The objective of the DMT is to meet daily with the goal of coming up with faster, more accurate diagnoses in support of a patient’s care team.
Experience from a Diagnostic Management Team Focused on the Liver
Next to speak will be Heather Stevenson-Lerner, MD, PhD, a liver and transplantation pathologist and Assistant Professor, Department of Pathology, UTMB. She will discuss a DMT organized around diseases of the liver. This is a useful, step-by-step description of an effective DMT, illustrated with case studies that demonstrate how diagnostic management teams can make a positive and substantial contribution to improving individual patient outcomes.
The webinar’s third presenter is Christopher Zahner, MD, a resident pathologist at UTMB. He will share how to pull together all the information needed to support DMT interpretations. From the electronic health record (EHR) system to other overlooked sources of useful data, Zahner will explain the most productive ways to assemble any information that will be useful to the diagnostic management team and that will make a positive difference in patient care.
To register for the webinar and see details about the topics to be discussed, use this link (or copy and paste this URL into your browser: https://ddaily.wpengine.com/webinar/using-diagnostic-management-teams-to-add-value-with-clinical-laboratory-tests-and-pathologists-expertise).
This is an essential webinar for any pathologist or lab manager wanting to put the lab front and center in contributing clinical value in ways that directly improve patient outcomes while reducing medical costs. With hospital lab budgets shrinking and fee-for-service payments being slashed, the time is right for your lab team to consider how organizing diagnostic management teams can be the perfect vehicle to demonstrate why clinical lab tests and expertise can be a diagnostic game-changer within your hospital or health system.
And don’t forget, your participation in this webinar can be the foundation for a highly-successful effort to collaborate with physicians and clinical services, to the benefit of both the parent hospital and individual patients. That makes this webinar the smartest investment you can make for crafting your lab’s test utilization and added-value programs in support of clinical care.
—Michael McBride
Related Information:
Webinar: Using Diagnostic Management Teams to Add Value with Clinical Laboratory Tests and Pathologists’ Expertise
Pathologist Michael LaPosata, MD, Delivers the Message about Diagnostic Management Teams and Clinical Laboratory Testing to Attendees at Arizona Meeting
Jan 10, 2018 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Pathology, Laboratory Testing
CMS sends letter to Orig3n notifying the genetic test company that it may not have the required certifications to market its genetic tests
Orig3n’s recent ill-fated “DNA Day” promotion to offer free genetic tests during an NFL football game this past fall pushed Orig3n into the media spotlight. The Massachusetts-based biotech company—which sells 18 different DNA tests on its website—suspended the promotion due to questions from the Centers for Medicare and Medicaid Services (CMS) and the Maryland Department of Health (MDH) regarding the legality of the testing under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
Since then, however, new details from BuzzFeed and GenomeWeb indicate that Orig3n may not have the required certifications to market their genetic tests after all. On October 30, 2017, CMS served Orig3n with an out-of-compliance notice. According to BuzzFeed, the letter came from Karen Dyer, MT (ASCP) DLM, Director, Division of Laboratory Services and the CLIA program at CMS.
In a letter to Kate Blanchard, Chief Operating Officer at Orig3n, Dyer wrote, “To apply for CLIA certification, Orig3n must contact both the Massachusetts and California state agencies immediately for guidance. Orig3n’s various tests analyze 18 genes related to health, from ‘muscle power’ to ‘sugar sensitivity’ to ‘age-related metabolism’. It offers genetic testing that provides information for the assessment of health.” The letter gave Orig3n a November 13 deadline to update CMS on issues regarding their CLIA certification.
Robin Smith, CEO, Orig3n, told GenomeWeb the notice “was the first time that any clear guidance was given regarding specific genes and requirements for CLIA/non-CLIA.” He also noted efforts Orig3n undertook over the prior year to fully certify their laboratory.
The test shown above is one of 18 genetic tests Orig3n offers direct to consumers. According to Vice, Orig3n claims their tests do not require FDA-approval “because the tests are not diagnostic [and] they don’t require it.” The Baltimore Sun reported that “Orig3n is confident it can receive the proper approvals and plans to have a fan giveaway later this season at one of our games.” (Photo copyright: Orig3n.)
Fortunately for Orig3n, meeting compliance and obtaining certification for their existing lab is no longer a requirement to resolve the issue. In a November press release, Orig3n announced the purchase of Interleukin Genetics. Orig3n plans to absorb Interleukin’s existing assets, including a CLIA-certified genetics laboratory in Waltham, Mass., capable of analyzing more than one million samples annually.
“Once we met with Interleukin Genetics, we saw a natural alignment between the two organizations regarding our shared commitment to a future of personalized health,” Smith noted. “With our trajectory of accelerated growth, we couldn’t imagine a better fit for acquisition. We are very pleased to be welcoming Interleukin Genetics to Orig3n.”
GenomeWeb asked Blanchard how the acquisition would impact Orig3n’s commercialization of the 18 tests in question by CMS, now that Orig3n owns a CLIA-certified lab, and through it, meets the requirements of CMS’ out-of-compliance notice. Blanchard declined to comment.
New Concerns Surrounding Interleukin Assets
Yet, in solving one set of problems, some experts believe Orig3n might have inherited a new set. In July 2016, GenomeWeb reported that Interleukin Genetics would be laying off 63% of its staff. Unable to secure a clinical services agreement, the company could not extend debt payment deferrals with its senior lenders. At the time of writing, debts totaled $5.6 million.
Further complicating matters, a 2015 peer-reviewed analysis published in the Journal of the American Dental Association (JADA) questioned the clinical validity of an inflammation management program called “Ilustra” that Interleukin claimed, “identifies individuals with an increased risk for severe and progressive periodontitis, due to a life-long genetic predisposition to over-produce Interleukin-1 (IL-1), a key mediator of inflammation.”
Another GenomeWeb article reported on the turbulent road the Ilustra program followed until Orig3n eventually pulled it from the market. GenomeWeb noted critics’ concerns about the marketing of precision medicine, genetic testing, and regulatory issues facing medical laboratories as these technologies mature.
Clinical Laboratories Continue to Field Concerns Over DTC Testing
“This [genetic] test would have been laughed out of the room if it had been presented to oncologists, or to professionals in medical genetics,” declared Scott Diehl, PhD, co-author of the JAMA analysis, a genetics researcher at Rutgers School of Dental Medicine, and Professor and Principal Investigator at Rutgers Biomedical Health Sciences.
GenomeWeb notes in their latest coverage that with Orig3n’s purchase of Interleukin Genetics, Diehl is once again concerned that the genetic tests in question might find their way back to the market.
When GenomeWeb questioned Orig3n about the concerns surrounding Interleukin’s Ilustra product, a spokesperson stated, “that was simply before Orig3n’s time with the company and they do not have a part in it.” Blanchard added, “[We are] looking at the entire Interleukin portfolio and implementing the tests if and when we decide it is appropriate.”
Regardless of the decisions made by Orig3n on future genetic tests and genetic service offerings, coverage of this event highlights a myriad of concerns—from regulatory scrutiny to the pitfalls of acquiring existing diagnostic tests or laboratory assets—facing clinical laboratories, anatomic pathologists, and other medical professionals working in the ever-shifting landscape of the modern healthcare system.
—Jon Stone
Related Information:
This DNA Testing Company Is Violating Federal Lab Testing Rule
Orig3n Acquires Interleukin Genetics, a Genetics-based Personalized Health Company, to Advance the Future of Health Faster
Orig3n’s Purchase of Interleukin’s CLIA Lab May Appease CMS, But Some Question Plans for Test Assets
Biotech Company Offers Fitness and Beauty-Focused Genetic Tests
Interleukin Genetics Slashes 63 Percent of Workforce, Shuts down Program and Mulls Sale
‘DNA Day’ Planned for Ravens Game Undergoes Federal and State Scrutiny
Interleukin Shutting Down Genetic Testing Program, Lays Off Staff
Divergent Findings on Interleukin Gum Disease Risk Test Raise Questions about Clinical Use
Interleukin 1 Genetic Tests Provide No Support for Reduction of Preventive Dental Care
Controversial Gum Disease Risk Test Highlights Precision Medicine Marketing, Regulatory Issues
State and Federal Agencies Throw Yellow Flag Delaying Free Genetic Tests at NFL Games in Baltimore—Are Clinical Laboratories on Notice about Free Testing?
Jan 8, 2018 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Laboratory Testing
Microbiome is once again leading scientists toward a new understanding of how human gut bacteria can impact the efficacy and side-effects of certain cancer therapies
Anatomic pathology researchers already know that a person’s genetics can affect the results of cancer treatments. Now it is becoming clear that a patient’s microbiome—which includes gut bacteria—may also impact the efficacy of particular cancer treatments. A recent study showed that gut bacteria can be used to determine whether a cancer drug will work for a certain individual and also if the patient might suffer side effects from certain cancer treatments.
Working with this knowledge, diagnostic test companies may possibly develop new clinical laboratory tests designed to help physicians better diagnose and treat cancer patients. This, in turn, advances personalized medicine and treatments for chronic diseases tailored to patients’ specific physiologies and conditions. This is a healthcare trend where medical laboratories can expect to play a critical role.
Gut Bacteria as Important as Genetics in Cancer Treatments
A recent article published in the journal Nature: npj Biofilms and Microbiomes, outlined a correlation between gut bacteria and side effects of irinotecan (sold as Camptosar), a drug used to treat metastatic colorectal cancer.
Libusha Kelly, PhD, Assistant Professor in the Departments of Systems and Computational Biology, and Microbiology and Immunology, led researchers from the Albert Einstein College of Medicine located in Bronx, N.Y., in conducting the study.
“We’ve known for some time that people’s genetic makeup can affect how they respond to a medication,” noted Kelly in an Einstein news release. “Now, it’s becoming clear that variations in one’s gut microbiome—the population of bacteria and other microbes that live in the digestive tract—can also influence the effects of treatment.”
Irinotecan is administered intravenously to colorectal cancer patients in an inactive form and is metabolized to an active form by liver enzymes. The drug is later converted back to an inactive form by other liver enzymes and the addition of a Glucuronidase chemical group. The irinotecan then enters the intestine for expulsion by the body.
Taken from the Einstein College of Medicine published study, the graph above illustrates “Two distinct metabolizer phenotypes or ‘metabotypes’ based on % SN-38 formation during a time course incubation of SN-38G with fecal samples from 20 individuals quantified by LC-MS/MS. Participants were sub-grouped into low (n = 16) and high (n = 4) metabolizer phenotypes. All samples were run in triplicate and values are the mean ± sem.” (Graphic copyright: Nature/Albert Einstein College of Medicine.)
However, bacteria residing in the digestive tract of some individuals prevent the medication from metabolizing properly and reactivates the medication, which transforms the irinotecan into a toxic substance that can cause side effects.
To perform the research, Kelly and her team collected fecal samples from 20 healthy individuals and treated those samples with inactive irinotecan. The samples were then examined and categorized by whether or not they were able to metabolize or reactivate the drug.
Identifying Potential for Side Effects in Patients a Powerful Tool for Medical Laboratories
Irinotecan can cause severe diarrhea and dehydration in up to 40% of patients who take the medication. By focusing on the presence of beta-glucuronidase (enzymes that are used to catalyze the breakdown of complex carbohydrates) the researchers found that gut bacteria can also be used to distinguish which patients will encounter side effects from the drug.
“As you can imagine, such patients are already quite ill, so giving them a treatment that causes intestinal problems can be very dangerous,” said Kelly in the news release. “At the same time, irinotecan is an important weapon against this type of cancer.”
Four of the 20 subjects in the study were determined to be high metabolizers. Due to differences in the composition of their microbiomes, the team concluded that the high metabolizers were more likely to experience side effects from irinotecan.
The research also demonstrated that beta-glucuronidase enzymes in the gut may adversely interact with some commonplace drugs, such as ibuprofen and other nonsteroidal anti-inflammatory medications (NSAIDs), morphine, and Tamoxifen, a drug that is prescribed mainly to breast cancer patients.
“In these cases, the issue for patients may not be diarrhea,” states Kelly in the news release. “Instead, if gut bacteria reactivate those drugs, then patients might be exposed to higher-than-intended doses. Our study provides a broad framework for understanding such drug-microbiome interactions.”
Microbiome Takes Center Stage in Pathology Research
As Dark Daily previously reported, from extending life to developing more powerful treatments for chronic diseases, the human microbiome is quickly becoming an important subject of research studies. The findings from such studies will trigger advances in precision medicine. And, the clinical laboratory assays developed from this research will give physicians the knowledge needed to select the most appropriate drug therapies and treatments for individual patients.
—JP Schlingman
Related Information:
Gut Bacteria Can Stop Cancer Drugs from Working
Gut Microbiome May Make Chemo Drug Toxic to Patients
Human Microbiome Signatures of Differential Colorectal Cancer Drug Metabolism
Researchers in Two Separate Studies Discover Gut Microbiome Can Affect Efficacy of Certain Cancer Drugs; Will Findings Lead to a New Clinical Laboratory Test?
Attention Microbiologists and Medical Laboratory Scientists: New Research Suggests an Organism’s Microbiome Might Be a Factor in Longer, More Active Lives
Mayo Clinic and Whole Biome Announce Collaboration to Research the Role of the Human Microbiome in Women’s Diseases Using Unique Medical Laboratory Tests
