Nov 14, 2018 | Coding, Billing, and Collections, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Physicians in Saskatchewan called for changes after wait times for anatomic pathology test results reached six weeks or more
Anatomic pathologist and histopathologist shortages have plagued the single-payer healthcare systems in Canada and the United Kingdom (UK) in recent years. The consequence is increased wait times for physicians in both countries to receive medical laboratory test results, which increases wait times across the entire healthcare continuum.
However, one Canadian province significantly reduced a backlog that had pushed wait times for surgical pathology test results to six weeks or more. It did this by having its pathologists perform first-stage examinations normally completed by pathology assistants or medical technologists.
The Saskatchewan Health Authority (SHA) announced in October it had cleared nearly half of the 2,600-plus biopsies that were waiting to be processed at hospital labs in Regina and Saskatoon, the Regina Leader-Post reported.
“I think we’ve been making amazing progress in the work,” Lenore Howey, Executive Director of Laboratory Services at SHA, told the newspaper. “It’s always good to take time to know and understand your process, so that we can put the right resources in the right places.”
Getting Anatomic Pathologists Involved
Howey stated the SHA cleared cases by having pathologists “assist with the work in the first phase”—or gross examination stage—of a biopsy. This is the part of the process during which pathology assistants or medical laboratory technologists typically record the size, weight, and description of a specimen and look for pathological changes.
In addition, the SHA hired an additional pathologist assistant and three histology/cytology technologists—one on a permanent basis and two on a temporary basis. Other improvements include:
- Working toward resolving problems with voice recognition transcription software being piloted in Regina for the gross examination phase of processing; and;
- Implementing an electronic specimen tracking system in Saskatoon, which eventually also may be used in Regina.
Physicians Express Dissatisfaction with Wait Times
Physicians attending the Saskatchewan Medical Association’s Spring Representative Assembly in May raised the backlog issue with Health Minister Jim Reiter, complaining about the impact on patient care. At that point, the backlog of pathology cases had hit 1,662 in Regina, while Saskatoon’s caseload totaled 1,005. Many of these biopsies involve cancer patients, thus delaying a diagnosis and the start of an appropriate treatment for these patients.
“I’m trying to get things done as expeditiously as possible,” urologist Francisco Garcia, MD, told the Leader-Post, “but for the first five or six weeks, I’m handcuffed in terms of what I’m able to do.”
Now, thanks to SHA’s efforts, as of Oct. 2 specimens in progress dropped to 785 in Regina and 748 in Saskatoon. Both numbers are within range of SHA’s target of 750.
“We do not have a backlog right now,” Lenore Howey, Executive Director of Laboratory Services at SHA, told the Leader-Post. “Our system is very stable, but we do have checks and balances to put in place so that we would never get there again, which we didn’t have prior.” (Photo copyright: Saskatchewan Health Authority.)
Wait Times Impacting Patient Care Worldwide
While Saskatchewan appears to have solved its most recent pathology reporting issue, this is not the first time the province has dealt with delays in lab testing reports. In 2011, Dark Daily reported on lengthy turnaround times for anatomic pathology test reports that averaged more than 12 days, which was blamed on shortage of pathologists dating back to 2001. (See, “Pathologist Shortage and Delays in Lab Test Reports Get Publicity in Saskatchewan,” August 15, 2011.)
And in October, Dark Daily reported that cancer patients in the UK are experiencing record waiting times for treatments, with more than 3,000 people waiting longer than two months to begin care, iNews reported. Delays there are being blamed in part on severe shortages of pathology staff. A 2017 workforce survey by the Royal College of Pathologists reported that only 3% of the National Health Service (NHS) histopathology departments responding to the survey had adequate staff. (See, “Shortage of Histopathologists in the United Kingdom Now Contributing to Record-Long Cancer-Treatment Waiting Times in England,” October 31, 2018.)
“Making sure pathology services can cope with current and future demand is essential if we are to ensure early diagnosis and improve outcomes for patients,” Jo Martin, PhD, President of the Royal College of Pathologists, told the BBC.
Increased workloads due to new NHS screening programs and an approaching retirement crisis—a quarter of all histopathologists in the UK are aged 55 or over—has caused the Royal College of Pathologists to call for more funded training places, better IT systems, and further investment in pathology services.
While the US healthcare system is not currently experiencing a shortage of clinical laboratory staff or anatomic pathologists, shortages in other countries illustrate the impact any delay in reporting results can have on patient care.
—Andrea Downing Peck
Related Information:
Backlog of Pathology Tests Cleared in Province
Technology and Staff Shortages Contribute to Biopsy Backlog
Pathology Staff Shortages Causing Delays to Cancer Diagnosis, Says Report
Cancer Waiting Times at their Worst Ever Level
Histopathology Workforce Survey 2018
Pathologists Shortage ‘Delaying Cancer Diagnosis’
Pathologists Shortage and Delays in Lab Test Reports Get Publicity in Saskatchewan
Shortage of Histopathologists in the United Kingdom Now Contributing to Record-Long Cancer-Treatment Waiting Times in England
May 23, 2018 | Digital Pathology, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Pathologists around the world will be interested to learn that, for the first time in the UK, prostate cancer has surpassed breast cancer in numbers of deaths annually and nearly 40% of prostate cancer diagnoses occur in stages three and four
Early detection of prostate cancer, and the ability to identify its more aggressive forms, are important goals for every nation’s health system. However, a new study in the United Kingdom (UK) will be of interest to all anatomic pathologists handling prostate biopsies. Researchers determined that late diagnosis of prostate cancer is an issue that should be addressed by healthcare policymakers in the UK.
In 2015, deaths due to prostate cancer surpassed those of breast cancer in the UK. According to data from Cancer Research UK, this trend continued into 2016 with 11,631 deaths from prostate cancer and 11,538 deaths from breast cancer. The trend continued even though breast cancer saw roughly 8,000 more new cases in 2015, according to the same data.
Now, a report from Orchid—a UK male cancer charity—highlights a trend that should interest medical laboratories and histopathology (anatomic pathology in the US) groups that analyze prostate cancer samples. They found that 37% of UK prostate cancer cases involved diagnoses in stages three or four.
Late-Stage Diagnosis of Prostate Cancer: The US and UK Compared
“With prostate cancer due to be the most prevalent cancer in the UK within the next 12 years, we are facing a potential crisis in terms of diagnostics, treatment, and patient care,” stated Rebecca Porta, Chief Executive of Orchid, in a press release. “Urgent action needs to be taken now if we are to be in a position to deliver world class outcomes for prostate cancer patients and their families in the future.”
Orchid Chief Executive Rebecca Porta (far right) and her team are shown above receiving a check from the Industrial Agents Society (AIS) to help fund the charity’s research into male specific cancers, such as prostate cancer. (Photo copyright: AIS.)
The latest data from the Centers for Disease Control and Prevention (CDC) on prostate cancer and mortality rates in the US shows an interesting picture. In 2014, 172,258 men received a prostate cancer diagnosis. However, deaths from prostate cancer were at 28,343.
According to Statista, an international statistics portal, the UK is home to more than 32.3-million males. And, Statista’s data shows the US is home to 159.1-million males. This implies that despite the US having nearly five times the number of males, the number of prostate cancer deaths/year in the UK is significantly higher in relation to population size.
Cancer Research UK notes that despite decreasing by 13% in the last decade, prostate cancer mortality rates are still 21% higher than in the 1970s.
Awareness and Early Detection Key Components in the Fight Against Cancer
A study published in BMC Public Health offers one possible explanation for this disparity.
“When compared to analogous countries in Europe, Canada, and Australia, older adults in the UK have markedly different survival outcomes,” noted lead author of the study Sara Macdonald, PhD, Lecturer in Primary Care at the Institute of Health and Wellbeing at the University of Glasgow, Scotland.
“Poorer outcomes in the UK are at least in part attributable to later stage diagnoses,” she explained. “Older adults should be vigilant about cancer. Yet, this is not reflected in the news media coverage of cancer risk. Taken together, invisibility, inaccuracy, and information overload build a skewed picture that cancer is a disease which affects younger people.”
While treatment options have improved in the past decade, early detection is a key part of successful treatment—especially as prostate cancer has both aggressive and slow variants. Effective timely health screening also is of critical concern.
In the US, however, prolific prostatic-specific antigen (PSA) testing and other screenings for chronic disease—particularly within the elderly population—is under increased scrutiny and criticism, which Dark Daily reported on in April. (See, “Kaiser Health News Labels Routine Clinical Laboratory Testing and Other Screening of Elderly Patients an ‘Epidemic’ in US,” April 11, 2018.)
New Tools to Detect Prostate Cancer
Faster diagnosis and the ability to detect whether a prostate cancer is slow or aggressive could help to shift these numbers around the world.
According to BBC News, the NHS hopes to reduce diagnosis times and make the screening process less invasive by using magnetic resonance imaging (MRI). Hashim Ahmed, PhD, Chairman of Urology, Imperial College London, told BBC News, “Fast access to high-quality prostate MRI allows many men to avoid invasive biopsies as well as allowing precision biopsy in those men requiring it to find high-risk tumors much earlier.”
A team from the University of Dundee is trialing a shear wave elastography imaging (SWEI) process to detect prostate tumors as well. Speaking with The Guardian, team leader and Chair of the School of Medicine at The University of Dundee, Dr. Ghulam Nabi, noted, “We have been able to show a stark difference in results between our technology and existing techniques such as MRI. The technique has picked up cancers which MRI did not reveal. We can now see with much greater accuracy what tissue is cancerous, where it is, and what level of treatment it needs. This is a significant step forward.”
Should these tools prove successful, they might help to reverse current trends in the UK and offer greater insight and options for the histopathology groups there, as well as the medical laboratories, oncologists, and other medical specialists helping to treat cancer.
Until then, raising awareness and streamlining both detection and treatment protocols will remain a critical concern, not just in the UK, but around the world as the human population continues to age.
—Jon Stone
Related Information:
Prostate Cancer: Four in 10 Cases Diagnosed Late, Charity Says
New Report Reveals 4 in 10 Prostate Cancer Cases Are Diagnosed Late and an Impending Crisis in Prostate Cancer Provision
Prostate Cancer Deaths Overtake Those from Breast Cancer
Cutting Prostate Cancer Diagnosis Times
Prostate Cancer on the Rise; Time to Revisit Guidelines?
More High-Risk Prostate Cancer Now in the US than Before
Prostate Cancer Breakthrough as UK Team Develops More Accurate Test
Mass Media and Risk Factors for Cancer: The Under-Representation of Age
Kaiser Health News Labels Routine Clinical Laboratory Testing and Other Screening of Elderly Patients an ‘Epidemic’ in US
Genetic Fingerprint Helps Researchers Identify Aggressive Prostate Cancer from Non-aggressive Types and Determine If Treatment Will Be Effective
Mar 14, 2018 | Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Mounting financial and patient-care problems in UK show NHS may not provide a quality blueprint for fixing US healthcare system flaws
Patients scheduled for elective surgeries—such as hip replacements or penciled in for routine outpatient appointments—have been turned away this winter from National Health Service (NHS) hospitals as the United Kingdom’s (UK’s) public healthcare system suffers another care emergency.
This latest crisis in the UK should provide further evidence to anatomic pathologists and medical laboratory leaders that the United States healthcare system is not alone in facing mounting financial and patient care questions. While an NHS-like single-payer healthcare system in the US is the goal of many reformers, the UK’s current crisis indicates such a system has serious flaws.
UK News Organizations Disagree with Government Leaders as to Cause of Crisis
NHS officials estimate as many as 55,000 elective operations and outpatient procedures were cancelled as hospitals attempted to free up capacity for the sickest patients. The Telegraph reported that the bed shortfall is blamed on a spike in winter flu, with budget cuts to social services for home healthcare, staff shortages, and an aging population further pressuring the healthcare system.
In late January, the NHS’ National Emergency Pressure Panel (NEPP) announced that planned operations, such as elective surgeries, that had been “suspended because of pressure on the NHS in January,” would be able to resume in February, Sky News reported.
Meanwhile, in response to the original decision in January to have hospitals stop performing elective surgeries and similar procedures, an editorial in The Guardian challenged Prime Minister Theresa May’s suggestion that the current crisis was primarily due to the flu epidemic.
“This is not the flu: it is a system-wide crisis brought about by seven years of mounting austerity,” The Guardian’s editors wrote. “Oh, and that is getting worse, too. The official defense is that this is not a crisis because there is a plan … But planning can’t magic up highly trained doctors and nurses. Plans do not make hospital beds. And while vaccination helps, you can’t entirely plan your way out of the impact of flu.”
Doctors Report ‘Intolerable Conditions’ at 68 Hospitals
The crisis reached new heights when specialists in emergency medicine from 68 hospitals sent a letter to the prime minister stating the “current level of safety compromise is at times intolerable, despite the best efforts of staff.” The letter, published in The Guardian, also pointed out media coverage reporting anecdotal accounts of “appalling” situations in many emergency departments “are not outliers.” According the doctors, conditions include:
- Over 120 patients a day managed in corridors, some dying prematurely;
- An average of 10-12 hours from decision to admit a patient until they are transferred to a bed;
- Over 50 patients at a time awaiting beds in the emergency department; and,
- Patients sleeping in clinics as makeshift wards.
One doctor, Richard Fawcett, MD, drew media attention when he used Twitter to apologized for “third world conditions” caused by overcrowding in the hospital where he works, The Telegraph reported.
Richard Fawcett, MD (above), a consultant in emergency medicine for University Hospitals of North Midlands NHS Trust, drew widespread media attention in England when he apologized to patients on Twitter for the “third world conditions” this winter at the hospital where he works. A Lieutenant Colonel in the British Royal Army, Fawcett has done three deployments to Afghanistan. (Photo copyright: Midlands Air Ambulance Charity.)
NHS officials acknowledged staff criticism but attempted to paint the crisis as temporary. University of North Midlands NHS Trust (UHNM) told BBC News that area hospitals had been under “severe and sustained pressure over the Christmas period,” which had “continued into the new year.”
“Our staff want the very best for our patients and at times they find the situation frustrating, which can be reflected on social media. However, we are a leading trauma, stroke, and cardiac center and have been regularly praised by external independent commentators for the quality of compassionate care provided at our hospitals despite all our pressures,” Dr. John Oxtoby, Consultant Radiologist and Deputy Medical Director, UHNM, told BBC News.
“We have to keep going and turn up in a fit state to do the best job that we can. But it’s been really tough, particularly on more junior staff,” one hospital staff member told The Guardian. “And when they ask me, ‘Will it always be like this and will it get better?’ I cannot say it will improve as the truth is it won’t unless the NHS gets the resources and investment it needs.”
Basic Elements of Care Neglected
This is not the first time the NHS has come under fire for substandard patient care.
Between 400 and 1,200 patients are estimated to have died as result of poor care between January 2005 and March 2008 at Stafford Hospital, reported The Guardian. A 2010 report into care at the hospital, now named County Hospital and run by UHNM, found a litany of problems.
“For many patients, the most basic elements of care were neglected,” inquiry Chairman Sir Robert Francis, QC, told The Guardian. “Some patients needing pain relief either got it late or not at all. Others were left unwashed for up to a month … The standards of hygiene were at times awful, with families forced to remove used bandages and dressings from public areas and clean toilets themselves for fear of catching infections.”
Reports of substandard patient care within the United Kingdom’s National Health Service are not new. British barrister Sir Robert Francis, QC (above), led investigations into the Stafford Hospital scandal, which uncovered that an estimated 400 to 1200 patients died between 2005 and 2008 at the facility due to appalling conditions and lax procedures. (Photo copyright: The Telegraph.)
Why not this crisis in US? Because, even if our system of healthcare has flaws, it is responsive to consumer/patient demand. Whereas, in the UK, the NHS is always budget short and so is always struggling to invest in expanding hospital/physician capacity to meet the steady increase in patient demand.
Dark Daily’s goal in reporting on this story is to help anatomic pathologists and clinical laboratory leaders in the United States understand that every country’s health system—like ours—has its share of unique problems and is not perfect.
—Andrea Downing Peck
Related Information:
NHS Patients Dying in Hospital Corridors, A/E Doctors Tell Theresa May
The Guardian View on the Crisis: It’s Not Just the Flu
Mid Staffs Hospital Scandal: The Essential Guide
NHS Crisis: ‘I Live in Fear I’ll Miss a Seriously Ill Patient and They Will Die’
Hospitals to Delay Non-Urgent Operations
NHS to Lift Suspension of Elective Surgery as Hospital Pressures ‘Ease’
Dec 22, 2017 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Laboratory Testing
New study published in the Annals of Family Medicine (AFM) indicates that despite efforts to improve EHR usability and efficiency, primary care physicians continue to spend more than 50% of their workdays on computerized physician order entry (CPOE) and other clerical tasks instead of engaging in direct patient care
Do electronic health record (EHR) systems improve or degrade the productivity of physicians? That question has been the subject of robust debate. Now comes a new study in a peer-reviewed journal with a surprising finding: physicians spend up to 50% or more of their workday on EHR-related tasks.
In theory, EHRs offer a wealth of benefits over traditional paper-based systems. In practice, however, between interoperability concerns and implementation costs, they have proven a daunting undertaking for even the largest healthcare systems.
While EHRs might offer easy access to patient data—including medical laboratory records and anatomic pathology reports—this information doesn’t enter itself into databases or make itself instantly accessible. That requires human interaction, which is time consuming and prone to errors.
Thus, research from the American Medical Association (AMA) and the University of Wisconsin revealing that the time it takes to enter data, address communications, and perform other clerical tasks adds up to more than 50% of a physician’s workday is of paramount importance. That’s because physician dissatisfaction and departures from medical practice have increased each year since the EHR revolution began, and reports are the situation is getting worse.
In their retrospective cohort study involving 142 family medicine physicians, published in the Annals of Family Medicine (AFM), Brian G. Arndt, MD, from the School of Medicine and Public Health, Department of Family Medicine and Community Health, University of Wisconsin, et al, reported that clinicians spend 52% of their 11.4-hour workday interacting with an EHR system. On average, nearly 1.5 hours of this EHR interaction occurred outside clinic hours during physicians’ personal time. The researchers assessed interactions using event logs from the Epic EHR system spanning from July 1, 2013, to June 30, 2016.
Researchers validated their data through direct observation of 14 nonresident family medicine physicians from May through June of 2016. This observation showed similar findings. During clinical hours, 60% of physician time related to non-EHR tasks, with 40% of time devoted to EHR tasks.
Documentation Burden Leads to Physician Burnout, Dissatisfaction
“Our family medicine physicians spent 44% of their workday (157 minutes) in the EHR doing clerical and other administrative tasks,” study authors reported. “Computerized physician order entry accounted for 12.1% of their clinic hours (43 minutes) in the EHR. The burden related to order entry has been associated with clinician burnout, dissatisfaction, and intent to leave practice.”
Researchers tracked various tasks and assigned them to categories. Of the tasks tracked, only 32.1% fell under the heading of “medical care.” Reviewing chart notes, chart medications, and problem lists topped medical care tasks.
Review of clinical laboratory results in charts ranked near the bottom, with only 2.5% of the total time spent performing medical care tasks. These tasks, however, could offer opportunities for medical laboratories to help physicians identify opportunities to optimize reporting and test-ordering processes and improve productivity for clinicians who are responsible for most of the data entry burden associated with EHRs.
One potential solution to EHR burnout involves the use of medical scribes who work with physicians during and after a patient’s visit inputting encounter data. Alan Bank, MD, cardiologist at Allina Health, and medical scribe Jaeda Roth, are shown above during a patient visit. Bank told the StarTribune that he’s convinced scribes help doctors get more done and reduce billing errors. (Photo and caption copyright: Elizabeth Flores/StarTribune.)
Researchers also questioned the EHR’s role as a communication or telemedicine hub. “There is insufficient evidence that such asynchronous care improves health outcomes, cost, and overall healthcare use,” they noted.
However, even for intra-practice communications between healthcare professionals, EHRs may not be the most efficient approach. “Face-to-face communication is associated with increased efficiency,” the researchers noted. “Whereas more electronic communication among team members leads to greater clinician and staff dissatisfaction, as well as poorer clinical outcomes and increased healthcare use among patients with coronary artery disease.”
EHR Cost/Benefits Generate Debate
This latest study is not the first to suggest that EHRs are creating problems for clinicians. While there appear to be no trends between studies, multiple researchers have highlighted the workload created by EHR systems in recent years.
In a study published in the Annals of Internal Medicine (AIM), Christine A. Sinsky, MD, of the American Medical Association, et al, analyzed data from the observation of 57 US-based physicians in family medicine, internal medicine, cardiology, and orthopedics.
Comparing data across 430 hours of observation, researchers concluded, “For every hour physicians provide direct clinical face time to patients, nearly two additional hours are spent on EHR and desk work within the clinic day. Outside office hours, physicians spend another one to two hours of personal time each night doing additional computer and other clerical work.”
However, in a 2015 study published in the Annals of Family Medicine (AFM), Valerie Gilchrist, MD, Chair of the Department of Family Medicine and Family Health at the School of Medicine and Public Health, University of Wisconsin, et al, found lower numbers. Observing 27 community-based family physicians across a single practice day, the researchers found that 39% of the practice day on average was devoted to office-based time. Of that time, 61% was spent on medical care related tasks.
Building a Better EHR
While medical laboratories and diagnostic specialists—such as anatomic pathologists—can work with physicians to streamline ordering and reporting processes relating to EHRs, much of the burden comes from how EHR systems are designed and used.
In a 2016 New England Journal of Medicine Catalyst Panel on EHRs, Tait Shanafelt, MD, Director of the Mayo Clinic Department Program on Physician Wellness, noted that one of the most contested features of EHR systems in the US, according to the AMA and Mayo Clinic, is computerized physician order entry (CPOE).
Later in the discussion, Sinsky discussed a recent trip to the UK, where she observed general practitioners (GPs) at the National Health Service (NHS). She noted that most GPs loved their EHRs. However, those EHRs were designed with GP input to best work with an NHS GP’s typical workflows and procedures. She also noted that overall usage is different in the UK, as EHRs there are not tied into billing systems.
As Dark Daily has reported, up to 70% of data stored in a patient’s electronic health record is clinical pathology laboratory related. As newer EHRs replace outdated models, it will remain critical for healthcare professionals—including clinical laboratory professionals who generate most of the data stored in EHRs—to assess, track, and report on what is working with various platforms and what is not.
Communicating this end-user data to EHR developers is essential to designing EHRs that reduce unneeded burden and clerical load on physicians, rather than increasing it.
Clinical laboratories tat wish to take proactive steps might contact physicians and other professionals in their workgroups to tailor data generation, reporting, and ordering processes to the EHRs in use at those practices.
—Jon Stone
Related Information:
Primary Care Doctors Spend More Than 50% of Workday on EHR Tasks, American Medical Association Study Finds
Tethered to the EHR: Primary Care Physician Workload Assessment Using EHR Event Log Data and Time-motion Observations
Study: EHRs Bloat Clerical Workload for Docs
Harried Doctors Hail the Rise of the Medical Scribe
Type and Click Tasks Drain Half the Primary Care Workday
Allocation of Physician Time in Ambulatory Practice: A Time and Motion Study in 4 Specialties
Doctors Wasting Over Two-Thirds of Their Time Doing Paperwork
Physician Activities During Time Out of the Examination Room
Heavy Burden of EHRs Could Contribute to Physician Burnout
Sep 18, 2017 | Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Testing, Uncategorized
Owlstone Medical’s breath biopsy platform takes aim at breath biomarkers for an earlier diagnosis of cancer; could it supplant tissue biopsies sent to pathology labs?
For many years, medical laboratory scientists and pathologists have known that human breath contains molecules and substances that have the potential to be used as biomarkers for detecting different diseases and health conditions. The challenge was always how to create clinical laboratory test technology that could use human breath samples to produce accurate and clinically useful information.
Stated differently, breath, the essence of life, may contain medical laboratory test biomarkers that could provide early-detection advantages to pathology groups in their fight against cancer. Now diagnostics company Owlstone Medical—developer of the Breath Biopsy platform—is about to conduct a clinical study in collaboration with the United Kingdom’s (UK’s) National Health Service (NHS) and others to demonstrate the effectiveness of its breath-based diagnostic tests.
Anatomic pathology groups and clinical laboratory leaders know human breath contains volatile organic compounds (VOCs) that can be useful diagnostic biomarkers for medical laboratory testing. Many possible breath tests have been researched. One such test, the urea breath test for detecting Helicobacter pylori (H. pylori), has been in clinical use for 20 years. As part of the test, patients with suspect stomach ulcers or other gastric concerns, swallow a tablet with urea and exhale carbon dioxide that is measured for H. pylori bacteria.
According to an Owlstone Medical news release, the new study, called the “PAN Cancer Trial for Early Detection of Cancer in Breath,” will explore the ability of Owlstone Medical’s Breath Biopsy platform to detect cancers of the:
Current medical care standards call for these cancers to be diagnosed by analyzing biopsied tissue specimens. If Owlstone Medical’s breath test performs well during trial, it could provide advantages over traditional tissue-based cancer testing that include:
- A non-invasive approach to finding cancer earlier;
- A lower price point as compared to a tissue biopsy cancer test; and
- Faster return of test results, since tissue would not need to be collected from patients during surgical procedures and sent to medical laboratories for analysis.
“By 2030, the number of new cancer cases per year is expected to rise to around 22-million globally. Some cancers are diagnosed very late when there are few treatment options available. Non-invasive detection of cancer in breath could make a real difference to survival,” stated Richard Gilbertson, PhD, Li Ka Shing Chair of Oncology, Director of the CRUK Cambridge Center, and Oncology Department Head at University of Cambridge, in the news release.
How the Breath Biopsy Platform Works
The Breath Biopsy platform relies on Owlstone Medical’s Field Asymmetric Ion Mobility Spectrometry (FAIMS) technology, which the diagnostics company explains is a “fast means to identifying volatile organic compound biomarkers in breath.”
Billy Boyle (above), co-founder and Chief Executive Officer at Owlstone Medical, demonstrates the ReCIVA Breath Sampler. “Positive results from the PAN cancer trial could be game-changing in the fight against cancer,” he noted in the news release. “Success in this study supports our vision of saving 100,000 lives and $1.5 billion in healthcare costs.” This technology has the potential to be disruptive to anatomic pathology, which relies on the analysis of biopsied tissue to detect cancer. (Photo copyright: Owlstone Medical.)
Here is how FAIMS works in the Breast Biopsy platform, according to the Owlstone Medical website:
- Gases are exchanged between circulating blood and inhaled fresh air in the lungs;
- VOC biomarkers in the body’s circulation system pass into air in the lungs, along with oxygen, carbon dioxide, and other gases;
- Exhaled breath contains those biomarkers exiting the body;
- Because it takes one minute for blood to flow around the body, a breath sample during that time makes possible collection and analysis of VOC biomarkers of any part of the body touched by the circulatory system.
One publication compared the capture of VOCs to liquid biopsies, another possible non-invasive cancer diagnostic technique being widely researched.
“The advantage to VOCs is that they can be picked up earlier than signatures searched for in liquid biopsies, meaning cancer can be diagnosed earlier and treated more effectively,” reported Pharmaphorum in its analysis of five technology companies fighting cancer.
As part of the clinical trial, breath samples will be collected in clinic settings with the hand-held Owlstone Medical ReCIVA Breath Sampler (equipped with a dime-sized FAIMS silicon chip). The samples will come from people with a suspected cancer diagnosis who are seeking care at Cambridge University Hospital’s Addenbrooke’s Hospital. To test reliability of the biomarkers, breath samples from patients with cancer and without cancer will be analyzed.
“You’re seeing a convergence of technology now, so we can actually run large-scale clinical studies to get the data to prove odor analysis has real utility,” stated Owlstone Medical co-founder and Chief Executive Officer Billy Boyle, in a New York Times article.
Breath Tests Popular Area for Research
The company’s Breath Biopsy platform is also being tested in a clinical trial for lung cancer being funded by the UK’s NHS. The study involves 3,000 people, the New York Times article reported.
This is not the first time we have reported on Owlstone Medical. A previous e-briefing explored the company’s technology in a study focused on diagnosis of lung cancer (See Dark Daily, “In the UK, Pathologists Are Watching Phase II of a Clinical Trial for a Breathalyzer System That Uses Only a Breath Specimen to Diagnose Lung Cancer,” May 11, 2015.)
Breath tests in general—because they generally are non-invasive, fast, and cost-effective—have been the subject of several other Dark Daily e-briefings as well, including those about:
Owlstone Medical’s ability to get backing from Britain’s NHS, as well as investments to the tune of $23.5 million (the most recent coming from Aviva Ventures) is a positive sign. That Owlstone Medical’s Breath Biopsy platform is credible enough to attract such respected collaborators in the cancer trials as the Cancer Research UK Cambridge Institute (CRUK), University of Cambridge, and Cambridge University Hospitals (CUH) NHS Foundation Trust is evidence that the company’s diagnostic technology is considered to have good potential for use in clinical care.
Medical laboratory managers and pathology group stakeholders will want to monitor these developments closely. Once proven in clinical trials such as those mentioned above, breath tests have the potential to supplant other medical laboratory diagnostics and perhaps lower the number of traditional biopsies sent to labs for diagnosis of cancer.
—Donna Marie Pocius
Related Information:
Owlstone Medical and Cancer Research UK (CRUK) Initiate Pan Cancer Clinical Trial to Evaluate Breath Biopsy for Early Detection of Disease New Cancer Detecting Breath Test to Undergo Clinical Trials
Five Tech Companies Advancing Against Cancer
Aviva Invests in Owlstone Medical Breath Biopsy Platform and its Expected Drive Adoption of Breath Biopsy in Healthcare
Owlstone Medical’s ReCIVA Named Invention of the Year in Top 50 Digital Health Awards
One Day a Machine Will Smell Whether You’re Sick
Cancer Breath Biomarker: CRUK and Owlstone Start Multi-Cancer Trail
In the UK, Pathologists Are Watching Phase II of a Clinical Trial for a Breathalyzer That Uses Only a Breath Specimen to Diagnose Lung Cancer
Companies Developing Non-Invasive and Wearable Glucose-Monitoring Devices That Can Report Test Data in Real Time to Physicians and Clinical Laboratories
Wisconsin Company Developing Breath-Based Diagnostic Test Technology That Can Detect Early-Stage Infections Within Two Years of Onset
Study into Use of Breath Analysis to Monitor Lung Cancer Therapy Enhances Clinical Laboratories Ability to Support Precision Medicine
