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
Jul 26, 2017 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
Decline in hospital-acquired conditions (HACs) overall since 2010 attributed to increased attention to safety protocols and practices by hospital staff in cooperation with clinical laboratory services
It’s now been almost nine years since the Medicare Program stopped paying hospitals and other providers for certain hospital-acquired conditions (HACs). Included in this list are hospital-acquired infections (HAIs). The goal is to substantially reduce the number of HACs and HAIs, thus improving patient outcomes, while substantially reducing the healthcare costs associated with these conditions.
So, almost nine years into these programs, has there been progress on these goals? This is a question of key interest to Medical laboratories and pathology groups because they have a front-line role in working with clinicians to diagnose and treat HAIs, while also looking to identify the transmission of HAIs within the hospital.
A recent report by the Agency for Healthcare Research and Quality (AHRQ), a division of the US Department of Health and Human Service (HHS), indicates that there has been progress in the goal of reducing HACs. The AHRQ report noted a 21% decline in HACs between 2010 and 2015. Data collected during that time indicates a reduction of more than 3.1 million HACs and nearly 125,000 patient deaths due to HACs.
In 2015 alone, nearly one million fewer HAC incidents occurred. The reduction saved “approximately $28 billion in healthcare costs,” an outcome which, the AHRQ report notes, is the result of increased attention to safety protocols in hospitals and a “period of concerted effort by hospitals throughout the country to reduce adverse events.”
Clinical Pathologists/Laboratories Play Key Role in HAI Prevention
Though many reported incidents are associated with adverse drug events, HAIs have been significantly reduced in recent years due to focused efforts on infection prevention. The report notes that clinical pathologists have become vital players in infection prevention programs, and that increased coordination between hospital medical laboratories and clinicians played a crucial role in the reduction.
Eileen O’Rourke is an Infection Preventionist at the Lankenau Medical Center in Philadelphia. And she has served as a leader and consultant for hospital-based infection prevention programs in Pennsylvania since 1984. In an article on the Wolters Kluwer Pharmacy OneSource blog, O’Rourke noted that successful infection prevention and control requires development of “a highly visible and administratively supported infection prevention and control program with qualified and trained personnel.” Clinical pathologists are part of that support team, providing surveillance, testing, and interpretation of data essential for identifying epidemiological origins of infection and pathogen distribution. And the vital services that clinical laboratories provide to reduce HAIs center on surveillance, prevention, and control.
The chart above was calculated on US Dollars in 2012. Since then, thanks to contributions by medical laboratories and pathologists in collaboration with hospitals, those costs have decreased significantly. (Image copyright: MLive.com.)
In an article for Lab Testing Matters, John Daly MD, Chief Medical Officer at the Commission on Office Laboratory Accreditation, and former Director of Clinical Laboratories for the Duke University Health System, highlights the importance of surveillance. He states that it is “an essential element of an infection control program” providing “data to identify infected patients and determine the site of infection” as well as “factors that contributed to the infection.” Medical laboratories must, Daly stresses, provide “easy access to high-quality and timely data and give guidance and support on how to use its resources for epidemiologic purposes.”
Daly argues that medical laboratories function as liaisons to clinical services, working to “improve the quality of specimens sent to the laboratory and promoting appropriate use of cultures and other laboratory tests.” The laboratory should, according to Daly, be involved in all aspects of the infection control programs. This ensures:
- Proper specimen collection;
- Accurate and rapid testing; and
- Accurate reporting of laboratory data.
Laboratory Data Provide ‘Early Warning’ for HAI Surveillance Systems
Robert A. Weinstein, MD, wrote in his 1978 article, “The Role of the Microbiology Laboratory in Surveillance and Control of Nosocomial Infections,” that medical laboratories and pathologists are central to prevention and control of HAIs. Laboratory records, Weinstein remarked, serve as important data sources that can identify early spread of infection, thus becoming an “early warning system” for a potential outbreak of infections. The sampling that laboratories perform identifies not only the strain of infection, but the method by which infection is spread, and the best treatment options. Nearly 40 years later his statements ring truer than ever, as anatomic pathology laboratory data continues to reveal patterns of infection faster and more precisely than ever before.
Sarah Mahoney, PhD, is a research scientist at Navitor Pharmaceuticals in Cambridge, Mass. In an article published in the American Journal of Clinical Pathology, she states that in surveilling patterns of infection, pathologists also decipher the source of infection. Mahoney wrote that it is “necessary to identify the causative organism” for surveillance and management control of HAIs. She also noted that pathologists must strive to discriminate between “hospital- and community-acquired infection” in order to provide clinicians with guidance for treatment, and to map “infection transmission within a clinical setting.”
Hospitals Rely on Medical Laboratories and Pathologists to Help Reduce HAIs
The concerted effort to reduce HACs and HAIs was inspired by incentives put forth by the US government. In 2008-2009, the Centers for Medicare and Medicaid Services (CMS) ceased paying for hospital-acquired conditions, including HAIs. Since that time, hospitals have worked to prevent and better manage HAIs. In the years since those incentives went into effect, hospitals have increasingly relied on medical laboratories and pathologists to provide necessary testing to prevent HAIs.
The CDC’s Antimicrobial Stewardship Programs create a further need for lab professionals to be involved in the identification, prevention, and treatment of HAIs. The core elements of the program state that the role of diagnostic laboratory testing—especially rapid diagnostic tests—is imperative in providing the necessary data needed to combat HAIs. The pressure is on for hospitals to reduce HAIs further to save lives and reduce costs. Thus, there is increased pressure on medical laboratories as well.
In an article in the College of American Pathologists’ online journal Cap Today,
Larry Massie, MD, Professor of Pathology at the University of New Mexico, and Chair of Pathology and Laboratory Medicine for the New Mexico VA Health Care System in Albuquerque, states that turn-around time is crucial for HAIs, but that laboratories often have difficulty keeping up with large volumes of samples. Massie suggests the use of new technologies could speed up turnaround time, particular for large healthcare providers.
The fight to reduce HAIs and HACs is showing significant progress, and clinical laboratories, working in tandem with clinicians and prevention programs, are a fundamental part of the success of HAI reduction. Clinical pathologists and laboratories often are the front line in prevention and management of HAIs, and the work they do in identifying infections is essential in the assessment and control of those infections.
— Amanda Warren
Related Information:
National Scorecard on Rates of Hospital-Acquired Conditions 2010 to 2015: Interim Data from National Efforts to Make Health Care Safer
How Hospitals Can Reduce Hospital-Acquired Infections
HAI Data and Statistics
Hospital Acquired Infection: Molecular Study and Infection Control Guidelines
Rapid Sequencing and Characterization of Pathogens in Hospital-Acquired Infections
The Role of the Microbiology Laboratory in Surveillance and Control of Nosocomial Infections
Core Elements of Hospital Antibiotic Stewardship Program
Pressure’s on to Halt Nosocomial Infections
Hospital Acquired Infections
Surveillance of Hospital-acquired Infections: A Model for Settings with Resource Constraints
The Laboratory and Infection Control
Role of the Microbiologist in Infection Control and Hospital Epidemiology
Study Finds Occupying Hospital Bed Previously Used by Patient Receiving Antibiotics Increases Odds of Developing C.diff Infection
Oct 7, 2013 | Laboratory Hiring & Human Resources, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Management & Operations, News From Dark Daily
A sold-out audience gathered at the seventh annual Lab Quality Confab and heard speakers from the nation’s most innovative medical laboratories share case studies about success in cutting lab expenses and improving quality
DATELINE: NEW ORLEANS, LOUISIANA—At a time when medical laboratories in the United States are experiencing significant financial challenges, there was plenty of guarded optimism among the clinical laboratory managers and pathologists who gathered in this famous city last week for the seventh annual Lab Quality Confab.
One reason for this optimism is that speakers and attendees at this sold-out meeting are the nation’s leading experts in the use of Lean, Six Sigma, and process improvement methods in medical laboratories and pathology groups. They know how to cut lab costs while maintaining quality and boosting the productivity of the lab’s staff and automated systems. (more…)
Feb 6, 2013 | Instruments & Equipment, Laboratory News, Laboratory Pathology
The study found that a Robotic vapor-dispersing device kills and prevents spread of Drug-Resistant Organisms in high-risk patients by 64%
There is a new technology for disinfecting healthcare facilities that is likely to be useful for clinical laboratories and anatomic pathology groups.
A team at Johns Hopkins University Hospital recently published a study about their institution’s use of hydrogen peroxide vapor to disinfect hospital rooms.
The study was conducted over two and one-half years and involved hospital rooms used by thousands of patients. The goal of this study was to verify the effectiveness of a new robot-like device, known as Bioquell Q-10. This system disperses a hydrogen peroxide vapor to disinfect hospital rooms and was described in a news release issued by Baltimore-based Johns Hopkins University Hospital. (more…)
