Frost & Sullivan has identified the most promising point of care breath analysis technologies to detect and monitor acute respiratory distress syndrome, asthma, breast cancer, bronchitis and emphysema.
The sooner a physician can make a decision, the better the outcome for the patient. Frost & Sullivan’s health care team has been monitoring developments in point-of-care (PoC) breath analyzers that support early disease detection and monitoring.
More familiar to drivers in the breathalyzers that law enforcement officers employ to estimate blood-alcohol content, breath analysis also provides a number of advantages in diagnosing and monitoring respiratory diseases, diabetes and cancer. PoC breath analysis is both noninvasive and nonintrusive, in contrast to blood or urine tests, and can be performed repeatedly without adverse effects such as radiation exposure from X-rays. Most importantly, PoC breath analysis can provide faster results. For example, diseases cause changes in the pattern of volatile organic compounds (VOCs) in the blood that are exhaled when the blood exchanges carbon dioxide for oxygen in the lungs. Analyzing VOCs in breath samples would give physicians earlier indication of the presence of disease and, when monitoring a patient, determine progress in fighting a disease.
Frost & Sullivan has identified the most promising PoC breath analysis technologies to detect and monitor acute respiratory distress syndrome, asthma, breast cancer, bronchitis and emphysema.
Owlstone Medical (Cambridge, U.K.)
Owlstone Medical designed its handheld Breath Biopsy technology to collect and analyze exhaled VOCs for faster disease diagnosis and monitoring of drug toxicity and interactions. Patients hold the ReCIVA Breath Sampler over their mouth and nose and breathe for at least one minute—the time it takes for blood to circulate throughout the body—to measure VOC biomarkers in their breath. Among its uses is analyzing the biomarkers that originate from pulmonary tissue and indicate lung cancer or relate to tuberculosis. The technology also is being used in the STRATA (Stratification of Asthma Treatment by Breath Analysis) project in the United Kingdom to stratify asthma patients by inflammatory subtype in order to match them to the correct treatment to improve outcomes and reduce health care costs.
In April, Owlstone Medical formed a partnership with major pharmaceutical formulator AstraZeneca to use Breath Biopsy to identify biomarkers that are relevant to asthma and chronic obstructive pulmonary disease, including bronchitis and emphysema. The goal is to determine whether respiratory patients would benefit from different dosages or medications.
Mensenna Research Inc. (Newark, N.J.)
Connectivity plays a major role in the Mensenna BreathLink. Patients breathe normally through their mouth for two minutes into the tabletop system, which collects and concentrates the VOCs in their breath. A built-in gas chromatograph analyzes the VOCs with picomolar sensitivity (i.e., to parts per trillion). This data, or chromatogram, is encrypted and uploaded via the cloud to Mensenna’s central laboratory, where proprietary algorithms analyze it and send a report back to the system within minutes.
Tests have demonstrated that the BreathLink system has identified breast cancer and pulmonary tuberculosis. The National Cancer Institute funded an observational study of the Mensenna PoC breath analyzer as a predictor of breast cancer. The study was scheduled for completion in June, but no results have been posted yet.
University of Michigan (Ann Arbor, Mich.)
The American Lung Association estimates that approximately 200,000 cases of acute respiratory distress syndrome (ARDS) occur annually in the United States. ARDS causes fluid to leak into the lungs, killing 30 to 50% of those affected. Scientists at the University of Michigan hope that their breath analyzer will improve ARDS patients’ chances of survival. The researchers are developing an automated, mobile gas chromatograph that weighs about 9 pounds. The device is equipped with proprietary algorithms that enable it to analyze the VOCs in a breath sample down to parts per billion in order to determine indications of ARDS within 20 minutes. This is faster, less painful, and more accurate than a single blood test, lung biopsy or chest X-ray, which the inventors say can miss the disease.
Based on promising data, the team received a National Institutes of Health R21 exploratory/developmental grant to conduct further testing on patients. The scientists have several patents pending for the system and are considering the formation of a start-up company. They envision that the system could improve outcomes for asthma, pneumonia and sepsis.
The Road Ahead
Frost & Sullivan research indicates that PoC breath analysis will have an impact on health care quite soon. This is borne out by U.S. Food and Drug Administration approval of these types of diagnostic and health monitoring technologies. The most significant approval was in March, when the agency cleared the BreathID Hp Lab system developed by Exalenz Bioscience Ltd. of Modi’in, Israel, to detect Helicobacter pylori bacteria in children between the ages of 3 and 17. If untreated, this infection can cause chronic disease later in life. The speed, sensitivity and accuracy of PoC breath analysis to improve patient outcomes will spur the use of these diagnostic tools globally.
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