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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Recent advances in breath analyzer technologies may give pathologists new diagnostic tools

Does breath analysis have a promising future in pathology and clinical laboratory testing? That day may not be far off. Scientists in multiple research laboratories are developing cost-effective, non-invasive diagnostic test technologies based on breath specimens from patients.

Researchers say that breath analysis can provide critical information in real time and deliver numerous advantages over fluid and image-based testing. In fact, glucose testing via breath specimen may be just around the corner!

On May 31, 2011, Xhale, Inc. was issued a patent for its system and method for non-invasive monitoring of glucose concentrations in blood to provide critical information in the diagnosis and treatment of diabetes. The Xhale system consists of a small handheld device that analyzes exhaled breath condensate.

Xhale recognizes that blood glucose testing is a huge market for a medical laboratory test that offers benefits over existing clinical laboratory testing methodologies. According to data from the 2011 National Diabetes Fact Sheet, released January 26, 2011, a total of 25.8 million children and adults in the U.S.—that’s 8.3% of the population—have diabetes.

“The great value of this [breath analysis] technology lies in its ability to provide important information to patients and healthcare providers that can be used to make better healthcare decisions,” said Richard Melker, M.D., Ph.D., Chief Technology Officer and Co-founder of Xhale, Inc. Other advantages, Melker said, are reduced healthcare costs and improved health outcomes. He added that patients, caregivers, healthcare providers and payers, alike, would benefit from the new breath-based testing technology for test blood glucose levels.

After collecting a breath sample from people who were health and people who had cancer, the Nano Artificial NOSE developed by Technion was able to accurately determine whether the breath sample was positive or negative for cancer. (Photo by

After collecting a breath sample from people who were health and people who had cancer, the Nano Artificial NOSE developed by Technion was able to accurately determine whether the breath sample was positive or negative for cancer. (Photo by

Meanwhile, Menssana Research, a biotechnology company in Fort Lee, New Jersey, is testing a point-of-care (POC) breath test for rapid identification of biomarkers of active pulmonary tuberculosis (TB) and other diseases, according to the company’s website and an article in the New York Times.

Menssana conducted a study and estimated that one-third of the world’s population is infected with Mycobacterium tuberculosis. The report recognized that developing countries have an urgent need for rapid, cost-effective diagnostic tools and clinical laboratory tests to detect the disease. TB killed 1.6 million people in 2005 alone.

Menssana’s BreathLinkLINK device is a desktop system designed to work with an Internet connection. Michael Phillips, M.D., the company’s Chief Executive and a Professor of Clinical Medicine at New York Medical College in Valhalla, New York, said in the article that the system’s analyzers can detect compounds in the breath in concentrations of parts per trillion. “This is a billion times more sensitive than breath analyzers used by the police to detect blood-alcohol concentrations,” Phillips noted.

According to Menssana, an international study of patients in India, UK, and the Philippines, showed that POC breath analyzers detected TB-related volatile organic compounds (VOCs) in 191 patients with 80% accuracy. The study pointed out that, although the viability of breath analysis to detect TB was established, current practice includes the use of GC/MS gas chromatography/mass spectrometry for diagnostic purposes. However, GC/MS methodology is expensive and turnaround times are slow.

Asthma is the target for another research effort to use breath analysis to diagnosis the disease. Marielle W. H. Pijnenburg, M.D., who specializes in pediatric respiratory medicine at Erasmus University Medical Center in Rotterdam, the Netherlands, assessed a new hand-held device to measure exhaled nitric oxide (NO) from asthma patients, according to the New York Times article and an abstract published at She found these particular devices to be expensive and the results—while useful—were not applicable to all asthma patients.

About 25 million Americans—8% of the population—had asthma in 2009. The cost of treating asthma in the U.S. totaled about $56 billion in 2007, according to the Centers for Disease Control.

Also targeting asthma is a research project funded by the Hartwell Foundation in Memphis, Tennessee. It awarded a grant to Cristina E. Davis, Ph.D., Associate Professor of Mechanical and Aerospace Engineering at the University of California, Davis, to develop a portable breath analyzer for pediatric asthma. “We want a hand-held device that is convenient for children to hold and use, so that they can monitor their condition,” stated Frederick A. Dombrose, who is President of the Hartwell Foundation.

Detection of cancer using breath analysis is the goal of Technion, which is the Israel Institute of Technology in Haifa, Israel. It has conducted a small, initial breath-based cancer detection study. It used specimens from 82 patients with either head-and-neck cancer, lung cancer, or no cancer.

The Technion research team used tailor-made detection equipment called the Nano Artificial NOSE. The device was able to distinguish between samples from cancer patients and samples from healthy volunteers. It also distinguished between the two types of cancers.

“There are clear signatures in the breath for [various diseases], said Raed Dweik, M.D., Director of the Pulmonary Vascular program at the Cleveland Clinic. He studies breath analysis and was quoted in the New York Times article. “My sense is that breath analysis is the future of medical testing,” he stated.

It is difficult to predict how much time will be required for any of these breath analysis technologies to gain full regulatory approval and be ready for clinical use in medical laboratories and other patient care settings. That means, in the near term, pathologists and clinical laboratory managers won’t need to evaluate any of these diagnostic technologies and proprietary medical lab testing systems for use in their own clinical laboratories.

On the other hand, with so many different research and biotech companies studying various ways to use breath analysis to diagnose disease, it is probably only a matter of time before useful clinical laboratory tests that utilize breath analysis enter the healthcare marketplace.

—Pamela Scherer McLeod

Related Information:

Point-of-Care Breath Test for Biomarkers of Active Pulmonary Tuberculosis

THE DARK REPORT, May 2009: New Report: POC Market Will Grow 30% by 2013

Beyond the Breathalyzer: Seeking Telltale Signs of Disease

For information about breath tests

Gas Chromatography Mass Spectrometry Analysis

Xhale Issued U.S. Patent for Non-invasive Monitoring of Blood Glucose Using Exhaled Breath

“Electronic nose” can sniff out cancer in breath of patients