TechSectors - Medical Device: Medical Breathalyzer

Researchers and healthcare professionals have speculated for years that the future of disease diagnosis is in the breath. And that future may not be far off . Researchers around the globe are working on various breath-based technologies to not only diagnose illnesses, but identify the ingestion of drugs of abuse and provide defi nitive medication adherence documentation. The science behind these technologies is based on previously unexpected fi ndings that many substances found in the blood show up in one’s breath. “Because the lungs have a huge surface area to exchange gases, what appears in the breath is a good refl ection of what is present in the blood,” reports Dr. Richard Melker, Professor of Anesthesiology at the University of Florida and Chief Technology Offi cer of Xhale, Inc. “We now believe that a large number of compounds of medical interest are available for analysis in the breath; a few years ago people wouldn’t have believed that. But, we’re on the cusp of a whole new medical era.”

Currently, one of the most common uses of breath-based technology is the alcohol breath analyzer. Invented in 1954 by Dr. Robert F. Borkenstein, this technology has undergone a variety of changes over the years, but there have been no major advances in over two decades. But with new sensor technology, this decades-old tool is on the verge of a major transformation. Today’s alcohol breath analyzers face major issues with interfering compounds. At times, diabetics may have elevated acetone levels, which can result in false positive breath analyzer readings. Also, it has been reported that compounds in some common cleaning fl uids absorbed through the skin may cause erroneous results. Th e new generation of alcohol breath analyzers will have the ability to measure not only ethanol, but will be able to separate that measurement from other compounds. Th is delineation will provide evidential proof of innocence or guilt.

Exhaled breath is an ideal non-invasive medium for many diagnostic tests. Breath-based tests will allow real-time results, because unlike other biological media, exhaled breath is present on a continuous, non-invasive basis. Th e collection of breath samples is straightforward and painless: no specimen has to be sent to a laboratory, no waiting for results is needed, no complicated steps exist, and mixing or handling of fl uids isn’t necessary, making it more convenient, effi cient, and cost-eff ective than blood- and urinebased testing systems.

As reported in the August 2007 issue of Cancer, researchers at Zhejiang University in Hangzhou, China identifi ed potential biomarkers of lung cancer in the breath of patients with the disease. They identifi ed 11 volatile organic compounds (VOC) in the breath of patients with lung cancer that correlated with four VOCs found at the cellular level of four lung cancer types. Breath-based research is also being conducted on breast cancer and heart disease diagnosis, and to correlate the levels of glucose found in the breath with levels of glucose found in the blood. For diabetics, self-monitoring of blood glucose is the only way by which they can calculate drug dosage and maintain safe glucose levels. A breath-based monitoring system would eliminate “fi ngersticks,” making glucose testing painless and much more convenient for diabetics.

Another emerging area in breath-based technology is medication adherence monitoring. According to the National Council on Patient Information and Education (NCPIE), approximately 50% of patients are not taking their medications as prescribed. Lack of medication adherence leads to unnecessary disease progression, a lower quality of life, and even death. But one of the most serious results of poor medication adherence is the emergence of drugresistant strains in diseases such as tuberculosis and HIV/AIDS. By tagging drugs with compounds that can be measured in the breath, medications can be detected via a small hand-held monitor. Th is technology not only verifi es that a patient took the right medication and the right dose at the right time, it can also remind patients when to take medications.

In the near future, it can be expected that breath-based technology will overtake many medical markets due to its elements of convenience, non-invasiveness, cost eff ectiveness, and accuracy.

Ms. Casson is the Public Relations and Communication Coordinator for Xhale, Inc.