Another Breathalyzer to Detect Disease

First there was BreathLink, described as a breathalyzer for the detection of breast cancer and pulmonary tuberculosis. It's been 6 years since I first highlighted the concept of using breathalyzers for disease detection (see this blog July 4, 2011). BreathLink is currently undergoing extensive clinical trials. If all goes well, it may receive final FDA approval as a diagnostic test within another year or two.

Now there's another one, called Breath Biopsy. This one is at an earlier stage of development but is somewhat broader in scope. Breath Biopsy is, in effect, a platform to detect virtually any volatile organic compound (VOC) that might appear in the breath in a disease state. Current clinical trials about to get underway to validate Breath Biopsy tests for early-stage lung and colon/rectum cancers, and it is being considered for the possible detection of cancers of the bladder, kidney, esophagus, pancreas, prostate and brain. Several other possible uses have been proposed, including evaluating how patients with chronic obstructive pulmonary disease (COPD) are responding to treatment, and even studying a patient's microbiome - the bacteria in their digestive system - to determine which drugs might work best on their specific disease.

Compared to blood tests and biopsies, breath analysis would be safe and cheap. But before any breathalyser-based tests can be approved by the FDA, they will have to demonstrate their accuracy and reliability in extensive clinical trials. As the experience with BreathLink has shown, regulatory approval can take years or even decades, not days or months. You may encounter a breathalyzer test in your lifetime, but don't hold your breath.