Our sensors have >100 independent signals, and so have the high dimensionality prior sensor devices have not had.

Prior devices may have had many elements but produced sensor signals with only a few material principal components. The CSA is highly dimensional, each of the array of over 100 reactive indicators are highly diverse chemically, a very wide range of volatile organic compounds (VOCs). The colorimetric sensor array has proven very well suited to identifying the fingerprint of highly complex mixtures.  The ability to identify the signature of complex mixtures proves crucial for the assessment of disease from breath, as disease processes such as lung cancer tumor metabolism or bacterial metabolism each produce a signature pattern composed of dozens of out-gassed volatile organic compounds (VOCs), the entire pattern being the recognizable signature.  A recent breakthrough material and new classes of sensors have improved sensitivity and significantly increased dimensionality. The most recent sensor includes over 100 indicators, older versions were limited to 36.

The first generation has been used to diagnose lung cancer with accuracy comparable to CT. The first generation of Metabolomx technology developed by Professor Kenneth Suslick at the University of Illinois used dyes as the color changing component.  This first generation of the colorimetric sensor array technology was used in the Cleveland Clinic lung cancer studies reported by Dr. Peter Mazzone (2007) and in the new study currently in press reporting 81% average C-statistic on lung cancer detection (comparable that of CT) and the ability to identify lung cancer subtype.

The breakthrough nanoporous structure and other advances have resulted in a >100x increase in sensitivity, far greater shelf life, reproducibility and manufacturability. In 2008 a new breakthrough method of sensor implementation was developed, wherein the chemical indicators are embedded in a nanoporous pigment matrix instead of dye.   The nanoporous pigment, a silicon-based sol-gel, has enormous surface area at the nanoscale, increasing interaction area between analyte and indicator, and so in comparison with the previous dye-based sensor results in a >20x increase in sensitivity to a wide range of volatile molecules including species crucial for disease diagnosis.  In addition to superior sensitivity, nanoporous pigment sensors, the “2^nd gen sensor”, there are at least 5 advances represented in the current gen Metabolomx sensor versus those utilized in all the published results. Together, these and other technical advances result in a >100x increase in sensitivity, exhibit far greater shelf life, reproducibility and manufacturability.

The sensor is inexpensive and disposable. The cost and performance easily match the requirements for a one time use medical exam. The CSA sensor is constructed on a simple plastic or paper like media. The sensor is inexpensive and disposable. The cost and performance easily match the requirements for a one time use medical exam. The CSA is typically built into a disposable exam card that is used once with each patient exam. The current generation CSA exam card is printed on a plastic substrate, contained in a tube, through which breath can be passed. The exam card containing the CSA is used inside the Metabolomx breath analysis instrument. The breath analysis instrument (BAI) captures a precise quantity of breath, in a specific portion of the breath cycle and controls the exposure of the CSA exam card to the captured breath at a precise flow rate and volume.  The specific portion of the breath cycle to be sampled depends on the condition to be diagnosed.