Medical Diagnostics Business Segment

The Isotope Ratio Medical Diagnostics instrument market segment is driven by two distinctly different application areas. The near term business opportunity is in breath-based component testing, but there is an emerging market for specific biomarker analysis in tissue and body fluids such as blood and urine.

Breath analysis, particularly for carbon-13 and oxygen-18 enriched CO₂, is a very powerful and generally applicable diagnostic platform for many organ function and specific disease state tests.  While the application area has some current commercial exposure with the H.Pylori test, this market potential is largely untapped. The technique is non-invasive, easy to apply, precise, and accurate.  The performance envelope of the IRMS 3000 makes it an ideal instrument for use in a clinical environment for direct patient care.

There are two different types of instrumentation serving this application area.  These are long path Infra Red (IR) and Mass Spectrometry (MS). MS has long been recognized as the best approach for this type of testing, exhibiting fewer interferences and better linearity. The Monitor MG-AIRA, predecessor to the IRMS 3000, has been proven in parallel data validation studies with the Europa-PDZ mass spectrometer instrument, the de-facto standard in this field.

The analysis of body fluids for isotopically labeled biomarkers requires instrumentation that can either analyze for isotopic enrichment in the intact bio-molecule, usually in combination with a chromatographic separations step, or through degradation of the bio-molecule after chromatographic separation in a combustion interface.  This application area is in the R&D phase of development, but has significant promise for the future.   The Monitor IRMS 3000, shown in Figure 6, can also be used to measure deuterium isotope ratios in kinetic profiling of biomedical pathways.