Espicom View: While there are a number of competitors vying to enter the breathalyser market, Toshiba is one of the largest with a significant presence in the medical device industry. The company will be able to use its expertise from its other business segments to develop the product, while using its healthcare sales channels to market the device effectively. An increasing number of breathalyser diagnostics are likely to be entering development through a number of companies, with the possibility of non-invasive testing an attractive highlight. However, these systems will need to prove their accuracy against laboratory testing, which is currently dominating the diagnostic field.
Toshiba has developed a prototype of a compact breath analyser that can detect a wide range of trace gases in exhaled breath. The device has the potential to provide analysis that can be applied to health monitoring and diagnosis of disease. Toshiba believes that the analyser as a promising tool along a continuum ranging from diet and exercise advice to disease diagnosis.
In order to develop the capabilities of the new analyser, Toshiba has commissioned Waseda University to undertake clinical measurements of acetone concentrations in exhaled breath and to correlate the results with fat metabolism, an approach that may advance understanding of how to develop diets and food supplements. The research will start on April 1.
Toshiba has applied gas analysis technologies that it has cultivated in its semiconductor and other manufacturing activities to the breath analyser. A breath exhaled into the equipment is irradiated with an infrared laser, and trace gases detected across the absorption spectrum. The adoption of a quantum cascade laser as the light source has allowed Toshiba to develop desktop-sized equipment that delivers accuracy comparable with that of current floor-mounted breath analysers.
The current version of the equipment can detect acetaldehyde, methane and acetone. Toshiba will extend this to other gases, including isotopes of carbon dioxide, carbon monoxide and nitric monoxide, toward starting production to order in 2015. This will move the device from testing metabolic diseases to diagnosis of metabolic health, helicobacter pylori and airway inflammation. A number of breath components have been identified as disease indicators and some of these have been listed in the following table:
|Breath Component||Disease Indicated|
|Sulphur compounds||Hepatic diseases/lung cancer|
|Nitric oxide||Asthma and pulmonary diseases|
|Pentane||Breast cancer/rheumatoid arthritis|
|Methane||Colonic fermentation/small intestinal bacterial overgrowth|
|Volatile fatty acids||Anaerobic bacterial infections/tuberculosis|
|Source: Oxford Medical Diagnostics|
A number of breathalyser diagnostics are entering development for a range of diseases, spanning from the diagnosis or monitoring of diabetes to the diagnosis of tuberculosis or asthma. Toshiba is one of the largest companies to have come forward with its development offering. A number of small start-up companies are currently aiming to tap into this market such as Xhale. The latter already has a number of commercialised products, one of which is a drug adherence monitor using exhaled breath. The company is now adapting this technology to other indications, such as metabolic pathway assessment and glucose monitoring.
Oxford Medical Diagnostics, a company that develops breath and industrial gas analysers, is also developing a diagnostic breathalyser for the monitoring of Type I diabetes. Additionally, Rapid Biosensor Systems has a product in development that can detect the presence of the tuberculosis antigen. The company has an agreement with Ortho Clinical Diagnostics ( Johnson & Johnson) for the manufacture of this system and exclusive worldwide rights for the tuberculosis application. Rapid Biosensor Systems is also developing the device for the detection of malaria and Escherichia coli. Unlike other systems in development, this company's offering does not use lasers to analyse gases in the breath but uses a biochemical coated that reacts with tuberculosis bacilli.
Although a number of breath analysers are entering development, none have yet made it to market. It could be a while before one of these devices receives regulatory approval, leaving enough time for more competitors to emerge. Toshiba's offering is a likely frontrunner, and it will have the potential to be used in the diagnosis of multiple diseases.