The patented microreactor and its aminooxy coating work together to provide an unparalleled advantage that no other technology has developed — the microchip design concentrates the biomarkers (x10,000) into measurable amounts, and the coating ensures selective retention of the carbonyl biomarkers, thereby, giving a clean sample that only contains carbonyl cancer markers – a critical advantage when quantifying low-abundant markers. Concentrations of four specific biomarkers that are independently proven to be elevated in breath samples of LC patients are then quantified and reported. BDx’s competitors rely on pattern recognition that is often confounded by environmental and clinical variables. Also, these technologies require a large breath sample volume (need to collect breath for ~10 mins) in order to collect enough sample to observe low-abundant biomarker patterns. Not only is this inconvenient for the patient, but it may result in a drastic drop in sensitivity if sample collection is insufficient due to medical reasons.
The OneBreath test will not require an expensive equipment component at the site of collection. Once embedded on the microreactor, the cancer markers are stable and can be shipped to a MS lab for quantitative analysis. Alternatively, they can be eluted on-site and the solution transported in a sealed vial. Both methods have been successfully used by us. Methanol- as well as ethanol-solubilized biomarker adducts have been shipped from South America to the USA during our early studies, with consistent results. Samples will be shipped to our diagnostic lab partners who have the necessary analytical instrumentation for sample analysis.
In contrast, available data on competing technologies has shown that their breath tests will require an expensive and/or non-portable apparatus at the point of collection. Thus, the set-up costs for their equipment range from $8,000 to $40,000. Also, equipment for collection and analysis will require regular calibration checks and will likely have regular maintenance requirements. Finally, none of the competing technologies provide precise quantification of the volatile cancer biomarkers in breath.
Our preliminary results also showed OneBreath to be more specific than a PET scan (77% vs. 39% specificity) in distinguishing LC from benign pulmonary disease. This finding suggests that the OneBreath test could be employed following a CT scan that shows either a suspicious nodule or adenopathy within the chest. Potentially, this application could be used to guide patients toward observation in the case of benign pulmonary disease or toward biopsy in cases of malignancy.