Lung cancer is the leading cause of cancer deaths worldwide. The high mortality is in part due to the lack of good tests for early detection and treatment. Our technology diagnoses the presence of cancer via analysis of the specific fingerprint of volatile organic molecules produced by tumor metabolism, out- gassed from tumor tissue to blood and excreted in urine. Specific Technologies has pioneered a novel, highly sensitive and high dimensional chemical sensor array which in some respects mimics biological olfactory sensing, in that exposure to volatile molecules produces a complex sensor pattern allows even complex mixtures to be discriminated. Motivated by recent studies demonstrating that canines presented with urine samples can be trained to detect early stage cancer with high accuracy, we present preliminary data suggesting that our VOC-sensitive sensor responds with patterns discriminative of lung cancer when exposed urine headspace gas. If confirmed in more extensive testing, this assay would offer a non-invasive, rapid (1 hour), low-cost (order $10), point-of-care diagnostic for early stage lung cancer which we believe will be of significant value across a wide range of clinical settings, initially serving as an adjunct diagnostic for patients wth indeterminate pulmonary nodules, perhaps eventually allowing for lung cancer pre-screening in high-risk individuals. This assay of the presence of active tumor metabolism may also enable non-invasive and inexpensive monitoring of the efficacy of chemotherapy.
The proposed research effort will develop an assay of the headspace gas of a small urine sample as a rapid, inexpensive and non-invasive diagnostic test for the presence of lung cancer, initially as a follow up of CT with indeterminate nodules. A further application of this technology would be a urine headspace analysis to non-invasively and inexpensively monitor the efficacy of chemotherapy treatment. Page 1