Internal Validation Research Trial

February 1, 2015

27 sputum samples: 15 lung cancer sputum samples and 12 sputum samples from patients without lung cancer, December, 2008

T. Bauer II, MD, Helen F. Graham Cancer Center; D. Merrick, MD, Denver VA Medical Center; T. C. Kennedy, MD, University of Colorado Health Science Center; C. Dorian, Biomoda

In this internal study, the assay revealed 100% specificity and 100% sensitivity.

Researchers investigated meso Tetra (4-Carboxyphenyl) Porphine (TCPP), a porphyrin that can label cancer cells. The primary objective of this project was to determine the utility of TCPP-labeling of sputum samples for the detection of lung cancer. Two groups of subjects were studied including one group of 15 subjects diagnosed with lung cancer and the other group of 12 normal subjects who did not have a history or diagnosis of lung cancer. The hypothesis was that sputum specimens labeled with TCPP can detect lung cancer cells when observed under a microscope with ultraviolet light. The TCPP-labeled cancer cells fluoresce brighter and are distinguishable from normal cells. To test this hypothesis sputum cells were labeled with the CyPath® Early Lung Cancer Detection Assay, and slides were observed under an ultraviolet microscope.

Sputum samples containing red fluorescing cells were considered positive for lung cancer. In this study, 15 of the 15 samples from lung cancer patients displayed red, fluorescing cells and 12 out of the 12 samples from normal patients reveals no red fluorescing cells, resulting in 100% accuracy in this dataset.