Cancer diagnostics company Biomoda, Inc. (OTCBB: BMOD) (www.biomoda.com) today announced top-line results of its pilot study for lung cancer which shows highly significant evidence of CyPath®'s ability to discriminate between cancer and non-cancer groups based on sputum samples collected in a non-invasive manner.
Sensitivity of the assay was determined at 77% with specificity at 58% accounting for patient factors, and an overall accuracy of 81.3% in the ability to correctly classify groups of study participants into the cancer or high-risk cohorts. A Receiver Operating Characteristic (ROC) analysis of the sensitivity and specificity was shown to have an associated "p value" of less than .001, resulting in a statistically significant finding of CyPath®'s ability to discriminate between high-risk and cancer groups.
"The results demonstrate that CyPath® is a significant new biomarker for lung cancer that can be optimized for use as an inexpensive, noninvasive lung cancer diagnostic for large at-risk populations," Biomoda CEO Maria Zannes said.
"The objective of the study was to determine whether differences in CyPath® readings can differentiate between the two cohorts - cancer and high-risk. We now know the answer is yes," said Dr. Thomas Bauer, chief of thoracic surgery at Christiana Care Health System and Principal Investigator (PI) of the study. "We are able to both identify and quantify cellular characteristics that differ between groups of individuals at high risk for developing cancer and those who already have the disease."
The pilot study analyzed sputum samples from two cohorts: the high-risk cohort of 102 military veterans who smoked more than 20 "pack years," were asymptomatic for lung cancer and/or had not been diagnosed with lung cancer, and a control group of 26 patients diagnosed with primary lung cancer who had not started treatment. Each participant provided a deep-lung sputum sample which was processed onto 12 slides, representing about 600,000 cells from each individual, a small percentage of the total number of cells collected in each sample. The slides were immersed in the CyPath® labeling solution and viewed under a fluorescent microscope for the presence of fluorescing cells, which represent positive findings. Additional information about the study is posted on the Biomoda website in Q&A format.
Quantitative measurements of the fluorescence on the CyPath®-labeled sample slides and other patient metrics were statistically analyzed to determine the predictive accuracy of the molecular marker technology.
"The next step is to improve the sensitivity and specificity of CyPath® by completing ongoing research to optimize the assay," Zannes said. "For example, automating the process so that we can read the entire sputum sample, representing many millions of cells rather than 600,000, will clearly increase the likelihood of finding cancer cells that may be present."
The high-risk cohort included individuals who had multiple risk factors, including heavy smoking, compromised pulmonary systems and other lung diseases. CyPath® appears to bind to both cancerous and dysplastic, or pre-cancerous, cells. However, this study did not include morphological analysis of red cells, and differentiation between dysplastic cells and cancer cells was not part of the pilot study. Biomoda is conducting research now to define the cell matrices for quantitative measurement and increase CyPath®'s ability to not only identify lung cancer but to stage the disease by identifying all cells labeled with CyPath® in a sample.
"The pilot study has been enormously valuable in terms of defining our path toward optimization and ultimately the launch of a pivotal study," Biomoda President John Cousins said. "We expect to expand our internal research team and establish partnerships with major medical and scientific research institutions, both of which will speed our optimization efforts and clinical work. We are confident that CyPath® will be an important weapon in the fight against lung cancer."
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