Trial Information

Sputum Labeling Utilizing Synthetic Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer

Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) is a porphyrin that can label cancer cells by
reacting to the increased number of low-density lipoproteins coating the surface of cancer
cells and the porous nature of the cancer cell membrane, causing the cell to fluoresce under
specific wavelengths of light. The primary objective of this clinical trial was to
determine the clinical sensitivity and specificity of the CyPath® Lung Cancer Detection
Assay ("CyPath® Assay") using sputum specimens from two cohorts of Participants. The Study
design included a protocol to assess the capability of the Biomoda CyPath® Lung Cancer
Detection Assay to detect cancer in comparison with routine high-resolution, low-dose
Computed Tomography (LDCT) scans.

Study results showed that the CyPath® Assay is a significant new biomarker for lung cancer
with sensitivity at 77% and specificity at 58%, and an overall accuracy of 81.3% in the
ability of the CyPath® assay and specific patient factors to correctly classify groups of
Study participants into the cancer or high-risk cohorts. Testing for the Study was
performed at multiple locations to assess the efficacy of the CyPath® Assay to detect lung
cancer cells exfoliated from lung tumors present in deep-lung sputum. Participants who
satisfied the inclusion/exclusion criteria were enrolled in the Study and assigned to one of
two cohorts (smoker with clear LDCT scan or "high-risk normals," and lung cancer confirmed
by pathology or "cancer").

Optimization of the Assay can lead to improved sensitivity and specificity. Increase in
sample size and evaluation of the entire sputum sample can increase data collection and
differentiation between cohorts. Technicians in the current Study examined 12 slides
containing approximately 600,000 cells. The average sputum sample pellet translates to a
potential of approximately 3.5 million cells for evaluation. Evaluating the full sputum
sample with the CyPath® Assay can be accomplished through flow cytometry and would increase
the capture and analysis of exfoliated cancer cells in the sample. In-house studies
evaluated samples from five different cancer cell lines using flow cytometry. Preliminary
results showed that cancer cell lines were detected with significant fluorescence apart from
normal cell fluorescence. Refinements for using the flow cytometer include optimizing the
liquid-based assay and sample analysis and focus on concentration, incubation time and
optimal sample volume.