Pilot Clinical Trial Q & A
Biomoda’s pilot clinical study on the CyPath® diagnostic assay demonstrated that CyPath® is a significant new biomarker for lung cancer. Study results will be published in a medical journal. By establishing CyPath®’s ability to correctly classify groups of study participants into the cancer or high-risk cohorts, the pilot study lays the foundation for further work to optimize the assay, launch the large-scale pivotal trial and prepare for commercialization of CyPath® as a non-invasive, inexpensive and accurate diagnostic tool for the detection of lung cancer.
What were the objectives of the pilot study?
The overall objective of the study was to determine the baseline clinical sensitivity and specificity of the Biomoda CyPath® diagnostic assay using deep-lung sputum samples from two cohorts of participants: individuals at high risk for lung cancer and individuals diagnosed with lung cancer and pre-therapy. Most important, the study determined that CyPath® is a significant, new biomarker for lung cancer and identified considerable quantitative differences between the high-risk and the cancer cohorts of the study.
Additionally, we reached a number of other important milestones:
We established protocols to recruit participants for the high-risk, cancer and other cohorts to meet the criteria required for future clinical trials;
We established protocols and procedures for improved sample collection;
We are able to collect adequate sputum samples from large groups of participants in all cohorts;
We met the reproducibility and reliability standards under Good Laboratory Practices (GLP) with regard to sputum collection, sputum processing and slide preparation procedures.
We established methods for the formulation stability and shelf life of the assay reagents and materials, as well as staining procedures and analysis and scoring methods for sputum samples.
The clinical trial has set a strong foundation to set standard operating procedures (SOPs), design the protocols for the larger pivotal trial and scale up use of the assay.
Biomoda’s research team expects ongoing work to optimize the assay will lead to improved sensitivity and specificity numbers. For example, we prepared only 12 slides from each sample in the pilot study, representing about 600,000 cells, and we know that the entire sample contains many millions of cells. Evaluating the entire deep-lung sputum sample, we believe, will improve both sensitivity and specificity. We are also continuing to refine the use of fluorescent microscopy to identify cancer and pre-cancerous cells that should result in increased specificity by differentiating between debris, dysplastic or inflamed cells that may be reflected in high-risk samples and cancerous cells contained in samples from cancer patients. This may lead to use of the assay to identify the type of lung cancer and stage the disease. This capability also can lead to use of the assay to detect pre-cancerous cells in high-risk individuals.
What are the most important conclusions from the pilot study?
· CyPath® is a significant, new biomarker for cancer.
· We can objectively identify and quantify cellular characteristics from the sample on the slide and have patents pending on this technology.
· We confirmed that the CyPath® test is simple, inexpensive and easy to perform on large at-risk populations.
· An adequate sputum sample can be collected from most individuals using an FDA-approved device for the clearance of respiratory secretions.
· The CyPath® test can be performed and processed quickly.
· Necessary refinements and optimization of the assay can be completed with methods and technologies that are currently available.