Biomoda Inc. (fka BMODQ)

[The Rainmaker]

This was the page before they took it down...this is very exciting

CLINICAL AND VALIDATION STUDIES

Thomas Bauer, MD
Chief, Thoracic Surgery
Helen F. Graham Cancer Center, Christiana Care
Principal Investigator


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

Sample Collection Complete; Study Completion and Release of Top-Line Results: First-Quarter 2011

The study is designed to assess the efficacy of Biomoda’s CyPath® Early Detection Lung Cancer Assay to detect lung cancer cells in deep lung sputum. Participants who satisfy the inclusion/exclusion criteria were enrolled in the study and assigned to one of two cohorts: Cancer Cohort or High-Risk Cohort.

The sputum samples were collected at Radiology Associates of Albuquerque and the Helen F. Graham Cancer Center, Christiana Care Health System by a licensed Respiratory Therapist/Nurse. Samples were identified with an identification number to blind the sample identity. Each subject’s sputum specimen was processed onto twelve (12) microscope slides at the Biomoda Laboratory and labeled with CyPath®. The Biomoda Laboratory processed each sputum sample onto slides using the ThinPrep T2000 processor. Biomoda performed the CyPath® labeling and scoring of the slides. Denver Veterans Administration Medical Center Pathology Department or National Jewish Hospital Pathology Department, both in Denver, Colorado, performed PAP staining of one of the subject’s sample slides and evaluated the cells on the slide for the presence of cancer cells and macrophages. Macrophages are an indicator that the sputum sample is from deep within the lungs. A cytotechnologist and pathologist reviewed each slide and recorded results on a specimen adequacy form. The study compares the results of the CyPath® Assay in the Cancer Cohort and a subset of the High-Risk Cohort, including those participants who showed no nodules in their CT scans (considered “normals” by the study.) CT scans were evaluated by a licensed, independent and blinded radiologist.

Clinical findings from PAP and CT scans may be used in the diagnosis and treatment of study participants, according to standard practice. Findings from the CyPath® assay will not be used in the diagnosis or treatment of participants. Study participants included male and female individuals who met the requirements from the two cohorts, listed below:

•Patients with known primary or recurrent lung cancer prior to therapy or other treatment (must be at least one year since any previous therapy), with central (bronchogenic) and/or peripheral tumors.
•Participants may have other forms of cancer but the cancer must not have metastasized to the lungs.
•U.S. military veterans who are heavy smokers (defined as 20 pack years or greater, i.e., one pack per day for 20 years or two packs per day for 10 years).
•Study participants must be willing to have medical information released if indicated.
Participants who meet any of the following criteria will be excluded from the study:

•Recurring lung cancer outside the lung cavity
•Lung cancer that metastasized from other cancers in the body
•Severe obstructive lung disease
•Angina with minimal exertion
•Pregnancy
•Worked in the mining industry.
Sample collection for this study is complete, and results of sample reading have been provided for statistical analysis and algorithm development. Top-line results will be published before the end of first-quarter 2011. A paper will be written and submitted to a peer review journal for publication.