Biomoda

Biomoda, Inc. operates as a development-stage in-vitro diagnostics company, having been incorporated in New Mexico on January 3, 1990. The firm's primary focus is on the development of assays for the early detection of cancer. The company's business model centers on creating and marketing diagnostic tests performed in clinical reference laboratories using body-fluid samples. Its foundational technology was initially based on a patent exclusively licensed from Los Alamos National Laboratories. One of the key figures associated with the company's technology is Maria Zannes, who served on the Board of Directors and later became the CEO and President of bioAffinity Technologies, which continued the development of the technology.

The company's principal product under development was the CyPath Lung assay, a test designed for the early detection of lung cancer. This test utilizes a sputum sample, which is deep lung fluid, to identify cancerous or aberrant cells. The technology works by using a porphyrin molecule that binds to cancer cells, causing them to glow red under fluorescent light, making them detectable under a microscope. The process involves preparing a single-cell suspension from the sputum, which is then labeled with the fluorescent porphyrin TCPP. This sample is analyzed using flow cytometry, a technique that rapidly measures the physical and chemical properties of cells. The CyPath Lung test is intended to be used in conjunction with imaging methods like low-dose CT scans to improve the accuracy of early lung cancer diagnosis and reduce false positives.

Biomoda has been a publicly traded company on the OTC Bulletin Board. SEC filings from 2010 indicate the company was in the development stage, had not generated revenues from product sales, and had incurred net losses. The technology, specifically the CyPath assay, was later acquired or its development was continued by bioAffinity Technologies. Recent publications show that the CyPath Lung test, under bioAffinity, has demonstrated high sensitivity and specificity in detecting lung cancer, particularly for small nodules. The test is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies.

Keywords: cancer diagnostics, in-vitro diagnostics, lung cancer detection, CyPath Lung, sputum analysis, flow cytometry, porphyrin-based assay, early cancer detection, medical diagnostics, clinical laboratory tests, noninvasive diagnostics, bioAffinity Technologies, laboratory developed test, TCPP, Los Alamos National Laboratories, medical technology, oncology diagnostics, molecular diagnostics, cell analysis, fluorescent labeling