Biomoda, a cancer diagnostics company and Obio, a corporation formed to pursue public and private funding for cancer research in Ohio, have signed a memorandum of understanding (MOU) to establish a CLIA-certified Biomoda clinical laboratory in Ohio to support ongoing R&D on Biomoda’s porphyrin-based assay for the detection of early-stage cancer.
Biomoda currently is conducting clinical trials of its CyPath labeling solution, an inexpensive, noninvasive assay designed to identify early-stage lung cancer by binding to cancer cells and causing them to fluoresce under ultraviolet light.
Biomoda is seeking FDA approval of its screening technology as a Class III medical device. CyPath is currently for investigational use only.
According to the companies, initially, the lab formed in partnership between Biomoda and Obio could employ up to 12 trained technicians to prepare fluid and tissue samples for immersion into the CyPath labeling solution and subsequent screening under an ultraviolet microscope.
Pending FDA approval, widespread commercialization of the CyPath product would require significant expansion of the lab facility, creating additional jobs and a positive impact on Ohio’s economy.
John Cousins, president of Biomoda, said: “We are ready to expand our strategic alliance with Obio to include operational facilities that will put us in closer contact with Ohio’s top-rated medical, scientific and technical resources. Ohio is proactively attracting promising biotech companies to the state through public initiatives that support research and commercialization. This fits perfectly with our strategic plan for taking CyPath into the marketplace.”
The Clinical Laboratory Improvement Amendments (CLIA) were passed by Congress in 1988 to establish standards for laboratory testing and ensure the accuracy and reliability of patient test results. Laboratories that meet CLIA standards are certified by the US Department of Health and Human Services.