ALBUQUERQUE, N.M., Sept. 10 /PRNewswire-FirstCall/ -- Biomoda, Inc. (http://www.biomoda.com) of Albuquerque, N.M., maker of early lung cancer detection testing and other cancer diagnostic technology, announced today an agreement with Quintiles Consulting of Rockville, Md., for regulatory consulting and design of clinical studies of Biomoda’s proprietary test for detection of early lung cancer as part of the company’s clinical programs.
“Quintiles has the experience, skills and understanding of the full range of review perspectives that bear on agency evaluations of new medical tests and devices,” said John Cousins, President of Biomoda. “They will provide guidance, input and review to structure protocol, data content and collection and other information relative to making sure information is gathered in appropriate formats for future FDA submittals by our company.”
Quintiles Consulting (http://www.quintiles.com) is the regulatory consulting unit of Quintiles Transnational Corp, a global corporation powering the next generation of healthcare by providing a broad range of professional services in product development, financial partnering and commercialization for the pharmaceutical, biotechnology and medical device industries. Quintiles Consulting helps companies navigate regulatory challenges and improve efficiencies from early discovery through commercialization. Among its services, Quintiles Consulting provides advice and strategies in the areas of product development, regulatory submissions and compliance, bioresearch monitoring, quality systems, validation, and pricing and reimbursement.
Biomoda’s technology is based on a patented porphyrin application that preferentially binds to cancerous or aberrant cells extracted from lung sputum samples. Cancerous cells glow red under fluorescent light to allow detection under a microscope. The patented technology, a non-invasive cytology based assay, is designed for cancer screening of large populations at a reasonable cost. Current diagnostic methods for lung cancer, including CT scans and X- rays, often detect the disease only at more advanced stages and are relatively expensive.
Lung cancer claims more lives than any other cancer. The expected 5-year survival rate for all patients combined in whom lung cancer is diagnosed is 15 percent and by contrast, the 5-year survival rate for cases detected when the disease is still localized is 50 percent. At the present time, only 16 percent of lung cancer cases are diagnosed at this early stage.
Cautionary Statement: Investors should be aware that trading in the company’s stock through market makers and quotation on the OTC Bulletin Board entails risk. Due in part to the decreased trading price of our stock and reduced analyst coverage, the trading price may change quickly, and market makers may not be able to execute trades quickly. Please contact your broker if you have further questions about executing trades. “Safe Harbor” Statement: This press release contains “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are naturally subject to uncertainty and changes in circumstances. Actual results may vary materially from expectations contained herein. Biomoda is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
Biomoda, Inc.
CONTACT: John Cousins of Biomoda, Inc., +1-505-821-0875
