ALBUQUERQUE, N.M., Sept. 10 /PRNewswire-FirstCall/ -- Biomoda, Inc. (OTC Bulletin Board: BMOD) (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
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