Guided Therapeutics seeks premarket approval from FDA for LuViva Advanced Cervical Scan

Guided Therapeutics, Inc.Jul 26 2012

Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) today announced that it met with the Food and Drug Administration (FDA) on July 20, 2012. The company believes the meeting was very positive and plans to work with FDA to finalize the path forward to gain premarket approval (PMA) for the LuViva^® Advanced Cervical Scan, a non-invasive device used to detect cervical disease that leads to cancer, instantly and at the point of care.    

The preliminary plan calls for the company to file a PMA amendment using existing clinical data to address the agency's questions stemming from its January 20, 2012 "not approvable" letter. The company maintained at the meeting with the FDA that the new data analysis to be included in the amended PMA demonstrates the clinical benefit of LuViva in light of new cervical cancer screening guidelines adopted earlier this year.

"We are pleased with both the tenor and substance of the meeting with FDA and believe we have a good plan to move the PMA process forward through what we hope will be a quick review and approval for LuViva," said Mark L. Faupel, Ph.D., President and CEO of Guided Therapeutics. "We believe that once approved, LuViva will have a very positive impact on the U.S. healthcare system by improving the standard of care for the early detection of cervical disease, and providing women and doctors the first test with instant results."

LuViva has been under FDA PMA review since September 23, 2010. The company received a "not approvable" letter for the product on January 20, 2012. In May, 2012 the company requested a meeting with the agency, and suggested a path for possible approval to which the FDA was receptive. After a PMA amendment is submitted, the FDA has 180 days during which it can respond.

In addition to the recently announced CE Mark, LuViva has marketing approval from Health Canada. Guided Therapeutics was awarded ISO 13485 certification in January, 2011. The company continues to anticipate a launch in international markets later in 2012.