Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) today announced that it has submitted the application for CE Mark approval for LuViva® Advanced Cervical Scan. The CE Mark is required to market LuViva in the 27 nations that comprise the European Union (EU).
“The filing of our CE Mark approval application for LuViva is a significant milestone for the company and puts us on track, when approved, for a full-scale European launch in the third quarter of this year”
"The filing of our CE Mark approval application for LuViva is a significant milestone for the company and puts us on track, when approved, for a full-scale European launch in the third quarter of this year," said Mark L. Faupel, Ph.D., president and CEO of Guided Therapeutics. "We view the international market segment as significant opportunity for LuViva because of the product's versatility and ability to adapt to the various diagnostic routines in different countries."
Distribution agreements are currently in various stages of completion for several EU and Asian countries, including Germany, the United Kingdom and several South Asian countries. The company also has initial orders for clinical and demonstrations units in hand for European and Asian countries.
LuViva received Health Canada marketing approval on December 14, 2011. Guided Therapeutics received its ISO 13485 certification in January 2011. LuViva remains under U.S. Food and Drug Administration premarket approval review for which the company intends to request an independent panel review of its application, as well as, explore other options with the agency.
According to the European Cancer Observatory, 146 million women are targeted by cervical cancer screening programs which are currently running or being established in the EU.
The study used to support LuViva's CE Mark application was the multi-center U.S. pivotal trial in which 1,607 women at risk for developing cervical disease were diagnosed. In this patient population, LuViva was able to detect cervical cancer up to two years earlier than the Pap test, human papillomavirus (HPV) test, colposcopy and biopsy. LuViva detected 86.3 percent of the cervical disease cases that had been missed by Pap, HPV tests and biopsy. LuViva would have reduced the number of unnecessary biopsies by about 40 percent. LuViva detected cervical disease equally in women ages 16 to 86 years and across a broad spectrum of races.
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