"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 products 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 LuVivas 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.
About LuViva® Advanced Cervical Scan
LuViva is a technologically advanced diagnostic device that scans the cervix with light and uses spectroscopy to measure how light interacts with the cervical tissue. Spectroscopy identifies chemical and structural indicators of precancer that may be below the surface of the cervix or misdiagnosed as benign. This technique is called biophotonics. Unlike Pap, HPV tests or biopsies, LuViva does not require laboratory analysis or a tissue sample, and is designed to provide results immediately, which eliminates costly, painful and unnecessary testing. LuViva is designed for use with women who have undergone initial screening and are called back for follow up with a colposcopy examination, which in many cases involves taking a biopsy of the cervix. The device is used in conjunction with the LuViva® Cervical Guide single-use patient interface and calibration disposable.
About Guided Therapeutics
Guided Therapeutics, Inc. is developing a rapid and painless testing platform for the early detection of disease based on its patented biophotonic technology that utilizes light to detect disease at the cellular level. The companys first planned product is the LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease instantly and at the point of care. In a multi-center clinical trial, with women at risk for cervical disease, the technology was able to detect cervical cancer up to two years earlier than conventional modalities, according to published reports. Guided Therapeutics has also entered into a partnership with Konica Minolta Opto to develop a non-invasive test for Barretts Esophagus using the technology platform. For more information, visit: www.guidedinc.com.
Posted by Sean Fenske, Editor-in-Chief, MDT