The approval by Health Canada provides LuViva access to the United States largest trading partner and to other markets that recognize Canadian device approval.
"Receiving Health Canada marketing approval for LuViva is a significant milestone for the product and the company," said Mark L. Faupel, Ph.D., CEO and president of Guided Therapeutics, Inc. "We are in discussions with potential distributors in Canada and expect this approval to advance the process. Additionally, the Health Canada approval helps to jumpstart and support the regulatory process in some Latin America and Southeast Asian countries."
Each year, about 5.7 million women in Canada undergo Pap test screening for cervical cancer, with as many as 400,000 receiving an abnormal Pap result. These women are then scheduled for a follow-up exam, called a colposcopy, which typically includes a biopsy. The wait times for colposcopy examinations in Canada are two to six months. LuViva is designed to reduce wait times and provide results immediately at the point of care.
"We believe that LuViva has the potential to bring a new level of efficiency to womens healthcare in Canada and improve the standard of care by providing immediate results with a painless, one-minute test," said Dr. Faupel.
LuViva scans the cervix with light to identify cancer and pre-cancer painlessly and non-invasively. Guided Therapeutics patented biophotonic technology is able to distinguish between normal and diseased tissue by detecting changes at the cellular level. Unlike Pap or human papillomavirus (HPV) tests, LuViva does not require laboratory analysis or a tissue sample.
The Health Canada application was filed under the former name, "LightTouch" and will be amended to reflect the name change to LuViva.
About Guided Therapeutics
Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP) 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 same technology platform. For more information, visit: www.guidedinc.com .
Posted by Sean Fenske, Editor-in-Chief, MDT