April 20, 2012 — Guided Therapeutics Inc. announced this week that the LuViva Advanced Cervical Scan is being introduced to medical leaders at the 40th Anniversary Meeting of the British Society for Colposcopy and Cervical Pathology (BSCCP) in Gateshead, United Kingdom, by Eurosurgical Ltd., the company’s U.K. distributor. The meeting runs April 18-20.
In the U.K., LuViva is initially intended as a follow-up test after a positive Pap test. Today in the U.K., approximately 400,000 women annually are referred to more than 170 institutions for a follow-up or colposcopy examination, which often involves a biopsy of the cervix. Based on its clinical trial results, LuViva could eliminate approximately 40 percent of unnecessary follow-up procedures and could identify serious cervical disease up to two years earlier than the standard of care.
“The BSCCP meeting is an important gathering of leading women’s healthcare providers from across the U.K. and Ireland and an excellent venue to introduce LuViva ahead of its anticipated launch later this year,” said Mark L. Faupel, Ph.D., CEO and president of Guided Therapeutics Inc.
Eurosurgical purchased, and recently received, the first LuViva demonstration unit shipped to the European Union. Demonstration units are designed to educate the sales force and show the functionality of the product to medical professionals. The company anticipates CE mark approval in the second quarter of 2012.
“Eurosurgical is pleased to be at the forefront of improving women’s healthcare through new and innovative technologies like LuViva,” said Peter Parker, managing director of Eurosurgical Ltd.
LuViva is a 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 pre-cancerous cells 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.
The Guided Therapeutics LuViva Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use.