The LuViva® Advanced Cervical Scan continues to demonstrate the capability to screen the general population for cervical cancer and to eliminate unnecessary testing for women who are screened by other methods, according to recent studies presented at the 25th Turkish Society of Gynecology Oncology Congress.
The LuViva, developed by Guided Therapeutics, Inc. (OTCBB:GTHP) (OTCQB:GTHP), is designed to eliminate costly, painful and unnecessary follow up testing following a positive Pap, human papillomavirus (HPV) or other screening test. It has also been used in clinical studies in Turkey and Nigeria as a means to screen women for cervical cancer where the availability of infrastructure necessary for Pap and HPV testing is restricted.
Results of the most recent Turkish screening study were presented by Professor Dr. Ali Ayhan of Baskent University in Ankara and President of the Turkish Society of Gynecologic Oncology. Dr. Ayhan concluded that the performance of LuViva for primary screening was comparable to that of HPV and Pap screening, and that LuViva also had the added advantage of providing an immediate result.
“These results support our marketing efforts from North Africa to Southwest Asia that LuViva is a solution to the widespread problem of lack of proper medical facilities to screen for cervical cancer,” said Zafer Yazici, CEO and President of I.T.E.M. Medical Technologies Group in Turkey. “As a result, in 2015 we expect to place between 50 and 100 LuViva devices in clinics to improve early detection of cervical cancer, and to build upon those numbers in the following years.”
Dr. Leo B. Twiggs, of the Miller School of Medicine at the University of Miami, reported on new results from international evaluations that supported the use of LuViva as an effective triage test in countries with established screening programs. Specifically, evaluations at five international centers and one U.S. center, involving 287 women referred to colposcopy and biopsy, showed that LuViva's sensitivity ranged from 91% to 100% and specificity ranged from 33% to 46%.
“These results further indicate a successful transition of LuViva from controlled clinical trials to postmarket evaluations in a wide range of clinical environments around the world,” said Gene Cartwright, CEO and President of Guided Therapeutics. “Results of these studies confirm recently published studies from Nigeria, the U.S. and Canada, which support our sales and marketing efforts throughout the world.”
Published studies of the LuViva are available at http://www.guidedinc.com/publications/.
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 may result in eliminating costly, painful and unnecessary additional testing. LuViva is intended 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. (OTCBB:GTHP) (OTCQB:GTHP) is the maker of a rapid and painless testing platform based on its patented biophotonic technology that utilizes light for the early detection of disease at the cellular level. The Company’s first 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 is also developing a non-invasive test for the early detection of esophageal cancer using the technology platform. For more information, visit: www.guidedinc.com.
The Guided Therapeutics LuViva® Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use. LuViva, the wave logo and "Early detection, better outcomes" are registered trademarks owned by Guided Therapeutics, Inc.
Forward-Looking Statements Disclaimer: A number of the matters and subject areas discussed in this news release that is not historical or current facts deal with potential future circumstances and developments. The discussion of such matters and subject areas is qualified by the inherent risks and uncertainties surrounding future expectations generally and also may materially differ from Guided Therapeutics’ actual future experience involving any of or more of such matters and subject areas. Such risks and uncertainties include those related to the early stage of products in development, the uncertainty of market acceptance of products, the uncertainty of development or effectiveness of distribution channels, the intense competition in the medical device industry, the uncertainty of capital to develop products, the uncertainty of regulatory approval of products, dependence on licensed intellectual property, as well as those that are more fully described from time to time under the heading “Risk Factors” in Guided Therapeutics’ reports filed with the SEC, including Guided Therapeutics’ Annual Report on Form 10-K for the fiscal year ended December 31, 2013, and subsequent quarterly reports.
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