Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) today announced that it will begin enrollment this week in a multi-center clinical trial to expand claims for the LuViva® Advanced Cervical Scan to include front-line screening for cervical cancer.
The trial will be run by principal investigator, Dr. Daron G. Ferris, Director, HPV Prevention Program and Professor of Obstetrics and Gynecology at the Medical College of Georgia at Georgia Regents University in Augusta, Georgia. Dr. Ferris is the author of five peer-reviewed journal articles about LuViva and is the past-president of the American Society of Colposcopy and Cervical Pathology. The trial will take place at Georgia Regents University as well as CerviCusco, a Peruvian registered non-profit organization founded by Dr. Ferris, to address the exceedingly high rate of cervical cancer in rural Peru.
“Despite cervical cancer being the leading cause of cancer deaths in women in Peru, screening rates are less than 30 percent, even in advantaged urban areas of the country,” said Dr. Ferris. “As a result, Peru has one of the highest rates of cervical cancer in the world. We are excited to be conducting research with Guided Therapeutics to help prevent cervical cancer, by detecting premalignant changes of the cervix early when it can be treated effectively.”
“The lack of access to healthcare is a leading contributing factor to the large number of cases and the high death-rate from cervical cancer in developing countries,” said Gene Cartwright, Chief Executive Officer of Guided Therapeutics. “LuViva, which provides immediate results without the need for laboratory support, is an ideal technology to help fight cervical cancer with early detection. We are grateful for Dr. Ferris’ continued support for the technology and his vision for how it can save the lives of women around the world.”
The blinded trial is expected to enroll between 600 and 800 women, 160 women in Augusta and the remainder in Peru, and the results will be used to update and validate LuViva’s software for use as a primary screener for cervical disease that leads to cancer, much like the Pap test is used today. LuViva will be compared with Visual Examination with Acetic Acid, or VIA, with cytology, HPV, colposcopy and biopsy, where taken, as the Gold Standard. The trial is expected to take six to nine months.
The LuViva is currently approved for use, outside the U.S., in a population of women identified as being at risk for cervical cancer by abnormal cytology (Pap), human papillomavirus (HPV) test or previous cervical disease. LuViva is under premarket approval (PMA) review by the U.S. Food and Drug Administration.
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 are 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.
Bill Wells, 770-242-8723
Alison Ziegler, 212-554-5469