Potential new claim for device would greatly expand market opportunity
SAN FRANCISCO--(BUSINESS WIRE)-- Millions of women around the world who do not have access to Pap test screening for cervical cancer could benefit from a non-invasive test that scans the cervix with light, according to results of a clinical trial presented at the American Society for Colposcopy and Cervical Pathology (ASCCP) biennial meeting, being held March 14-17 at the Hyatt Regency in San Francisco, California.
The study evaluated the potential for primary screening using a subset of patients from a clinical trial involving 1,607 women using the LuViva® Advanced Cervical Scan, developed by Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP). This study compared the LuViva to the standard of care of Pap test, human papillomavirus (HPV), colposcopy and biopsy. The new results indicate both the potential of the LuViva for cervical cancer screening as well as the need for larger clinical trials to confirm the safety and efficacy of the LuViva for screening. The lead author of the presentation was Dr. Lisa Flowers, Associate Professor, General Obstetrics & Gynecology at Emory University School of Medicine in Atlanta.
“We believe that our clinical studies indicate that, in addition to diagnosing cervical disease in a prescreened population that has access to the Pap test, the LuViva test can be modified to be used as an alternative to the Pap test, particularly in areas where there is little or no laboratory infrastructure,” said Mark L. Faupel, Ph.D., CEO and president of Guided Therapeutics, Inc.
According to the World Health Organization, cancer of the cervix is the second most common cancer in women worldwide, with about 500,000 new cases and 250,000 deaths each year. Almost 80% of cases occur in low-income countries, where laboratory infrastructure is limited.
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. (OTCBB: GTHP) (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 company’s 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 Barrett’s Esophagus 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: 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, 2010, and subsequent quarterly reports.
Guided Therapeutics, Inc.
Alison Ziegler, 212-554-5469
Bill Wells, 770-242-8723 Ext. 241
KEYWORDS: United States North America California Georgia
INDUSTRY KEYWORDS: Health Clinical Trials Oncology