The March 12, 2014, recommendation by a U.S. Food and Drug Administration (FDA) panel to use human papillomavirus (HPV) testing as an alternative to Pap testing for screening of women for cervical cancer has the potential to increase the need for the LuViva® Advanced Cervical Scan in developed countries, according to Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP). As part of its CE Mark, LuViva is already approved for use in the European Union as a triage test to be used after a positive HPV test and/or a positive Pap test.
“Based on published studies, we would expect a gradual shift to HPV screening to increase the number of initially positive results compared to the Pap smear,” said Gene Cartwright, Chief Executive Officer of Guided Therapeutics. “A high percentage of these screening positives are actually false positives. The LuViva technology has been proven to be capable of determining which of the screened Pap smear positives are false positives. We expect similar performance when the LuViva technology is applied to HPV screening results.”
“Because the number of positives and false positives has been proven to be higher when HPV is used as a screening test, as reported in several peer-reviewed journals including The Lancet, the need for a technology like LuViva, that can determine which of the initially screened positives are actually false positives should increase if HPV screening is adopted.”
LuViva as a potential screening solution in developing countries --
“Separately, in developing markets the need for lab infrastructure and the expense of Pap and HPV tests often leads to countries screening only low percentages of their female population for cervical cancer. The Ministries of Health in Turkey and Nigeria view LuViva as a potential solution for screening and are conducting clinical trials to use LuViva as a primary screening device. With LuViva, there is no biopsy sample taken and the result is available immediately which is an important feature to prevent losing positively tested women to follow up,” Mr. Cartwright added.
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 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, 2012, and subsequent quarterly reports.
Bill Wells, 770-242-8723
Alison Ziegler, 212-554-5469