NORCROSS, Ga.--(BUSINESS WIRE)--Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, announced today that its Russian and Eastern European distribution partner, Newmars Group Kft., along with Hungarian physicians, reported new clinical results that demonstrate the early detection capability of the LuViva Advanced Cervical Scan. The study protocol was novel in that a positive LuViva test could result in a decision to biopsy a tissue sample to confirm the development of cervical cancer, even when the Pap and HPV tests were normal. In these cases, LuViva proved to be the more sensitive test, finding cervical cancer missed by Pap and HPV tests.
According to Dr. Zoltan Hernadi of the University of Debrecen in Hungary, “…We were impressed by cases in which both the Pap and HPV tests were negative but LuViva was positive and the patient was later found by her biopsy result to be developing cervical cancer. This clearly demonstrates the value of LuViva for the early detection of cervical cancer.”
The new data were initially reported at the Eurasian Cancer Screening Conference held in Minsk, Belarus on May 17-18, 2108. In the study, which showed results comparable to other studies conducted in the US and Europe, the sensitivity of LuViva was 100% (no false negatives) and 45% of women with a negative LuViva result could have avoided additional testing, including biopsy. The confidence that a woman with a negative LuViva result was free of cervical cancer was 100%, again consistent with previous studies.
“We are extremely pleased LuViva continues to perform exceptionally well in a variety of clinical settings and with different users working under a variety of protocols, including triage and primary screening,” said Gene Cartwright, CEO of Guided Therapeutics. “We look forward to launching the LuViva in Russia and Eastern Europe in the near future,” he added.
According to the World Health Organization, cervical cancer is ranked as one of the most frequent cancers in women. Central and Eastern Europe have a population of approximately 112 million women above 15 years of age, who are at risk of developing cervical cancer. The current estimates indicate approximately 1,971 per 100,000 new cases diagnosed and 886 per 100,000 deaths annually in Central and Eastern Europe, making the control of this deadly disease a priority for those countries.
About LuViva® Advanced Cervical Scan
The 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. It has also been used in clinical studies in Turkey, Indonesia, and Nigeria as a means to screen women for cervical cancer where the availability of infrastructure necessary for Pap and HPV testing is restricted. The device is used in conjunction with the LuViva® Cervical Guide single-use patient interface.
About Guided Therapeutics
Guided Therapeutics, Inc. (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. 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 in the U.S. 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 commercialization of products, 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 sufficiency of capital raised in prior financings and the ability to realize their expected benefits, the uncertainty of future capital to develop products or continue as a going concern, the uncertainty of regulatory approval of products, and the 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, 2016 and subsequent filings.