VANCOUVER, Canada--(BUSINESS WIRE)--Results of a study presented at a major international women’s health conference indicate that the LuViva® Advanced Cervical Scan was able predict which women would progress from mild cervical abnormalities to more severe forms of the disease that require treatment. The LuViva was developed and is made by Guided Therapeutics, Inc. (OTCQB:GTHP).
The results were presented at the XXI FIGO World Congress of Gynecology and Obstetrics in Vancouver, Canada, by Leo B. Twiggs, M.D., Professor Emeritus, University of Miami Miller School of Medicine and past president of the American Society of Colposcopy and Cervical Pathology.
Cervical precancer, or dysplasia, is classified into three stages called cervical intraepithelial neoplasia one, two or three (CIN 1, 2, 3) with CIN 3 being the most advanced. About 60% to 80% of CIN 1 cases revert to normal with no treatment necessary. However, all cases of cervical cancer start out as CIN 1 and it is difficult to predict which cases will advance. The goal of the study with LuViva was to see if its use of spectroscopy could predict which cases would advance to a more severe stage.
“A CIN 1 diagnosis presents a clinical challenge in that it is very common due to persistent human papillomavirus, or HPV, infection and may progress or revert back to normal. This uncertainty is stressful for the patient and can lead to overtreatment,” said Dr. Twiggs. “While our findings should be studied further, having a tool to help eliminate unnecessary treatment and indicate who should be watched more closely is a very valuable addition to improving women’s healthcare.”
The study, involving an analysis of subjects followed for two years enrolled in a U.S. pivotal trial, looked at 135 women who were diagnosed with CIN 1 or ruled as normal during their first examination but had an abnormal, or positive, LuViva result. Of those, 91.3% (21/23) with abnormal spectroscopy scans having either CIN 1 or normal on the day of their scan were found to progress to CIN2/3 during two year follow-up. To review the presentation, click here. (http://www.guidedinc.com/wp-content/uploads/2015/10/FIGO-2015-Twiggs-LuViva-Advanced-Cervical-Scan.pdf).
FIGO - the International Federation of Gynecology and Obstetrics - is the only organization that brings together professional societies of obstetricians and gynecologists on a global basis. Currently it has member societies in 125 countries or territories.
World-wide, the market for cervical cancer screening and diagnostics, as currently practiced using cytology (Pap test) for primary screening, is estimated at $6 billion and is projected to grow to almost $9 billion by 2020. Worldwide there are about 2.6 billion women aged 15 years and older who are at risk of developing cervical cancer.
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. 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. The device is used in conjunction with the LuViva® Cervical Guide single-use patient interface and calibration disposable.
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 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 sufficiency of capital raised in our prior financings and our 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, 2014, and subsequent filings.