Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, a rapid and painless testing platform for cervical cancer detection based on its patented biophotonic technology, announced today it had filed the results of its multicenter clinical trial with the U.S. Food and Drug Administration (FDA).
The study protocol was developed through interactions with FDA and enrolled 480 women referred to biopsy because of abnormal Pap and/or HPV tests. Of the 428 women that completed the study, 99 were determined by expert independent pathology to have significant cervical disease that can lead to cancer, and of these, 32 cases of disease (32.3%) went undetected by the current standard of care consisting of colposcopy-directed biopsy. The primary goal of the study was to show that LuViva could detect a significant number of these “missed” precancerous lesions.
The results showed that LuViva detected 21 of the 32 (66%) disease cases that were missed by the current standard of care, increasing the detection rate from 68% without LuViva to 89% with LuViva. Moreover, all primary and secondary endpoints regarding the sensitivity and specificity of LuViva were met with a high degree of statistical certainty (p < 0.0001). There were no safety issues or adverse events related to LuViva reported among the study participants.
“The study results exceeded expectations and demonstrate that LuViva has the potential to address an important clinical need in a highly impactful way,” said Guided Therapeutics President and CEO Mark Faupel. “We look forward to FDA’s review of the study results and working with our physician team to publish them in a prestigious medical journal.”
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, 2025, and subsequent filings.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260616805816/en/
Media gallery
