PEACHTREE CORNERS, Ga.--(BUSINESS WIRE)--Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, announced today that its Chinese Partner, Shandong Yaohua Medical Instrument Corporation (SMI), has filed its application for LuViva with the Chinese National Medical Products Administration (NMPA). The application included results from 449 women tested at four leading medical institutions in China. The results of the study were above that required for a successful study as defined by the study protocol, with a test sensitivity of 83% and a test specificity of 54%.
Sensitivity and specificity describe the accuracy of a test that reports the presence or absence of a disease, in this case cervical precancers and cancers. Individuals who have the disease are considered "positive" and those who do not are considered "negative". Sensitivity is a measure of how well a test can identify true positives and specificity is a measure of how well a test can identify true negatives.
The results of the study support the potential use of LuViva to both diagnose and screen for cervical disease when the disease can be treated effectively and economically, while in its earliest stages before it has become invasive. Firstly, due to the high false positive rates of Pap and HPV screening, only about 20% of women who screen positive on Pap and HPV testing have cervical disease that needs treatment, and the combination of sensitivity and specificity shown by LuViva means that 54% of these women could have avoided unnecessary biopsies with 93% confidence that a negative LuViva test result indicates absence of cervical precancer. Secondly, as a potential screening test, LuViva’s 83% ability to identify moderate and high grade precancer is substantially better than that published for the Pap test which is on average about 40%-50%, based on an oft-cited meta-analysis of many studies.
“Obviously, we are thrilled by the outcome of our Chinese study and look forward to working with SMI and the Chinese NMPA to help ensure speedy approval of our safe and effective technology,” said Mark Faupel, CEO of Guided Therapeutics. "Equally important, the results of the Chinese study are significant because they were produced by the same LuViva technology and AI based algorithms we are using for our current US FDA study, which has now enrolled more than half of the expected number of required patients.”
The filing with NMPA triggers the continuation of the working relationship between the Company and SMI, with milestones and minimum payments to GTI for devices, disposables, services and royalties of more than $125 million over the next six years.
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, 2023, and subsequent filings.
