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PEACHTREE CORNERS, Ga., October 22, 2024--(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.