On August 13, 2025 Guided Therapeutics, Inc. (OTC:QB 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, reported that it had enrolled enough patients to begin closing out the study and starting data analysis (Press release, Guided Therapeutics, AUG 13, 2025, View Source [SID1234655224]). Data analysis will consist of completing the ongoing external review of all biopsy samples, reviewing and entering data from the study case report forms and performing the statistical analysis pursuant to the study protocol. All four participating clinics have reached their minimum specified quotas resulting in a total of approximately 430 patients enrolled. Part of the pathology analysis is intended to determine the number of patients with and without disease to ensure a representative mix of disease types. Once this part of the analysis has been completed, all clinical sites will be closed out from enrolling additional patients and the clinical report will be filed with the FDA, expected later this year. Additionally, there have been no adverse events linked to the use of the LuViva device, further supporting FDA’s designation of LuViva as a non-significant risk device.
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"We want to thank all of physicians and staff at the clinical sites who made this study possible," said Mark Faupel, CEO of Guided Therapeutics. "As we move from the testing phase to the analysis phase of the study, we have met the Company’s primary 2025 objective. We are optimistic that we have conducted a successful study and look forward to the results of the statistical analyses."