Guided Therapeutics Continues FDA Progress and Schedules Key Meeting to Finalize Clinical Study Protocol for the LuViva® Advanced Cervical Scan

On August 27, 2020 Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless cervical cancer detection test based on its patented biophotonic technology, reported that it will meet with the FDA to finalize the protocol for its clinical study in support of its Premarketing Application for the LuViva Advanced Cervical Scan (Press release, Guided Therapeutics, AUG 27, 2020, View Source [SID1234564110]). The meeting has been set for October 14, 2020. The FDA already has provided the Company with guidance for drafting the study protocol through useful feedback on the Company’s Pre-submission documents and its previous meeting with the FDA.

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To gear up for the clinical study, the Company is interviewing potential clinical sites. The study plans to enroll patients at four clinical sites that represent a cross section of the U.S. population of women who are screened for cervical cancer. Because of limitations inherent in current imaging technology, as much as 40% to 50% of disease is missed, even with invasive and expensive biopsy. Under the draft protocol submitted to FDA for review, LuViva will be studied to document its ability to detect a significant number of these missed diagnoses. New national guidelines for cervical cancer management published in April of 2020 stress a preferred risk-based approach, a primary feature of LuViva’s AI-based risk profile algorithms.

"Once FDA has completed the review of the study protocol, we intend to begin enrolling patients as soon as practicable," said Gene Cartwright, CEO. "Starting our study will be major milestone for the Company’s plans to commercialize LuViva in the U.S."