Guided Therapeutics Reports After Meeting with FDA They Will Start Study in Support of its Application for FDA Approval

October 21, 2020

Guided Therapeutics, Inc. announced today the successful outcome of its October 14, 2020 meeting with FDA. The purpose of the meeting was to finalize the protocol (procedure) for its new clinical study in support of its Premarketing Application for the LuViva® Advanced Cervical Scan (i.e., FDA approval).

Guided Therapeutics filed the minutes from this meeting with FDA yesterday, which the agency will review and provide any final comments on the meeting and study protocol.

Currently, women are screened for cervical cancer using one or more laboratory-based tests that require a tissue sample. Women who test positive on these screening tests are referred to biopsy of the suspect cervical tissue. Unfortunately, because of limitations in current imaging technology, 40- 50% of the time the disease is not detected when it is actually present. In addition, the screening tests may generate up to 80% false positives. LuViva does not require a tissue sample and produces an immediate result, so that treatment can begin sooner. Previous clinical studies that included two year follow up showed that LuViva detected a significant number of these missed cases. The Company has received broad agreement from the FDA on the new study’s methodology and patient population in order to demonstrate LuViva’s ability to significantly improve the early detection of cervical cancer. The study is expected to take a few months once enrollment begins and will include approximately 300 to 600 patients.

“Reaching agreement with FDA on the intended use of LuViva and the study to support that intended use is a major milestone for us,” said Gene Cartwright, CEO. “We look forward to filing the protocol with the participating clinical sites and beginning the study as soon as practicable.”

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