Guided Therapeutics, Inc. announced today that it had submitted its protocol to FDA for a clinical study to support the marketing of the LuViva® Advanced Cervical Scan in the United States.
Guided Therapeutics notes that under FDA’s Investigational Device Exemption guidelines, the Agency typically responds to companies in 30 days with comments or other observations regarding a study protocol. Earlier this year, the Company filed with FDA Pre-Submission documents and met with the Agency to agree on LuViva’s new indication for use and supporting clinical trial design. FDA provided written feedback based on both the Pre-submission documents and meeting minutes that provided the Company with guidance for drafting the study protocol.
According to the protocol, LuViva will be studied to assess its ability to help detect a significant number of up to 40% to 50% cases missed at the point of biopsy because of limitations in current imaging technology. New national guidelines for cervical cancer management published in April of 2020 stress a risk-based approach, a feature already included in LuViva’s AI-based risk profile algorithms. Because the available technology of visually examining the cervix under magnification often cannot detect the correct area to biopsy, or at times fails to detect the disease at all, there is a strong need for a more sensitive test like LuViva to identify more women with disease so treatment can begin sooner.
“FDA has been very responsive and helpful as the new indication for use and study to support the device claims were developed,” said Gene Cartwright, CEO of Guided Therapeutics. “We look forward to starting and completing our new study as the next major milestones in achieving FDA approval for LuViva.”