PEACHTREE CORNERS, Ga.–(BUSINESS WIRE)–Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless cervical cancer detection test based on its patented biophotonic technology, announced today that it had submitted its protocol to FDA for a clinical study to support marketing of the LuViva® Advanced Cervical Scan in the United States.
“We look forward to starting and completing our new study as the next major milestones in achieving FDA approval for LuViva.”
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 the 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. “We look forward to starting and completing our new study as the next major milestones in achieving FDA approval for LuViva.”
About Guided Therapeutics
Guided Therapeutics, Inc. (OTCQB: GTHP) is the maker of a rapid and painless testing platform based on its patented biophotonic technology that utilizes light for the early detection of disease at the cellular level. The Company’s first product is the LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease instantly and at the point of care. In a multi-center clinical trial with women at risk for cervical disease, the technology was able to detect cervical cancer up to two years earlier than conventional modalities, according to published reports. For more information, visit: www.guidedinc.com.
The Guided Therapeutics LuViva® Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use in the U.S. LuViva, the wave logo and “Early detection, better outcomes” are registered trademarks owned by Guided Therapeutics, Inc.
Forward-Looking Statements Disclaimer: A number of the matters and subject areas discussed in this news release that are not historical or current facts deal with potential future circumstances and developments. The discussion of such matters and subject areas is qualified by the inherent risks and uncertainties surrounding future expectations generally and also may materially differ from Guided Therapeutics’ actual future experience involving any of or more of such matters and subject areas. Such risks and uncertainties include those related to the early stage of commercialization of products, the uncertainty of market acceptance of products, the uncertainty of development or effectiveness of distribution channels, the intense competition in the medical device industry, the sufficiency of capital raised in prior financings and the ability to realize their expected benefits, the uncertainty of future capital to develop products or continue as a going concern, the uncertainty of regulatory approval of products, and the dependence on licensed intellectual property, as well as those that are more fully described from time to time under the heading “Risk Factors” in Guided Therapeutics’ reports filed with the SEC, including Guided Therapeutics’ Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and subsequent filings.