Therapy Areas: Devices
Guided Therapeutics Receives Institutional Review Board Approval to Start Clinical Study for FDA Approval of the LuViva Advanced Cervical Scan
20 July 2022 - - US-based cervical cancer detection testing platform developer Guided Therapeutics, Inc. (OTCQB: GTHP) has obtained Institutional Review Board approval to initiate its clinical trial aimed at obtaining FDA approval for the company's flagship product, the LuViva Advanced Cervical Scan, the company said.

The study protocol has been approved by WCG IRB, a leader in quality ethical review with over 50 years of experience and their approval is accepted by multiple clinical sites including the two key centers that have agreed to participate in the LuViva study.

Both of these centers have enough patient volume to provide the number of patients required by FDA, projected to be up to approximately 400 women.

The study is expected to start enrolling patients in about 30 to 60 days.

LuViva is already approved for sale in the European Union under the CE Mark and currently is undergoing clinical trials in China for National Medical Products Administration approval, China's equivalent of the US FDA.

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.

The Guided Therapeutics LuViva Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use in the US LuViva, the wave logo and "Early detection, better outcomes" are registered trademarks owned by Guided Therapeutics, Inc.