PEACHTREE CORNERS, Ga.– Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless testing platform for cervical cancer detection based on its patented biophotonic technology, announced that it has obtained Institutional Review Board (IRB) approval to initiate its clinical trial aimed at obtaining FDA approval for the Company’s flagship product, the LuViva Advanced Cervical Scan.
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 U.S FDA.
“Multiple COVID-19 surges have had a significant impact on the start of our study, as it has for most non-COVID related products,” said Gene Cartwright, CEO of Guided Therapeutics. “We are extremely gratified to have received a blanket IRB approval from WCG IRB that allows us to begin our study at prestigious medical institutions that are excited to be working with LuViva.”
