Guided Therapeutics, Inc. or the “Company”, the maker of LuViva, a rapid and painless cervical cancer detection system based on the Company’s patented biophotonic technology, provided an update regarding the start of its pivotal clinical trial. The results of this clinical study will be used to support the Company’s application for U.S. FDA approval. The clinics involved in the study represent a mix of academic and community practices as well as representative population demographics. The first of the two academic centers opened for study recruitment in April and expects enrollment and testing to commence on their next colposcopy clinic scheduled for May 5th. At the second academic center, all internal scientific and institutional review boards have approved the study and final preparations are being made to begin training there. The two community-based clinics have approved the study, signed clinical trial agreements, and are preparing to start the study. It is estimated that approximately 400 women will be tested. Additional information regarding the study can be found at Clinicaltrials.gov.

“We are extremely pleased to have four excellent clinical centers planning to enroll patients for our study,” said Mark Faupel, CEO of Guided Therapeutics. “We believe the addition of the two community clinics will shorten the timeline to completion of the study and provide us with a well-balanced and representative sample of the U.S. female population.”

Source: businesswire.com