Guided Therapeutics wants an independent panel to review the pre-market approval application for its LuViva cervical scan, after the FDA issues a "not-approvable" letter, and files for CE Mark approval in the European Union.
Guided Therapeutics (OTC:GTHP) said it plans to ask an independent panel to review a pre-market approval application to the FDA for its LuViva advanced cervical scan after receiving a "not-approvable" letter from the agency.
The LuViva device scans the cervix with light to check for indicators of pre-cancer below the surface of the cervix. The federal watchdog agency wants additional clinical data on a newer version of the device, according to Guided Therapeutics president & CEO Mark Faupel.
The FDA also recommended excluding adolescent women and women with ASC-H referral Pap tests from the study population, "even though they were part of the original agreed upon study protocol," Faupel said during a conference call with analysts. "This could be as simple as a change in labeling or a request to reanalyze our data without these subjects."
"We are disappointed that the FDA has issued a not-approvable letter after previously telling the company that a panel review of LuViva would not be necessary since the agency understood LuViva's technology, it understood the clinical application and had also reviewed similar devices in the past," Faupel added in prepared remarks. "As to the request for additional clinical data, we believe that we’ve already addressed this point effectively and that we have proven the device’s accuracy in studies involving more than 3,000 women with no adverse events. The other items in the letter, such as a new request for outlining and testing a cleaning procedure, will be addressed routinely."
Meanwhile Guided Therapeutics will press ahead with approval bids in Asia and Europe. Faupel said European sales could begin as soon as the second half of the year.
"In the meantime, our clinical trial data system, two of our clinical trial sites and one of our major suppliers has already undergone successful FDA audits and we will continue working with the agency on a path to approval," he said.
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