FDA asks Guided Therapeutics to provide additional information on LuViva PMA

Jul 15 2011

Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP), developer of a rapid and painless biophotonic testing platform for the early detection of cancer, today announced that, after a series of meetings with the U.S. Food and Drug Administration (FDA), and after reviewing draft responses, the FDA has asked the company to provide additional information in the company's response to one remaining question. The company expects to be able to adequately provide the additional information in a timely manner.

The LuViva is under FDA premarket approval (PMA) review for use as a test after initial screening for cervical disease. As part of the review, the company received a series of questions from the FDA regarding the PMA application earlier in the year.

"We believe that we have made considerable progress in working with the FDA toward scheduling a panel review meeting that would continue to support an early 2012 U.S. launch of the LuViva, assuming we receive approval," said Mark L. Faupel, CEO and president of Guided Therapeutics, Inc. "While a September PMA panel meeting is no longer scheduled, the company anticipates requesting a panel meeting as soon as possible thereafter, barring any additional questions, or requests, from the FDA."

"Plans remain in place for a late 2011, or early 2012 international launch and we plan on announcing additional partnerships and additional progress on the international front in the coming weeks and months," Dr. Faupel said.