FDA accepts to file PMA application for LightTouch Cervical Scanner

Guided Therapeutics, Inc.Dec 3 2010

Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP) announced that it was notified by the U.S. Food and Drug Administration (FDA) that the company's premarket approval application (PMA) for the LightTouch™ Cervical Scanner, for patients at risk for cervical cancer, is "suitable for filing."

“This brings us one step closer to realizing our goal of improving the early detection of cervical disease and reducing the false positives and unnecessary biopsies that result with the current standard of care.”

"Receiving the 'suitable for filing' letter from the FDA is a significant milestone in the regulatory review process and means that our application was sufficiently complete and is ready for substantive review," said Mark L. Faupel, Ph.D., President and CEO of Guided Therapeutics. "This brings us one step closer to realizing our goal of improving the early detection of cervical disease and reducing the false positives and unnecessary biopsies that result with the current standard of care."

The FDA notification sets September 23, 2010 as the date of acceptance of the filing and states that FDA will schedule the Obstetrics and Gynecology Devices Panel meeting to review the PMA at a date to be determined.

More than $6 billion is spent each year in the U.S. alone to diagnose cervical cancer. The chance for successful treatment is greatly increased by early detection, according to the National Cancer Institute. Each year about 55 million Pap (Papanicolau) tests are performed in the U.S. to detect cervical abnormalities that could lead to cancer. Of these tests, approximately six percent are abnormal, requiring additional medical evaluation, such as a biopsy. However, the majority of biopsies reveal no cervical disease, meaning that a significant number of potentially avoidable procedures are performed every year.

In the pivotal trial to support the PMA filing, more than 1,600 women at risk for cervical disease were tested with the LightTouch™. Results of the trial showed that:

• LightTouch detected cervical disease up to two years earlier than Pap test, HPV (human papillomavirus) test, colposcopy and biopsy.
• LightTouch detected 86.3% of cervical disease cases that had been missed by Pap, HPV tests and biopsy.
• LightTouch would have reduced the number of avoidable biopsies by about 40 percent.

Additionally, Guided Therapeutics' clinical trial indicated that women aged 16-20 were just as likely to have cervical disease as women 21 and older and current methods of early detection, such as HPV testing, are not recommended for this age group. LightTouch detected cervical disease equally well in both adolescent and adult women.

For more information on the clinical trial, visit www.guidedinc.com/asccp2010.htm.