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30.03.2010 13:15:00

Guided Therapeutics LightTouch Cervical Scan FDA Trial Indicates Improved Detection of Significant Disease over Pap in Private Office Setting

The Guided Therapeutics, Inc. (GT) (Pink Sheets: GTHP) LightTouch™ Cervical Scanner increased detection of significant disease over Pap tests in women seen in a busy private practice setting, according to results of a U.S. Food and Drug Administration (FDA) pivotal clinical trial presented at the American Society for Colposcopy and Cervical Pathology biennial meeting.

The study, which is the basis for seeking FDA approval, enrolled 1,607 subjects in a multi-center trial, including two private practice California women’s clinical centers. Data from a subset of 320 women was analyzed after being evaluated using a smaller, lower-cost commercial prototype. In the subgroup, LightTouch increased detection of significant disease by 56% over the Pap, according to a presentation authored by Dr. Marc L. Winter of the Orange Coast Women’s Medical Group and Dr. Daniel R. Sternfeld of the Saddleback Women’s Medical Group, both of Laguna Hills, CA.

"The purpose of engaging two large private practices in the study was to gain real-world experience with our technology and improve its potential for performance in the private office setting,” said Mark L. Faupel, Ph.D., President and CEO of GT. "We believe that the results indicate that our technology has the potential to improve the efficiency of the private office by detecting disease earlier and eliminating unnecessary follow up testing.”

"(LightTouch) offers the potential of a cost effective and efficient modality for earlier detection of CIN2+ (significant) disease in women at risk for cervical disease, while at the same time reducing the number of colposcopies, biopsies and other invasive surgical procedures currently performed on normal and benign cervices,” according to the presentation of the pivotal trial results.

In addition to Orange Coast and Saddleback, the pivotal clinical trial was carried out at the University of Miami, Dr. Leo Twiggs, principal investigator (PI); the University of Texas Southwestern Medical Center, Dallas, Dr. Claudia Werner PI; Emory University, Atlanta, GA, Dr. Lisa Flowers, (PI); University of Connecticut, Hartford, Connecticut, Dr. Manocher Lashgari (PI); Medical College of Georgia, Augusta, Georgia, Dr. Daron Ferris (PI); University of Arkansas, Little Rock, Arkansas, Dr. Alexander Burnett (PI); Pathology conducted by Dr. Ed Wilkinson, University of Florida, Gainesville, Florida, and; Dr. Stephen Raab, University of Colorado, Denver, Colorado.

To read more about the clinical trial, visit www.guidedinc.com/asccp2010.htm.

About Guided Therapeutics

Guided Therapeutics, Inc. (Pink Sheets: GTHP) is developing a rapid and painless test for the early detection of disease that leads to cervical cancer. The technology is designed to provide an objective result at the point of care thereby improving the management of cervical disease. Unlike Pap and HPV tests, the device does not require a painful tissue sample and results are known immediately. GT has also entered into a partnership with Konica Minolta Opto to develop a non-invasive test for Barrett’s Esophagus using the LightTouch technology platform. For more information, visit GT’s web site www.guidedinc.com.

The Guided Therapeutics LightTouch™ Cervical Scanner is an investigational device and is limited by federal law to investigational use.

The project described was supported by an Award from the National Cancer Institute. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health.

"Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995. A number of the matters and subject areas discussed in this news release that are not historical or current facts deal with potential future circumstances and developments. The discussion of such matters and subject areas is qualified by the inherent risks and uncertainties surrounding future expectations generally and also may materially differ from Guided Therapeutics’ actual future experience involving any of or more of such matters and subject areas. Such risks and uncertainties include: the early stage of products in development, the uncertainty of market acceptance of products, the uncertainty of development or effectiveness of distribution channels, the intense competition in the medical device industry, the uncertainty of capital to develop products, the uncertainty of regulatory approval of products, dependence on licensed intellectual property, as well as those that are more fully described from time to time under the heading "Risk Factors” in Guided Therapeutics’ reports filed with the SEC, including Guided Therapeutics’ Annual Report on Form 10-KA for the fiscal year ended December 31, 2009 and subsequent quarterly reports.

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