The press release from a couple of weeks ago as posted on the National Cervical Cancer Coalition website.
nccc-online.org
Guided Therapeutics LightTouch Cervical Scan FDA Clinical Trial Indicates Adolescent's Risk for Cervical Disease on Par with Adult Women
Guided Therapeutics LightTouch Cervical Scan FDA Clinical Trial Indicates Adolescent's Risk for Cervical Disease on Par with Adult Women
LAS VEGAS, Mar 25, 2010 (BUSINESS WIRE) -- Women 16 to 20 years of age are just as likely to have significant cervical disease as women 21 and older, according to results of a U.S. Food and Drug Administration (FDA) pivotal clinical trial of the Guided Therapeutics, Inc. (GT) (Pink Sheets: GTHP) LightTouch(TM) Cervical Scanner, being presented at the American Society for Colposcopy and Cervical Pathology biennial meeting.
The study, which is the basis for seeking FDA approval, indicated that 18 percent of the 290 adolescent subjects in the trial presented with significant disease, the same as the group of 1,317 women aged 21 and older. Five of the adolescent subjects that were missed by the current standard of care of Pap test, HPV test and biopsy during the trial were correctly identified as having significant cervical disease by the LightTouch at the time, according to results of follow up examinations.
"These results indicate that cervical disease is a significant problem across a large section of the population," said Mark L. Faupel, Ph.D., President and CEO of GT. "We believe that our scanning technology offers a means for early detection of disease in younger women and may create an opportunity to preserve reproductive health."
The pivotal study examined 1,607 women who received the LightTouch test and other tests routinely used to refer women to biopsy. Included in study were 290 women between the ages of 16 and 20, 52 of whom were found to have precancer and cancer missed by the current diagnostic standard of care consisting of Pap test, HPV test, colposcopy and biopsy. The current diagnostic procedures missed 9.6% (5 of 52) of precancers and cancers in adolescent women with follow up.
"(The results call) ...into question recent guidelines for reducing surveillance of cervical disease in women below the age of 21. (LightTouch) ...is a cost effective point of care test that provides immediate results and demonstrated an ability to identify 91% of adolescent women with CIN2+ (significant cervical disease). (LightTouch) ...also showed potential to reduce by a third the number of adolescent women without dysplasia that were referred to biopsy and colposcopy," according to a poster presentation of the pivotal trial results.
The presentation was authored by Dr. Lisa Flowers, Associate Professor, General Obstetrics & Gynecology at Emory University School of Medicine in Atlanta.
In addition to Emory University, 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; University of Connecticut, Hartford, Connecticut, Dr. Manocher Lashgari (PI); Medical College of Georgia, Augusta, Georgia, Dr. Daron Ferris (PI); Orange Coast Women's Medical Group, Laguna Hills, California, Dr. Marc Winter (PI); Saddleback Women's Medical Group, Laguna Hills, California, Dr. Daniel Sternfeld (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. |
