January 3, 2011 — Guided Therapeutics Inc. 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.”
The FDA notification said that FDA will schedule the Obstetrics and Gynecology Devices Panel meeting to review the PMA at a date to be determined.
The chance for successful treatment of cervical cancer is greatly increased by early detection, according to the National Cancer Institute. Each year about 55 million Pap (Papanicolau) tests are performed in the United States 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 percent 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, the 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.
The LightTouch scans the cervix with light to identify cancer and pre-cancer painlessly and noninvasively. Its patented biophotonic technology is able to distinguish between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. Unlike Pap or HPV tests, the LightTouch test does not require laboratory analysis or a tissue sample, is designed to provide results immediately and eliminate costly unnecessary testing.
For more information: www.guidedinc.com