Guided Therapeutics Granted Approval for Human Clinical Studies of Light-based Test for Barrett’s Esophagus Pipeline Product
Institutional Review Board rules test is non-significant risk to patients
GTHP.OB 1.33 0.00
Press Release Source: Guided Therapeutics, Inc. On Monday March 7, 2011, 8:30 am EST
NORCROSS, Ga.--(BUSINESS WIRE)-- Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP), developer of a rapid and painless testing platform that uses biophotonics for the early detection of disease, today announced that it has received Institutional Review Board (IRB) approval to begin testing its light-based detection technology in humans for Barrett’s Esophagus, a precursor for esophageal cancer. The IRB also categorized the technology as “non-significant risk,” which indicates the technology is fundamentally safe when used as directed.
“We are excited to move ahead with the second product based on our patented light-based, disease detection platform,” said Mark L. Faupel, CEO and president of Guided Therapeutics, Inc. “Receiving IRB approval, as well as being classified as “non-significant risk,” are both very important achievements for advancing this product extension. Our next milestones will be to complete the development of our prototypes and begin the first clinical study, which we expect to initiate in the second or third quarter of 2011.”
The new product for the detection of Barrett’s Esophagus, a precursor for esophageal cancer, is being co-developed with Konica Minolta Opto, Inc. of Japan and is based on the company’s LightTouch™ non-invasive cervical cancer detection technology, which is undergoing the U.S. Food and Drug Administration’s premarket approval process.
According to the World Health Organization (WHO), esophageal cancer ranks just below cervical cancer in newly diagnosed cases. New cases of esophageal cancer are estimated at 410,000 worldwide, with more than 16,000 new cases a year and more than 14,000 deaths in the U.S. alone. Barrett’s esophagus is believed to be caused by excessive acid reflux.
About The Technology Platform
The LightTouch disease detection platform, which consists of a base unit and single-patient-use calibration disposable, scans tissue with light to identify cancer and pre-cancer painlessly and non-invasively. The proprietary, patented biophotonic technology is able to distinguish between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. Unlike traditional tests, the Guided Therapeutics test does not require laboratory analysis or a tissue sample, is designed to provide results immediately and eliminate costly unnecessary testing. |
