Biophotonics testing platform gets 'green light' for human clinical studies

Guided Therapeutics (GI; Norcross, GA) has received Institutional Review Board (IRB) approval to begin testing its biophotonics-based detection technology in humans for Barrett’s esophagus, a condition believed to be caused by excessive acid reflux and that serves as a precursor for esophageal cancer. The IRB also categorized the technology as a “non-significant risk,” deeming it safe when used as directed.

The new product for Barrett’s esophagus detection is being co-developed with Konica Minolta Opto, Inc. (Tokyo, Japan) and is based on the company’s LightTouch non-invasive cervical cancer detection technology, which is undergoing FDA pre-market approval process.

Mark L. Faupel, CEO and president of Guided Therapeutics, Inc., says that the company's next milestones will be to complete the development of their prototypes and begin the first clinical study, which they expect to initiate in the second or third quarter of 2011.

The World Health Organization (WHO) states that 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.

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Posted by Lee Mather

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