GT initiates premarket approval process for cancer detection device

The content and schedule for submitting the modules, which represent major sections of the entire premarket approval (PMA) application, were agreed to in advance by Guided Therapeutics (GT) and the FDA. The PMA is reviewed by the FDA staff and a panel of experts. The technology has reportedly undergone safety evaluations by FDA and is considered to be non-significant risk by hospital institutional review boards.

According to the company, the GT LightTouch technology systematically and rapidly scans the cervix to identify cancer and pre-cancer painlessly and non-invasively by analyzing the wavelengths of light reflected from cervical tissue.

The technology distinguishes 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 a tissue sample or laboratory analysis, and is designed to provide results immediately, the company said.

Mark Faupel, president and CEO of GT, said: Submitting the preclinical module of our PMA is a highly significant event for the company and is a key step in gaining access to the multi-billion dollar US cervical cancer detection market.

The submission is the culmination of several years work by the company that we believe, if the device is approved, will create value for our shareholders and bring an important new technology to help save women’s lives. We are now focused upon completing and submitting the clinical and manufacturing modules early next year.