Guided Therapeutics completes subject enrollment in cancer device study

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

Since the pivotal trial began, approximately 1,900 women have been tested to demonstrate the technology’s accuracy in detecting cervical disease, including an arm of the study that assessed effectiveness of the commercial version of the device and single-use disposable. Guided Therapeutics said that the technology has already undergone safety evaluations by the FDA and is considered to be non-significant risk by hospital institutional review boards.

Unlike Pap or HPV tests, the non-invasive test does not require a tissue sample or laboratory analysis, and results are available immediately. In all, nearly 3,000 women have enrolled in studies using prototypes of the non-invasive cervical cancer detection device with no instances of significant or unexpected adverse events.

Mark Faupel, president and CEO of Guided Therapeutics, said: “Completing subject enrollment in our pivotal FDA clinical trial is a major milestone in product development. I want to thank our principal investigators, their staff and the women who participated in the trial. Our next steps are to analyze the results and to file our premarket approval application with the FDA.”