Guided Therapeutics files cervical cancer detection device with FDA
This article was originally published in Clinica
Executive Summary
Guided Therapeutics has filed a premarket approval (PMA) application with the US FDA for its LightTouch cervical scanner. The noninvasive point-of-care device is designed to identify patients at risk of cervical cancer using the Norcross, Georgia firm's "biophotonics" technology. This involves shining light onto the cervix and then analysing the wavelengths of light reflected from cervical tissue. As light responds differently to normal and diseased cells, this can detect cancer or precancerous lesions. A 1,600-patient pivotal trial formed the basis of the application. It found that LightTouch detected cervical disease up to two years earlier than the current standards of care – Pap testing, human papillomavirus testing, colposcopy and biopsy. This could lead to more effective treatment. The device also detected 86.3% of cases missed by other methods.
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