Noninvasive Cervical Cancer Test Reduces False-Positives

A multicenter clinical trial has found that a noninvasive device that uses light to identify cervical disease could reduce by 55% the number of unnecessary follow-up procedures resulting from false-positive findings.

The device also showed a sensitivity of 95%. Moreover, the device was able to correctly identify 18 cases of high-grade precancer that had been labeled normal or atypical squamous cells of undetermined significance (ASCUS), an increase in detection of about 18%. The study involved 506 women ranging in years from 16-75. The women underwent an examination using the new light device, and the results were compared to histopathology.

The new device is being developed by a wholly owned subsidiary of SpectRx, Inc. (Norcross, GA, USA; www.spectrx.com), called Guided Therapeutics, Inc.
The device creates an image of the cervix that highlights the location and severity of disease. The technology distinguishes between normal and diseased tissue by detecting biochemical and morphologic changes at the cellular level. The test does not require a tissue sample or laboratory analysis, and results are available immediately.

"Our device has shown the ability to more accurately locate and identify precancers and, just as importantly, identify when a woman is free of cervical disease,” said Keith D. Ignotz, CEO of Guided Therapeutics.




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