Detector May Reduce False Cancer Diagnoses

NORCROSS, Ga., July 12 -- A new device for detecting cervical cancer has detected 25 percent more disease than the Pap test, according to SpectRx Inc, who manufactures the device. The company said clinical trials of the prototype device also showed it could reduce by half the occurrence of false-positive results over that reported for human papillomavirus (HPV) testing.

The device uses SpectRx's proprietary biophotonic technology to locate cancers and precancers, "painlessly and noninvasively," by analyzing light reflected from the cervix. The device creates an image of the cervix indicating the location and severity of disease. The technology distinguishes between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. Unlike Pap or HPV tests, the SpectRx test does not require a tissue sample or laboratory analysis.

SpectRx said false-positives, or a positive indication of disease when none is present, continue to be the most common criticism of cervical cancer detection methods because they create unnecessary health costs and anxiety for patients.

SpectRx has submitted a protocol for pivotal clinical trials of its device to the US Food and Drug Administration. Pivotal clinical trials are expected to begin in late 2002 or early 2003, to be followed by an application for regulatory approval in 2003.