SpectRx completes milestone clinical study of new noninvasive cervical cancer device.

2002 DEC 12 - (NewsRx.com & NewsRx.net) -- SpectRx, Inc., (SPRX) announced that it has completed the multicenter, prepivotal clinical trial of its noninvasive cervical cancer detection device, and the company is making final preparations to begin its FDA pivotal trial.

Analysis of results from the first 414 women in the prepivotal study indicates that the SpectRx device detected 16% more high-grade precancers than Pap tests, the majority of which were the thin layer Pap tests. These results suggest that the SpectRx device could reduce by more than half the 2.2 million unnecessary follow up colposcopic exams and 1.6 million unnecessary biopsies resulting from uncertain or false positive Pap test results. In the U.S., approximately $6 billion is spent annually on unnecessary Pap test follow-up testing.

Women tested with the SpectRx device were scheduled for follow-up of a suspicious Pap test or pre-existing disease of the cervix. This is the same type of patient population as projected for the FDA pivotal trial, which SpectRx expects to begin in late 2002 or early 2003, to be followed by an application for regulatory approval in late 2003.

"This milestone study provides strong evidence that our technology has the potential to make a significant positive impact on the management of cervical disease," said Mark Faupel, chief technical officer of SpectRx, Inc. "The SpectRx test is designed to noninvasively provide a result at the point of care and has the potential to significantly increase disease detection while reducing expensive and anxiety provoking false positive results. We believe this ...