Cervical cancer detection prototypes indicate lower false positive rate than HPV test.

2002 AUG 15 - (NewsRx.com & NewsRx.net) -- SpectRx, Inc., (SPRX) reported that results from a clinical study of its noninvasive cervical cancer detection devices indicate that the technology could potentially reduce by half the occurrence of false positives over that reported for human papillomavirus (HPV) testing.

Additionally, the prototypes - which utilize the company's proprietary biophotonic technology - detected 15% more high-grade precancers than Pap tests.

On the strength of these findings, SpectRx submitted a protocol for pivotal clinical trials of its device to the U.S. Food and Drug Administration (FDA). Pivotal clinical trials are expected to begin in late 2002 or early 2003, and are expected to be followed by an application for regulatory approval in 2003.

The study, funded in part by the National Cancer Institute and conducted at four leading clinical centers in the U.S., included 274 women, who were enrolled and tested as the first phase of a "dress rehearsal" for FDA pivotal trials. The prototypes ...