SpectRx
This article was originally published in The Gray Sheet
Executive Summary
Pivotal trials of firm's non-invasive, biophotonic cervical cancer test are expected to begin by early 2003. SpectRx announces July 9 that protocols have been submitted to FDA. Preliminary data from a National Cancer Institute study in 274 women showed a prototype test detected 15% more high-grade "pre-cancers" than standard Pap tests, and could potentially cut by half the number of false positives detected by human papilloma virus (HPV) tests. Previously, the device demonstrated a sensitivity of 92% and specificity of 80%, versus sensitivity of 76% and specificity of 80% for the thin-layer Pap test, according to SpectRx (1"The Gray Sheet" April 22, 2002, In Brief)...