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SpectRx cancer assay

This article was originally published in The Gray Sheet

Executive Summary

Pivotal clinical trials for the non-invasive cervical cancer detection device will begin by early 2003, SpectRx announces April 15. Clinical results indicate that the third-generation device detects 17% more high-grade pre-cancer compared to thin-layer Pap tests and 28% more than traditional Pap tests. The device also boasts a sensitivity of 92% and specificity of 80%, versus sensitivity of 76% and specificity of 80% for the thin-layer Pap test when compared to colposcopy and histopathology, the firm claims (1"The Gray Sheet" April 17, 2000, p. 18)...

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SpectRx

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)...

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