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SpectRx/Welch Allyn Cervical Cancer Detection PMA Expected By 2002

This article was originally published in The Gray Sheet

Executive Summary

Premarket approval application submission for a non-invasive cervical cancer detection system co-developed by SpectRx and Welch Allyn will occur in late 2001 or early 2002, SpectRx says.

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SpectRx cancer assay

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)...

SpectRx cancer assay

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)...

SpectRx Expanding Clinical Study Of Continuous Glucose Monitoring System

SpectRx says it is looking to enroll investigators for the next round of clinical studies of the company's evolving continuous glucose monitoring system prototypes.

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