This article was originally published in The Gray Sheet
Amends May 1997 premarket approval application for the Prep liquid-based cytology sample preparation system, the company says Dec. 3. AutoCyte's amendment responds to FDA's request for clarification on Prep's ability to differentiate various levels of cervical disease, and the firm conducted a new study on the liquid-based preparation system's ability to present cellular materials that allow for the correct diagnosis of all levels of cervical abnormality, including low-grade, high-grade and cancerous cervical lesions. AutoCyte is also pursuing U.S. regulatory approval of its Screen computerized image analysis system, which analyzes slides prepared by Prep
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