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Ventana HPV (Human Papilloma Virus) episode adds new chapter to US "home brew" debate

This article was originally published in Clinica

Executive Summary

In the latest twist in its slowly-evolving policy regarding "home-brew" tests, the US FDA has informed Ventana Medical Systems of Tucson, Arizona, that it cannot market its automated slide-based staining system for the detection of the human papillomavirus without going through the agency's premarket approval process.






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