This document provides guidelines for handling, documenting, storing, and processing formalin-fixed, paraffin-embedded (FFPE) tissue specimens for the examination of isolated proteins during the pre-examination phase. It supports molecular in-vitro diagnostic testing, including laboratory-developed tests, and is intended for use by medical and molecular pathology laboratories, IVD developers, biobanks, and regulatory authorities. Although it does not apply to protein examination by immunohistochemistry, it acknowledges that international, national, or regional regulations may apply.