Epithelial cell adhesion molecule (EpCAM) IVD, antibody

Epithelial cell adhesion molecule (EpCAM) in vitro diagnostic (IVD) antibody tests detect the presence of EpCAM proteins in clinical samples, such as blood or tissue. These tests are primarily used to identify or monitor conditions linked to elevated EpCAM levels, including certain cancers like colorectal, breast, and ovarian tumors, as well as inflammatory or autoimmune diseases.

These devices are typically regulated as IVDs, with classification and supply depending on the jurisdiction and intended use. They may require validation for diagnostic accuracy and compliance with standards like ISO 13485 or FDA 21 CFR Part 820, though specifics vary by market. Always verify local regulatory requirements before use or procurement.