Estrogen (oestrogen)/progesterone receptor IVD, antibody

Estrogen/progesterone receptor IVD antibodies are laboratory tools designed to detect the presence and quantity of estrogen (oestrogen) or progesterone receptors in tissue samples. Clinically, these tests help guide decisions in cancer diagnostics—particularly in breast and endometrial cancers—by identifying hormone-sensitive tumors that may respond to targeted therapies like hormone therapy.

These devices are typically in-vitro diagnostics (IVDs) regulated as medical devices rather than drugs, with classification varying by jurisdiction. They’re usually supplied as kits or reagents for use in pathology labs, requiring validation for accuracy and reliability in clinical settings. Compliance with standards like ISO 13485 or FDA 21 CFR Part 820 is common, though specifics depend on the regulatory pathway of each individual product.