44 devices · GMDN 56791
Anaplastic lymphoma kinase (ALK) in-vitro diagnostic (IVD) antibody tests detect the presence or concentration of ALK protein in tissue samples, aiding in the diagnosis of cancers like anaplastic large cell lymphoma or certain lung cancers. These assays help clinicians confirm ALK gene rearrangements, guiding targeted therapy decisions and personalized treatment plans.
These diagnostic devices are typically regulated as high-risk medical devices due to their role in cancer diagnosis, with classification varying by jurisdiction. They are supplied as kits or reagents for laboratory use, often requiring validation in accredited testing facilities to ensure accurate and reliable results for patient care.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.