SMAD4, IMMUNOHISTOCHEMISTRY (IHC)

Message
This test is ordered by pathologists.


Test Code
1694339441


CPT Codes
88342-TC, Primary;88341-TC, if additional IHC

Preferred Specimen
Tissue


Other Acceptable Specimens
Formalin-fixed, paraffin-embedded (FFPE) tissue block and cytology (cell block) specimens.


Methodology
Immunohistochemistry (IHC)

FDA Status
This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by WVUH in a manner consistent with CLIA requirements.

Clinical Significance
SMAD4 IHC staining is primarily used in the diagnosis of pancreatic adenocarcinoma. This marker was validated for both surgical pathology and cytology (cell block) specimens.

SMAD4 (aka DPC4) is a tumor suppressor in the transforming growth factor (TGF)-beta signaling pathway that is genetically inactivated in
approximately 55% of all pancreatic adenocarcinomas. Normally, the protein acts as a tumor suppressor and inhibits epithelial  cell proliferation. Inactivation is relatively specific for pancreatic adenocarcinoma, but only 55% sensitive. It is 34% sensitive in ampullary carcinoma and may not be inactivated in IPMN. Loss of expression (no staining) is specific for pancreatic malignancy (in-situ or invasive).


Performing Laboratory
West Virginia University Hospitals, Inc.



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.