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Test ID SMAD4 SMAD4 Immunostain, Technical Component Only


Ordering Guidance


This test includes only technical performance of the stain (no pathologist interpretation is performed). If diagnostic consultation by a pathologist is required order PATHC / Pathology Consultation.



Shipping Instructions


Attach the green pathology address label and the pink Immunostain Technical Only label included in the kit to the outside of the transport container.



Specimen Required


Supplies: Immunostain Technical Only Envelope (T693)

Specimen Type: Tissue

Container/Tube: Immunostain Technical Only Envelope

Preferred: 2 unstained positively charged glass slide (25- x 75- x 1-mm) per test ordered; sections 4-microns thick.

Acceptable: Formalin-fixed, paraffin-embedded (FFPE) tissue block


Useful For

Identification of loss of SMAD4 (mothers against decapentaplegic homolog 4 drosophila) expression within pancreatic ductal adenocarcinoma

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
IHTOA IHC Additional, Tech Only No No
IHTOI IHC Initial, Tech Only No No

Testing Algorithm

For the initial technical component only immunohistochemical (IHC) stain performed, the appropriate bill-only test ID will be reflexed and charged (IHTOI). For each additional technical component only IHC stain performed, an additional bill-only test ID will be reflexed and charged (IHTOA).

Method Name

Immunohistochemistry (IHC)

Reporting Name

SMAD4 IHC, Tech Only

Specimen Type

TECHONLY

Specimen Stability Information

Specimen Type Temperature Time Special Container
TECHONLY Ambient (preferred)
  Refrigerated 

Clinical Information

SMAD4 (mothers against decapentaplegic homolog 4 drosophila) is a tumor suppressor and transcription factor that is part of the transforming growth factor beta signaling pathway. Normally SMAD4 is expressed within the nucleus of epithelial cells, while loss of SMAD4 expression is caused by inactivation of the SMAD4 gene due to sporadic genetic variants. The status of SMAD4 expression is useful in the diagnosis of pancreatic adenocarcinoma.

Interpretation

This test does not include pathologist interpretation, only technical performance of the stain. If interpretation is required, order PATHC / Pathology Consultation for a full diagnostic evaluation or second opinion of the case.

 

The positive and negative controls are verified as showing appropriate immunoreactivity and documentation is retained at Mayo Clinic Rochester. If a control tissue is not included on the slide, a scanned image of the relevant quality control tissue is available upon request; call 855-516-8404.

 

Interpretation of this test should be performed in the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Clinical Reference

1. Hata T, Suenaga M, Marchionni L, et al: Genome-wide somatic copy number alterations and mutations in high-grade pancreatic intraepithelial neoplasia. Am J of Pathol. 2018;188(7):1723-1733

2. Voorneveld PW, Jacobs RJ, Kodach LL, et al: A meta-analysis of SMAD4 immunohistochemistry as a prognostic marker in colorectal cancer. Translational Oncology. 2015;8(1):18-24

3. Chen Y, Hsiao P, Weng C, et al: SMAD4 Loss triggers the phenotypic changes of pancreatic ductal adenocarcinoma cells. BMC Cancer. 2014;14(181):1-14

Day(s) Performed

Monday through Friday

Report Available

1 to 3 days

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

88342-TC, primary

88341-TC, if additional IHC

LOINC Code Information

Result ID Test Result Name Result LOINC Value
613981 SMAD4 IHC, Tech Only No LOINC Needed
Mayo Clinic Laboratories | IHC Catalog Additional Information:

mcl-ihc