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Test Code MAGE4 Melanoma-associated antigen-A4 (MAGE-A4), Semi-Quantitative Immunohistochemistry, Manual


Shipping Instructions


Attach the green "Attention Pathology" address label (T498) to the outside of the transport container before putting into the courier mailer.



Necessary Information


A pathology/diagnostic report and a brief history are required.



Specimen Required


Specimen Type: Tissue

Supplies: Pathology Packaging Kit (T554)

Submit:

Formalin-fixed, paraffin-embedded tissue block

OR

3 Unstained glass, positively charged slides with 4-microns formalin-fixed, paraffin-embedded tissue

Additional Information: One slide will be stained with hematoxylin and eosin and returned.


Useful For

Determining expression of melanoma-associated antigen-A4 (MAGE-A4) in synovial sarcoma and other neoplasms

 

As an aid in screening patients who may be eligible for TECELRA (afamitresgene autoleucel) therapy

Method Name

Immunohistochemistry (IHC)

Reporting Name

MAGE-A4, SemiQuant IHC, Manual

Specimen Type

Special

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

Specimen Type Temperature Time
Special Ambient (preferred)
  Refrigerated 

Reference Values

An interpretive report will be provided.

Interpretation

Melanoma-associated antigen-A4 (MAGE-A4) in synovial sarcomas is determined positive when there is at least moderate to strong cytoplasmic and/or nuclear staining in greater than or equal to 75% of tumor cells.(1)

 

This result should be interpreted in the appropriate clinical context.

Clinical Reference

1. Instruction manual: MAGE-A4 IHC 1F9 pharmDx Interpretation Manual-Synovial Sarcoma. Agilent Technologies, Inc; 08/29/2024

2. Caballero O, Chen Y. Cancer/testis (CT) antigens Potential targets for immunotherapy. Cancer Science 2009;100(11):2014-2021

3. Hong D, Van Tine B, Biswas S, et al. Autologous T cell therapy for MAGE-A4+ solid cancers in HLA-A*02+ patients a phase 1 trial. Nature Medicine 2023;29:104-114

4. Wang T, Navenot JM, Rafail S, et al. Identifying MAGE-A4-positive tumors for TCR T cell therapies in HLA-A*02-eligible patients. Mol Ther Methods Clin Dev. 2024;32(2):101265. Published 2024 May 14. doi:10.1016/j.omtm.2024.101265

Day(s) Performed

Monday through Friday

Report Available

5 to 7 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

88360

LOINC Code Information

Test ID Test Order Name Order LOINC Value
MAGE4 MAGE-A4, SemiQuant IHC, Manual In Process

 

Result ID Test Result Name Result LOINC Value
622998 Interpretation 59465-5
622999 Participated in the Interpretation No LOINC Needed
623000 Report electronically signed by 19139-5
623001 Material Received 81178-6
623002 Disclaimer 62364-5
623003 Case Number 80398-1

Forms

If not ordering electronically, complete, print, and send a Immunohistochemical (IHC)/In Situ Hybridization (ISH) Stains Request (T763) with the specimen.