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HelpTest 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, ManualSpecimen Type
SpecialSpecimen Minimum Volume
See Specimen Required
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Special | Ambient (preferred) | |
| Refrigerated | ||
Reject Due To
| Decalcified paraffin embedded tissue | Reject |
| Wet/frozen tissue | Reject |
| Cytology smears | Reject |
| Nonformalin fixed tissue including alcohol-formalin-acetic acid (AFA), 95% ethanol, PREFER fixatives or Zinc formalin | Reject |
| Nonparaffin embedded tissue | Reject |
| Noncharged slides | Reject |
| ProbeOn slides | Reject |
| Snowcoat slides | Reject |
Clinical Information
Melanoma-associated antigen-A4 (MAGE-A4) is a cancer testis antigen (CTA). CTAs are targets for T-cell receptor immunotherapy. The MAGE-A4 immunohistochemical assay aids in identifying patients with synovial sarcoma and potentially other tumors for treatment with TECELRA (afamitresgene autoleucel), a MAGE-A4-directed genetically modified autologous T-cell immunotherapy.
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.
Cautions
This test has been validated for nondecalcified paraffin-embedded tissue specimens fixed in 10% neutral-buffered formalin. Recommended fixation time is between 6 and 48 hours. This assay has not been validated on tissues subjected to the decalcification process or use of alternative fixatives for bone and bone marrow specimens or cell blocks.
Age of a cut paraffin section can affect immunoreactivity. Stability thresholds vary widely among published literature and are antigen dependent. Best practice is for paraffin sections to be cut within 6 weeks.
The charge of glass slides can be affected by environmental factors and subsequently may alter slide staining. Sending unsuitable glass slides can result in inconsistent staining due to poor slide surface chemistry.
Best practices for storage of positively charged slides:
-Minimize time slides are stored after being unpackaged
-Limit exposure to high humidity and heat
Method Description
Immunohistochemistry on sections of paraffin-embedded tissue.(Unpublished Mayo method)
Day(s) Performed
Monday through Friday
Report Available
5 to 7 daysPerforming 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 |