Test Code MSTF Myeloid Sarcoma, FISH, Tissue

Ordering Guidance

This test does not include a pathology consultation. If a pathology consultation is requested, order PATHC / Pathology Consultation, and appropriate testing will be added at the discretion of the pathologist and performed at an additional charge.

Mayo Clinic Hematopathology consultants are involved in both the pre-analytic (tissue adequacy and probe selection, when applicable).

This test is not appropriate for testing blood and bone marrow from patients with acute myeloid leukemia/myeloid sarcoma. If a non-paraffin embedded bone marrow or blood sample is received for this test, the test will be canceled and automatically reordered by the laboratory as AMLFA / Adult Acute Myeloid Leukemia Panel, FISH, Varies or AMLFP / Pediatric Acute Myeloid Leukemia Panel, FISH, Varies depending on the age of the patient.

Shipping Instructions

Advise Express Mail or equivalent if not on courier service.

Necessary Information

1. A pathology report is required for testing to be performed. If not provided, appropriate testing and/or interpretation may be compromised or delayed. Acceptable pathology reports include working drafts, preliminary pathology, or surgical pathology reports.

2. The following information must be included in the report provided:

-Patient name

-Block number - must be on all blocks, slides, and paperwork

-Date of collection

-Tissue source

3. A reason for testing must be provided. If this information is not provided, an appropriate indication for testing may be entered by Mayo Clinic Laboratories.

4. A list of probes is required if select probes are necessary or if the patient is being tracked for known abnormalities. See Table in Clinical Information.

Specimen Required

Submit only 1 of the following specimens:

Preferred

Specimen Type: Tissue block

Collection Instructions:

1. Submit a formalin-fixed, paraffin-embedded tumor tissue block. Blocks prepared with alternative fixation methods will be attempted but are less favorable for successful results.

2. Provide fixation method used.

Additional Information:

1. Paraffin embedded specimens can be from any anatomic location (skin, soft tissue, lymph node, etc).

2. Bone specimens that have been decalcified will be attempted for testing, but the success rate is approximately 50%.

Acceptable

Specimen Type: Tissue slides

Slides: 1 Hematoxylin and eosin-stained and 2 unstained for each probe set

Collection Instructions:

1. Include 1 hematoxylin and eosin-stained slide for the entire test order.

2. If individual probe sets are chosen: For each probe set ordered, 2 consecutive, unstained, 5 micron-thick sections placed on positively charged slides.

3. If a complete myeloid sarcoma FISH panel is ordered, include 10 consecutive, unstained, 5 micron-thick sections placed on positively charged slides.

Forms

If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request (T726) with the specimen.

Useful For

Detecting, at diagnosis, recurrent common chromosome abnormalities associated with acute myeloid leukemia (AML)/myeloid sarcomas in paraffin-embedded specimens

Monitoring response to therapy by tracking known chromosome abnormalities in patients with AML or myeloid sarcoma

Reflex Tests

Test ID	Reporting Name	Available Separately	Always Performed
_I099	Interphases, 25-99	No, (Bill Only)	No
_I300	Interphases, >=100	No, (Bill Only)	No
_IL25	Interphases, <25	No, (Bill Only)	No
_PADD	Probe, +1	No, (Bill Only)	No
_PB02	Probe, +2	No, (Bill Only)	No
_PB03	Probe, +3	No, (Bill Only)	No
_PBCT	Probe, +2	No, (Bill Only)	No

Testing Algorithm

This test includes a charge for the probe application, analysis, and professional interpretation of results for one probe set (2 individual fluorescence in situ hybridization [FISH] probes). Additional charges will be incurred for all reflex or additional probe sets performed. Analysis charges will be incurred based on the number of cells analyzed per probe set. If no cells are available for analysis, no analysis charges will be incurred.

This test may be ordered in 2 distinct ways allowing different combinations of probes to be analyzed based on the clinical question.

1. Standard (diagnostic) acute myeloid leukemia (AML)/myeloid sarcoma paraffin-embedded FISH panel

2. Individual AML/myeloid sarcoma paraffin-embedded FISH probes chosen, per client request, from probes listed below

If individual FISH probes are needed, the specific probes requested must be noted on the request form or in the reason for referral. If no FISH probes are indicated, the standard (diagnostic) panel will be performed.

The standard (diagnostic) panel includes testing for the following abnormalities, using the FISH probes listed:

t(8;21)(q21.3;q22) or RUNX1::RUNX1T1 fusion, RUNX1T1/RUNX1 probe set

t(9;22)(q34;q11.2) or BCR::ABL1 fusion, ABL1/BCR probe set

t(11q23;var) or KMT2A rearrangement, KMT2A break-apart probe set

t(15;17)(q24;q21) or PML::RARA fusion, PML/RARA probe set

inv(16) or t(16;16) or CBFB::MYH11 fusion, MYH11/CBFB probe set

Appropriate ancillary probes may be performed at consultant discretion to render comprehensive assessment. Any additional probes will have the results included within the final report and will be performed at an additional charge.

Method Name

Fluorescence In Situ Hybridization (FISH)

Reporting Name

Myeloid Sarcoma, FISH, Ts

Specimen Type

Tissue

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

Specimen Type	Temperature	Time
Tissue	Ambient (preferred)
	Refrigerated

Reject Due To

All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Reference Values

An interpretive report will be provided.

Day(s) Performed

Monday through Friday

Report Available

7 to 10 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed using an analyte specific reagent. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

88291

88271 x 2 (if appropriate)

88271 (if appropriate)