MDM2 FISH

TEST: 484326
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CPT: 88377
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Special Instructions

Pertinent clinical diagnostic information, including the pathology report documenting tumor origin and grade, should be included with the specimen. Additional charges will be applied for the embedding process if formalin-fixed tissue is submitted.

Expected Turnaround Time

3 - 5 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Specimen Requirements

Specimen

Adipocytic tumors; formalin-fixed paraffin-embedded (FFPE) tissue

Volume

Four slides (4 micron) on positively charged slides or one paraffin block

Minimum Volume

Two slides (4 micron) on positively charged slides or one paraffin block

Container

Paraffin block

Collection

Time from tissue acquisition to fixation should be as short as possible; samples for MDM2 testing should be fixed in 10% neutral buffered formalin for six to 72 hours.

Storage Instructions

Maintain specimen at room temperature

Stability Requirements

Kit insert/vendor-provided

Causes for Rejection

Use of fixatives other than 10% formalin; improper embedded preparation; poor fixation less than six hours and greater than 72 hours; decalcified bone or bone core; absence or quantity or tumor insufficient for analysis

Test Details

Use

This test is used for classification of certain tumors. MDM2 amplifications are frequently detected in well-differentiated liposarcoma (WDL), which includes atypical lipomatous tumor (ALT) and in dedifferentiated liposarcoma (DDL)

Limitations

Use of fixatives other than 10% formalin or fixation times less than six hours or more than 72 hours may not yield reliable results. Suboptimal pre-analytic variables, including cold ischemia time outside the recommended guidelines, extended duration of fixation, fixation other than paraformaldehyde and tissue decalcification, may negatively impact results. Results of the MDM2 FISH assay should always be used in conjunction with other information available from the clinical evaluation of the patient and other prognostic factors, such as tumor size, histologic grade, and other known risk factors.

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.

Methodology

Fluorescence in situ hybridization (FISH)

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
484326 MDM2 FISH 93805-0 484327 FISH Result 93805-0
484326 MDM2 FISH 93805-0 484335 Treating Physician N/A
484326 MDM2 FISH 93805-0 484336 Specimen Type 31208-2
484326 MDM2 FISH 93805-0 484338 Container(s) Received 74384-9
484326 MDM2 FISH 93805-0 484339 Referring Physician N/A
484326 MDM2 FISH 93805-0 484340 Body Site 39111-0
484326 MDM2 FISH 93805-0 484341 Electronically Signed by 19139-5
484326 MDM2 FISH 93805-0 484342 Proxy Release by 19139-5
484326 MDM2 FISH 93805-0 484343 Client Specimen ID 48767-8
484326 MDM2 FISH 93805-0 484344 Clinical Data 55752-0
484326 MDM2 FISH 93805-0 484346 Revision Text N/A
484326 MDM2 FISH 93805-0 484348 Test(s) Cancelled N/A
484326 MDM2 FISH 93805-0 484349 Reviewing Pathologist 19469-5
484326 MDM2 FISH 93805-0 484350 Additional Notation 48767-8
484326 MDM2 FISH 93805-0 484351 Disclaimer 62364-5
484326 MDM2 FISH 93805-0 484353 Interpretation OR Diagnosis 50595-8
484326 MDM2 FISH 93805-0 484354 Comments 77202-0
484326 MDM2 FISH 93805-0 484355 General Results 93805-0
484326 MDM2 FISH 93805-0 484356 Non Standard Comments 8251-1
484326 MDM2 FISH 93805-0 484377 Bill Code Entry Hold N/A
484326 MDM2 FISH 93805-0 484357 MDM2 FISH N/A

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The LOINC® codes are copyright © 1994-2021, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf