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Test ID PM3CX Lymph3Cx Assay, Primary Mediastinal Large B-cell Lymphoma and Diffuse Large B-cell Lymphoma, mRNA Gene Expression, NanoString, Tissue


Ordering Guidance


This test does not include a pathology consultation. If a pathology consultation is requested, PATHC / Pathology Consultation will be ordered and performed at an additional charge.



Necessary Information


Pathology report (final or preliminary) must accompany specimen in order for testing to be performed. At minimum, it should contain the following information:

1. Patient name

2. Block number-must be on all blocks, slides, and paperwork (can be handwritten on the paperwork)

3. Tissue collection date

4. Source of the tissue



Specimen Required


Submit only 1 of the following specimens:

 

Preferred:

Specimen Type: Tissue slides

Slides: 1 stained and 7 unstained

Collection Instructions: Submit 1 slide stained with hematoxylin and eosin and 7 consecutive, unstained, 5-micron thick sections placed on positively charged slides.

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

 

Acceptable:

Specimen Type: Tissue block

Collection Instructions: Submit a formalin-fixed, paraffin-embedded tumor tissue block.


Useful For

Only indicated for formalin-fixed paraffin-embedded specimens from patients diagnosed with large B-cell lymphoma

Genetics Test Information

This assay is only indicated for patients diagnosed with large B-cell lymphoma for the purposes of determining a final diagnosis of primary mediastinal large B-cell lymphoma (PMBCL) vs diffuse large B-cell lymphoma (DLBCL) and to provide the cell-of-origin information for cases determined to be DLBCL. This assay is only intended to be run using RNA derived from formalin-fixed paraffin-embedded tissue specimens.

 

PMBCL is recognized by the World Health Organization's (WHO) publication "Classification of Tumours of the Haematopoietic and Lymphoid Systems" as a distinct lymphoid neoplasm,(1) but correct diagnosis can be difficult due to dependence upon correlation of clinical variables, presentation, and immunohistochemistry assays. This is further complicated by the occasional presentation of PMBCL outside the mediastinum.(2)

 

WHO also recognizes 2 distinct molecular subtypes of diffuse large B-cell lymphoma (DLBCL): Germinal center B-cell (GCB) type and activated B-cell (ABC) type, as well as a third "Unclassifiable" group.(1)

 

Molecular gene expression offers robust and accurate determination of both the diagnosis of PMBCL and sub-classification of DLBCL.(3,4)

Highlights

The NanoString nCounter system analyzes gene expression without a complementary DNA synthesis step, greatly increasing tolerance of degraded RNA, inhibitors associated with the formalin fixation process, bias, and other artifacts that can often adversely affect enzymatic reactions. Following RNA isolation and overnight hybridization, all washing, immobilization, and scanning steps are automated. This improves precision of the assay and reduces hands-on processing time, providing a rapid turnaround for results, highly desirable attributes for testing in a clinical setting.(4)

Additional Tests

Test ID Reporting Name Available Separately Always Performed
AZSLR Slide Review No, (Bill Only) Yes

Testing Algorithm

When this test is ordered, slide review will always be performed at an additional charge.

Method Name

Gene Expression by Digital Counting of Fluorescent Bar-Coded Probes

Reporting Name

Lymph3Cx, Lg Bcell Lymphoma,mRNA,Ts

Specimen Type

Tissue, Paraffin

Specimen Minimum Volume

Minimum 60% tumor with or without macrodissection.
Minimum required unstained tissue section input: 0.12 mm(3)
Slides: If the tumor surface area is less than or equal to 4 mm(2), submit a minimum of 3 slides; if the tumor surface area is 5 to 11 mm(2), submit a minimum of 2 slides; if the tumor surface area is greater than 11 mm(2), submit a minimum of 1 slide.

Specimen Stability Information

Specimen Type Temperature Time Special Container
Tissue, Paraffin Ambient (preferred)
  Refrigerated 

Reference Values

Not applicable

Day(s) Performed

Monday through Friday

Report Available

7 to 12 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

0120U

88381

LOINC Code Information

Test ID Test Order Name Order LOINC Value
PM3CX Lymph3Cx, Lg Bcell Lymphoma,mRNA,Ts 93785-4

 

Result ID Test Result Name Result LOINC Value
606164 Lymph3Cx, Large B-cell Lymphoma, mRNA, Tissue 93779-7
606165 PMBCL Probability 93780-5
606185 PMBCL Call 93782-1
606166 DLBCL Probability 93781-3
606186 DLBCL COO 93783-9

NY State Approved

No