Geisinger Medical Laboratories/Geisinger Proven Diagnostics Test Catalog

Order Display Name: Geisinger Epic Procedure Code Or ID CPT Code:  

MYGENVAR CUSTOM GENE PANEL 5-50 MUTATIONS, NEXT GENERATION SEQUENCING

ORDERING INFORMATION:
Geisinger Epic Procedure Code: LAB4149         Geisinger Epic ID: 168607

SPECIMEN COLLECTION
Specimen type:
Formalin-fixed, paraffin-embedded tissue (FFPE) OR Fresh tissue (including bone marrow aspirate) OR Whole blood
Preferred collection container:
Glass Slides
Specimen required:
PREFERRED:
FFPE tissue:  Six (6) unstained slides (USS), 10 µm thickness each, in slide folder (protected from light)
Bone marrow: 3 mL lavender-top K2 EDTA tube (part of Bone Marrow Panel Collection – Bone Marrow Aspirate – Two [2] K2 EDTA Tube[s])
Fresh tissue:  Place in liquid medium (e.g., RPMI)
Whole blood:  Two (2) - 6 mL pink-top K2 EDTA tube (minimum of 4 mL in each tube)

ALTERNATE:
Whole blood: Four (4) - 3 mL lavender-top K2 EDTA tubes
Special notes:
FFPE tissue: Testing can only be ordered by a pathologist. For non-Geisinger sites, send six (6) USS/10 µm thickness, H&E slide, source of specimen and tumor assessment.  Alternatively, send the FFPE block and additional information. 
Bone marrow:  Testing can only be ordered by a pathologist. For non-Geisinger sites, collection tube is included in the bone marrow (BM) collection kit.
Whole blood:  Testing is ordered using test Blood Nucleic Acid Extraction, BLDNAE, Lab3520, Test 790019014.

NOTE: Isolated/extracted nucleic acids are acceptable only from CLIA-certified laboratories or a laboratory meeting equivalent requirements as determined by CAP and/or CMS.


SPECIMEN PROCESSING
Specimen processing instructions:
Mix well immediately. Do not centrifuge or separate plasma from cells. 
Transport temperature:
FFPE tissue:  Room temperature (18-25°C)
Bone marrow/fresh tissue/whole blood: Refrigerated (2-8°C) 
Specimen stability:
FFPE Tissue: Room temperature (18-25°C), indefinitely
Bone marrow/fresh tissue/whole blood: Refrigerated (2-8°C), 3 days.  Specimen must be extracted within 3 days.
Rejection criteria:
FFPE blocks containing no tumor (evaluated by pathologist). FFPE tissues that have been decalcified. Insufficient DNA and/or RNA. Wrong collection tube. Improper storage or transport temperature. Stability limits exceeded. Shared or comingled specimens.

TEST DETAILS
Reference interval:
Negative (no mutations detected).
Additional information:
For molecular testing, original tube is required.
CPT code(s):
81445
Note: The billing party has sole responsibility for CPT coding.  Any questions regarding coding should be directed to the payer being billed.  The CPT codes provided by GML are based on AMA guidelines and are for informational purposes only.
Test includes:
This custom testing gene panel uses targeted next-generation sequencing (NGS) to detect genomic alterations including: tumor mutation burden (TMB), microsatellite instability (MSI), single base-pair mutations and small insertions/deletions in the coding regions or adjacent intron/exon boundaries, copy number variants (CNV), gene rearrangements (RNA fusion) and exon skipping.

Mutations will be reported based on the custom request.

Methodology:
DNA/RNA Extraction
Next Generation Sequencing
Synonyms:
Oncomine Comprehensive Assay Plus, Solid Tumor Gene Panel, Solid Tumor DNA/RNA Gene Panel, NGS, Next-Generation Sequencing
Clinical significance:
The MyGenVar Custom 5-50 Gene Panel targets DNA and RNA variants by high-throughput sequencing. It helps determine diagnostic classification and provide prognostic or therapeutic information for clinical management.
Doctoral Director(s:)
Yi Ding MD, PhD    
Review Date: 01/12/2022

Performing Locations

Geisinger Medical Center

Performing laboratory: Molecular Diagnostics
Technical Lead: Ronnie Rovenolt, Becky Knock
Frequency: Daily, Monday-Friday
Performed STAT? No
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