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Specimen Collection Manual and Test Catalog

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MYGENVARCYTO PANCREATIC CYST AND BILE DUCT FLUID GENE PANEL, NEXT GENERATION SEQUENCING

Geisinger Epic Procedure Code:  LAB4906    Geisinger Epic ID:  186437
Test Restriction:  LAB ORDER ONLY

SPECIMEN COLLECTION
Specimen type: 

Fine needle aspiration (FNA) of pancreatic cyst fluid, bile duct brushing or other cyst fluid


Preferred collection container: 
Alternate collection container: 
ThinPrep PreservCyt Vial
RPMI
Specimen required: 

Fresh, undiluted FNA of cyst fluid (preferred), RPMI aliquot, RPMI supernatant or sample in PreservCyt container. Minimum 600 uL.
For non-Geisinger sites, send fresh, undiluted FNA of cyst fluid or bile duct brushing. Alternately, send fluid/brushing in RPMI media or a PreserveCyt container. 
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
Processing instructions: 

Deliver to cytology for processing and aliquoting. Do not centrifuge the sample.


Transport temperature: 

Refrigerated (2-8°C)


Specimen stability: 

Refrigerated (2-8°C), 3 days.  Specimen must be extracted within 3 days.
For RPMI media samples, extract within 3 days (preferred) or up to 30 days. 
For PreservCyt samples, extract within 3 days (preferred) or up to 90 days.


Rejection criteria: 

Insufficient DNA and/or RNA. Wrong collection tube. Improper storage or transport temperature. Stability limits exceeded. 
Special Note: FFPE sample (if testing can only be performed from a cell block, please order CUSTG50GP).



TEST DETAILS
Reference interval: 

Negative (no mutations detected).


Additional information: 

Reverse transcriptase qPCR analysis is performed on select specimens to detect mRNA expression of the CEACAM5 gene using primers and probe for the CEACAM5 gene and GAPDH as the housekeeping control gene


CPT code(s):  81459
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. Gene expression profiling of CEACAM5 is performed on select specimens.

The following mutations will be reported on the pancreatic cyst and bile duct fluid gene panel:

DNA based mutation analysis includes the following genes: ACVR1B, AKT1, AKT2, APC, ARAF, ARID1A, ARID1B, ARID2, ATM, ATR, ATRX, AXIN1, AXIN2, BAP1, BARD1, BRAF, BRCA1, BRCA2, BRIP1, CASP8, CDK12, CDKN2A, CDKN2B, CHEK1, CHEK2, CTNNB1, DAXX, EGFR, ELF3, EP300, EPCAM, EPHA2, ERBB2, ERBB3, ERBB4, FANCA, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCL, FAT1, FGFR1, FGFR2, FGFR3, FGFR4, GNAS, HDAC2, HIF1A, HNF1A, HRAS, IDH1, IDH2, KIT, KRAS, MAP2K4, MEN1, MET, MLH1, MRE11, MSH2, MSH6, MTOR, NBN, NF1, NF2, NOTCH1, NRAS, NTRK1, NTRK2, NTRK3, PALB2, PBRM1, PIK3CA, PMS1, PMS2, PTEN, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD54L, RET, RNF43, ROS1, SMAD2, SMAD4, SMO, SRC, STK11, TERT, TGFBR2, TP53, TSC1, TSC2, VHL. 

Copy number variant analysis includes the following genes: ACVR1B, AKT1, AKT2, APC, ARAF, ARID1A, ARID1B, ARID2, ATM, ATR, ATRX, , AXIN1, AXIN2, BAP1, BARD1, BRAF, BRCA1, BRCA2, BRIP1, CASP8, CDK12, CDKN2A, CDKN2B, CHEK1, CHEK2, DAXX, EGFR, ELF3, EP300, EPCAM, EPHA2, ERBB2, ERBB3, ERBB4, FANCA, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCL, FAT1, FGFR1, FGFR2, FGFR3, FGFR4, GNAS, HDAC2, HNF1A, IDH2, KIT, KRAS, MAP2K4, MEN1, MET, MLH1, MRE11, MSH2, MSH6, MTOR, NBN, NF1, NF2, NOTCH1, NRAS, NTRK1, NTRK3, PALB2, PBRM1, PIK3CA, PMS1, PMS2, PTEN, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD54L, RET, RNF43, ROS1, SMAD2, SMAD4, SMO, SRC,  STK11, TERT, TGFBR2, TP53, TSC1, TSC2, VHL. 

RNA based fusion analysis includes the following driver genes: AKT1, AKT2, ALK, BRAF, BRCA1, CDKN2A, ERBB2, ERBB4, EGFR, FGFR1, FGFR2, FGFR3, MET, NOTCH1, NTRK1, NTRK2, NTRK3, NUTM1, PIK3CA, PRKACA, PRKACB, RAF1, RET, ROS1, TERT. 

RNA based exon analysis includes the following genes: BRAF, BRCA1, EGFR, MET, NTRK1. 

RNA based gene expression includes the following: CEACAM5. 


Methodology: 
DNA/RNA Extraction
Next Generation Sequencing
Real-time Reverse Transcription Polymerase Chain Reaction (RT-PCR)
Synonyms: 

Oncomine Comprehensive Assay Plus, Solid Tumor Gene Panel, Solid Tumor DNA/RNA Gene Panel, NGS, Next-Generation Sequencing, Pancreatic Cyst and Bile Duct Fluid Gene Panel, Pancreatic cyst fluid, FNA, bile duct brushing


Clinical significance: 

The MyGenVarCyto Pancreatic Cyst and Bile Duct Fluid 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:  11/17/2025

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