Special Collection

At least 10% blasts must be present in the Fresh, Snap-Frozen, or OCT samples. At least 25% blasts/tumor must be present in the FFPE tissue blocks or scrolls (based on internal pathology review). Sample acquisition PRIOR to receiving treatment is strongly preferred. 

Outpatient Submit with Specimen

Collect

Specimen Type Type of Container Volume of Specimen Status
Bone marrow 4 mL Purple tube (EDTA) 4 mL Preferred
Whole blood 4 mL Purple tube (EDTA) 4 mL Preferred
OCT-embedded tissue Tissue cassette 0.05 gram tissue Preferred
OCT-embedded tissue Cryogenic tube 0.05 gram tissue Alternate
Paraffin embedded tissue Paraffin block   Preferred
Tissue (Fresh) Tissue culture transport media 0.05 grams Preferred
Tissue (Fresh) Sterile container with saline 0.05 grams Alternate
Tissue (Snap-frozen) Tissue cassette mass 0.05 grams Preferred
Tissue (Snap-frozen) Cryogenic tube mass 0.05 grams Alternate
Tissue scrolls (FFPE) Sterile container   Preferred

Outpatient Specimen Preparation

Bone marrow:  If delay in transport is greater than 24 hours, refrigerate
                        Transport to the lab immediately after collection

Whole blood: If delay in transport is greater than 24 hours, refrigerate
                      Transport to the lab immediately after collection

OCT-embedded tissue: Keep frozen
                                      Protect from heat
                                      Transport to laboratory as soon as possible

Paraffin embedded tissue: Protect from heat
                                           Keep at room temperature

Tissue (Fresh): Transport to the lab immediately after collection
                         Keep at room temperature

Tissue (Snap-frozen): Freeze immediately after collection.
                                   Keep frozen
                                   Protect from heat
                                   Transport to laboratory as soon as possible

Tissue scrolls (FFPE): Protect from heat
                                    Keep at room temperature
                                    Must accompany H&E slide from the same tissue block used to make FFPE scrolls
                                    Must accompany H&E slide from adjacent section
 

Unacceptable Conditions

Delayed or improper handling, Wrong type of specimen, Wrong collection tube, Wrong temperature, Insufficient tumor content in tumor sample

Stability

Bone marrow: Room temperature 24 hour(s)
Bone marrow: Refrigerated 48 hour(s)

Whole blood: Room temperature 24 hour(s)
Whole blood: Refrigerated 48 hour(s) 

OCT-embedded tissue: Frozen 3 day(s)

Paraffin embedded tissue: Room temperature 6 month(s)

Tissue (Fresh): Room temperature 24 hour(s)
Tissue (Fresh): Refrigerated 48 hour(s)

Tissue (Snap-frozen): Frozen 3 day(s)

Tissue scrolls (FFPE): Room temperature 6 month(s)

 

Remarks

If you are an external healthcare provider with no access to Nationwide Children’s Epic system, submission of a completed Oncology Genetic Test Requisition Form is required. If you are an internal ordering provider with access to Nationwide Children’s Epic system, no requisition form is required; please place the lab order electronically in Epic.

If submitting a tissue scroll specimen, please use this Tissue Scroll Calculator tool to determine the thickness and number of tissue scrolls to send to the laboratory.

SPECIMEN INFORMATION:

Fresh and snap-frozen tissue specimens must contain minimum of 10% tumor. Formalin-fixed paraffin embedded (FFPE) tissue block and FFPE tissue scroll specimens must contain minimum of 25% tumor. Please submit the pathology report from the submitted sample. Internal pathology review will also be performed to determine the tumor content in specimen.

If sending FFPE tissue scrolls, an H&E slide from a consecutive cut is also required. Please contact the laboratory at (614) 722-5321 to request the scroll calculator application to be emailed to you to determine the number of scrolls required.

All specimens must be labeled with a patient name and one other identifier (DOB, MRN, Specimen ID#, etc). Sample acquisition prior to receiving therapy is strongly preferred.

SPECIMEN SHIPPING:

Specimens must be shipped as soon as possible after collection due to time-sensitive specimen stability. Ship all samples via overnight courier. Whenever possible, send specimen immediately after collection. For fresh tumor tissue, ship the sample refrigerated using cold packs. If specimen cannot be sent on the collection date, then snap-freeze the tumor tissue immediately after collection and ship the sample frozen (bury the entire tissue in dry ice). Lab must receive specimen within 48 hours. FFPE tissue and FFPE tissue scrolls should be sent at room temperature via overnight shipping. Saturday deliveries are accepted; please check Saturday Delivery on shipment labels.

Clinical Information

This test evaluates for the presence of oncogenic gene fusions in hematologic malignancies. Chromosomal translocations resulting in gene fusions are a hallmark of hematologic neoplasias and can help define the diagnosis and potential treatment options. Identifying a specific oncogenic fusion present in the patient offers an opportunity to treat the patient with inhibitors specific to the oncogenic fusion present in the patient.

This panel provides fusion information for 148 gene fusion partners relevant to lymphoid and myeloid malignancies as well as lymphomas, including gene fusion partners associated with Philadelphia chromosome-like (Ph-like) B-cell acute lymphoblastic leukemia, and some, but not all IGH-CRLF2 gene fusions. Please note, this test is not recommended as a first-line diagnostic assay for lymphomas due to reduced sensitivity for detecting genomic rearrangements with cancer associated immunoglobulin loci (IgG, IgL, IgK). Lymphomas that have tested negative for Ig rearrangements by FISH or other methodologies are acceptable. The fusion partner genes included in this panel are listed below:

AICDA, ASB13, BCL2A1, BCL3, ALK, BCL11B, BATF3, BCL2, ABL1, ABL2, BCL6, BCR, BIRC3, BLNK, BMF, BMP7, CBFB, CCDC50, CCND1, CCND2, CCND3, CD274, CD44, CDC25A, CDK6, CDKN2A, CDKN2B, CEBPA, CEBPD, CEBPE, CEBPG, CHD1, CHIC2, CIITA, CREB3L2, CREBBP, CRLF2, CSF1R, CTLA4, CYB5R2, DEK, DENND3, DNMT3B, DNTT, DUSP22, E2F2, EBF1, EIF4A1, ENTPD1, EPOR, ERG, ETV6, EXOC2, FAM216A, FGFR1, FLT3, FOXP1, FUT8, GLIS2, HOXA10, HOXA9, ID4, IKZF1, IKZF2, IKZF3, IL16, IRF4, IRF8, ITPKB, JAK2, KAT6A, KIAA0101, KLF2, KMT2A, LIMD1, LMO1, LMO2, LRMP, LYL1, LZTS1, MAL, MALT1, MAML3, MECOM, MKL1, MLF1, MLLT10, MLLT4, MME, MUC1, MYBL1, MYC, MYH11, NEK6, NF1, NFKB1, NFKB2, NME1, NOTCH1, NTRK3, NUP214, NUP98, P2RY8, PAG1, PAICS, PAX5, PBX1, PDCD1, PDCD1LG2, PDGFRA, PDGFRB, PICALM, PIM1, PIM2, PML, PPAT, PRDM16, PRKAR2B, PTK2B, PTPN1, PYCR1, RAB29, RAG1, RAG2, RANBP1, RARA, RBM15, ROS1, RUNX1, RUNX1T1, S1PR2, SEMA6A, SERPINA9, SETD2, SH3BP5, SOX11, STIL, STRBP, TCF3, TFG, TLX1, TLX3, TNFRSF13B, TNFSF4, TP63, TYK2, WT1, ZCCHC7

Positive results may be confirmed by RT-PCR with Sanger sequencing.

Days Performed

Monday through Saturday

Set Up Schedule

All tests not performed daily.

Typical Turnaround

3 weeks

Lab Area

Institute for Genomic Medicine

Methodology

Anchored Multiplex PCR (AMP), Next Generation Sequencing (NGS)

CPT Codes

81456

Synonyms

  • Heme fusion,Leukemia fusion,Leukemia translocation,Leukemia rearrangement,Lymphoma fusion , Lymphoma translocation,Lymphoma rearrangement,Myeloma fusion,Myeloma translocation,Myeloma rearrangement,Blood cancer fusion detection,Heme cancer fusion,Tumor, Tumor somatic profiling,Tumor molecular,Tumor fusion,Somatic fusion,RNA fusion,Cancer gene fusion,Pan-heme fusion,Pan heme fusion,Hematologic fusion,Archer FusionPlex NGS,Philadelphia chromosome-like ALL, Ph-like ALL, Ph like ALL, B-ALL fusion
  • IGM test

Special Collection

At least 10% blasts must be present in the Fresh, Snap-Frozen, or OCT samples. At least 25% blasts/tumor must be present in the FFPE tissue blocks or scrolls (based on internal pathology review). Sample acquisition PRIOR to receiving treatment is strongly preferred. 

Collect

Specimen Type Type of Container Volume of Specimen Status
Bone marrow 4 mL Purple tube (EDTA) 4 mL Preferred
Whole blood 4 mL Purple tube (EDTA) 4 mL Preferred
OCT-embedded tissue Tissue cassette 0.05 gram tissue Preferred
OCT-embedded tissue Cryogenic tube 0.05 gram tissue Alternate
Paraffin embedded tissue Paraffin block   Preferred
Tissue (Fresh) Tissue culture transport media 0.05 grams Preferred
Tissue (Fresh) Sterile container with saline 0.05 grams Alternate
Tissue (Snap-frozen) Tissue cassette mass 0.05 grams Preferred
Tissue (Snap-frozen) Cryogenic tube mass 0.05 grams Alternate
Tissue scrolls (FFPE) Sterile container   Preferred

Minimum Volume

Specimen Type Type of Container Minimum Volume
Bone marrow 4 mL Purple tube (EDTA) 1 mL
Whole blood 4 mL Purple tube (EDTA) 1 mL
OCT-embedded tissue Tissue cassette  
OCT-embedded tissue Cryogenic tube  
Paraffin embedded tissue Paraffin block  
Tissue (Fresh) Tissue culture transport media  
Tissue (Fresh) Sterile container with saline  
Tissue (Snap-frozen) Tissue cassette  
Tissue (Snap-frozen) Cryogenic tube  
Tissue scrolls (FFPE) Sterile container  

Inpatient Specimen Preparation

Bone marrow:  If delay in transport is greater than 24 hours, refrigerate
                        Transport to the lab immediately after collection

Whole blood: If delay in transport is greater than 24 hours, refrigerate
                      Transport to the lab immediately after collection

OCT-embedded tissue: Keep frozen
                                      Protect from heat
                                      Transport to laboratory as soon as possible

Paraffin embedded tissue: Protect from heat
                                           Keep at room temperature

Tissue (Fresh): Transport to the lab immediately after collection
                         Keep at room temperature

Tissue (Snap-frozen): Freeze immediately after collection.
                                   Keep frozen
                                   Protect from heat
                                   Transport to laboratory as soon as possible

Tissue scrolls (FFPE): Protect from heat
                                    Keep at room temperature
                                    Must accompany H&E slide from the same tissue block used to make FFPE scrolls
                                    Must accompany H&E slide from adjacent section

 

Unacceptable Conditions

Delayed or improper handling, Wrong type of specimen, Wrong collection tube, Wrong temperature, Insufficient tumor content in tumor sample

Stability

Bone marrow: Room temperature 24 hour(s)
Bone marrow: Refrigerated 48 hour(s)

Whole blood: Room temperature 24 hour(s)
Whole blood: Refrigerated 48 hour(s) 

OCT-embedded tissue: Frozen 3 day(s)

Paraffin embedded tissue: Room temperature 6 month(s)

Tissue (Fresh): Room temperature 24 hour(s)
Tissue (Fresh): Refrigerated 48 hour(s)

Tissue (Snap-frozen): Frozen 3 day(s)

Tissue scrolls (FFPE): Room temperature 6 month(s)

 

Remarks

If you are an external healthcare provider with no access to Nationwide Children’s Epic system, submission of a completed Oncology Genetic Test Requisition Form is required. If you are an internal ordering provider with access to Nationwide Children’s Epic system, no requisition form is required; please place the lab order electronically in Epic.

If submitting a tissue scroll specimen, please use this Tissue Scroll Calculator tool to determine the thickness and number of tissue scrolls to send to the laboratory.

SPECIMEN INFORMATION:

Fresh and snap-frozen tissue specimens must contain minimum of 10% tumor. Formalin-fixed paraffin embedded (FFPE) tissue block and FFPE tissue scroll specimens must contain minimum of 25% tumor. Please submit the pathology report from the submitted sample. Internal pathology review will also be performed to determine the tumor content in specimen.

If sending FFPE tissue scrolls, an H&E slide from a consecutive cut is also required. Please contact the laboratory at (614) 722-5321 to request the scroll calculator application to be emailed to you to determine the number of scrolls required.

All specimens must be labeled with a patient name and one other identifier (DOB, MRN, Specimen ID#, etc). Sample acquisition prior to receiving therapy is strongly preferred.

SPECIMEN SHIPPING:

Specimens must be shipped as soon as possible after collection due to time-sensitive specimen stability. Ship all samples via overnight courier. Whenever possible, send specimen immediately after collection. For fresh tumor tissue, ship the sample refrigerated using cold packs. If specimen cannot be sent on the collection date, then snap-freeze the tumor tissue immediately after collection and ship the sample frozen (bury the entire tissue in dry ice). Lab must receive specimen within 48 hours. FFPE tissue and FFPE tissue scrolls should be sent at room temperature via overnight shipping. Saturday deliveries are accepted; please check Saturday Delivery on shipment labels.

Clinical Information

This test evaluates for the presence of oncogenic gene fusions in hematologic malignancies. Chromosomal translocations resulting in gene fusions are a hallmark of hematologic neoplasias and can help define the diagnosis and potential treatment options. Identifying a specific oncogenic fusion present in the patient offers an opportunity to treat the patient with inhibitors specific to the oncogenic fusion present in the patient.

This panel provides fusion information for 148 gene fusion partners relevant to lymphoid and myeloid malignancies as well as lymphomas, including gene fusion partners associated with Philadelphia chromosome-like (Ph-like) B-cell acute lymphoblastic leukemia, and some, but not all IGH-CRLF2 gene fusions. Please note, this test is not recommended as a first-line diagnostic assay for lymphomas due to reduced sensitivity for detecting genomic rearrangements with cancer associated immunoglobulin loci (IgG, IgL, IgK). Lymphomas that have tested negative for Ig rearrangements by FISH or other methodologies are acceptable. The fusion partner genes included in this panel are listed below:

AICDA, ASB13, BCL2A1, BCL3, ALK, BCL11B, BATF3, BCL2, ABL1, ABL2, BCL6, BCR, BIRC3, BLNK, BMF, BMP7, CBFB, CCDC50, CCND1, CCND2, CCND3, CD274, CD44, CDC25A, CDK6, CDKN2A, CDKN2B, CEBPA, CEBPD, CEBPE, CEBPG, CHD1, CHIC2, CIITA, CREB3L2, CREBBP, CRLF2, CSF1R, CTLA4, CYB5R2, DEK, DENND3, DNMT3B, DNTT, DUSP22, E2F2, EBF1, EIF4A1, ENTPD1, EPOR, ERG, ETV6, EXOC2, FAM216A, FGFR1, FLT3, FOXP1, FUT8, GLIS2, HOXA10, HOXA9, ID4, IKZF1, IKZF2, IKZF3, IL16, IRF4, IRF8, ITPKB, JAK2, KAT6A, KIAA0101, KLF2, KMT2A, LIMD1, LMO1, LMO2, LRMP, LYL1, LZTS1, MAL, MALT1, MAML3, MECOM, MKL1, MLF1, MLLT10, MLLT4, MME, MUC1, MYBL1, MYC, MYH11, NEK6, NF1, NFKB1, NFKB2, NME1, NOTCH1, NTRK3, NUP214, NUP98, P2RY8, PAG1, PAICS, PAX5, PBX1, PDCD1, PDCD1LG2, PDGFRA, PDGFRB, PICALM, PIM1, PIM2, PML, PPAT, PRDM16, PRKAR2B, PTK2B, PTPN1, PYCR1, RAB29, RAG1, RAG2, RANBP1, RARA, RBM15, ROS1, RUNX1, RUNX1T1, S1PR2, SEMA6A, SERPINA9, SETD2, SH3BP5, SOX11, STIL, STRBP, TCF3, TFG, TLX1, TLX3, TNFRSF13B, TNFSF4, TP63, TYK2, WT1, ZCCHC7

Positive results may be confirmed by RT-PCR with Sanger sequencing.

Days Performed

Monday through Saturday

Set Up Schedule

All tests not performed daily.

Typical Turnaround

3 weeks

CPT Codes

81456

Lab Area

Institute for Genomic Medicine

Synonyms

  • Heme fusion,Leukemia fusion,Leukemia translocation,Leukemia rearrangement,Lymphoma fusion , Lymphoma translocation,Lymphoma rearrangement,Myeloma fusion,Myeloma translocation,Myeloma rearrangement,Blood cancer fusion detection,Heme cancer fusion,Tumor, Tumor somatic profiling,Tumor molecular,Tumor fusion,Somatic fusion,RNA fusion,Cancer gene fusion,Pan-heme fusion,Pan heme fusion,Hematologic fusion,Archer FusionPlex NGS,Philadelphia chromosome-like ALL, Ph-like ALL, Ph like ALL, B-ALL fusion
  • IGM test

Estimated Patient Price

$2,500 - $5,000

Synonyms

  • Heme fusion,Leukemia fusion,Leukemia translocation,Leukemia rearrangement,Lymphoma fusion , Lymphoma translocation,Lymphoma rearrangement,Myeloma fusion,Myeloma translocation,Myeloma rearrangement,Blood cancer fusion detection,Heme cancer fusion,Tumor, Tumor somatic profiling,Tumor molecular,Tumor fusion,Somatic fusion,RNA fusion,Cancer gene fusion,Pan-heme fusion,Pan heme fusion,Hematologic fusion,Archer FusionPlex NGS,Philadelphia chromosome-like ALL, Ph-like ALL, Ph like ALL, B-ALL fusion
  • IGM test

CPT Codes

81456

Clinical Information

This test evaluates for the presence of oncogenic gene fusions in hematologic malignancies. Chromosomal translocations resulting in gene fusions are a hallmark of hematologic neoplasias and can help define the diagnosis and potential treatment options. Identifying a specific oncogenic fusion present in the patient offers an opportunity to treat the patient with inhibitors specific to the oncogenic fusion present in the patient.

This panel provides fusion information for 148 gene fusion partners relevant to lymphoid and myeloid malignancies as well as lymphomas, including gene fusion partners associated with Philadelphia chromosome-like (Ph-like) B-cell acute lymphoblastic leukemia, and some, but not all IGH-CRLF2 gene fusions. Please note, this test is not recommended as a first-line diagnostic assay for lymphomas due to reduced sensitivity for detecting genomic rearrangements with cancer associated immunoglobulin loci (IgG, IgL, IgK). Lymphomas that have tested negative for Ig rearrangements by FISH or other methodologies are acceptable. The fusion partner genes included in this panel are listed below:

AICDA, ASB13, BCL2A1, BCL3, ALK, BCL11B, BATF3, BCL2, ABL1, ABL2, BCL6, BCR, BIRC3, BLNK, BMF, BMP7, CBFB, CCDC50, CCND1, CCND2, CCND3, CD274, CD44, CDC25A, CDK6, CDKN2A, CDKN2B, CEBPA, CEBPD, CEBPE, CEBPG, CHD1, CHIC2, CIITA, CREB3L2, CREBBP, CRLF2, CSF1R, CTLA4, CYB5R2, DEK, DENND3, DNMT3B, DNTT, DUSP22, E2F2, EBF1, EIF4A1, ENTPD1, EPOR, ERG, ETV6, EXOC2, FAM216A, FGFR1, FLT3, FOXP1, FUT8, GLIS2, HOXA10, HOXA9, ID4, IKZF1, IKZF2, IKZF3, IL16, IRF4, IRF8, ITPKB, JAK2, KAT6A, KIAA0101, KLF2, KMT2A, LIMD1, LMO1, LMO2, LRMP, LYL1, LZTS1, MAL, MALT1, MAML3, MECOM, MKL1, MLF1, MLLT10, MLLT4, MME, MUC1, MYBL1, MYC, MYH11, NEK6, NF1, NFKB1, NFKB2, NME1, NOTCH1, NTRK3, NUP214, NUP98, P2RY8, PAG1, PAICS, PAX5, PBX1, PDCD1, PDCD1LG2, PDGFRA, PDGFRB, PICALM, PIM1, PIM2, PML, PPAT, PRDM16, PRKAR2B, PTK2B, PTPN1, PYCR1, RAB29, RAG1, RAG2, RANBP1, RARA, RBM15, ROS1, RUNX1, RUNX1T1, S1PR2, SEMA6A, SERPINA9, SETD2, SH3BP5, SOX11, STIL, STRBP, TCF3, TFG, TLX1, TLX3, TNFRSF13B, TNFSF4, TP63, TYK2, WT1, ZCCHC7

Positive results may be confirmed by RT-PCR with Sanger sequencing.

Methodology

Anchored Multiplex PCR (AMP), Next Generation Sequencing (NGS)

Special Collection

At least 10% blasts must be present in the Fresh, Snap-Frozen, or OCT samples. At least 25% blasts/tumor must be present in the FFPE tissue blocks or scrolls (based on internal pathology review). Sample acquisition PRIOR to receiving treatment is strongly preferred. 

Outpatient Submit with Specimen

Collect

Specimen Type Type of Container Volume of Specimen Status
Bone marrow 4 mL Purple tube (EDTA) 4 mL Preferred
Whole blood 4 mL Purple tube (EDTA) 4 mL Preferred
OCT-embedded tissue Tissue cassette 0.05 gram tissue Preferred
OCT-embedded tissue Cryogenic tube 0.05 gram tissue Alternate
Paraffin embedded tissue Paraffin block   Preferred
Tissue (Fresh) Tissue culture transport media 0.05 grams Preferred
Tissue (Fresh) Sterile container with saline 0.05 grams Alternate
Tissue (Snap-frozen) Tissue cassette mass 0.05 grams Preferred
Tissue (Snap-frozen) Cryogenic tube mass 0.05 grams Alternate
Tissue scrolls (FFPE) Sterile container   Preferred

Minimum Volume

Specimen Type Type of Container Minimum Volume
Bone marrow 4 mL Purple tube (EDTA) 1 mL
Whole blood 4 mL Purple tube (EDTA) 1 mL
OCT-embedded tissue Tissue cassette  
OCT-embedded tissue Cryogenic tube  
Paraffin embedded tissue Paraffin block  
Tissue (Fresh) Tissue culture transport media  
Tissue (Fresh) Sterile container with saline  
Tissue (Snap-frozen) Tissue cassette  
Tissue (Snap-frozen) Cryogenic tube  
Tissue scrolls (FFPE) Sterile container  

Inpatient Specimen Preparation

Bone marrow:  If delay in transport is greater than 24 hours, refrigerate
                        Transport to the lab immediately after collection

Whole blood: If delay in transport is greater than 24 hours, refrigerate
                      Transport to the lab immediately after collection

OCT-embedded tissue: Keep frozen
                                      Protect from heat
                                      Transport to laboratory as soon as possible

Paraffin embedded tissue: Protect from heat
                                           Keep at room temperature

Tissue (Fresh): Transport to the lab immediately after collection
                         Keep at room temperature

Tissue (Snap-frozen): Freeze immediately after collection.
                                   Keep frozen
                                   Protect from heat
                                   Transport to laboratory as soon as possible

Tissue scrolls (FFPE): Protect from heat
                                    Keep at room temperature
                                    Must accompany H&E slide from the same tissue block used to make FFPE scrolls
                                    Must accompany H&E slide from adjacent section

 

Outpatient Specimen Preparation

Bone marrow:  If delay in transport is greater than 24 hours, refrigerate
                        Transport to the lab immediately after collection

Whole blood: If delay in transport is greater than 24 hours, refrigerate
                      Transport to the lab immediately after collection

OCT-embedded tissue: Keep frozen
                                      Protect from heat
                                      Transport to laboratory as soon as possible

Paraffin embedded tissue: Protect from heat
                                           Keep at room temperature

Tissue (Fresh): Transport to the lab immediately after collection
                         Keep at room temperature

Tissue (Snap-frozen): Freeze immediately after collection.
                                   Keep frozen
                                   Protect from heat
                                   Transport to laboratory as soon as possible

Tissue scrolls (FFPE): Protect from heat
                                    Keep at room temperature
                                    Must accompany H&E slide from the same tissue block used to make FFPE scrolls
                                    Must accompany H&E slide from adjacent section
 

InLab Processing

Send to Molecular Genetics Lab with all submitted paperwork. CPA needs to order GENSP in Sunquest for Non-EPIC lab order.

Stability

Bone marrow: Room temperature 24 hour(s)
Bone marrow: Refrigerated 48 hour(s)

Whole blood: Room temperature 24 hour(s)
Whole blood: Refrigerated 48 hour(s) 

OCT-embedded tissue: Frozen 3 day(s)

Paraffin embedded tissue: Room temperature 6 month(s)

Tissue (Fresh): Room temperature 24 hour(s)
Tissue (Fresh): Refrigerated 48 hour(s)

Tissue (Snap-frozen): Frozen 3 day(s)

Tissue scrolls (FFPE): Room temperature 6 month(s)

 

Unacceptable Conditions

Delayed or improper handling, Wrong type of specimen, Wrong collection tube, Wrong temperature, Insufficient tumor content in tumor sample

Days Performed

Monday through Saturday

Set Up Schedule

All tests not performed daily.

Typical Turnaround

3 weeks

Remarks

If you are an external healthcare provider with no access to Nationwide Children’s Epic system, submission of a completed Oncology Genetic Test Requisition Form is required. If you are an internal ordering provider with access to Nationwide Children’s Epic system, no requisition form is required; please place the lab order electronically in Epic.

If submitting a tissue scroll specimen, please use this Tissue Scroll Calculator tool to determine the thickness and number of tissue scrolls to send to the laboratory.

SPECIMEN INFORMATION:

Fresh and snap-frozen tissue specimens must contain minimum of 10% tumor. Formalin-fixed paraffin embedded (FFPE) tissue block and FFPE tissue scroll specimens must contain minimum of 25% tumor. Please submit the pathology report from the submitted sample. Internal pathology review will also be performed to determine the tumor content in specimen.

If sending FFPE tissue scrolls, an H&E slide from a consecutive cut is also required. Please contact the laboratory at (614) 722-5321 to request the scroll calculator application to be emailed to you to determine the number of scrolls required.

All specimens must be labeled with a patient name and one other identifier (DOB, MRN, Specimen ID#, etc). Sample acquisition prior to receiving therapy is strongly preferred.

SPECIMEN SHIPPING:

Specimens must be shipped as soon as possible after collection due to time-sensitive specimen stability. Ship all samples via overnight courier. Whenever possible, send specimen immediately after collection. For fresh tumor tissue, ship the sample refrigerated using cold packs. If specimen cannot be sent on the collection date, then snap-freeze the tumor tissue immediately after collection and ship the sample frozen (bury the entire tissue in dry ice). Lab must receive specimen within 48 hours. FFPE tissue and FFPE tissue scrolls should be sent at room temperature via overnight shipping. Saturday deliveries are accepted; please check Saturday Delivery on shipment labels.

Clinical Information

This test evaluates for the presence of oncogenic gene fusions in hematologic malignancies. Chromosomal translocations resulting in gene fusions are a hallmark of hematologic neoplasias and can help define the diagnosis and potential treatment options. Identifying a specific oncogenic fusion present in the patient offers an opportunity to treat the patient with inhibitors specific to the oncogenic fusion present in the patient.

This panel provides fusion information for 148 gene fusion partners relevant to lymphoid and myeloid malignancies as well as lymphomas, including gene fusion partners associated with Philadelphia chromosome-like (Ph-like) B-cell acute lymphoblastic leukemia, and some, but not all IGH-CRLF2 gene fusions. Please note, this test is not recommended as a first-line diagnostic assay for lymphomas due to reduced sensitivity for detecting genomic rearrangements with cancer associated immunoglobulin loci (IgG, IgL, IgK). Lymphomas that have tested negative for Ig rearrangements by FISH or other methodologies are acceptable. The fusion partner genes included in this panel are listed below:

AICDA, ASB13, BCL2A1, BCL3, ALK, BCL11B, BATF3, BCL2, ABL1, ABL2, BCL6, BCR, BIRC3, BLNK, BMF, BMP7, CBFB, CCDC50, CCND1, CCND2, CCND3, CD274, CD44, CDC25A, CDK6, CDKN2A, CDKN2B, CEBPA, CEBPD, CEBPE, CEBPG, CHD1, CHIC2, CIITA, CREB3L2, CREBBP, CRLF2, CSF1R, CTLA4, CYB5R2, DEK, DENND3, DNMT3B, DNTT, DUSP22, E2F2, EBF1, EIF4A1, ENTPD1, EPOR, ERG, ETV6, EXOC2, FAM216A, FGFR1, FLT3, FOXP1, FUT8, GLIS2, HOXA10, HOXA9, ID4, IKZF1, IKZF2, IKZF3, IL16, IRF4, IRF8, ITPKB, JAK2, KAT6A, KIAA0101, KLF2, KMT2A, LIMD1, LMO1, LMO2, LRMP, LYL1, LZTS1, MAL, MALT1, MAML3, MECOM, MKL1, MLF1, MLLT10, MLLT4, MME, MUC1, MYBL1, MYC, MYH11, NEK6, NF1, NFKB1, NFKB2, NME1, NOTCH1, NTRK3, NUP214, NUP98, P2RY8, PAG1, PAICS, PAX5, PBX1, PDCD1, PDCD1LG2, PDGFRA, PDGFRB, PICALM, PIM1, PIM2, PML, PPAT, PRDM16, PRKAR2B, PTK2B, PTPN1, PYCR1, RAB29, RAG1, RAG2, RANBP1, RARA, RBM15, ROS1, RUNX1, RUNX1T1, S1PR2, SEMA6A, SERPINA9, SETD2, SH3BP5, SOX11, STIL, STRBP, TCF3, TFG, TLX1, TLX3, TNFRSF13B, TNFSF4, TP63, TYK2, WT1, ZCCHC7

Positive results may be confirmed by RT-PCR with Sanger sequencing.

Synonyms

  • Heme fusion,Leukemia fusion,Leukemia translocation,Leukemia rearrangement,Lymphoma fusion , Lymphoma translocation,Lymphoma rearrangement,Myeloma fusion,Myeloma translocation,Myeloma rearrangement,Blood cancer fusion detection,Heme cancer fusion,Tumor, Tumor somatic profiling,Tumor molecular,Tumor fusion,Somatic fusion,RNA fusion,Cancer gene fusion,Pan-heme fusion,Pan heme fusion,Hematologic fusion,Archer FusionPlex NGS,Philadelphia chromosome-like ALL, Ph-like ALL, Ph like ALL, B-ALL fusion
  • IGM test

Methodology

Anchored Multiplex PCR (AMP), Next Generation Sequencing (NGS)

CPT Codes

81456

Estimated Patient Price

$2,500 - $5,000

DC Code

5321

Downtime Availability

4-Not available
Outpatient Requirements

Special Collection

At least 10% blasts must be present in the Fresh, Snap-Frozen, or OCT samples. At least 25% blasts/tumor must be present in the FFPE tissue blocks or scrolls (based on internal pathology review). Sample acquisition PRIOR to receiving treatment is strongly preferred. 

Outpatient Submit with Specimen

Collect

Specimen Type Type of Container Volume of Specimen Status
Bone marrow 4 mL Purple tube (EDTA) 4 mL Preferred
Whole blood 4 mL Purple tube (EDTA) 4 mL Preferred
OCT-embedded tissue Tissue cassette 0.05 gram tissue Preferred
OCT-embedded tissue Cryogenic tube 0.05 gram tissue Alternate
Paraffin embedded tissue Paraffin block   Preferred
Tissue (Fresh) Tissue culture transport media 0.05 grams Preferred
Tissue (Fresh) Sterile container with saline 0.05 grams Alternate
Tissue (Snap-frozen) Tissue cassette mass 0.05 grams Preferred
Tissue (Snap-frozen) Cryogenic tube mass 0.05 grams Alternate
Tissue scrolls (FFPE) Sterile container   Preferred

Outpatient Specimen Preparation

Bone marrow:  If delay in transport is greater than 24 hours, refrigerate
                        Transport to the lab immediately after collection

Whole blood: If delay in transport is greater than 24 hours, refrigerate
                      Transport to the lab immediately after collection

OCT-embedded tissue: Keep frozen
                                      Protect from heat
                                      Transport to laboratory as soon as possible

Paraffin embedded tissue: Protect from heat
                                           Keep at room temperature

Tissue (Fresh): Transport to the lab immediately after collection
                         Keep at room temperature

Tissue (Snap-frozen): Freeze immediately after collection.
                                   Keep frozen
                                   Protect from heat
                                   Transport to laboratory as soon as possible

Tissue scrolls (FFPE): Protect from heat
                                    Keep at room temperature
                                    Must accompany H&E slide from the same tissue block used to make FFPE scrolls
                                    Must accompany H&E slide from adjacent section
 

Unacceptable Conditions

Delayed or improper handling, Wrong type of specimen, Wrong collection tube, Wrong temperature, Insufficient tumor content in tumor sample

Stability

Bone marrow: Room temperature 24 hour(s)
Bone marrow: Refrigerated 48 hour(s)

Whole blood: Room temperature 24 hour(s)
Whole blood: Refrigerated 48 hour(s) 

OCT-embedded tissue: Frozen 3 day(s)

Paraffin embedded tissue: Room temperature 6 month(s)

Tissue (Fresh): Room temperature 24 hour(s)
Tissue (Fresh): Refrigerated 48 hour(s)

Tissue (Snap-frozen): Frozen 3 day(s)

Tissue scrolls (FFPE): Room temperature 6 month(s)

 

Remarks

If you are an external healthcare provider with no access to Nationwide Children’s Epic system, submission of a completed Oncology Genetic Test Requisition Form is required. If you are an internal ordering provider with access to Nationwide Children’s Epic system, no requisition form is required; please place the lab order electronically in Epic.

If submitting a tissue scroll specimen, please use this Tissue Scroll Calculator tool to determine the thickness and number of tissue scrolls to send to the laboratory.

SPECIMEN INFORMATION:

Fresh and snap-frozen tissue specimens must contain minimum of 10% tumor. Formalin-fixed paraffin embedded (FFPE) tissue block and FFPE tissue scroll specimens must contain minimum of 25% tumor. Please submit the pathology report from the submitted sample. Internal pathology review will also be performed to determine the tumor content in specimen.

If sending FFPE tissue scrolls, an H&E slide from a consecutive cut is also required. Please contact the laboratory at (614) 722-5321 to request the scroll calculator application to be emailed to you to determine the number of scrolls required.

All specimens must be labeled with a patient name and one other identifier (DOB, MRN, Specimen ID#, etc). Sample acquisition prior to receiving therapy is strongly preferred.

SPECIMEN SHIPPING:

Specimens must be shipped as soon as possible after collection due to time-sensitive specimen stability. Ship all samples via overnight courier. Whenever possible, send specimen immediately after collection. For fresh tumor tissue, ship the sample refrigerated using cold packs. If specimen cannot be sent on the collection date, then snap-freeze the tumor tissue immediately after collection and ship the sample frozen (bury the entire tissue in dry ice). Lab must receive specimen within 48 hours. FFPE tissue and FFPE tissue scrolls should be sent at room temperature via overnight shipping. Saturday deliveries are accepted; please check Saturday Delivery on shipment labels.

Clinical Information

This test evaluates for the presence of oncogenic gene fusions in hematologic malignancies. Chromosomal translocations resulting in gene fusions are a hallmark of hematologic neoplasias and can help define the diagnosis and potential treatment options. Identifying a specific oncogenic fusion present in the patient offers an opportunity to treat the patient with inhibitors specific to the oncogenic fusion present in the patient.

This panel provides fusion information for 148 gene fusion partners relevant to lymphoid and myeloid malignancies as well as lymphomas, including gene fusion partners associated with Philadelphia chromosome-like (Ph-like) B-cell acute lymphoblastic leukemia, and some, but not all IGH-CRLF2 gene fusions. Please note, this test is not recommended as a first-line diagnostic assay for lymphomas due to reduced sensitivity for detecting genomic rearrangements with cancer associated immunoglobulin loci (IgG, IgL, IgK). Lymphomas that have tested negative for Ig rearrangements by FISH or other methodologies are acceptable. The fusion partner genes included in this panel are listed below:

AICDA, ASB13, BCL2A1, BCL3, ALK, BCL11B, BATF3, BCL2, ABL1, ABL2, BCL6, BCR, BIRC3, BLNK, BMF, BMP7, CBFB, CCDC50, CCND1, CCND2, CCND3, CD274, CD44, CDC25A, CDK6, CDKN2A, CDKN2B, CEBPA, CEBPD, CEBPE, CEBPG, CHD1, CHIC2, CIITA, CREB3L2, CREBBP, CRLF2, CSF1R, CTLA4, CYB5R2, DEK, DENND3, DNMT3B, DNTT, DUSP22, E2F2, EBF1, EIF4A1, ENTPD1, EPOR, ERG, ETV6, EXOC2, FAM216A, FGFR1, FLT3, FOXP1, FUT8, GLIS2, HOXA10, HOXA9, ID4, IKZF1, IKZF2, IKZF3, IL16, IRF4, IRF8, ITPKB, JAK2, KAT6A, KIAA0101, KLF2, KMT2A, LIMD1, LMO1, LMO2, LRMP, LYL1, LZTS1, MAL, MALT1, MAML3, MECOM, MKL1, MLF1, MLLT10, MLLT4, MME, MUC1, MYBL1, MYC, MYH11, NEK6, NF1, NFKB1, NFKB2, NME1, NOTCH1, NTRK3, NUP214, NUP98, P2RY8, PAG1, PAICS, PAX5, PBX1, PDCD1, PDCD1LG2, PDGFRA, PDGFRB, PICALM, PIM1, PIM2, PML, PPAT, PRDM16, PRKAR2B, PTK2B, PTPN1, PYCR1, RAB29, RAG1, RAG2, RANBP1, RARA, RBM15, ROS1, RUNX1, RUNX1T1, S1PR2, SEMA6A, SERPINA9, SETD2, SH3BP5, SOX11, STIL, STRBP, TCF3, TFG, TLX1, TLX3, TNFRSF13B, TNFSF4, TP63, TYK2, WT1, ZCCHC7

Positive results may be confirmed by RT-PCR with Sanger sequencing.

Days Performed

Monday through Saturday

Set Up Schedule

All tests not performed daily.

Typical Turnaround

3 weeks

Lab Area

Institute for Genomic Medicine

Methodology

Anchored Multiplex PCR (AMP), Next Generation Sequencing (NGS)

CPT Codes

81456

Synonyms

  • Heme fusion,Leukemia fusion,Leukemia translocation,Leukemia rearrangement,Lymphoma fusion , Lymphoma translocation,Lymphoma rearrangement,Myeloma fusion,Myeloma translocation,Myeloma rearrangement,Blood cancer fusion detection,Heme cancer fusion,Tumor, Tumor somatic profiling,Tumor molecular,Tumor fusion,Somatic fusion,RNA fusion,Cancer gene fusion,Pan-heme fusion,Pan heme fusion,Hematologic fusion,Archer FusionPlex NGS,Philadelphia chromosome-like ALL, Ph-like ALL, Ph like ALL, B-ALL fusion
  • IGM test
Inpatient Requirements

Special Collection

At least 10% blasts must be present in the Fresh, Snap-Frozen, or OCT samples. At least 25% blasts/tumor must be present in the FFPE tissue blocks or scrolls (based on internal pathology review). Sample acquisition PRIOR to receiving treatment is strongly preferred. 

Collect

Specimen Type Type of Container Volume of Specimen Status
Bone marrow 4 mL Purple tube (EDTA) 4 mL Preferred
Whole blood 4 mL Purple tube (EDTA) 4 mL Preferred
OCT-embedded tissue Tissue cassette 0.05 gram tissue Preferred
OCT-embedded tissue Cryogenic tube 0.05 gram tissue Alternate
Paraffin embedded tissue Paraffin block   Preferred
Tissue (Fresh) Tissue culture transport media 0.05 grams Preferred
Tissue (Fresh) Sterile container with saline 0.05 grams Alternate
Tissue (Snap-frozen) Tissue cassette mass 0.05 grams Preferred
Tissue (Snap-frozen) Cryogenic tube mass 0.05 grams Alternate
Tissue scrolls (FFPE) Sterile container   Preferred

Minimum Volume

Specimen Type Type of Container Minimum Volume
Bone marrow 4 mL Purple tube (EDTA) 1 mL
Whole blood 4 mL Purple tube (EDTA) 1 mL
OCT-embedded tissue Tissue cassette  
OCT-embedded tissue Cryogenic tube  
Paraffin embedded tissue Paraffin block  
Tissue (Fresh) Tissue culture transport media  
Tissue (Fresh) Sterile container with saline  
Tissue (Snap-frozen) Tissue cassette  
Tissue (Snap-frozen) Cryogenic tube  
Tissue scrolls (FFPE) Sterile container  

Inpatient Specimen Preparation

Bone marrow:  If delay in transport is greater than 24 hours, refrigerate
                        Transport to the lab immediately after collection

Whole blood: If delay in transport is greater than 24 hours, refrigerate
                      Transport to the lab immediately after collection

OCT-embedded tissue: Keep frozen
                                      Protect from heat
                                      Transport to laboratory as soon as possible

Paraffin embedded tissue: Protect from heat
                                           Keep at room temperature

Tissue (Fresh): Transport to the lab immediately after collection
                         Keep at room temperature

Tissue (Snap-frozen): Freeze immediately after collection.
                                   Keep frozen
                                   Protect from heat
                                   Transport to laboratory as soon as possible

Tissue scrolls (FFPE): Protect from heat
                                    Keep at room temperature
                                    Must accompany H&E slide from the same tissue block used to make FFPE scrolls
                                    Must accompany H&E slide from adjacent section

 

Unacceptable Conditions

Delayed or improper handling, Wrong type of specimen, Wrong collection tube, Wrong temperature, Insufficient tumor content in tumor sample

Stability

Bone marrow: Room temperature 24 hour(s)
Bone marrow: Refrigerated 48 hour(s)

Whole blood: Room temperature 24 hour(s)
Whole blood: Refrigerated 48 hour(s) 

OCT-embedded tissue: Frozen 3 day(s)

Paraffin embedded tissue: Room temperature 6 month(s)

Tissue (Fresh): Room temperature 24 hour(s)
Tissue (Fresh): Refrigerated 48 hour(s)

Tissue (Snap-frozen): Frozen 3 day(s)

Tissue scrolls (FFPE): Room temperature 6 month(s)

 

Remarks

If you are an external healthcare provider with no access to Nationwide Children’s Epic system, submission of a completed Oncology Genetic Test Requisition Form is required. If you are an internal ordering provider with access to Nationwide Children’s Epic system, no requisition form is required; please place the lab order electronically in Epic.

If submitting a tissue scroll specimen, please use this Tissue Scroll Calculator tool to determine the thickness and number of tissue scrolls to send to the laboratory.

SPECIMEN INFORMATION:

Fresh and snap-frozen tissue specimens must contain minimum of 10% tumor. Formalin-fixed paraffin embedded (FFPE) tissue block and FFPE tissue scroll specimens must contain minimum of 25% tumor. Please submit the pathology report from the submitted sample. Internal pathology review will also be performed to determine the tumor content in specimen.

If sending FFPE tissue scrolls, an H&E slide from a consecutive cut is also required. Please contact the laboratory at (614) 722-5321 to request the scroll calculator application to be emailed to you to determine the number of scrolls required.

All specimens must be labeled with a patient name and one other identifier (DOB, MRN, Specimen ID#, etc). Sample acquisition prior to receiving therapy is strongly preferred.

SPECIMEN SHIPPING:

Specimens must be shipped as soon as possible after collection due to time-sensitive specimen stability. Ship all samples via overnight courier. Whenever possible, send specimen immediately after collection. For fresh tumor tissue, ship the sample refrigerated using cold packs. If specimen cannot be sent on the collection date, then snap-freeze the tumor tissue immediately after collection and ship the sample frozen (bury the entire tissue in dry ice). Lab must receive specimen within 48 hours. FFPE tissue and FFPE tissue scrolls should be sent at room temperature via overnight shipping. Saturday deliveries are accepted; please check Saturday Delivery on shipment labels.

Clinical Information

This test evaluates for the presence of oncogenic gene fusions in hematologic malignancies. Chromosomal translocations resulting in gene fusions are a hallmark of hematologic neoplasias and can help define the diagnosis and potential treatment options. Identifying a specific oncogenic fusion present in the patient offers an opportunity to treat the patient with inhibitors specific to the oncogenic fusion present in the patient.

This panel provides fusion information for 148 gene fusion partners relevant to lymphoid and myeloid malignancies as well as lymphomas, including gene fusion partners associated with Philadelphia chromosome-like (Ph-like) B-cell acute lymphoblastic leukemia, and some, but not all IGH-CRLF2 gene fusions. Please note, this test is not recommended as a first-line diagnostic assay for lymphomas due to reduced sensitivity for detecting genomic rearrangements with cancer associated immunoglobulin loci (IgG, IgL, IgK). Lymphomas that have tested negative for Ig rearrangements by FISH or other methodologies are acceptable. The fusion partner genes included in this panel are listed below:

AICDA, ASB13, BCL2A1, BCL3, ALK, BCL11B, BATF3, BCL2, ABL1, ABL2, BCL6, BCR, BIRC3, BLNK, BMF, BMP7, CBFB, CCDC50, CCND1, CCND2, CCND3, CD274, CD44, CDC25A, CDK6, CDKN2A, CDKN2B, CEBPA, CEBPD, CEBPE, CEBPG, CHD1, CHIC2, CIITA, CREB3L2, CREBBP, CRLF2, CSF1R, CTLA4, CYB5R2, DEK, DENND3, DNMT3B, DNTT, DUSP22, E2F2, EBF1, EIF4A1, ENTPD1, EPOR, ERG, ETV6, EXOC2, FAM216A, FGFR1, FLT3, FOXP1, FUT8, GLIS2, HOXA10, HOXA9, ID4, IKZF1, IKZF2, IKZF3, IL16, IRF4, IRF8, ITPKB, JAK2, KAT6A, KIAA0101, KLF2, KMT2A, LIMD1, LMO1, LMO2, LRMP, LYL1, LZTS1, MAL, MALT1, MAML3, MECOM, MKL1, MLF1, MLLT10, MLLT4, MME, MUC1, MYBL1, MYC, MYH11, NEK6, NF1, NFKB1, NFKB2, NME1, NOTCH1, NTRK3, NUP214, NUP98, P2RY8, PAG1, PAICS, PAX5, PBX1, PDCD1, PDCD1LG2, PDGFRA, PDGFRB, PICALM, PIM1, PIM2, PML, PPAT, PRDM16, PRKAR2B, PTK2B, PTPN1, PYCR1, RAB29, RAG1, RAG2, RANBP1, RARA, RBM15, ROS1, RUNX1, RUNX1T1, S1PR2, SEMA6A, SERPINA9, SETD2, SH3BP5, SOX11, STIL, STRBP, TCF3, TFG, TLX1, TLX3, TNFRSF13B, TNFSF4, TP63, TYK2, WT1, ZCCHC7

Positive results may be confirmed by RT-PCR with Sanger sequencing.

Days Performed

Monday through Saturday

Set Up Schedule

All tests not performed daily.

Typical Turnaround

3 weeks

CPT Codes

81456

Lab Area

Institute for Genomic Medicine

Synonyms

  • Heme fusion,Leukemia fusion,Leukemia translocation,Leukemia rearrangement,Lymphoma fusion , Lymphoma translocation,Lymphoma rearrangement,Myeloma fusion,Myeloma translocation,Myeloma rearrangement,Blood cancer fusion detection,Heme cancer fusion,Tumor, Tumor somatic profiling,Tumor molecular,Tumor fusion,Somatic fusion,RNA fusion,Cancer gene fusion,Pan-heme fusion,Pan heme fusion,Hematologic fusion,Archer FusionPlex NGS,Philadelphia chromosome-like ALL, Ph-like ALL, Ph like ALL, B-ALL fusion
  • IGM test

Estimated Patient Price

$2,500 - $5,000
Overview/Billing

Synonyms

  • Heme fusion,Leukemia fusion,Leukemia translocation,Leukemia rearrangement,Lymphoma fusion , Lymphoma translocation,Lymphoma rearrangement,Myeloma fusion,Myeloma translocation,Myeloma rearrangement,Blood cancer fusion detection,Heme cancer fusion,Tumor, Tumor somatic profiling,Tumor molecular,Tumor fusion,Somatic fusion,RNA fusion,Cancer gene fusion,Pan-heme fusion,Pan heme fusion,Hematologic fusion,Archer FusionPlex NGS,Philadelphia chromosome-like ALL, Ph-like ALL, Ph like ALL, B-ALL fusion
  • IGM test

CPT Codes

81456
Interpretation

Clinical Information

This test evaluates for the presence of oncogenic gene fusions in hematologic malignancies. Chromosomal translocations resulting in gene fusions are a hallmark of hematologic neoplasias and can help define the diagnosis and potential treatment options. Identifying a specific oncogenic fusion present in the patient offers an opportunity to treat the patient with inhibitors specific to the oncogenic fusion present in the patient.

This panel provides fusion information for 148 gene fusion partners relevant to lymphoid and myeloid malignancies as well as lymphomas, including gene fusion partners associated with Philadelphia chromosome-like (Ph-like) B-cell acute lymphoblastic leukemia, and some, but not all IGH-CRLF2 gene fusions. Please note, this test is not recommended as a first-line diagnostic assay for lymphomas due to reduced sensitivity for detecting genomic rearrangements with cancer associated immunoglobulin loci (IgG, IgL, IgK). Lymphomas that have tested negative for Ig rearrangements by FISH or other methodologies are acceptable. The fusion partner genes included in this panel are listed below:

AICDA, ASB13, BCL2A1, BCL3, ALK, BCL11B, BATF3, BCL2, ABL1, ABL2, BCL6, BCR, BIRC3, BLNK, BMF, BMP7, CBFB, CCDC50, CCND1, CCND2, CCND3, CD274, CD44, CDC25A, CDK6, CDKN2A, CDKN2B, CEBPA, CEBPD, CEBPE, CEBPG, CHD1, CHIC2, CIITA, CREB3L2, CREBBP, CRLF2, CSF1R, CTLA4, CYB5R2, DEK, DENND3, DNMT3B, DNTT, DUSP22, E2F2, EBF1, EIF4A1, ENTPD1, EPOR, ERG, ETV6, EXOC2, FAM216A, FGFR1, FLT3, FOXP1, FUT8, GLIS2, HOXA10, HOXA9, ID4, IKZF1, IKZF2, IKZF3, IL16, IRF4, IRF8, ITPKB, JAK2, KAT6A, KIAA0101, KLF2, KMT2A, LIMD1, LMO1, LMO2, LRMP, LYL1, LZTS1, MAL, MALT1, MAML3, MECOM, MKL1, MLF1, MLLT10, MLLT4, MME, MUC1, MYBL1, MYC, MYH11, NEK6, NF1, NFKB1, NFKB2, NME1, NOTCH1, NTRK3, NUP214, NUP98, P2RY8, PAG1, PAICS, PAX5, PBX1, PDCD1, PDCD1LG2, PDGFRA, PDGFRB, PICALM, PIM1, PIM2, PML, PPAT, PRDM16, PRKAR2B, PTK2B, PTPN1, PYCR1, RAB29, RAG1, RAG2, RANBP1, RARA, RBM15, ROS1, RUNX1, RUNX1T1, S1PR2, SEMA6A, SERPINA9, SETD2, SH3BP5, SOX11, STIL, STRBP, TCF3, TFG, TLX1, TLX3, TNFRSF13B, TNFSF4, TP63, TYK2, WT1, ZCCHC7

Positive results may be confirmed by RT-PCR with Sanger sequencing.

Methodology

Anchored Multiplex PCR (AMP), Next Generation Sequencing (NGS)
NCH Lab Only

Special Collection

At least 10% blasts must be present in the Fresh, Snap-Frozen, or OCT samples. At least 25% blasts/tumor must be present in the FFPE tissue blocks or scrolls (based on internal pathology review). Sample acquisition PRIOR to receiving treatment is strongly preferred. 

Outpatient Submit with Specimen

Collect

Specimen Type Type of Container Volume of Specimen Status
Bone marrow 4 mL Purple tube (EDTA) 4 mL Preferred
Whole blood 4 mL Purple tube (EDTA) 4 mL Preferred
OCT-embedded tissue Tissue cassette 0.05 gram tissue Preferred
OCT-embedded tissue Cryogenic tube 0.05 gram tissue Alternate
Paraffin embedded tissue Paraffin block   Preferred
Tissue (Fresh) Tissue culture transport media 0.05 grams Preferred
Tissue (Fresh) Sterile container with saline 0.05 grams Alternate
Tissue (Snap-frozen) Tissue cassette mass 0.05 grams Preferred
Tissue (Snap-frozen) Cryogenic tube mass 0.05 grams Alternate
Tissue scrolls (FFPE) Sterile container   Preferred

Minimum Volume

Specimen Type Type of Container Minimum Volume
Bone marrow 4 mL Purple tube (EDTA) 1 mL
Whole blood 4 mL Purple tube (EDTA) 1 mL
OCT-embedded tissue Tissue cassette  
OCT-embedded tissue Cryogenic tube  
Paraffin embedded tissue Paraffin block  
Tissue (Fresh) Tissue culture transport media  
Tissue (Fresh) Sterile container with saline  
Tissue (Snap-frozen) Tissue cassette  
Tissue (Snap-frozen) Cryogenic tube  
Tissue scrolls (FFPE) Sterile container  

Inpatient Specimen Preparation

Bone marrow:  If delay in transport is greater than 24 hours, refrigerate
                        Transport to the lab immediately after collection

Whole blood: If delay in transport is greater than 24 hours, refrigerate
                      Transport to the lab immediately after collection

OCT-embedded tissue: Keep frozen
                                      Protect from heat
                                      Transport to laboratory as soon as possible

Paraffin embedded tissue: Protect from heat
                                           Keep at room temperature

Tissue (Fresh): Transport to the lab immediately after collection
                         Keep at room temperature

Tissue (Snap-frozen): Freeze immediately after collection.
                                   Keep frozen
                                   Protect from heat
                                   Transport to laboratory as soon as possible

Tissue scrolls (FFPE): Protect from heat
                                    Keep at room temperature
                                    Must accompany H&E slide from the same tissue block used to make FFPE scrolls
                                    Must accompany H&E slide from adjacent section

 

Outpatient Specimen Preparation

Bone marrow:  If delay in transport is greater than 24 hours, refrigerate
                        Transport to the lab immediately after collection

Whole blood: If delay in transport is greater than 24 hours, refrigerate
                      Transport to the lab immediately after collection

OCT-embedded tissue: Keep frozen
                                      Protect from heat
                                      Transport to laboratory as soon as possible

Paraffin embedded tissue: Protect from heat
                                           Keep at room temperature

Tissue (Fresh): Transport to the lab immediately after collection
                         Keep at room temperature

Tissue (Snap-frozen): Freeze immediately after collection.
                                   Keep frozen
                                   Protect from heat
                                   Transport to laboratory as soon as possible

Tissue scrolls (FFPE): Protect from heat
                                    Keep at room temperature
                                    Must accompany H&E slide from the same tissue block used to make FFPE scrolls
                                    Must accompany H&E slide from adjacent section
 

InLab Processing

Send to Molecular Genetics Lab with all submitted paperwork. CPA needs to order GENSP in Sunquest for Non-EPIC lab order.

Stability

Bone marrow: Room temperature 24 hour(s)
Bone marrow: Refrigerated 48 hour(s)

Whole blood: Room temperature 24 hour(s)
Whole blood: Refrigerated 48 hour(s) 

OCT-embedded tissue: Frozen 3 day(s)

Paraffin embedded tissue: Room temperature 6 month(s)

Tissue (Fresh): Room temperature 24 hour(s)
Tissue (Fresh): Refrigerated 48 hour(s)

Tissue (Snap-frozen): Frozen 3 day(s)

Tissue scrolls (FFPE): Room temperature 6 month(s)

 

Unacceptable Conditions

Delayed or improper handling, Wrong type of specimen, Wrong collection tube, Wrong temperature, Insufficient tumor content in tumor sample

Days Performed

Monday through Saturday

Set Up Schedule

All tests not performed daily.

Typical Turnaround

3 weeks

Remarks

If you are an external healthcare provider with no access to Nationwide Children’s Epic system, submission of a completed Oncology Genetic Test Requisition Form is required. If you are an internal ordering provider with access to Nationwide Children’s Epic system, no requisition form is required; please place the lab order electronically in Epic.

If submitting a tissue scroll specimen, please use this Tissue Scroll Calculator tool to determine the thickness and number of tissue scrolls to send to the laboratory.

SPECIMEN INFORMATION:

Fresh and snap-frozen tissue specimens must contain minimum of 10% tumor. Formalin-fixed paraffin embedded (FFPE) tissue block and FFPE tissue scroll specimens must contain minimum of 25% tumor. Please submit the pathology report from the submitted sample. Internal pathology review will also be performed to determine the tumor content in specimen.

If sending FFPE tissue scrolls, an H&E slide from a consecutive cut is also required. Please contact the laboratory at (614) 722-5321 to request the scroll calculator application to be emailed to you to determine the number of scrolls required.

All specimens must be labeled with a patient name and one other identifier (DOB, MRN, Specimen ID#, etc). Sample acquisition prior to receiving therapy is strongly preferred.

SPECIMEN SHIPPING:

Specimens must be shipped as soon as possible after collection due to time-sensitive specimen stability. Ship all samples via overnight courier. Whenever possible, send specimen immediately after collection. For fresh tumor tissue, ship the sample refrigerated using cold packs. If specimen cannot be sent on the collection date, then snap-freeze the tumor tissue immediately after collection and ship the sample frozen (bury the entire tissue in dry ice). Lab must receive specimen within 48 hours. FFPE tissue and FFPE tissue scrolls should be sent at room temperature via overnight shipping. Saturday deliveries are accepted; please check Saturday Delivery on shipment labels.

Clinical Information

This test evaluates for the presence of oncogenic gene fusions in hematologic malignancies. Chromosomal translocations resulting in gene fusions are a hallmark of hematologic neoplasias and can help define the diagnosis and potential treatment options. Identifying a specific oncogenic fusion present in the patient offers an opportunity to treat the patient with inhibitors specific to the oncogenic fusion present in the patient.

This panel provides fusion information for 148 gene fusion partners relevant to lymphoid and myeloid malignancies as well as lymphomas, including gene fusion partners associated with Philadelphia chromosome-like (Ph-like) B-cell acute lymphoblastic leukemia, and some, but not all IGH-CRLF2 gene fusions. Please note, this test is not recommended as a first-line diagnostic assay for lymphomas due to reduced sensitivity for detecting genomic rearrangements with cancer associated immunoglobulin loci (IgG, IgL, IgK). Lymphomas that have tested negative for Ig rearrangements by FISH or other methodologies are acceptable. The fusion partner genes included in this panel are listed below:

AICDA, ASB13, BCL2A1, BCL3, ALK, BCL11B, BATF3, BCL2, ABL1, ABL2, BCL6, BCR, BIRC3, BLNK, BMF, BMP7, CBFB, CCDC50, CCND1, CCND2, CCND3, CD274, CD44, CDC25A, CDK6, CDKN2A, CDKN2B, CEBPA, CEBPD, CEBPE, CEBPG, CHD1, CHIC2, CIITA, CREB3L2, CREBBP, CRLF2, CSF1R, CTLA4, CYB5R2, DEK, DENND3, DNMT3B, DNTT, DUSP22, E2F2, EBF1, EIF4A1, ENTPD1, EPOR, ERG, ETV6, EXOC2, FAM216A, FGFR1, FLT3, FOXP1, FUT8, GLIS2, HOXA10, HOXA9, ID4, IKZF1, IKZF2, IKZF3, IL16, IRF4, IRF8, ITPKB, JAK2, KAT6A, KIAA0101, KLF2, KMT2A, LIMD1, LMO1, LMO2, LRMP, LYL1, LZTS1, MAL, MALT1, MAML3, MECOM, MKL1, MLF1, MLLT10, MLLT4, MME, MUC1, MYBL1, MYC, MYH11, NEK6, NF1, NFKB1, NFKB2, NME1, NOTCH1, NTRK3, NUP214, NUP98, P2RY8, PAG1, PAICS, PAX5, PBX1, PDCD1, PDCD1LG2, PDGFRA, PDGFRB, PICALM, PIM1, PIM2, PML, PPAT, PRDM16, PRKAR2B, PTK2B, PTPN1, PYCR1, RAB29, RAG1, RAG2, RANBP1, RARA, RBM15, ROS1, RUNX1, RUNX1T1, S1PR2, SEMA6A, SERPINA9, SETD2, SH3BP5, SOX11, STIL, STRBP, TCF3, TFG, TLX1, TLX3, TNFRSF13B, TNFSF4, TP63, TYK2, WT1, ZCCHC7

Positive results may be confirmed by RT-PCR with Sanger sequencing.

Synonyms

  • Heme fusion,Leukemia fusion,Leukemia translocation,Leukemia rearrangement,Lymphoma fusion , Lymphoma translocation,Lymphoma rearrangement,Myeloma fusion,Myeloma translocation,Myeloma rearrangement,Blood cancer fusion detection,Heme cancer fusion,Tumor, Tumor somatic profiling,Tumor molecular,Tumor fusion,Somatic fusion,RNA fusion,Cancer gene fusion,Pan-heme fusion,Pan heme fusion,Hematologic fusion,Archer FusionPlex NGS,Philadelphia chromosome-like ALL, Ph-like ALL, Ph like ALL, B-ALL fusion
  • IGM test

Methodology

Anchored Multiplex PCR (AMP), Next Generation Sequencing (NGS)

CPT Codes

81456

Estimated Patient Price

$2,500 - $5,000

DC Code

5321

Downtime Availability

4-Not available

Lab Area

Lab Area
Institute for Genomic Medicine