Special Collection

At least 10% tumor must be present in the submitted Fresh, Snap-frozen, OCT, or Bone Marrow samples. At least 25% tumor must be present in the submitted FFPE tissue block or FFPE tissue scrolls (based on internal pathology review). Sample acquisition PROIR to receiving treatment is strongly preferred.

Outpatient Submit with Specimen

Collect

Specimen Type Type of Container Volume of Specimen Status
Tissue (Snap-frozen) Tissue cassette 50 mg Preferred
Tissue (Snap-frozen) Cryogenic tube 50 mg Alternate
OCT-embedded tissue Tissue cassette 50 mg Preferred
OCT-embedded tissue Cryogenic tube 50 mg Alternate
Paraffin embedded tissue Paraffin block   Preferred
Tissue (Fresh) Tissue culture transport media 50 mg Preferred
Tissue (Fresh) Sterile container with saline 50 mg Alternate
Tissue scrolls (FFPE) Sterile container   Preferred

Outpatient Specimen Preparation

Tissue (Snap-frozen): Freeze immediately after collection.
                                   Transport to laboratory as soon as possible
                                   Protect from heat
                                   Tumor sample must contain a minimum of 10% tumor
                                   Keep frozen

OCT-embedded tissue: Keep frozen
                                      Transport to laboratory as soon as possible
                                      Protect from heat
                                      Tumor sample must contain a minimum of 10% tumor
                                      Freeze immediately after collection.

Paraffin embedded tissue: Protect from heat
                                           Keep at room temperature


Tissue (Fresh): Refrigerate after collection. If delay in transport is greater than 24 hours, freeze.
                         Transport to lab on ice immediately after collection
                         Protect from heat
                         Do not add fixative
                         Do not formalin fix the sample
                         Keep refrigerated

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

Unacceptable Conditions

Delayed or improper handling, Wrong type of specimen, Wrong temperature, Tissue degradation, Inadequate tissue, Insufficient tumor content in tumor sample

Stability

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

OCT-embedded tissue: Frozen 3 day(s)

Paraffin embedded tissue: Room temperature 6 month(s)

Tissue (Fresh): Refrigerated 48 hour(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 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 solid tumors. Gene fusions seen in cancers frequently involve tyrosine kinases where constitutive activation results in augmented downstream signaling and tumor proliferation. Targeted therapies directed at constitutively-activated oncogenic tyrosine kinases have been demonstrated to be effective against cancers with fusions involving certain genes, such as ALK, ROS1, PDGFB, RET, NTRK1, NTRK2, NTRK3FGFR1, FGFR2, FGFR3, BRAF, and CRAF. 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 test provides fusion information for 151 gene fusion partners relevant to solid tumors, including those associated with soft tissue sarcomas (see below for the list of fusion partner genes included in this test):

ABL1, ABL2, ACVR2A, AKT1, AKT2, AKT3, ALK, AR, ARHGAP26, ARHGAP6, AXL, BCOR, BRAF, BRD3, BRD4, C11orf95, CAMTA1, CCNB3, CCND1, CD274, CIC,CREB3L2, CRTC1, CSF1, CSF1R, CTNNB1, DNAJB1, EGF, EGFR, EPC1, ERBB2, ERBB4, ERG, ESR1, ESRRA, ETV1, ETV4, ETV5, ETV6, EWSR1, FGF1, FGFR1, FGFR2, FGFR3, FGR, FOS, FOSB, FOXO1, FOXO4, FOXR2, FUS, GLI1, GRB7, HMGA2, HRAS, HTN3, IDH1, IDH2, IGF1R, INSR, JAK1, JAK2, JAK3, JAZF1, KIT, KRAS, MAML1, MAML2, MAML3, MAP2K1, MAST1, MAST2, MBTD1, MDM2, MEAF6 ,MET, MGEA5, MKL2, MN1, MSANTD3, MSMB, MUSK, MYB, MYBL1, MYC, MYOD1, NCOA1, NCOA2, NCOA3, NDRG1, NFATC2, NFE2L2, NFIB, NOTCH1, NOTCH2, NR4A3, NRAS, NRG1, NTRK1, NTRK2, NTRK3, NUMBL, NUTM1, PAX3, PAX7, PAX8, PDGFB, PDGFD, PDGFRA, PDGFRB, PHF1, PHKB, PIK3CA, PKN1, PLAG1, PPARG, PRDM10, PRKACA, PRKACB, PRKCA, PRKCB, PRKCD, PRKD1, PRKD2, PRKD3, QKI, RAD51B, RAF1, RELA, RET, ROS1, RSPO2, RSPO3, SETD2, SS18, SS18L1, STAT6, TAF15, TCF12, TERT, TFE3, TFEB, TFG, THADA, TMPRSS2, TTYH1, USP6, VGLL2, WWTR1, YAP1, YWHAE

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

  • Solid tumor fusion detection, Solid cancer fusion panel, Solid tumor translocation detection, Solid tumor rearrangement detection, Tumor profiling, Tumor somatic profiling, Tumor molecular profiling, Tumor fusion profiling, Somatic fusion detection, RNA fusion detection, Cancer gene fusion detection, Sarcoma fusion detection, Archer FusionPlex NGS Assay, IGM Test, Archer
  • PanSolid

Special Collection

At least 10% tumor must be present in the submitted Fresh, Snap-frozen, OCT, or Bone Marrow samples. At least 25% tumor must be present in the submitted FFPE tissue block or FFPE tissue scrolls (based on internal pathology review). Sample acquisition PROIR to receiving treatment is strongly preferred.

Collect

Specimen Type Type of Container Volume of Specimen Status
Tissue (Snap-frozen) Tissue cassette 50 mg Preferred
Tissue (Snap-frozen) Cryogenic tube 50 mg Alternate
OCT-embedded tissue Tissue cassette 50 mg Preferred
OCT-embedded tissue Cryogenic tube 50 mg Alternate
Paraffin embedded tissue Paraffin block   Preferred
Tissue (Fresh) Tissue culture transport media 50 mg Preferred
Tissue (Fresh) Sterile container with saline 50 mg Alternate
Tissue scrolls (FFPE) Sterile container   Preferred

Minimum Volume

Specimen Type Type of Container Minimum Volume
Tissue (Snap-frozen) Tissue cassette  
Tissue (Snap-frozen) Cryogenic tube  
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 scrolls (FFPE) Sterile container  

Inpatient Specimen Preparation

Tissue (Snap-frozen): Freeze immediately after collection.
                                   Transport to laboratory as soon as possible
                                   Protect from heat
                                   Tumor sample must contain a minimum of 10% tumor
                                   Keep frozen

OCT-embedded tissue: Keep frozen
                                      Transport to laboratory as soon as possible
                                      Protect from heat
                                      Tumor sample must contain a minimum of 10% tumor
                                      Freeze immediately after collection.

Paraffin embedded tissue: Protect from heat
                                           Keep at room temperature


Tissue (Fresh): Refrigerate after collection. If delay in transport is greater than 24 hours, freeze.
                         Transport to lab on ice immediately after collection
                         Protect from heat
                         Do not add fixative
                         Do not formalin fix the sample
                         Keep refrigerated

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

Unacceptable Conditions

Delayed or improper handling, Wrong type of specimen, Wrong temperature, Tissue degradation, Inadequate tissue, Insufficient tumor content in tumor sample

Stability

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

OCT-embedded tissue: Frozen 3 day(s)

Paraffin embedded tissue: Room temperature 6 month(s)

Tissue (Fresh): Refrigerated 48 hour(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 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 solid tumors. Gene fusions seen in cancers frequently involve tyrosine kinases where constitutive activation results in augmented downstream signaling and tumor proliferation. Targeted therapies directed at constitutively-activated oncogenic tyrosine kinases have been demonstrated to be effective against cancers with fusions involving certain genes, such as ALK, ROS1, PDGFB, RET, NTRK1, NTRK2, NTRK3FGFR1, FGFR2, FGFR3, BRAF, and CRAF. 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 test provides fusion information for 151 gene fusion partners relevant to solid tumors, including those associated with soft tissue sarcomas (see below for the list of fusion partner genes included in this test):

ABL1, ABL2, ACVR2A, AKT1, AKT2, AKT3, ALK, AR, ARHGAP26, ARHGAP6, AXL, BCOR, BRAF, BRD3, BRD4, C11orf95, CAMTA1, CCNB3, CCND1, CD274, CIC,CREB3L2, CRTC1, CSF1, CSF1R, CTNNB1, DNAJB1, EGF, EGFR, EPC1, ERBB2, ERBB4, ERG, ESR1, ESRRA, ETV1, ETV4, ETV5, ETV6, EWSR1, FGF1, FGFR1, FGFR2, FGFR3, FGR, FOS, FOSB, FOXO1, FOXO4, FOXR2, FUS, GLI1, GRB7, HMGA2, HRAS, HTN3, IDH1, IDH2, IGF1R, INSR, JAK1, JAK2, JAK3, JAZF1, KIT, KRAS, MAML1, MAML2, MAML3, MAP2K1, MAST1, MAST2, MBTD1, MDM2, MEAF6 ,MET, MGEA5, MKL2, MN1, MSANTD3, MSMB, MUSK, MYB, MYBL1, MYC, MYOD1, NCOA1, NCOA2, NCOA3, NDRG1, NFATC2, NFE2L2, NFIB, NOTCH1, NOTCH2, NR4A3, NRAS, NRG1, NTRK1, NTRK2, NTRK3, NUMBL, NUTM1, PAX3, PAX7, PAX8, PDGFB, PDGFD, PDGFRA, PDGFRB, PHF1, PHKB, PIK3CA, PKN1, PLAG1, PPARG, PRDM10, PRKACA, PRKACB, PRKCA, PRKCB, PRKCD, PRKD1, PRKD2, PRKD3, QKI, RAD51B, RAF1, RELA, RET, ROS1, RSPO2, RSPO3, SETD2, SS18, SS18L1, STAT6, TAF15, TCF12, TERT, TFE3, TFEB, TFG, THADA, TMPRSS2, TTYH1, USP6, VGLL2, WWTR1, YAP1, YWHAE

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

  • Solid tumor fusion detection, Solid cancer fusion panel, Solid tumor translocation detection, Solid tumor rearrangement detection, Tumor profiling, Tumor somatic profiling, Tumor molecular profiling, Tumor fusion profiling, Somatic fusion detection, RNA fusion detection, Cancer gene fusion detection, Sarcoma fusion detection, Archer FusionPlex NGS Assay, IGM Test, Archer
  • PanSolid

Estimated Patient Price

$2,500 - $5,000

Synonyms

  • Solid tumor fusion detection, Solid cancer fusion panel, Solid tumor translocation detection, Solid tumor rearrangement detection, Tumor profiling, Tumor somatic profiling, Tumor molecular profiling, Tumor fusion profiling, Somatic fusion detection, RNA fusion detection, Cancer gene fusion detection, Sarcoma fusion detection, Archer FusionPlex NGS Assay, IGM Test, Archer
  • PanSolid

CPT Codes

81456

Clinical Information

This test evaluates for the presence of oncogenic gene fusions in solid tumors. Gene fusions seen in cancers frequently involve tyrosine kinases where constitutive activation results in augmented downstream signaling and tumor proliferation. Targeted therapies directed at constitutively-activated oncogenic tyrosine kinases have been demonstrated to be effective against cancers with fusions involving certain genes, such as ALK, ROS1, PDGFB, RET, NTRK1, NTRK2, NTRK3FGFR1, FGFR2, FGFR3, BRAF, and CRAF. 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 test provides fusion information for 151 gene fusion partners relevant to solid tumors, including those associated with soft tissue sarcomas (see below for the list of fusion partner genes included in this test):

ABL1, ABL2, ACVR2A, AKT1, AKT2, AKT3, ALK, AR, ARHGAP26, ARHGAP6, AXL, BCOR, BRAF, BRD3, BRD4, C11orf95, CAMTA1, CCNB3, CCND1, CD274, CIC,CREB3L2, CRTC1, CSF1, CSF1R, CTNNB1, DNAJB1, EGF, EGFR, EPC1, ERBB2, ERBB4, ERG, ESR1, ESRRA, ETV1, ETV4, ETV5, ETV6, EWSR1, FGF1, FGFR1, FGFR2, FGFR3, FGR, FOS, FOSB, FOXO1, FOXO4, FOXR2, FUS, GLI1, GRB7, HMGA2, HRAS, HTN3, IDH1, IDH2, IGF1R, INSR, JAK1, JAK2, JAK3, JAZF1, KIT, KRAS, MAML1, MAML2, MAML3, MAP2K1, MAST1, MAST2, MBTD1, MDM2, MEAF6 ,MET, MGEA5, MKL2, MN1, MSANTD3, MSMB, MUSK, MYB, MYBL1, MYC, MYOD1, NCOA1, NCOA2, NCOA3, NDRG1, NFATC2, NFE2L2, NFIB, NOTCH1, NOTCH2, NR4A3, NRAS, NRG1, NTRK1, NTRK2, NTRK3, NUMBL, NUTM1, PAX3, PAX7, PAX8, PDGFB, PDGFD, PDGFRA, PDGFRB, PHF1, PHKB, PIK3CA, PKN1, PLAG1, PPARG, PRDM10, PRKACA, PRKACB, PRKCA, PRKCB, PRKCD, PRKD1, PRKD2, PRKD3, QKI, RAD51B, RAF1, RELA, RET, ROS1, RSPO2, RSPO3, SETD2, SS18, SS18L1, STAT6, TAF15, TCF12, TERT, TFE3, TFEB, TFG, THADA, TMPRSS2, TTYH1, USP6, VGLL2, WWTR1, YAP1, YWHAE

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% tumor must be present in the submitted Fresh, Snap-frozen, OCT, or Bone Marrow samples. At least 25% tumor must be present in the submitted FFPE tissue block or FFPE tissue scrolls (based on internal pathology review). Sample acquisition PROIR to receiving treatment is strongly preferred.

Outpatient Submit with Specimen

Collect

Specimen Type Type of Container Volume of Specimen Status
Tissue (Snap-frozen) Tissue cassette 50 mg Preferred
Tissue (Snap-frozen) Cryogenic tube 50 mg Alternate
OCT-embedded tissue Tissue cassette 50 mg Preferred
OCT-embedded tissue Cryogenic tube 50 mg Alternate
Paraffin embedded tissue Paraffin block   Preferred
Tissue (Fresh) Tissue culture transport media 50 mg Preferred
Tissue (Fresh) Sterile container with saline 50 mg Alternate
Tissue scrolls (FFPE) Sterile container   Preferred

Minimum Volume

Specimen Type Type of Container Minimum Volume
Tissue (Snap-frozen) Tissue cassette  
Tissue (Snap-frozen) Cryogenic tube  
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 scrolls (FFPE) Sterile container  

Inpatient Specimen Preparation

Tissue (Snap-frozen): Freeze immediately after collection.
                                   Transport to laboratory as soon as possible
                                   Protect from heat
                                   Tumor sample must contain a minimum of 10% tumor
                                   Keep frozen

OCT-embedded tissue: Keep frozen
                                      Transport to laboratory as soon as possible
                                      Protect from heat
                                      Tumor sample must contain a minimum of 10% tumor
                                      Freeze immediately after collection.

Paraffin embedded tissue: Protect from heat
                                           Keep at room temperature


Tissue (Fresh): Refrigerate after collection. If delay in transport is greater than 24 hours, freeze.
                         Transport to lab on ice immediately after collection
                         Protect from heat
                         Do not add fixative
                         Do not formalin fix the sample
                         Keep refrigerated

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

Outpatient Specimen Preparation

Tissue (Snap-frozen): Freeze immediately after collection.
                                   Transport to laboratory as soon as possible
                                   Protect from heat
                                   Tumor sample must contain a minimum of 10% tumor
                                   Keep frozen

OCT-embedded tissue: Keep frozen
                                      Transport to laboratory as soon as possible
                                      Protect from heat
                                      Tumor sample must contain a minimum of 10% tumor
                                      Freeze immediately after collection.

Paraffin embedded tissue: Protect from heat
                                           Keep at room temperature


Tissue (Fresh): Refrigerate after collection. If delay in transport is greater than 24 hours, freeze.
                         Transport to lab on ice immediately after collection
                         Protect from heat
                         Do not add fixative
                         Do not formalin fix the sample
                         Keep refrigerated

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

InLab Processing

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

Stability

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

OCT-embedded tissue: Frozen 3 day(s)

Paraffin embedded tissue: Room temperature 6 month(s)

Tissue (Fresh): Refrigerated 48 hour(s)

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

Unacceptable Conditions

Delayed or improper handling, Wrong type of specimen, Wrong temperature, Tissue degradation, Inadequate tissue, 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 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 solid tumors. Gene fusions seen in cancers frequently involve tyrosine kinases where constitutive activation results in augmented downstream signaling and tumor proliferation. Targeted therapies directed at constitutively-activated oncogenic tyrosine kinases have been demonstrated to be effective against cancers with fusions involving certain genes, such as ALK, ROS1, PDGFB, RET, NTRK1, NTRK2, NTRK3FGFR1, FGFR2, FGFR3, BRAF, and CRAF. 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 test provides fusion information for 151 gene fusion partners relevant to solid tumors, including those associated with soft tissue sarcomas (see below for the list of fusion partner genes included in this test):

ABL1, ABL2, ACVR2A, AKT1, AKT2, AKT3, ALK, AR, ARHGAP26, ARHGAP6, AXL, BCOR, BRAF, BRD3, BRD4, C11orf95, CAMTA1, CCNB3, CCND1, CD274, CIC,CREB3L2, CRTC1, CSF1, CSF1R, CTNNB1, DNAJB1, EGF, EGFR, EPC1, ERBB2, ERBB4, ERG, ESR1, ESRRA, ETV1, ETV4, ETV5, ETV6, EWSR1, FGF1, FGFR1, FGFR2, FGFR3, FGR, FOS, FOSB, FOXO1, FOXO4, FOXR2, FUS, GLI1, GRB7, HMGA2, HRAS, HTN3, IDH1, IDH2, IGF1R, INSR, JAK1, JAK2, JAK3, JAZF1, KIT, KRAS, MAML1, MAML2, MAML3, MAP2K1, MAST1, MAST2, MBTD1, MDM2, MEAF6 ,MET, MGEA5, MKL2, MN1, MSANTD3, MSMB, MUSK, MYB, MYBL1, MYC, MYOD1, NCOA1, NCOA2, NCOA3, NDRG1, NFATC2, NFE2L2, NFIB, NOTCH1, NOTCH2, NR4A3, NRAS, NRG1, NTRK1, NTRK2, NTRK3, NUMBL, NUTM1, PAX3, PAX7, PAX8, PDGFB, PDGFD, PDGFRA, PDGFRB, PHF1, PHKB, PIK3CA, PKN1, PLAG1, PPARG, PRDM10, PRKACA, PRKACB, PRKCA, PRKCB, PRKCD, PRKD1, PRKD2, PRKD3, QKI, RAD51B, RAF1, RELA, RET, ROS1, RSPO2, RSPO3, SETD2, SS18, SS18L1, STAT6, TAF15, TCF12, TERT, TFE3, TFEB, TFG, THADA, TMPRSS2, TTYH1, USP6, VGLL2, WWTR1, YAP1, YWHAE

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

Synonyms

  • Solid tumor fusion detection, Solid cancer fusion panel, Solid tumor translocation detection, Solid tumor rearrangement detection, Tumor profiling, Tumor somatic profiling, Tumor molecular profiling, Tumor fusion profiling, Somatic fusion detection, RNA fusion detection, Cancer gene fusion detection, Sarcoma fusion detection, Archer FusionPlex NGS Assay, IGM Test, Archer
  • PanSolid

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% tumor must be present in the submitted Fresh, Snap-frozen, OCT, or Bone Marrow samples. At least 25% tumor must be present in the submitted FFPE tissue block or FFPE tissue scrolls (based on internal pathology review). Sample acquisition PROIR to receiving treatment is strongly preferred.

Outpatient Submit with Specimen

Collect

Specimen Type Type of Container Volume of Specimen Status
Tissue (Snap-frozen) Tissue cassette 50 mg Preferred
Tissue (Snap-frozen) Cryogenic tube 50 mg Alternate
OCT-embedded tissue Tissue cassette 50 mg Preferred
OCT-embedded tissue Cryogenic tube 50 mg Alternate
Paraffin embedded tissue Paraffin block   Preferred
Tissue (Fresh) Tissue culture transport media 50 mg Preferred
Tissue (Fresh) Sterile container with saline 50 mg Alternate
Tissue scrolls (FFPE) Sterile container   Preferred

Outpatient Specimen Preparation

Tissue (Snap-frozen): Freeze immediately after collection.
                                   Transport to laboratory as soon as possible
                                   Protect from heat
                                   Tumor sample must contain a minimum of 10% tumor
                                   Keep frozen

OCT-embedded tissue: Keep frozen
                                      Transport to laboratory as soon as possible
                                      Protect from heat
                                      Tumor sample must contain a minimum of 10% tumor
                                      Freeze immediately after collection.

Paraffin embedded tissue: Protect from heat
                                           Keep at room temperature


Tissue (Fresh): Refrigerate after collection. If delay in transport is greater than 24 hours, freeze.
                         Transport to lab on ice immediately after collection
                         Protect from heat
                         Do not add fixative
                         Do not formalin fix the sample
                         Keep refrigerated

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

Unacceptable Conditions

Delayed or improper handling, Wrong type of specimen, Wrong temperature, Tissue degradation, Inadequate tissue, Insufficient tumor content in tumor sample

Stability

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

OCT-embedded tissue: Frozen 3 day(s)

Paraffin embedded tissue: Room temperature 6 month(s)

Tissue (Fresh): Refrigerated 48 hour(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 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 solid tumors. Gene fusions seen in cancers frequently involve tyrosine kinases where constitutive activation results in augmented downstream signaling and tumor proliferation. Targeted therapies directed at constitutively-activated oncogenic tyrosine kinases have been demonstrated to be effective against cancers with fusions involving certain genes, such as ALK, ROS1, PDGFB, RET, NTRK1, NTRK2, NTRK3FGFR1, FGFR2, FGFR3, BRAF, and CRAF. 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 test provides fusion information for 151 gene fusion partners relevant to solid tumors, including those associated with soft tissue sarcomas (see below for the list of fusion partner genes included in this test):

ABL1, ABL2, ACVR2A, AKT1, AKT2, AKT3, ALK, AR, ARHGAP26, ARHGAP6, AXL, BCOR, BRAF, BRD3, BRD4, C11orf95, CAMTA1, CCNB3, CCND1, CD274, CIC,CREB3L2, CRTC1, CSF1, CSF1R, CTNNB1, DNAJB1, EGF, EGFR, EPC1, ERBB2, ERBB4, ERG, ESR1, ESRRA, ETV1, ETV4, ETV5, ETV6, EWSR1, FGF1, FGFR1, FGFR2, FGFR3, FGR, FOS, FOSB, FOXO1, FOXO4, FOXR2, FUS, GLI1, GRB7, HMGA2, HRAS, HTN3, IDH1, IDH2, IGF1R, INSR, JAK1, JAK2, JAK3, JAZF1, KIT, KRAS, MAML1, MAML2, MAML3, MAP2K1, MAST1, MAST2, MBTD1, MDM2, MEAF6 ,MET, MGEA5, MKL2, MN1, MSANTD3, MSMB, MUSK, MYB, MYBL1, MYC, MYOD1, NCOA1, NCOA2, NCOA3, NDRG1, NFATC2, NFE2L2, NFIB, NOTCH1, NOTCH2, NR4A3, NRAS, NRG1, NTRK1, NTRK2, NTRK3, NUMBL, NUTM1, PAX3, PAX7, PAX8, PDGFB, PDGFD, PDGFRA, PDGFRB, PHF1, PHKB, PIK3CA, PKN1, PLAG1, PPARG, PRDM10, PRKACA, PRKACB, PRKCA, PRKCB, PRKCD, PRKD1, PRKD2, PRKD3, QKI, RAD51B, RAF1, RELA, RET, ROS1, RSPO2, RSPO3, SETD2, SS18, SS18L1, STAT6, TAF15, TCF12, TERT, TFE3, TFEB, TFG, THADA, TMPRSS2, TTYH1, USP6, VGLL2, WWTR1, YAP1, YWHAE

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

  • Solid tumor fusion detection, Solid cancer fusion panel, Solid tumor translocation detection, Solid tumor rearrangement detection, Tumor profiling, Tumor somatic profiling, Tumor molecular profiling, Tumor fusion profiling, Somatic fusion detection, RNA fusion detection, Cancer gene fusion detection, Sarcoma fusion detection, Archer FusionPlex NGS Assay, IGM Test, Archer
  • PanSolid
Inpatient Requirements

Special Collection

At least 10% tumor must be present in the submitted Fresh, Snap-frozen, OCT, or Bone Marrow samples. At least 25% tumor must be present in the submitted FFPE tissue block or FFPE tissue scrolls (based on internal pathology review). Sample acquisition PROIR to receiving treatment is strongly preferred.

Collect

Specimen Type Type of Container Volume of Specimen Status
Tissue (Snap-frozen) Tissue cassette 50 mg Preferred
Tissue (Snap-frozen) Cryogenic tube 50 mg Alternate
OCT-embedded tissue Tissue cassette 50 mg Preferred
OCT-embedded tissue Cryogenic tube 50 mg Alternate
Paraffin embedded tissue Paraffin block   Preferred
Tissue (Fresh) Tissue culture transport media 50 mg Preferred
Tissue (Fresh) Sterile container with saline 50 mg Alternate
Tissue scrolls (FFPE) Sterile container   Preferred

Minimum Volume

Specimen Type Type of Container Minimum Volume
Tissue (Snap-frozen) Tissue cassette  
Tissue (Snap-frozen) Cryogenic tube  
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 scrolls (FFPE) Sterile container  

Inpatient Specimen Preparation

Tissue (Snap-frozen): Freeze immediately after collection.
                                   Transport to laboratory as soon as possible
                                   Protect from heat
                                   Tumor sample must contain a minimum of 10% tumor
                                   Keep frozen

OCT-embedded tissue: Keep frozen
                                      Transport to laboratory as soon as possible
                                      Protect from heat
                                      Tumor sample must contain a minimum of 10% tumor
                                      Freeze immediately after collection.

Paraffin embedded tissue: Protect from heat
                                           Keep at room temperature


Tissue (Fresh): Refrigerate after collection. If delay in transport is greater than 24 hours, freeze.
                         Transport to lab on ice immediately after collection
                         Protect from heat
                         Do not add fixative
                         Do not formalin fix the sample
                         Keep refrigerated

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

Unacceptable Conditions

Delayed or improper handling, Wrong type of specimen, Wrong temperature, Tissue degradation, Inadequate tissue, Insufficient tumor content in tumor sample

Stability

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

OCT-embedded tissue: Frozen 3 day(s)

Paraffin embedded tissue: Room temperature 6 month(s)

Tissue (Fresh): Refrigerated 48 hour(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 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 solid tumors. Gene fusions seen in cancers frequently involve tyrosine kinases where constitutive activation results in augmented downstream signaling and tumor proliferation. Targeted therapies directed at constitutively-activated oncogenic tyrosine kinases have been demonstrated to be effective against cancers with fusions involving certain genes, such as ALK, ROS1, PDGFB, RET, NTRK1, NTRK2, NTRK3FGFR1, FGFR2, FGFR3, BRAF, and CRAF. 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 test provides fusion information for 151 gene fusion partners relevant to solid tumors, including those associated with soft tissue sarcomas (see below for the list of fusion partner genes included in this test):

ABL1, ABL2, ACVR2A, AKT1, AKT2, AKT3, ALK, AR, ARHGAP26, ARHGAP6, AXL, BCOR, BRAF, BRD3, BRD4, C11orf95, CAMTA1, CCNB3, CCND1, CD274, CIC,CREB3L2, CRTC1, CSF1, CSF1R, CTNNB1, DNAJB1, EGF, EGFR, EPC1, ERBB2, ERBB4, ERG, ESR1, ESRRA, ETV1, ETV4, ETV5, ETV6, EWSR1, FGF1, FGFR1, FGFR2, FGFR3, FGR, FOS, FOSB, FOXO1, FOXO4, FOXR2, FUS, GLI1, GRB7, HMGA2, HRAS, HTN3, IDH1, IDH2, IGF1R, INSR, JAK1, JAK2, JAK3, JAZF1, KIT, KRAS, MAML1, MAML2, MAML3, MAP2K1, MAST1, MAST2, MBTD1, MDM2, MEAF6 ,MET, MGEA5, MKL2, MN1, MSANTD3, MSMB, MUSK, MYB, MYBL1, MYC, MYOD1, NCOA1, NCOA2, NCOA3, NDRG1, NFATC2, NFE2L2, NFIB, NOTCH1, NOTCH2, NR4A3, NRAS, NRG1, NTRK1, NTRK2, NTRK3, NUMBL, NUTM1, PAX3, PAX7, PAX8, PDGFB, PDGFD, PDGFRA, PDGFRB, PHF1, PHKB, PIK3CA, PKN1, PLAG1, PPARG, PRDM10, PRKACA, PRKACB, PRKCA, PRKCB, PRKCD, PRKD1, PRKD2, PRKD3, QKI, RAD51B, RAF1, RELA, RET, ROS1, RSPO2, RSPO3, SETD2, SS18, SS18L1, STAT6, TAF15, TCF12, TERT, TFE3, TFEB, TFG, THADA, TMPRSS2, TTYH1, USP6, VGLL2, WWTR1, YAP1, YWHAE

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

  • Solid tumor fusion detection, Solid cancer fusion panel, Solid tumor translocation detection, Solid tumor rearrangement detection, Tumor profiling, Tumor somatic profiling, Tumor molecular profiling, Tumor fusion profiling, Somatic fusion detection, RNA fusion detection, Cancer gene fusion detection, Sarcoma fusion detection, Archer FusionPlex NGS Assay, IGM Test, Archer
  • PanSolid

Estimated Patient Price

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

Synonyms

  • Solid tumor fusion detection, Solid cancer fusion panel, Solid tumor translocation detection, Solid tumor rearrangement detection, Tumor profiling, Tumor somatic profiling, Tumor molecular profiling, Tumor fusion profiling, Somatic fusion detection, RNA fusion detection, Cancer gene fusion detection, Sarcoma fusion detection, Archer FusionPlex NGS Assay, IGM Test, Archer
  • PanSolid

CPT Codes

81456
Interpretation

Clinical Information

This test evaluates for the presence of oncogenic gene fusions in solid tumors. Gene fusions seen in cancers frequently involve tyrosine kinases where constitutive activation results in augmented downstream signaling and tumor proliferation. Targeted therapies directed at constitutively-activated oncogenic tyrosine kinases have been demonstrated to be effective against cancers with fusions involving certain genes, such as ALK, ROS1, PDGFB, RET, NTRK1, NTRK2, NTRK3FGFR1, FGFR2, FGFR3, BRAF, and CRAF. 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 test provides fusion information for 151 gene fusion partners relevant to solid tumors, including those associated with soft tissue sarcomas (see below for the list of fusion partner genes included in this test):

ABL1, ABL2, ACVR2A, AKT1, AKT2, AKT3, ALK, AR, ARHGAP26, ARHGAP6, AXL, BCOR, BRAF, BRD3, BRD4, C11orf95, CAMTA1, CCNB3, CCND1, CD274, CIC,CREB3L2, CRTC1, CSF1, CSF1R, CTNNB1, DNAJB1, EGF, EGFR, EPC1, ERBB2, ERBB4, ERG, ESR1, ESRRA, ETV1, ETV4, ETV5, ETV6, EWSR1, FGF1, FGFR1, FGFR2, FGFR3, FGR, FOS, FOSB, FOXO1, FOXO4, FOXR2, FUS, GLI1, GRB7, HMGA2, HRAS, HTN3, IDH1, IDH2, IGF1R, INSR, JAK1, JAK2, JAK3, JAZF1, KIT, KRAS, MAML1, MAML2, MAML3, MAP2K1, MAST1, MAST2, MBTD1, MDM2, MEAF6 ,MET, MGEA5, MKL2, MN1, MSANTD3, MSMB, MUSK, MYB, MYBL1, MYC, MYOD1, NCOA1, NCOA2, NCOA3, NDRG1, NFATC2, NFE2L2, NFIB, NOTCH1, NOTCH2, NR4A3, NRAS, NRG1, NTRK1, NTRK2, NTRK3, NUMBL, NUTM1, PAX3, PAX7, PAX8, PDGFB, PDGFD, PDGFRA, PDGFRB, PHF1, PHKB, PIK3CA, PKN1, PLAG1, PPARG, PRDM10, PRKACA, PRKACB, PRKCA, PRKCB, PRKCD, PRKD1, PRKD2, PRKD3, QKI, RAD51B, RAF1, RELA, RET, ROS1, RSPO2, RSPO3, SETD2, SS18, SS18L1, STAT6, TAF15, TCF12, TERT, TFE3, TFEB, TFG, THADA, TMPRSS2, TTYH1, USP6, VGLL2, WWTR1, YAP1, YWHAE

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% tumor must be present in the submitted Fresh, Snap-frozen, OCT, or Bone Marrow samples. At least 25% tumor must be present in the submitted FFPE tissue block or FFPE tissue scrolls (based on internal pathology review). Sample acquisition PROIR to receiving treatment is strongly preferred.

Outpatient Submit with Specimen

Collect

Specimen Type Type of Container Volume of Specimen Status
Tissue (Snap-frozen) Tissue cassette 50 mg Preferred
Tissue (Snap-frozen) Cryogenic tube 50 mg Alternate
OCT-embedded tissue Tissue cassette 50 mg Preferred
OCT-embedded tissue Cryogenic tube 50 mg Alternate
Paraffin embedded tissue Paraffin block   Preferred
Tissue (Fresh) Tissue culture transport media 50 mg Preferred
Tissue (Fresh) Sterile container with saline 50 mg Alternate
Tissue scrolls (FFPE) Sterile container   Preferred

Minimum Volume

Specimen Type Type of Container Minimum Volume
Tissue (Snap-frozen) Tissue cassette  
Tissue (Snap-frozen) Cryogenic tube  
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 scrolls (FFPE) Sterile container  

Inpatient Specimen Preparation

Tissue (Snap-frozen): Freeze immediately after collection.
                                   Transport to laboratory as soon as possible
                                   Protect from heat
                                   Tumor sample must contain a minimum of 10% tumor
                                   Keep frozen

OCT-embedded tissue: Keep frozen
                                      Transport to laboratory as soon as possible
                                      Protect from heat
                                      Tumor sample must contain a minimum of 10% tumor
                                      Freeze immediately after collection.

Paraffin embedded tissue: Protect from heat
                                           Keep at room temperature


Tissue (Fresh): Refrigerate after collection. If delay in transport is greater than 24 hours, freeze.
                         Transport to lab on ice immediately after collection
                         Protect from heat
                         Do not add fixative
                         Do not formalin fix the sample
                         Keep refrigerated

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

Outpatient Specimen Preparation

Tissue (Snap-frozen): Freeze immediately after collection.
                                   Transport to laboratory as soon as possible
                                   Protect from heat
                                   Tumor sample must contain a minimum of 10% tumor
                                   Keep frozen

OCT-embedded tissue: Keep frozen
                                      Transport to laboratory as soon as possible
                                      Protect from heat
                                      Tumor sample must contain a minimum of 10% tumor
                                      Freeze immediately after collection.

Paraffin embedded tissue: Protect from heat
                                           Keep at room temperature


Tissue (Fresh): Refrigerate after collection. If delay in transport is greater than 24 hours, freeze.
                         Transport to lab on ice immediately after collection
                         Protect from heat
                         Do not add fixative
                         Do not formalin fix the sample
                         Keep refrigerated

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

InLab Processing

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

Stability

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

OCT-embedded tissue: Frozen 3 day(s)

Paraffin embedded tissue: Room temperature 6 month(s)

Tissue (Fresh): Refrigerated 48 hour(s)

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

Unacceptable Conditions

Delayed or improper handling, Wrong type of specimen, Wrong temperature, Tissue degradation, Inadequate tissue, 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 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 solid tumors. Gene fusions seen in cancers frequently involve tyrosine kinases where constitutive activation results in augmented downstream signaling and tumor proliferation. Targeted therapies directed at constitutively-activated oncogenic tyrosine kinases have been demonstrated to be effective against cancers with fusions involving certain genes, such as ALK, ROS1, PDGFB, RET, NTRK1, NTRK2, NTRK3FGFR1, FGFR2, FGFR3, BRAF, and CRAF. 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 test provides fusion information for 151 gene fusion partners relevant to solid tumors, including those associated with soft tissue sarcomas (see below for the list of fusion partner genes included in this test):

ABL1, ABL2, ACVR2A, AKT1, AKT2, AKT3, ALK, AR, ARHGAP26, ARHGAP6, AXL, BCOR, BRAF, BRD3, BRD4, C11orf95, CAMTA1, CCNB3, CCND1, CD274, CIC,CREB3L2, CRTC1, CSF1, CSF1R, CTNNB1, DNAJB1, EGF, EGFR, EPC1, ERBB2, ERBB4, ERG, ESR1, ESRRA, ETV1, ETV4, ETV5, ETV6, EWSR1, FGF1, FGFR1, FGFR2, FGFR3, FGR, FOS, FOSB, FOXO1, FOXO4, FOXR2, FUS, GLI1, GRB7, HMGA2, HRAS, HTN3, IDH1, IDH2, IGF1R, INSR, JAK1, JAK2, JAK3, JAZF1, KIT, KRAS, MAML1, MAML2, MAML3, MAP2K1, MAST1, MAST2, MBTD1, MDM2, MEAF6 ,MET, MGEA5, MKL2, MN1, MSANTD3, MSMB, MUSK, MYB, MYBL1, MYC, MYOD1, NCOA1, NCOA2, NCOA3, NDRG1, NFATC2, NFE2L2, NFIB, NOTCH1, NOTCH2, NR4A3, NRAS, NRG1, NTRK1, NTRK2, NTRK3, NUMBL, NUTM1, PAX3, PAX7, PAX8, PDGFB, PDGFD, PDGFRA, PDGFRB, PHF1, PHKB, PIK3CA, PKN1, PLAG1, PPARG, PRDM10, PRKACA, PRKACB, PRKCA, PRKCB, PRKCD, PRKD1, PRKD2, PRKD3, QKI, RAD51B, RAF1, RELA, RET, ROS1, RSPO2, RSPO3, SETD2, SS18, SS18L1, STAT6, TAF15, TCF12, TERT, TFE3, TFEB, TFG, THADA, TMPRSS2, TTYH1, USP6, VGLL2, WWTR1, YAP1, YWHAE

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

Synonyms

  • Solid tumor fusion detection, Solid cancer fusion panel, Solid tumor translocation detection, Solid tumor rearrangement detection, Tumor profiling, Tumor somatic profiling, Tumor molecular profiling, Tumor fusion profiling, Somatic fusion detection, RNA fusion detection, Cancer gene fusion detection, Sarcoma fusion detection, Archer FusionPlex NGS Assay, IGM Test, Archer
  • PanSolid

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

New York DOH Approval Status

New York DOH Approval Status
This test is New York state approved