Special Collection

At least 10% tumor (30% if bone marrow) must be present in the submitted sample (based on internal pathology review). FFPE unstained charged slides are preferred; please submit 6 slides (3 micron thick, not decalcified) AND consecutively cut H&E slide

Outpatient Submit with Specimen

Collect

Specimen Type Type of Container Volume of Specimen Status
Unstained tissue slide Charged Slides 6 slides (3 micron) Preferred
Bone marrow 3 mL Green tube (Sodium heparin), No Gel 3 mL Alternate
OCT-embedded tissue Tissue cassette   Alternate
OCT-embedded tissue Cryogenic tube   Alternate
Paraffin embedded tissue Paraffin block   Alternate
Tissue (Fresh) Sterile container with saline   Alternate
Tissue (Snap-frozen) Tissue cassette   Alternate
Tissue (Snap-frozen) Cryogenic tube   Alternate

Outpatient Specimen Preparation

Unstained tissue slide: Keep at room temperature
                                     Protect from heat
                                     Must accompany H&E slide from adjacent section
                                     Do not decalcify

Bone marrow: Keep at room temperature
                       Transport to laboratory as soon as possible

OCT-embedded tissue: Keep frozen
                                      Immediately place on dry ice and transport frozen
                                      Protect from heat

Paraffin embedded tissue: Protect from heat
                                           Keep at room temperature
                                           Do not decalcify

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

Tissue (Snap-frozen): Freeze immediately after collection.
                                   Immediately place on dry ice and transport frozen
                                   Keep frozen
                                   Protect from heat


 

Unacceptable Conditions

Inadequate tissue, Delayed or improper handling, Tissue degradation, Wrong type of specimen, Decalcified tissue

Stability

Unstained tissue slide: Room temperature 6 month(s)

Bone marrow: Room temperature 24 hour(s)
Bone marrow: Refrigerated 72 hour(s)

OCT-embedded tissue: Frozen 6 month(s)

Paraffin embedded tissue: Room temperature 6 month(s)

Tissue (Fresh): Room temperature 24 hour(s)
Tissue (Fresh): Refrigerated 72 hour(s)

Tissue (Snap-frozen): Frozen 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.

Acceptable specimen types for this test include fresh tissue, snap-frozen tissue, OCT-embedded tissue, paraffin-embedded tissue, involved bone marrow, and unstained slides (6 consecutive, unstained, 3 micron-thick sections placed on positively charged slides; decalcified sections will not be accepted; must accompany a hematoxylin and eosin (H&E) stained slide from the adjacent section). Pathology review by a Nationwide Children's Laboratory Services pathologist will be performed on all tumor samples to verify tumor percentage.

Fresh tissue, snap-frozen tissue, OCT-embedded tissue, paraffin-embedded tissue, and unstained slides must contain minimum of ≥10% tumor content, while bone marrow requires ≥30% tumor content. Please submit the pathology report from the submitted sample. Internal pathology review will also be performed to determine the tumor content in specimen. 

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.

Send all samples via overnight courier service. Send snap-frozen or OCT-embedded tissue buried in dry ice. Send fresh tissue, paraffin-embedded tissue, or bone marrow at room temperature. Saturday deliveries are accepted; please check "Saturday Delivery" on shipment label for Saturday delivery. Please call (614) 722-5321 for any questions regarding this test. 

Clinical Information

This test is a FISH analysis performed on tumor specimens and identifies amplification of the ALK oncogene locus. Presence or absence of ALK amplification may be used to help assign risk classification for the patient's neuroblastoma or other tumors.

Children with neuroblastoma (NBL) are assigned a specific risk group (low, intermediate, or high) based on a variety of clinical and biological factors. Nationwide Children's Laboratory Services offers targeted ALK sequencing and ALK amplification detection by FISH as orderable clinical testing. ALK amplification is present in approximately 2% of all NBL cases. ALK amplification is usually seen with MYCN (N-Myc) amplification. ALK amplification and ALK mutations are rarely found in the same tumor. Copy number gains involving ALK (not amplification) can occur in a subset of cases. These copy number gains typically involve the entire gain of chromosome 2 or 2p (rather than a focal gain of ALK). These copy number changes are also seen in conjunction with the presence of MYCN amplification.

Days Performed

Monday through Saturday

Set Up Schedule

All tests not performed daily.

Typical Turnaround

1 week

Lab Area

Institute for Genomic Medicine

Methodology

Fluorescence in situ hybridization (FISH)

CPT Codes

88271, 88275

Synonyms

  • Neuroblastoma (NBL), ALK Oncogene Amplification, ALK FISH, Neuroblastoma FISH, NBL FISH, Oncology FISH, ALK (2p23.2-p23.1) Amplification, ALK FISH, IGM Test

Special Collection

At least 10% tumor (30% if bone marrow) must be present in the submitted sample (based on internal pathology review). FFPE unstained charged slides are preferred; please submit 6 slides (3 micron thick, not decalcified) AND consecutively cut H&E slide

Collect

Specimen Type Type of Container Volume of Specimen Status
Unstained tissue slide Charged Slides 6 slides (3 micron) Preferred
Bone marrow 3 mL Green tube (Sodium heparin), No Gel 3 mL Alternate
OCT-embedded tissue Tissue cassette   Alternate
OCT-embedded tissue Cryogenic tube   Alternate
Paraffin embedded tissue Paraffin block   Alternate
Tissue (Fresh) Sterile container with saline   Alternate
Tissue (Snap-frozen) Tissue cassette   Alternate
Tissue (Snap-frozen) Cryogenic tube   Alternate

Minimum Volume

Specimen Type Type of Container Minimum Volume
Unstained tissue slide Charged Slides  
Bone marrow 3 mL Green tube (Sodium heparin), No Gel  
OCT-embedded tissue Tissue cassette  
OCT-embedded tissue Cryogenic tube  
Paraffin embedded tissue Paraffin block  
Tissue (Fresh) Sterile container with saline  
Tissue (Snap-frozen) Tissue cassette  
Tissue (Snap-frozen) Cryogenic tube  

Inpatient Specimen Preparation

Unstained tissue slide: Keep at room temperature
                                     Protect from heat
                                     Must accompany H&E slide from adjacent section
                                     Do not decalcify

Bone marrow: Keep at room temperature
                       Transport to laboratory as soon as possible

OCT-embedded tissue: Keep frozen
                                      Immediately place on dry ice and transport frozen
                                      Protect from heat

Paraffin embedded tissue: Protect from heat
                                           Keep at room temperature
                                           Do not decalcify

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

Tissue (Snap-frozen): Freeze immediately after collection.
                                   Immediately place on dry ice and transport frozen
                                   Keep frozen
                                   Protect from heat

Unacceptable Conditions

Inadequate tissue, Delayed or improper handling, Tissue degradation, Wrong type of specimen, Decalcified tissue

Stability

Unstained tissue slide: Room temperature 6 month(s)

Bone marrow: Room temperature 24 hour(s)
Bone marrow: Refrigerated 72 hour(s)

OCT-embedded tissue: Frozen 6 month(s)

Paraffin embedded tissue: Room temperature 6 month(s)

Tissue (Fresh): Room temperature 24 hour(s)
Tissue (Fresh): Refrigerated 72 hour(s)

Tissue (Snap-frozen): Frozen 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.

Acceptable specimen types for this test include fresh tissue, snap-frozen tissue, OCT-embedded tissue, paraffin-embedded tissue, involved bone marrow, and unstained slides (6 consecutive, unstained, 3 micron-thick sections placed on positively charged slides; decalcified sections will not be accepted; must accompany a hematoxylin and eosin (H&E) stained slide from the adjacent section). Pathology review by a Nationwide Children's Laboratory Services pathologist will be performed on all tumor samples to verify tumor percentage.

Fresh tissue, snap-frozen tissue, OCT-embedded tissue, paraffin-embedded tissue, and unstained slides must contain minimum of ≥10% tumor content, while bone marrow requires ≥30% tumor content. Please submit the pathology report from the submitted sample. Internal pathology review will also be performed to determine the tumor content in specimen. 

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.

Send all samples via overnight courier service. Send snap-frozen or OCT-embedded tissue buried in dry ice. Send fresh tissue, paraffin-embedded tissue, or bone marrow at room temperature. Saturday deliveries are accepted; please check "Saturday Delivery" on shipment label for Saturday delivery. Please call (614) 722-5321 for any questions regarding this test. 

Clinical Information

This test is a FISH analysis performed on tumor specimens and identifies amplification of the ALK oncogene locus. Presence or absence of ALK amplification may be used to help assign risk classification for the patient's neuroblastoma or other tumors.

Children with neuroblastoma (NBL) are assigned a specific risk group (low, intermediate, or high) based on a variety of clinical and biological factors. Nationwide Children's Laboratory Services offers targeted ALK sequencing and ALK amplification detection by FISH as orderable clinical testing. ALK amplification is present in approximately 2% of all NBL cases. ALK amplification is usually seen with MYCN (N-Myc) amplification. ALK amplification and ALK mutations are rarely found in the same tumor. Copy number gains involving ALK (not amplification) can occur in a subset of cases. These copy number gains typically involve the entire gain of chromosome 2 or 2p (rather than a focal gain of ALK). These copy number changes are also seen in conjunction with the presence of MYCN amplification.

Days Performed

Monday through Saturday

Set Up Schedule

All tests not performed daily.

Typical Turnaround

1 week

CPT Codes

88271, 88275

Lab Area

Institute for Genomic Medicine

Synonyms

  • Neuroblastoma (NBL), ALK Oncogene Amplification, ALK FISH, Neuroblastoma FISH, NBL FISH, Oncology FISH, ALK (2p23.2-p23.1) Amplification, ALK FISH, IGM Test

Estimated Patient Price

< $1,000

Synonyms

  • Neuroblastoma (NBL), ALK Oncogene Amplification, ALK FISH, Neuroblastoma FISH, NBL FISH, Oncology FISH, ALK (2p23.2-p23.1) Amplification, ALK FISH, IGM Test

CPT Codes

88271, 88275

Clinical Information

This test is a FISH analysis performed on tumor specimens and identifies amplification of the ALK oncogene locus. Presence or absence of ALK amplification may be used to help assign risk classification for the patient's neuroblastoma or other tumors.

Children with neuroblastoma (NBL) are assigned a specific risk group (low, intermediate, or high) based on a variety of clinical and biological factors. Nationwide Children's Laboratory Services offers targeted ALK sequencing and ALK amplification detection by FISH as orderable clinical testing. ALK amplification is present in approximately 2% of all NBL cases. ALK amplification is usually seen with MYCN (N-Myc) amplification. ALK amplification and ALK mutations are rarely found in the same tumor. Copy number gains involving ALK (not amplification) can occur in a subset of cases. These copy number gains typically involve the entire gain of chromosome 2 or 2p (rather than a focal gain of ALK). These copy number changes are also seen in conjunction with the presence of MYCN amplification.

Methodology

Fluorescence in situ hybridization (FISH)

Special Collection

At least 10% tumor (30% if bone marrow) must be present in the submitted sample (based on internal pathology review). FFPE unstained charged slides are preferred; please submit 6 slides (3 micron thick, not decalcified) AND consecutively cut H&E slide

Outpatient Submit with Specimen

Collect

Specimen Type Type of Container Volume of Specimen Status
Unstained tissue slide Charged Slides 6 slides (3 micron) Preferred
Bone marrow 3 mL Green tube (Sodium heparin), No Gel 3 mL Alternate
OCT-embedded tissue Tissue cassette   Alternate
OCT-embedded tissue Cryogenic tube   Alternate
Paraffin embedded tissue Paraffin block   Alternate
Tissue (Fresh) Sterile container with saline   Alternate
Tissue (Snap-frozen) Tissue cassette   Alternate
Tissue (Snap-frozen) Cryogenic tube   Alternate

Minimum Volume

Specimen Type Type of Container Minimum Volume
Unstained tissue slide Charged Slides  
Bone marrow 3 mL Green tube (Sodium heparin), No Gel  
OCT-embedded tissue Tissue cassette  
OCT-embedded tissue Cryogenic tube  
Paraffin embedded tissue Paraffin block  
Tissue (Fresh) Sterile container with saline  
Tissue (Snap-frozen) Tissue cassette  
Tissue (Snap-frozen) Cryogenic tube  

Inpatient Specimen Preparation

Unstained tissue slide: Keep at room temperature
                                     Protect from heat
                                     Must accompany H&E slide from adjacent section
                                     Do not decalcify

Bone marrow: Keep at room temperature
                       Transport to laboratory as soon as possible

OCT-embedded tissue: Keep frozen
                                      Immediately place on dry ice and transport frozen
                                      Protect from heat

Paraffin embedded tissue: Protect from heat
                                           Keep at room temperature
                                           Do not decalcify

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

Tissue (Snap-frozen): Freeze immediately after collection.
                                   Immediately place on dry ice and transport frozen
                                   Keep frozen
                                   Protect from heat

Outpatient Specimen Preparation

Unstained tissue slide: Keep at room temperature
                                     Protect from heat
                                     Must accompany H&E slide from adjacent section
                                     Do not decalcify

Bone marrow: Keep at room temperature
                       Transport to laboratory as soon as possible

OCT-embedded tissue: Keep frozen
                                      Immediately place on dry ice and transport frozen
                                      Protect from heat

Paraffin embedded tissue: Protect from heat
                                           Keep at room temperature
                                           Do not decalcify

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

Tissue (Snap-frozen): Freeze immediately after collection.
                                   Immediately place on dry ice and transport frozen
                                   Keep frozen
                                   Protect from heat


 

InLab Processing

Send to Cytogenetics Lab with all submitted paperwork. For Non-EPIC lab orders, lab staff to order GENSP in Sunquest.

Stability

Unstained tissue slide: Room temperature 6 month(s)

Bone marrow: Room temperature 24 hour(s)
Bone marrow: Refrigerated 72 hour(s)

OCT-embedded tissue: Frozen 6 month(s)

Paraffin embedded tissue: Room temperature 6 month(s)

Tissue (Fresh): Room temperature 24 hour(s)
Tissue (Fresh): Refrigerated 72 hour(s)

Tissue (Snap-frozen): Frozen 6 month(s)

 

Unacceptable Conditions

Inadequate tissue, Delayed or improper handling, Tissue degradation, Wrong type of specimen, Decalcified tissue

Days Performed

Monday through Saturday

Set Up Schedule

All tests not performed daily.

Typical Turnaround

1 week

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.

Acceptable specimen types for this test include fresh tissue, snap-frozen tissue, OCT-embedded tissue, paraffin-embedded tissue, involved bone marrow, and unstained slides (6 consecutive, unstained, 3 micron-thick sections placed on positively charged slides; decalcified sections will not be accepted; must accompany a hematoxylin and eosin (H&E) stained slide from the adjacent section). Pathology review by a Nationwide Children's Laboratory Services pathologist will be performed on all tumor samples to verify tumor percentage.

Fresh tissue, snap-frozen tissue, OCT-embedded tissue, paraffin-embedded tissue, and unstained slides must contain minimum of ≥10% tumor content, while bone marrow requires ≥30% tumor content. Please submit the pathology report from the submitted sample. Internal pathology review will also be performed to determine the tumor content in specimen. 

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.

Send all samples via overnight courier service. Send snap-frozen or OCT-embedded tissue buried in dry ice. Send fresh tissue, paraffin-embedded tissue, or bone marrow at room temperature. Saturday deliveries are accepted; please check "Saturday Delivery" on shipment label for Saturday delivery. Please call (614) 722-5321 for any questions regarding this test. 

Clinical Information

This test is a FISH analysis performed on tumor specimens and identifies amplification of the ALK oncogene locus. Presence or absence of ALK amplification may be used to help assign risk classification for the patient's neuroblastoma or other tumors.

Children with neuroblastoma (NBL) are assigned a specific risk group (low, intermediate, or high) based on a variety of clinical and biological factors. Nationwide Children's Laboratory Services offers targeted ALK sequencing and ALK amplification detection by FISH as orderable clinical testing. ALK amplification is present in approximately 2% of all NBL cases. ALK amplification is usually seen with MYCN (N-Myc) amplification. ALK amplification and ALK mutations are rarely found in the same tumor. Copy number gains involving ALK (not amplification) can occur in a subset of cases. These copy number gains typically involve the entire gain of chromosome 2 or 2p (rather than a focal gain of ALK). These copy number changes are also seen in conjunction with the presence of MYCN amplification.

Synonyms

  • Neuroblastoma (NBL), ALK Oncogene Amplification, ALK FISH, Neuroblastoma FISH, NBL FISH, Oncology FISH, ALK (2p23.2-p23.1) Amplification, ALK FISH, IGM Test

Methodology

Fluorescence in situ hybridization (FISH)

CPT Codes

88271, 88275

Estimated Patient Price

< $1,000

DC Code

5321

Downtime Availability

4-Not available
Outpatient Requirements

Special Collection

At least 10% tumor (30% if bone marrow) must be present in the submitted sample (based on internal pathology review). FFPE unstained charged slides are preferred; please submit 6 slides (3 micron thick, not decalcified) AND consecutively cut H&E slide

Outpatient Submit with Specimen

Collect

Specimen Type Type of Container Volume of Specimen Status
Unstained tissue slide Charged Slides 6 slides (3 micron) Preferred
Bone marrow 3 mL Green tube (Sodium heparin), No Gel 3 mL Alternate
OCT-embedded tissue Tissue cassette   Alternate
OCT-embedded tissue Cryogenic tube   Alternate
Paraffin embedded tissue Paraffin block   Alternate
Tissue (Fresh) Sterile container with saline   Alternate
Tissue (Snap-frozen) Tissue cassette   Alternate
Tissue (Snap-frozen) Cryogenic tube   Alternate

Outpatient Specimen Preparation

Unstained tissue slide: Keep at room temperature
                                     Protect from heat
                                     Must accompany H&E slide from adjacent section
                                     Do not decalcify

Bone marrow: Keep at room temperature
                       Transport to laboratory as soon as possible

OCT-embedded tissue: Keep frozen
                                      Immediately place on dry ice and transport frozen
                                      Protect from heat

Paraffin embedded tissue: Protect from heat
                                           Keep at room temperature
                                           Do not decalcify

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

Tissue (Snap-frozen): Freeze immediately after collection.
                                   Immediately place on dry ice and transport frozen
                                   Keep frozen
                                   Protect from heat


 

Unacceptable Conditions

Inadequate tissue, Delayed or improper handling, Tissue degradation, Wrong type of specimen, Decalcified tissue

Stability

Unstained tissue slide: Room temperature 6 month(s)

Bone marrow: Room temperature 24 hour(s)
Bone marrow: Refrigerated 72 hour(s)

OCT-embedded tissue: Frozen 6 month(s)

Paraffin embedded tissue: Room temperature 6 month(s)

Tissue (Fresh): Room temperature 24 hour(s)
Tissue (Fresh): Refrigerated 72 hour(s)

Tissue (Snap-frozen): Frozen 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.

Acceptable specimen types for this test include fresh tissue, snap-frozen tissue, OCT-embedded tissue, paraffin-embedded tissue, involved bone marrow, and unstained slides (6 consecutive, unstained, 3 micron-thick sections placed on positively charged slides; decalcified sections will not be accepted; must accompany a hematoxylin and eosin (H&E) stained slide from the adjacent section). Pathology review by a Nationwide Children's Laboratory Services pathologist will be performed on all tumor samples to verify tumor percentage.

Fresh tissue, snap-frozen tissue, OCT-embedded tissue, paraffin-embedded tissue, and unstained slides must contain minimum of ≥10% tumor content, while bone marrow requires ≥30% tumor content. Please submit the pathology report from the submitted sample. Internal pathology review will also be performed to determine the tumor content in specimen. 

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.

Send all samples via overnight courier service. Send snap-frozen or OCT-embedded tissue buried in dry ice. Send fresh tissue, paraffin-embedded tissue, or bone marrow at room temperature. Saturday deliveries are accepted; please check "Saturday Delivery" on shipment label for Saturday delivery. Please call (614) 722-5321 for any questions regarding this test. 

Clinical Information

This test is a FISH analysis performed on tumor specimens and identifies amplification of the ALK oncogene locus. Presence or absence of ALK amplification may be used to help assign risk classification for the patient's neuroblastoma or other tumors.

Children with neuroblastoma (NBL) are assigned a specific risk group (low, intermediate, or high) based on a variety of clinical and biological factors. Nationwide Children's Laboratory Services offers targeted ALK sequencing and ALK amplification detection by FISH as orderable clinical testing. ALK amplification is present in approximately 2% of all NBL cases. ALK amplification is usually seen with MYCN (N-Myc) amplification. ALK amplification and ALK mutations are rarely found in the same tumor. Copy number gains involving ALK (not amplification) can occur in a subset of cases. These copy number gains typically involve the entire gain of chromosome 2 or 2p (rather than a focal gain of ALK). These copy number changes are also seen in conjunction with the presence of MYCN amplification.

Days Performed

Monday through Saturday

Set Up Schedule

All tests not performed daily.

Typical Turnaround

1 week

Lab Area

Institute for Genomic Medicine

Methodology

Fluorescence in situ hybridization (FISH)

CPT Codes

88271, 88275

Synonyms

  • Neuroblastoma (NBL), ALK Oncogene Amplification, ALK FISH, Neuroblastoma FISH, NBL FISH, Oncology FISH, ALK (2p23.2-p23.1) Amplification, ALK FISH, IGM Test
Inpatient Requirements

Special Collection

At least 10% tumor (30% if bone marrow) must be present in the submitted sample (based on internal pathology review). FFPE unstained charged slides are preferred; please submit 6 slides (3 micron thick, not decalcified) AND consecutively cut H&E slide

Collect

Specimen Type Type of Container Volume of Specimen Status
Unstained tissue slide Charged Slides 6 slides (3 micron) Preferred
Bone marrow 3 mL Green tube (Sodium heparin), No Gel 3 mL Alternate
OCT-embedded tissue Tissue cassette   Alternate
OCT-embedded tissue Cryogenic tube   Alternate
Paraffin embedded tissue Paraffin block   Alternate
Tissue (Fresh) Sterile container with saline   Alternate
Tissue (Snap-frozen) Tissue cassette   Alternate
Tissue (Snap-frozen) Cryogenic tube   Alternate

Minimum Volume

Specimen Type Type of Container Minimum Volume
Unstained tissue slide Charged Slides  
Bone marrow 3 mL Green tube (Sodium heparin), No Gel  
OCT-embedded tissue Tissue cassette  
OCT-embedded tissue Cryogenic tube  
Paraffin embedded tissue Paraffin block  
Tissue (Fresh) Sterile container with saline  
Tissue (Snap-frozen) Tissue cassette  
Tissue (Snap-frozen) Cryogenic tube  

Inpatient Specimen Preparation

Unstained tissue slide: Keep at room temperature
                                     Protect from heat
                                     Must accompany H&E slide from adjacent section
                                     Do not decalcify

Bone marrow: Keep at room temperature
                       Transport to laboratory as soon as possible

OCT-embedded tissue: Keep frozen
                                      Immediately place on dry ice and transport frozen
                                      Protect from heat

Paraffin embedded tissue: Protect from heat
                                           Keep at room temperature
                                           Do not decalcify

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

Tissue (Snap-frozen): Freeze immediately after collection.
                                   Immediately place on dry ice and transport frozen
                                   Keep frozen
                                   Protect from heat

Unacceptable Conditions

Inadequate tissue, Delayed or improper handling, Tissue degradation, Wrong type of specimen, Decalcified tissue

Stability

Unstained tissue slide: Room temperature 6 month(s)

Bone marrow: Room temperature 24 hour(s)
Bone marrow: Refrigerated 72 hour(s)

OCT-embedded tissue: Frozen 6 month(s)

Paraffin embedded tissue: Room temperature 6 month(s)

Tissue (Fresh): Room temperature 24 hour(s)
Tissue (Fresh): Refrigerated 72 hour(s)

Tissue (Snap-frozen): Frozen 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.

Acceptable specimen types for this test include fresh tissue, snap-frozen tissue, OCT-embedded tissue, paraffin-embedded tissue, involved bone marrow, and unstained slides (6 consecutive, unstained, 3 micron-thick sections placed on positively charged slides; decalcified sections will not be accepted; must accompany a hematoxylin and eosin (H&E) stained slide from the adjacent section). Pathology review by a Nationwide Children's Laboratory Services pathologist will be performed on all tumor samples to verify tumor percentage.

Fresh tissue, snap-frozen tissue, OCT-embedded tissue, paraffin-embedded tissue, and unstained slides must contain minimum of ≥10% tumor content, while bone marrow requires ≥30% tumor content. Please submit the pathology report from the submitted sample. Internal pathology review will also be performed to determine the tumor content in specimen. 

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.

Send all samples via overnight courier service. Send snap-frozen or OCT-embedded tissue buried in dry ice. Send fresh tissue, paraffin-embedded tissue, or bone marrow at room temperature. Saturday deliveries are accepted; please check "Saturday Delivery" on shipment label for Saturday delivery. Please call (614) 722-5321 for any questions regarding this test. 

Clinical Information

This test is a FISH analysis performed on tumor specimens and identifies amplification of the ALK oncogene locus. Presence or absence of ALK amplification may be used to help assign risk classification for the patient's neuroblastoma or other tumors.

Children with neuroblastoma (NBL) are assigned a specific risk group (low, intermediate, or high) based on a variety of clinical and biological factors. Nationwide Children's Laboratory Services offers targeted ALK sequencing and ALK amplification detection by FISH as orderable clinical testing. ALK amplification is present in approximately 2% of all NBL cases. ALK amplification is usually seen with MYCN (N-Myc) amplification. ALK amplification and ALK mutations are rarely found in the same tumor. Copy number gains involving ALK (not amplification) can occur in a subset of cases. These copy number gains typically involve the entire gain of chromosome 2 or 2p (rather than a focal gain of ALK). These copy number changes are also seen in conjunction with the presence of MYCN amplification.

Days Performed

Monday through Saturday

Set Up Schedule

All tests not performed daily.

Typical Turnaround

1 week

CPT Codes

88271, 88275

Lab Area

Institute for Genomic Medicine

Synonyms

  • Neuroblastoma (NBL), ALK Oncogene Amplification, ALK FISH, Neuroblastoma FISH, NBL FISH, Oncology FISH, ALK (2p23.2-p23.1) Amplification, ALK FISH, IGM Test

Estimated Patient Price

< $1,000
Overview/Billing

Synonyms

  • Neuroblastoma (NBL), ALK Oncogene Amplification, ALK FISH, Neuroblastoma FISH, NBL FISH, Oncology FISH, ALK (2p23.2-p23.1) Amplification, ALK FISH, IGM Test

CPT Codes

88271, 88275
Interpretation

Clinical Information

This test is a FISH analysis performed on tumor specimens and identifies amplification of the ALK oncogene locus. Presence or absence of ALK amplification may be used to help assign risk classification for the patient's neuroblastoma or other tumors.

Children with neuroblastoma (NBL) are assigned a specific risk group (low, intermediate, or high) based on a variety of clinical and biological factors. Nationwide Children's Laboratory Services offers targeted ALK sequencing and ALK amplification detection by FISH as orderable clinical testing. ALK amplification is present in approximately 2% of all NBL cases. ALK amplification is usually seen with MYCN (N-Myc) amplification. ALK amplification and ALK mutations are rarely found in the same tumor. Copy number gains involving ALK (not amplification) can occur in a subset of cases. These copy number gains typically involve the entire gain of chromosome 2 or 2p (rather than a focal gain of ALK). These copy number changes are also seen in conjunction with the presence of MYCN amplification.

Methodology

Fluorescence in situ hybridization (FISH)
NCH Lab Only

Special Collection

At least 10% tumor (30% if bone marrow) must be present in the submitted sample (based on internal pathology review). FFPE unstained charged slides are preferred; please submit 6 slides (3 micron thick, not decalcified) AND consecutively cut H&E slide

Outpatient Submit with Specimen

Collect

Specimen Type Type of Container Volume of Specimen Status
Unstained tissue slide Charged Slides 6 slides (3 micron) Preferred
Bone marrow 3 mL Green tube (Sodium heparin), No Gel 3 mL Alternate
OCT-embedded tissue Tissue cassette   Alternate
OCT-embedded tissue Cryogenic tube   Alternate
Paraffin embedded tissue Paraffin block   Alternate
Tissue (Fresh) Sterile container with saline   Alternate
Tissue (Snap-frozen) Tissue cassette   Alternate
Tissue (Snap-frozen) Cryogenic tube   Alternate

Minimum Volume

Specimen Type Type of Container Minimum Volume
Unstained tissue slide Charged Slides  
Bone marrow 3 mL Green tube (Sodium heparin), No Gel  
OCT-embedded tissue Tissue cassette  
OCT-embedded tissue Cryogenic tube  
Paraffin embedded tissue Paraffin block  
Tissue (Fresh) Sterile container with saline  
Tissue (Snap-frozen) Tissue cassette  
Tissue (Snap-frozen) Cryogenic tube  

Inpatient Specimen Preparation

Unstained tissue slide: Keep at room temperature
                                     Protect from heat
                                     Must accompany H&E slide from adjacent section
                                     Do not decalcify

Bone marrow: Keep at room temperature
                       Transport to laboratory as soon as possible

OCT-embedded tissue: Keep frozen
                                      Immediately place on dry ice and transport frozen
                                      Protect from heat

Paraffin embedded tissue: Protect from heat
                                           Keep at room temperature
                                           Do not decalcify

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

Tissue (Snap-frozen): Freeze immediately after collection.
                                   Immediately place on dry ice and transport frozen
                                   Keep frozen
                                   Protect from heat

Outpatient Specimen Preparation

Unstained tissue slide: Keep at room temperature
                                     Protect from heat
                                     Must accompany H&E slide from adjacent section
                                     Do not decalcify

Bone marrow: Keep at room temperature
                       Transport to laboratory as soon as possible

OCT-embedded tissue: Keep frozen
                                      Immediately place on dry ice and transport frozen
                                      Protect from heat

Paraffin embedded tissue: Protect from heat
                                           Keep at room temperature
                                           Do not decalcify

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

Tissue (Snap-frozen): Freeze immediately after collection.
                                   Immediately place on dry ice and transport frozen
                                   Keep frozen
                                   Protect from heat


 

InLab Processing

Send to Cytogenetics Lab with all submitted paperwork. For Non-EPIC lab orders, lab staff to order GENSP in Sunquest.

Stability

Unstained tissue slide: Room temperature 6 month(s)

Bone marrow: Room temperature 24 hour(s)
Bone marrow: Refrigerated 72 hour(s)

OCT-embedded tissue: Frozen 6 month(s)

Paraffin embedded tissue: Room temperature 6 month(s)

Tissue (Fresh): Room temperature 24 hour(s)
Tissue (Fresh): Refrigerated 72 hour(s)

Tissue (Snap-frozen): Frozen 6 month(s)

 

Unacceptable Conditions

Inadequate tissue, Delayed or improper handling, Tissue degradation, Wrong type of specimen, Decalcified tissue

Days Performed

Monday through Saturday

Set Up Schedule

All tests not performed daily.

Typical Turnaround

1 week

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.

Acceptable specimen types for this test include fresh tissue, snap-frozen tissue, OCT-embedded tissue, paraffin-embedded tissue, involved bone marrow, and unstained slides (6 consecutive, unstained, 3 micron-thick sections placed on positively charged slides; decalcified sections will not be accepted; must accompany a hematoxylin and eosin (H&E) stained slide from the adjacent section). Pathology review by a Nationwide Children's Laboratory Services pathologist will be performed on all tumor samples to verify tumor percentage.

Fresh tissue, snap-frozen tissue, OCT-embedded tissue, paraffin-embedded tissue, and unstained slides must contain minimum of ≥10% tumor content, while bone marrow requires ≥30% tumor content. Please submit the pathology report from the submitted sample. Internal pathology review will also be performed to determine the tumor content in specimen. 

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.

Send all samples via overnight courier service. Send snap-frozen or OCT-embedded tissue buried in dry ice. Send fresh tissue, paraffin-embedded tissue, or bone marrow at room temperature. Saturday deliveries are accepted; please check "Saturday Delivery" on shipment label for Saturday delivery. Please call (614) 722-5321 for any questions regarding this test. 

Clinical Information

This test is a FISH analysis performed on tumor specimens and identifies amplification of the ALK oncogene locus. Presence or absence of ALK amplification may be used to help assign risk classification for the patient's neuroblastoma or other tumors.

Children with neuroblastoma (NBL) are assigned a specific risk group (low, intermediate, or high) based on a variety of clinical and biological factors. Nationwide Children's Laboratory Services offers targeted ALK sequencing and ALK amplification detection by FISH as orderable clinical testing. ALK amplification is present in approximately 2% of all NBL cases. ALK amplification is usually seen with MYCN (N-Myc) amplification. ALK amplification and ALK mutations are rarely found in the same tumor. Copy number gains involving ALK (not amplification) can occur in a subset of cases. These copy number gains typically involve the entire gain of chromosome 2 or 2p (rather than a focal gain of ALK). These copy number changes are also seen in conjunction with the presence of MYCN amplification.

Synonyms

  • Neuroblastoma (NBL), ALK Oncogene Amplification, ALK FISH, Neuroblastoma FISH, NBL FISH, Oncology FISH, ALK (2p23.2-p23.1) Amplification, ALK FISH, IGM Test

Methodology

Fluorescence in situ hybridization (FISH)

CPT Codes

88271, 88275

Estimated Patient Price

< $1,000

DC Code

5321

Downtime Availability

4-Not available

Lab Area

Lab Area
Institute for Genomic Medicine