Special Collection

At least 60% tumor must be present in the submitted sample (Based on internal pathology review). Snap-frozen tissue is preferred.

Outpatient Submit with Specimen

Collect

Specimen Type Type of Container Volume of Specimen Status
Tissue (Snap-frozen) Tissue cassette mass 0.05 grams Preferred
Tissue (Snap-frozen) Cryogenic tube mass 0.05 grams Alternate
OCT-embedded tissue Tissue cassette mass 0.05 grams Alternate
OCT-embedded tissue Cryogenic tube mass 0.05 grams Alternate
Paraffin embedded tissue Paraffin block   Alternate
Tissue (Fresh) Sterile container with saline mass 0.05 grams Alternate
Tissue scrolls (FFPE) Sterile container   Alternate

Outpatient Specimen Preparation

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

OCT-embedded tissue: Freeze immediately after collection.
                                      Keep frozen
                                      Protect from heat
                                      Transport to laboratory as soon as possible

Paraffin embedded tissue: Keep at room temperature
                                           Protect from heat

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

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

Unacceptable Conditions

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

Stability

Tissue (Snap-frozen): Frozen 24 hour(s)

OCT-embedded tissue: Frozen 24 hour(s)

Paraffin embedded tissue: Room temperature 6 month(s)

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

Tissue (Snap-frozen): Frozen 24 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, and provider MUST call the laboratory at 722-5321 to initiate the sample transfer and testing.

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

SPECIMEN INFORMATION:

  1. At least 60% tumor must be present in the submitted CNS tumor sample. A result from a sample containing <60% tumor may be reported as unsatisfactory (no results reported). A pathology report from the submitted sample is required. An internal pathology review will also be performed on submitted tumor samples to verify tumor content.
  2. All specimens must be labeled with a patient name and other identifier (DOB, MRN, Specimen ID#, etc.). Sample acquisition prior to receiving therapy is strongly preferred.
  3. An FFPE tissue block is preferred over FFPE tissue scrolls. If submitting 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. Tissue blocks can be returned to the treating institution upon request.

SPECIMEN SHIPPING:

Ship all samples via overnight delivery. Saturday deliveries are accepted; please check Saturday Delivery on shipment label. 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). FFPE tissue and FFPE tissue scrolls should be sent at room temperature via overnight shipping.

Clinical Information

This Methylation Microarray Analysis is performed on Central Nervous System (CNS) tumors using the Illumina MethylationEPIC BeadChip version 2 platform and software developed by the Nationwide Children’s Hospital Institute for Genomic Medicine (IGM) to subtype CNS tumors. This array assesses the CNS tumor methylation profile and compares it to over 3,900 reference CNS cases to create a classification prediction score indicating the resemblance to a CNS tumor subtype (see reference below). Results will use the IGM CNS classifier to indicate a methylation class specific to a CNS subtype categorized as “consistent with," “no match, but potentially suggestive of,” or “tumor classification not determined,” as well as MGMT methylation status.

This analysis is intended to aid and refine the pathological diagnoses of CNS tumors. Results should be interpreted in conjunction with other laboratory findings, such as histology, and molecular testing. This analysis should NOT be used as a stand-alone diagnostic test. Patient samples of rare subtypes that are not in the classifier reference set may result in a low classifier prediction score.

References:

  1. Louis DN, Perry A, Wesseling P, et al. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. Neuro Oncol 23(8),1231-1251 (2021). PMID: 34185076.

Days Performed

Monday through Saturday

Set Up Schedule

All tests not performed daily.

Typical Turnaround

2 weeks

Lab Area

Institute for Genomic Medicine

Methodology

Methylation Microarray

CPT Codes

81287, 81479

Synonyms

  • Methyl array, methylation array, CNS tumor, Tumor classification, Central Nervous System array, Central Nervous System classification, Tumor subtyping, Tumor class, MGMT analysis, Brain cancer, Brain tumor, Methylation microarray, CNS cancer, MGMT methylation, Methylation, Cancer microarray, cancer array, MGMT, DKFZ, Methyl, CNS tumor, CNS subtype, array, CNS, Central Nervous System, Tumor, cancer, brain, microarray, IGM Test, CNS methyl

Special Collection

At least 60% tumor must be present in the submitted sample (Based on internal pathology review). Snap-frozen tissue is preferred.

Collect

Specimen Type Type of Container Volume of Specimen Status
Tissue (Snap-frozen) Tissue cassette mass 0.05 grams Preferred
Tissue (Snap-frozen) Cryogenic tube mass 0.05 grams Alternate
OCT-embedded tissue Tissue cassette mass 0.05 grams Alternate
OCT-embedded tissue Cryogenic tube mass 0.05 grams Alternate
Paraffin embedded tissue Paraffin block   Alternate
Tissue (Fresh) Sterile container with saline mass 0.05 grams Alternate
Tissue scrolls (FFPE) Sterile container   Alternate

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) Sterile container with saline  
Tissue scrolls (FFPE) Sterile container  

Inpatient Specimen Preparation

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

OCT-embedded tissue: Freeze immediately after collection.
                                      Keep frozen
                                      Protect from heat
                                      Transport to laboratory as soon as possible

Paraffin embedded tissue: Keep at room temperature
                                           Protect from heat

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

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

Unacceptable Conditions

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

Stability

Tissue (Snap-frozen): Frozen 24 hour(s)

OCT-embedded tissue: Frozen 24 hour(s)

Paraffin embedded tissue: Room temperature 6 month(s)

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

Tissue (Snap-frozen): Frozen 24 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, and provider MUST call the laboratory at 722-5321 to initiate the sample transfer and testing.

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

SPECIMEN INFORMATION:

  1. At least 60% tumor must be present in the submitted CNS tumor sample. A result from a sample containing <60% tumor may be reported as unsatisfactory (no results reported). A pathology report from the submitted sample is required. An internal pathology review will also be performed on submitted tumor samples to verify tumor content.
  2. All specimens must be labeled with a patient name and other identifier (DOB, MRN, Specimen ID#, etc.). Sample acquisition prior to receiving therapy is strongly preferred.
  3. An FFPE tissue block is preferred over FFPE tissue scrolls. If submitting 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. Tissue blocks can be returned to the treating institution upon request.

SPECIMEN SHIPPING:

Ship all samples via overnight delivery. Saturday deliveries are accepted; please check Saturday Delivery on shipment label. 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). FFPE tissue and FFPE tissue scrolls should be sent at room temperature via overnight shipping.

Clinical Information

This Methylation Microarray Analysis is performed on Central Nervous System (CNS) tumors using the Illumina MethylationEPIC BeadChip version 2 platform and software developed by the Nationwide Children’s Hospital Institute for Genomic Medicine (IGM) to subtype CNS tumors. This array assesses the CNS tumor methylation profile and compares it to over 3,900 reference CNS cases to create a classification prediction score indicating the resemblance to a CNS tumor subtype (see reference below). Results will use the IGM CNS classifier to indicate a methylation class specific to a CNS subtype categorized as “consistent with," “no match, but potentially suggestive of,” or “tumor classification not determined,” as well as MGMT methylation status.

This analysis is intended to aid and refine the pathological diagnoses of CNS tumors. Results should be interpreted in conjunction with other laboratory findings, such as histology, and molecular testing. This analysis should NOT be used as a stand-alone diagnostic test. Patient samples of rare subtypes that are not in the classifier reference set may result in a low classifier prediction score.

References:

  1. Louis DN, Perry A, Wesseling P, et al. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. Neuro Oncol 23(8),1231-1251 (2021). PMID: 34185076.

Days Performed

Monday through Saturday

Set Up Schedule

All tests not performed daily.

Typical Turnaround

2 weeks

CPT Codes

81287, 81479

Lab Area

Institute for Genomic Medicine

Synonyms

  • Methyl array, methylation array, CNS tumor, Tumor classification, Central Nervous System array, Central Nervous System classification, Tumor subtyping, Tumor class, MGMT analysis, Brain cancer, Brain tumor, Methylation microarray, CNS cancer, MGMT methylation, Methylation, Cancer microarray, cancer array, MGMT, DKFZ, Methyl, CNS tumor, CNS subtype, array, CNS, Central Nervous System, Tumor, cancer, brain, microarray, IGM Test, CNS methyl

Estimated Patient Price

$1,000 - $2,500

Synonyms

  • Methyl array, methylation array, CNS tumor, Tumor classification, Central Nervous System array, Central Nervous System classification, Tumor subtyping, Tumor class, MGMT analysis, Brain cancer, Brain tumor, Methylation microarray, CNS cancer, MGMT methylation, Methylation, Cancer microarray, cancer array, MGMT, DKFZ, Methyl, CNS tumor, CNS subtype, array, CNS, Central Nervous System, Tumor, cancer, brain, microarray, IGM Test, CNS methyl

CPT Codes

81287, 81479

Clinical Information

This Methylation Microarray Analysis is performed on Central Nervous System (CNS) tumors using the Illumina MethylationEPIC BeadChip version 2 platform and software developed by the Nationwide Children’s Hospital Institute for Genomic Medicine (IGM) to subtype CNS tumors. This array assesses the CNS tumor methylation profile and compares it to over 3,900 reference CNS cases to create a classification prediction score indicating the resemblance to a CNS tumor subtype (see reference below). Results will use the IGM CNS classifier to indicate a methylation class specific to a CNS subtype categorized as “consistent with," “no match, but potentially suggestive of,” or “tumor classification not determined,” as well as MGMT methylation status.

This analysis is intended to aid and refine the pathological diagnoses of CNS tumors. Results should be interpreted in conjunction with other laboratory findings, such as histology, and molecular testing. This analysis should NOT be used as a stand-alone diagnostic test. Patient samples of rare subtypes that are not in the classifier reference set may result in a low classifier prediction score.

References:

  1. Louis DN, Perry A, Wesseling P, et al. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. Neuro Oncol 23(8),1231-1251 (2021). PMID: 34185076.

Methodology

Methylation Microarray

Special Collection

At least 60% tumor must be present in the submitted sample (Based on internal pathology review). Snap-frozen tissue is preferred.

Outpatient Submit with Specimen

Collect

Specimen Type Type of Container Volume of Specimen Status
Tissue (Snap-frozen) Tissue cassette mass 0.05 grams Preferred
Tissue (Snap-frozen) Cryogenic tube mass 0.05 grams Alternate
OCT-embedded tissue Tissue cassette mass 0.05 grams Alternate
OCT-embedded tissue Cryogenic tube mass 0.05 grams Alternate
Paraffin embedded tissue Paraffin block   Alternate
Tissue (Fresh) Sterile container with saline mass 0.05 grams Alternate
Tissue scrolls (FFPE) Sterile container   Alternate

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) Sterile container with saline  
Tissue scrolls (FFPE) Sterile container  

Inpatient Specimen Preparation

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

OCT-embedded tissue: Freeze immediately after collection.
                                      Keep frozen
                                      Protect from heat
                                      Transport to laboratory as soon as possible

Paraffin embedded tissue: Keep at room temperature
                                           Protect from heat

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

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

Outpatient Specimen Preparation

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

OCT-embedded tissue: Freeze immediately after collection.
                                      Keep frozen
                                      Protect from heat
                                      Transport to laboratory as soon as possible

Paraffin embedded tissue: Keep at room temperature
                                           Protect from heat

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

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

InLab Processing

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

Stability

Tissue (Snap-frozen): Frozen 24 hour(s)

OCT-embedded tissue: Frozen 24 hour(s)

Paraffin embedded tissue: Room temperature 6 month(s)

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

Tissue (Snap-frozen): Frozen 24 hour(s)

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

Unacceptable Conditions

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

Days Performed

Monday through Saturday

Set Up Schedule

All tests not performed daily.

Typical Turnaround

2 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, and provider MUST call the laboratory at 722-5321 to initiate the sample transfer and testing.

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

SPECIMEN INFORMATION:

  1. At least 60% tumor must be present in the submitted CNS tumor sample. A result from a sample containing <60% tumor may be reported as unsatisfactory (no results reported). A pathology report from the submitted sample is required. An internal pathology review will also be performed on submitted tumor samples to verify tumor content.
  2. All specimens must be labeled with a patient name and other identifier (DOB, MRN, Specimen ID#, etc.). Sample acquisition prior to receiving therapy is strongly preferred.
  3. An FFPE tissue block is preferred over FFPE tissue scrolls. If submitting 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. Tissue blocks can be returned to the treating institution upon request.

SPECIMEN SHIPPING:

Ship all samples via overnight delivery. Saturday deliveries are accepted; please check Saturday Delivery on shipment label. 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). FFPE tissue and FFPE tissue scrolls should be sent at room temperature via overnight shipping.

Clinical Information

This Methylation Microarray Analysis is performed on Central Nervous System (CNS) tumors using the Illumina MethylationEPIC BeadChip version 2 platform and software developed by the Nationwide Children’s Hospital Institute for Genomic Medicine (IGM) to subtype CNS tumors. This array assesses the CNS tumor methylation profile and compares it to over 3,900 reference CNS cases to create a classification prediction score indicating the resemblance to a CNS tumor subtype (see reference below). Results will use the IGM CNS classifier to indicate a methylation class specific to a CNS subtype categorized as “consistent with," “no match, but potentially suggestive of,” or “tumor classification not determined,” as well as MGMT methylation status.

This analysis is intended to aid and refine the pathological diagnoses of CNS tumors. Results should be interpreted in conjunction with other laboratory findings, such as histology, and molecular testing. This analysis should NOT be used as a stand-alone diagnostic test. Patient samples of rare subtypes that are not in the classifier reference set may result in a low classifier prediction score.

References:

  1. Louis DN, Perry A, Wesseling P, et al. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. Neuro Oncol 23(8),1231-1251 (2021). PMID: 34185076.

Synonyms

  • Methyl array, methylation array, CNS tumor, Tumor classification, Central Nervous System array, Central Nervous System classification, Tumor subtyping, Tumor class, MGMT analysis, Brain cancer, Brain tumor, Methylation microarray, CNS cancer, MGMT methylation, Methylation, Cancer microarray, cancer array, MGMT, DKFZ, Methyl, CNS tumor, CNS subtype, array, CNS, Central Nervous System, Tumor, cancer, brain, microarray, IGM Test, CNS methyl

Methodology

Methylation Microarray

CPT Codes

81287, 81479

Estimated Patient Price

$1,000 - $2,500

DC Code

5321

Downtime Availability

4-Not available
Outpatient Requirements

Special Collection

At least 60% tumor must be present in the submitted sample (Based on internal pathology review). Snap-frozen tissue is preferred.

Outpatient Submit with Specimen

Collect

Specimen Type Type of Container Volume of Specimen Status
Tissue (Snap-frozen) Tissue cassette mass 0.05 grams Preferred
Tissue (Snap-frozen) Cryogenic tube mass 0.05 grams Alternate
OCT-embedded tissue Tissue cassette mass 0.05 grams Alternate
OCT-embedded tissue Cryogenic tube mass 0.05 grams Alternate
Paraffin embedded tissue Paraffin block   Alternate
Tissue (Fresh) Sterile container with saline mass 0.05 grams Alternate
Tissue scrolls (FFPE) Sterile container   Alternate

Outpatient Specimen Preparation

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

OCT-embedded tissue: Freeze immediately after collection.
                                      Keep frozen
                                      Protect from heat
                                      Transport to laboratory as soon as possible

Paraffin embedded tissue: Keep at room temperature
                                           Protect from heat

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

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

Unacceptable Conditions

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

Stability

Tissue (Snap-frozen): Frozen 24 hour(s)

OCT-embedded tissue: Frozen 24 hour(s)

Paraffin embedded tissue: Room temperature 6 month(s)

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

Tissue (Snap-frozen): Frozen 24 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, and provider MUST call the laboratory at 722-5321 to initiate the sample transfer and testing.

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

SPECIMEN INFORMATION:

  1. At least 60% tumor must be present in the submitted CNS tumor sample. A result from a sample containing <60% tumor may be reported as unsatisfactory (no results reported). A pathology report from the submitted sample is required. An internal pathology review will also be performed on submitted tumor samples to verify tumor content.
  2. All specimens must be labeled with a patient name and other identifier (DOB, MRN, Specimen ID#, etc.). Sample acquisition prior to receiving therapy is strongly preferred.
  3. An FFPE tissue block is preferred over FFPE tissue scrolls. If submitting 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. Tissue blocks can be returned to the treating institution upon request.

SPECIMEN SHIPPING:

Ship all samples via overnight delivery. Saturday deliveries are accepted; please check Saturday Delivery on shipment label. 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). FFPE tissue and FFPE tissue scrolls should be sent at room temperature via overnight shipping.

Clinical Information

This Methylation Microarray Analysis is performed on Central Nervous System (CNS) tumors using the Illumina MethylationEPIC BeadChip version 2 platform and software developed by the Nationwide Children’s Hospital Institute for Genomic Medicine (IGM) to subtype CNS tumors. This array assesses the CNS tumor methylation profile and compares it to over 3,900 reference CNS cases to create a classification prediction score indicating the resemblance to a CNS tumor subtype (see reference below). Results will use the IGM CNS classifier to indicate a methylation class specific to a CNS subtype categorized as “consistent with," “no match, but potentially suggestive of,” or “tumor classification not determined,” as well as MGMT methylation status.

This analysis is intended to aid and refine the pathological diagnoses of CNS tumors. Results should be interpreted in conjunction with other laboratory findings, such as histology, and molecular testing. This analysis should NOT be used as a stand-alone diagnostic test. Patient samples of rare subtypes that are not in the classifier reference set may result in a low classifier prediction score.

References:

  1. Louis DN, Perry A, Wesseling P, et al. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. Neuro Oncol 23(8),1231-1251 (2021). PMID: 34185076.

Days Performed

Monday through Saturday

Set Up Schedule

All tests not performed daily.

Typical Turnaround

2 weeks

Lab Area

Institute for Genomic Medicine

Methodology

Methylation Microarray

CPT Codes

81287, 81479

Synonyms

  • Methyl array, methylation array, CNS tumor, Tumor classification, Central Nervous System array, Central Nervous System classification, Tumor subtyping, Tumor class, MGMT analysis, Brain cancer, Brain tumor, Methylation microarray, CNS cancer, MGMT methylation, Methylation, Cancer microarray, cancer array, MGMT, DKFZ, Methyl, CNS tumor, CNS subtype, array, CNS, Central Nervous System, Tumor, cancer, brain, microarray, IGM Test, CNS methyl
Inpatient Requirements

Special Collection

At least 60% tumor must be present in the submitted sample (Based on internal pathology review). Snap-frozen tissue is preferred.

Collect

Specimen Type Type of Container Volume of Specimen Status
Tissue (Snap-frozen) Tissue cassette mass 0.05 grams Preferred
Tissue (Snap-frozen) Cryogenic tube mass 0.05 grams Alternate
OCT-embedded tissue Tissue cassette mass 0.05 grams Alternate
OCT-embedded tissue Cryogenic tube mass 0.05 grams Alternate
Paraffin embedded tissue Paraffin block   Alternate
Tissue (Fresh) Sterile container with saline mass 0.05 grams Alternate
Tissue scrolls (FFPE) Sterile container   Alternate

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) Sterile container with saline  
Tissue scrolls (FFPE) Sterile container  

Inpatient Specimen Preparation

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

OCT-embedded tissue: Freeze immediately after collection.
                                      Keep frozen
                                      Protect from heat
                                      Transport to laboratory as soon as possible

Paraffin embedded tissue: Keep at room temperature
                                           Protect from heat

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

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

Unacceptable Conditions

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

Stability

Tissue (Snap-frozen): Frozen 24 hour(s)

OCT-embedded tissue: Frozen 24 hour(s)

Paraffin embedded tissue: Room temperature 6 month(s)

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

Tissue (Snap-frozen): Frozen 24 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, and provider MUST call the laboratory at 722-5321 to initiate the sample transfer and testing.

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

SPECIMEN INFORMATION:

  1. At least 60% tumor must be present in the submitted CNS tumor sample. A result from a sample containing <60% tumor may be reported as unsatisfactory (no results reported). A pathology report from the submitted sample is required. An internal pathology review will also be performed on submitted tumor samples to verify tumor content.
  2. All specimens must be labeled with a patient name and other identifier (DOB, MRN, Specimen ID#, etc.). Sample acquisition prior to receiving therapy is strongly preferred.
  3. An FFPE tissue block is preferred over FFPE tissue scrolls. If submitting 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. Tissue blocks can be returned to the treating institution upon request.

SPECIMEN SHIPPING:

Ship all samples via overnight delivery. Saturday deliveries are accepted; please check Saturday Delivery on shipment label. 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). FFPE tissue and FFPE tissue scrolls should be sent at room temperature via overnight shipping.

Clinical Information

This Methylation Microarray Analysis is performed on Central Nervous System (CNS) tumors using the Illumina MethylationEPIC BeadChip version 2 platform and software developed by the Nationwide Children’s Hospital Institute for Genomic Medicine (IGM) to subtype CNS tumors. This array assesses the CNS tumor methylation profile and compares it to over 3,900 reference CNS cases to create a classification prediction score indicating the resemblance to a CNS tumor subtype (see reference below). Results will use the IGM CNS classifier to indicate a methylation class specific to a CNS subtype categorized as “consistent with," “no match, but potentially suggestive of,” or “tumor classification not determined,” as well as MGMT methylation status.

This analysis is intended to aid and refine the pathological diagnoses of CNS tumors. Results should be interpreted in conjunction with other laboratory findings, such as histology, and molecular testing. This analysis should NOT be used as a stand-alone diagnostic test. Patient samples of rare subtypes that are not in the classifier reference set may result in a low classifier prediction score.

References:

  1. Louis DN, Perry A, Wesseling P, et al. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. Neuro Oncol 23(8),1231-1251 (2021). PMID: 34185076.

Days Performed

Monday through Saturday

Set Up Schedule

All tests not performed daily.

Typical Turnaround

2 weeks

CPT Codes

81287, 81479

Lab Area

Institute for Genomic Medicine

Synonyms

  • Methyl array, methylation array, CNS tumor, Tumor classification, Central Nervous System array, Central Nervous System classification, Tumor subtyping, Tumor class, MGMT analysis, Brain cancer, Brain tumor, Methylation microarray, CNS cancer, MGMT methylation, Methylation, Cancer microarray, cancer array, MGMT, DKFZ, Methyl, CNS tumor, CNS subtype, array, CNS, Central Nervous System, Tumor, cancer, brain, microarray, IGM Test, CNS methyl

Estimated Patient Price

$1,000 - $2,500
Overview/Billing

Synonyms

  • Methyl array, methylation array, CNS tumor, Tumor classification, Central Nervous System array, Central Nervous System classification, Tumor subtyping, Tumor class, MGMT analysis, Brain cancer, Brain tumor, Methylation microarray, CNS cancer, MGMT methylation, Methylation, Cancer microarray, cancer array, MGMT, DKFZ, Methyl, CNS tumor, CNS subtype, array, CNS, Central Nervous System, Tumor, cancer, brain, microarray, IGM Test, CNS methyl

CPT Codes

81287, 81479
Interpretation

Clinical Information

This Methylation Microarray Analysis is performed on Central Nervous System (CNS) tumors using the Illumina MethylationEPIC BeadChip version 2 platform and software developed by the Nationwide Children’s Hospital Institute for Genomic Medicine (IGM) to subtype CNS tumors. This array assesses the CNS tumor methylation profile and compares it to over 3,900 reference CNS cases to create a classification prediction score indicating the resemblance to a CNS tumor subtype (see reference below). Results will use the IGM CNS classifier to indicate a methylation class specific to a CNS subtype categorized as “consistent with," “no match, but potentially suggestive of,” or “tumor classification not determined,” as well as MGMT methylation status.

This analysis is intended to aid and refine the pathological diagnoses of CNS tumors. Results should be interpreted in conjunction with other laboratory findings, such as histology, and molecular testing. This analysis should NOT be used as a stand-alone diagnostic test. Patient samples of rare subtypes that are not in the classifier reference set may result in a low classifier prediction score.

References:

  1. Louis DN, Perry A, Wesseling P, et al. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. Neuro Oncol 23(8),1231-1251 (2021). PMID: 34185076.

Methodology

Methylation Microarray
NCH Lab Only

Special Collection

At least 60% tumor must be present in the submitted sample (Based on internal pathology review). Snap-frozen tissue is preferred.

Outpatient Submit with Specimen

Collect

Specimen Type Type of Container Volume of Specimen Status
Tissue (Snap-frozen) Tissue cassette mass 0.05 grams Preferred
Tissue (Snap-frozen) Cryogenic tube mass 0.05 grams Alternate
OCT-embedded tissue Tissue cassette mass 0.05 grams Alternate
OCT-embedded tissue Cryogenic tube mass 0.05 grams Alternate
Paraffin embedded tissue Paraffin block   Alternate
Tissue (Fresh) Sterile container with saline mass 0.05 grams Alternate
Tissue scrolls (FFPE) Sterile container   Alternate

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) Sterile container with saline  
Tissue scrolls (FFPE) Sterile container  

Inpatient Specimen Preparation

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

OCT-embedded tissue: Freeze immediately after collection.
                                      Keep frozen
                                      Protect from heat
                                      Transport to laboratory as soon as possible

Paraffin embedded tissue: Keep at room temperature
                                           Protect from heat

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

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

Outpatient Specimen Preparation

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

OCT-embedded tissue: Freeze immediately after collection.
                                      Keep frozen
                                      Protect from heat
                                      Transport to laboratory as soon as possible

Paraffin embedded tissue: Keep at room temperature
                                           Protect from heat

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

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

InLab Processing

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

Stability

Tissue (Snap-frozen): Frozen 24 hour(s)

OCT-embedded tissue: Frozen 24 hour(s)

Paraffin embedded tissue: Room temperature 6 month(s)

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

Tissue (Snap-frozen): Frozen 24 hour(s)

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

Unacceptable Conditions

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

Days Performed

Monday through Saturday

Set Up Schedule

All tests not performed daily.

Typical Turnaround

2 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, and provider MUST call the laboratory at 722-5321 to initiate the sample transfer and testing.

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

SPECIMEN INFORMATION:

  1. At least 60% tumor must be present in the submitted CNS tumor sample. A result from a sample containing <60% tumor may be reported as unsatisfactory (no results reported). A pathology report from the submitted sample is required. An internal pathology review will also be performed on submitted tumor samples to verify tumor content.
  2. All specimens must be labeled with a patient name and other identifier (DOB, MRN, Specimen ID#, etc.). Sample acquisition prior to receiving therapy is strongly preferred.
  3. An FFPE tissue block is preferred over FFPE tissue scrolls. If submitting 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. Tissue blocks can be returned to the treating institution upon request.

SPECIMEN SHIPPING:

Ship all samples via overnight delivery. Saturday deliveries are accepted; please check Saturday Delivery on shipment label. 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). FFPE tissue and FFPE tissue scrolls should be sent at room temperature via overnight shipping.

Clinical Information

This Methylation Microarray Analysis is performed on Central Nervous System (CNS) tumors using the Illumina MethylationEPIC BeadChip version 2 platform and software developed by the Nationwide Children’s Hospital Institute for Genomic Medicine (IGM) to subtype CNS tumors. This array assesses the CNS tumor methylation profile and compares it to over 3,900 reference CNS cases to create a classification prediction score indicating the resemblance to a CNS tumor subtype (see reference below). Results will use the IGM CNS classifier to indicate a methylation class specific to a CNS subtype categorized as “consistent with," “no match, but potentially suggestive of,” or “tumor classification not determined,” as well as MGMT methylation status.

This analysis is intended to aid and refine the pathological diagnoses of CNS tumors. Results should be interpreted in conjunction with other laboratory findings, such as histology, and molecular testing. This analysis should NOT be used as a stand-alone diagnostic test. Patient samples of rare subtypes that are not in the classifier reference set may result in a low classifier prediction score.

References:

  1. Louis DN, Perry A, Wesseling P, et al. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. Neuro Oncol 23(8),1231-1251 (2021). PMID: 34185076.

Synonyms

  • Methyl array, methylation array, CNS tumor, Tumor classification, Central Nervous System array, Central Nervous System classification, Tumor subtyping, Tumor class, MGMT analysis, Brain cancer, Brain tumor, Methylation microarray, CNS cancer, MGMT methylation, Methylation, Cancer microarray, cancer array, MGMT, DKFZ, Methyl, CNS tumor, CNS subtype, array, CNS, Central Nervous System, Tumor, cancer, brain, microarray, IGM Test, CNS methyl

Methodology

Methylation Microarray

CPT Codes

81287, 81479

Estimated Patient Price

$1,000 - $2,500

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