Special Collection

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

Outpatient Submit with Specimen

Collect

Specimen Type Type of Container Volume of Specimen Status
Unstained tissue slides Unstained slides and consecutive cut H&E 10 slides,
10 microns thick
Preferred
Paraffin embedded tissue Paraffin block 1 block Preferred
Tissue (Snap-frozen) Tissue cassette 50 mg Alternate
Tissue (Snap-frozen) Cryogenic tube 50 mg Alternate
OCT-embedded tissue Tissue cassette 50 mg Alternate
OCT-embedded tissue Cryogenic tube 50 mg Alternate
Tissue (Fresh) Tissue culture transport media 50 mg Alternate
Tissue (Fresh) Sterile container with saline 50 mg Alternate
Tissue scrolls (FFPE) Sterile container 10-15 scrolls,
5-10 microns thick
Alternate
DNA
*Must be extracted in a
CLIA approved lab
Microcentrifuge tube Contact IGM lab Alternate


Outpatient Specimen Preparation

Unstained slides: Keep at room temperature
                          Protect from heat
                          Must accompany H&E slide from adjacent section
                          Samples decalcified with a strong acid are not accepted. EDTA-based decalcification                                      methods (such as Formical) are acceptable.
                        
Paraffin embedded tissue: Keep at room temperature
                                       Protect from heat

Tissue (Snap-frozen): Freeze immediately after collection
                                 Transport to laboratory as soon as possible

OCT-embedded tissue: Freeze immediately after collection
                                  Transport to laboratory as soon as possible

Tissue (Fresh): Do not add fixative
                       Do not formalin fix the sample
                       Transport to laboratory as soon as possible
                       Keep at room temperature or refrigerate

Tissue scrolls: Must accompany H&E slide from adjacent section
                      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

Unstained slides: Room temperature 12 months

Paraffin embedded tissue: Room temperature 12 months

Tissue (Snap-frozen): Frozen 36 months

OCT-embedded tissue: Frozen 36 months

Tissue (Fresh): Refrigerated 3 days
Tissue (Fresh): Room temperature 4 hours

Tissue scrolls (FFPE): Room temperature 12 months

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 or slide specimen, please submit 10-15 FFPE scrolls or slides (5-10 microns thick) and and adjacent H&E slide, or use this Tissue Scroll Calculator tool to determine the thickness and number of tissue scrolls to send to the laboratory (approximately 300mm2 at 10 microns thickness).

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 or slides, an H&E slide from a consecutive cut is also 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

81524

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). FFPE tissue is preferred.

Collect

Specimen Type Type of Container Volume of Specimen Status
Unstained tissue slides Unstained slides and consecutive cut H&E 10 slides,
10 microns thick
Preferred
Paraffin embedded tissue Paraffin block 1 block Preferred
Tissue (Snap-frozen) Tissue cassette 50 mg Alternate
Tissue (Snap-frozen) Cryogenic tube 50 mg Alternate
OCT-embedded tissue Tissue cassette 50 mg Alternate
OCT-embedded tissue Cryogenic tube 50 mg Alternate
Tissue (Fresh) Tissue culture transport media 50 mg Alternate
Tissue (Fresh) Sterile container with saline 50 mg Alternate
Tissue scrolls (FFPE) Sterile container 10-15 scrolls,
5-10 microns thick
Alternate
DNA
*Must be extracted in a
CLIA approved lab
Microcentrifuge tube Contact IGM lab Alternate


Minimum Volume

Specimen TypeType of ContainerVolume of SpecimenStatus
Unstained tissue slidesUnstained slides and consecutive cut H&E10 slides,
10 microns thick
Preferred
Paraffin embedded tissueParaffin block1 blockPreferred
Tissue (Snap-frozen)Tissue cassette30 mgAlternate
Tissue (Snap-frozen)Cryogenic tube30 mgAlternate
OCT-embedded tissueTissue cassette30 mgAlternate
OCT-embedded tissueCryogenic tube30 mgAlternate
Tissue (Fresh)Tissue culture transport media30 mgAlternate
Tissue (Fresh)Sterile container with saline30 mgAlternate
Tissue scrolls (FFPE)Sterile container10-15 scrolls,
5-10 microns thick
Alternate
DNA
*Must be extracted in a
CLIA approved lab
Microcentrifuge tubeContact IGM labAlternate


Inpatient Specimen Preparation

Unstained slides: Keep at room temperature
                          Protect from heat
                          Must accompany H&E slide from adjacent section
                          Samples decalcified with a strong acid are not accepted. EDTA-based decalcification                                      methods (such as Formical) are acceptable.
                        
Paraffin embedded tissue: Keep at room temperature
                                       Protect from heat

Tissue (Snap-frozen): Freeze immediately after collection
                                 Transport to laboratory as soon as possible

OCT-embedded tissue: Freeze immediately after collection
                                  Transport to laboratory as soon as possible

Tissue (Fresh): Do not add fixative
                         Do not formalin fix the sample
                         Transport to laboratory as soon as possible
                         Keep at room temperature or refrigerate

Tissue scrolls: Must accompany H&E slide from adjacent section
                     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

Unstained slides: Room temperature 12 months

Paraffin embedded tissue: Room temperature 12 months

Tissue (Snap-frozen): Frozen 36 months

OCT-embedded tissue: Frozen 36 months

Tissue (Fresh): Refrigerated 3 days
Tissue (Fresh): Room temperature 4 hours

Tissue scrolls (FFPE): Room temperature 12 months

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 or slide specimen, please submit 10-15 FFPE scrolls or slides (5-10 microns thick) and and adjacent H&E slide, or use this Tissue Scroll Calculator tool to determine the thickness and number of tissue scrolls to send to the laboratory (approximately 300mm2 at 10 microns thickness).

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 or slides, an H&E slide from a consecutive cut is also 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

81524

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

81524

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). FFPE tissue is preferred.

Outpatient Submit with Specimen

Collect

Specimen Type Type of Container Volume of Specimen Status
Unstained tissue slides Unstained slides and consecutive cut H&E 10 slides,
10 microns thick
Preferred
Paraffin embedded tissue Paraffin block 1 block Preferred
Tissue (Snap-frozen) Tissue cassette 50 mg Alternate
Tissue (Snap-frozen) Cryogenic tube 50 mg Alternate
OCT-embedded tissue Tissue cassette 50 mg Alternate
OCT-embedded tissue Cryogenic tube 50 mg Alternate
Tissue (Fresh) Tissue culture transport media 50 mg Alternate
Tissue (Fresh) Sterile container with saline 50 mg Alternate
Tissue scrolls (FFPE) Sterile container 10-15 scrolls,
5-10 microns thick
Alternate
DNA
*Must be extracted in a
CLIA approved lab
Microcentrifuge tube Contact IGM lab Alternate


Minimum Volume

Specimen TypeType of ContainerVolume of SpecimenStatus
Unstained tissue slidesUnstained slides and consecutive cut H&E10 slides,
10 microns thick
Preferred
Paraffin embedded tissueParaffin block1 blockPreferred
Tissue (Snap-frozen)Tissue cassette30 mgAlternate
Tissue (Snap-frozen)Cryogenic tube30 mgAlternate
OCT-embedded tissueTissue cassette30 mgAlternate
OCT-embedded tissueCryogenic tube30 mgAlternate
Tissue (Fresh)Tissue culture transport media30 mgAlternate
Tissue (Fresh)Sterile container with saline30 mgAlternate
Tissue scrolls (FFPE)Sterile container10-15 scrolls,
5-10 microns thick
Alternate
DNA
*Must be extracted in a
CLIA approved lab
Microcentrifuge tubeContact IGM labAlternate


Inpatient Specimen Preparation

Unstained slides: Keep at room temperature
                          Protect from heat
                          Must accompany H&E slide from adjacent section
                          Samples decalcified with a strong acid are not accepted. EDTA-based decalcification                                      methods (such as Formical) are acceptable.
                        
Paraffin embedded tissue: Keep at room temperature
                                       Protect from heat

Tissue (Snap-frozen): Freeze immediately after collection
                                 Transport to laboratory as soon as possible

OCT-embedded tissue: Freeze immediately after collection
                                  Transport to laboratory as soon as possible

Tissue (Fresh): Do not add fixative
                         Do not formalin fix the sample
                         Transport to laboratory as soon as possible
                         Keep at room temperature or refrigerate

Tissue scrolls: Must accompany H&E slide from adjacent section
                     Protect from heat, Keep at room temperature

Outpatient Specimen Preparation

Unstained slides: Keep at room temperature
                          Protect from heat
                          Must accompany H&E slide from adjacent section
                          Samples decalcified with a strong acid are not accepted. EDTA-based decalcification                                      methods (such as Formical) are acceptable.
                        
Paraffin embedded tissue: Keep at room temperature
                                       Protect from heat

Tissue (Snap-frozen): Freeze immediately after collection
                                 Transport to laboratory as soon as possible

OCT-embedded tissue: Freeze immediately after collection
                                  Transport to laboratory as soon as possible

Tissue (Fresh): Do not add fixative
                       Do not formalin fix the sample
                       Transport to laboratory as soon as possible
                       Keep at room temperature or refrigerate

Tissue scrolls: Must accompany H&E slide from adjacent section
                      Protect from heat, Keep at room temperature

InLab Processing

Send to the Institute for Genomic Medicine (IGM) Lab with all submitted paperwork. For Non-EPIC lab orders, lab staff to order GENSP in Sunquest.

Stability

Unstained slides: Room temperature 12 months

Paraffin embedded tissue: Room temperature 12 months

Tissue (Snap-frozen): Frozen 36 months

OCT-embedded tissue: Frozen 36 months

Tissue (Fresh): Refrigerated 3 days
Tissue (Fresh): Room temperature 4 hours

Tissue scrolls (FFPE): Room temperature 12 months

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 or slide specimen, please submit 10-15 FFPE scrolls or slides (5-10 microns thick) and and adjacent H&E slide, or use this Tissue Scroll Calculator tool to determine the thickness and number of tissue scrolls to send to the laboratory (approximately 300mm2 at 10 microns thickness).

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 or slides, an H&E slide from a consecutive cut is also 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

81524

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). FFPE tissue is preferred.

Outpatient Submit with Specimen

Collect

Specimen Type Type of Container Volume of Specimen Status
Unstained tissue slides Unstained slides and consecutive cut H&E 10 slides,
10 microns thick
Preferred
Paraffin embedded tissue Paraffin block 1 block Preferred
Tissue (Snap-frozen) Tissue cassette 50 mg Alternate
Tissue (Snap-frozen) Cryogenic tube 50 mg Alternate
OCT-embedded tissue Tissue cassette 50 mg Alternate
OCT-embedded tissue Cryogenic tube 50 mg Alternate
Tissue (Fresh) Tissue culture transport media 50 mg Alternate
Tissue (Fresh) Sterile container with saline 50 mg Alternate
Tissue scrolls (FFPE) Sterile container 10-15 scrolls,
5-10 microns thick
Alternate
DNA
*Must be extracted in a
CLIA approved lab
Microcentrifuge tube Contact IGM lab Alternate


Outpatient Specimen Preparation

Unstained slides: Keep at room temperature
                          Protect from heat
                          Must accompany H&E slide from adjacent section
                          Samples decalcified with a strong acid are not accepted. EDTA-based decalcification                                      methods (such as Formical) are acceptable.
                        
Paraffin embedded tissue: Keep at room temperature
                                       Protect from heat

Tissue (Snap-frozen): Freeze immediately after collection
                                 Transport to laboratory as soon as possible

OCT-embedded tissue: Freeze immediately after collection
                                  Transport to laboratory as soon as possible

Tissue (Fresh): Do not add fixative
                       Do not formalin fix the sample
                       Transport to laboratory as soon as possible
                       Keep at room temperature or refrigerate

Tissue scrolls: Must accompany H&E slide from adjacent section
                      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

Unstained slides: Room temperature 12 months

Paraffin embedded tissue: Room temperature 12 months

Tissue (Snap-frozen): Frozen 36 months

OCT-embedded tissue: Frozen 36 months

Tissue (Fresh): Refrigerated 3 days
Tissue (Fresh): Room temperature 4 hours

Tissue scrolls (FFPE): Room temperature 12 months

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 or slide specimen, please submit 10-15 FFPE scrolls or slides (5-10 microns thick) and and adjacent H&E slide, or use this Tissue Scroll Calculator tool to determine the thickness and number of tissue scrolls to send to the laboratory (approximately 300mm2 at 10 microns thickness).

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 or slides, an H&E slide from a consecutive cut is also 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

81524

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). FFPE tissue is preferred.

Collect

Specimen Type Type of Container Volume of Specimen Status
Unstained tissue slides Unstained slides and consecutive cut H&E 10 slides,
10 microns thick
Preferred
Paraffin embedded tissue Paraffin block 1 block Preferred
Tissue (Snap-frozen) Tissue cassette 50 mg Alternate
Tissue (Snap-frozen) Cryogenic tube 50 mg Alternate
OCT-embedded tissue Tissue cassette 50 mg Alternate
OCT-embedded tissue Cryogenic tube 50 mg Alternate
Tissue (Fresh) Tissue culture transport media 50 mg Alternate
Tissue (Fresh) Sterile container with saline 50 mg Alternate
Tissue scrolls (FFPE) Sterile container 10-15 scrolls,
5-10 microns thick
Alternate
DNA
*Must be extracted in a
CLIA approved lab
Microcentrifuge tube Contact IGM lab Alternate


Minimum Volume

Specimen TypeType of ContainerVolume of SpecimenStatus
Unstained tissue slidesUnstained slides and consecutive cut H&E10 slides,
10 microns thick
Preferred
Paraffin embedded tissueParaffin block1 blockPreferred
Tissue (Snap-frozen)Tissue cassette30 mgAlternate
Tissue (Snap-frozen)Cryogenic tube30 mgAlternate
OCT-embedded tissueTissue cassette30 mgAlternate
OCT-embedded tissueCryogenic tube30 mgAlternate
Tissue (Fresh)Tissue culture transport media30 mgAlternate
Tissue (Fresh)Sterile container with saline30 mgAlternate
Tissue scrolls (FFPE)Sterile container10-15 scrolls,
5-10 microns thick
Alternate
DNA
*Must be extracted in a
CLIA approved lab
Microcentrifuge tubeContact IGM labAlternate


Inpatient Specimen Preparation

Unstained slides: Keep at room temperature
                          Protect from heat
                          Must accompany H&E slide from adjacent section
                          Samples decalcified with a strong acid are not accepted. EDTA-based decalcification                                      methods (such as Formical) are acceptable.
                        
Paraffin embedded tissue: Keep at room temperature
                                       Protect from heat

Tissue (Snap-frozen): Freeze immediately after collection
                                 Transport to laboratory as soon as possible

OCT-embedded tissue: Freeze immediately after collection
                                  Transport to laboratory as soon as possible

Tissue (Fresh): Do not add fixative
                         Do not formalin fix the sample
                         Transport to laboratory as soon as possible
                         Keep at room temperature or refrigerate

Tissue scrolls: Must accompany H&E slide from adjacent section
                     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

Unstained slides: Room temperature 12 months

Paraffin embedded tissue: Room temperature 12 months

Tissue (Snap-frozen): Frozen 36 months

OCT-embedded tissue: Frozen 36 months

Tissue (Fresh): Refrigerated 3 days
Tissue (Fresh): Room temperature 4 hours

Tissue scrolls (FFPE): Room temperature 12 months

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 or slide specimen, please submit 10-15 FFPE scrolls or slides (5-10 microns thick) and and adjacent H&E slide, or use this Tissue Scroll Calculator tool to determine the thickness and number of tissue scrolls to send to the laboratory (approximately 300mm2 at 10 microns thickness).

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 or slides, an H&E slide from a consecutive cut is also 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

81524

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

81524
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). FFPE tissue is preferred.

Outpatient Submit with Specimen

Collect

Specimen Type Type of Container Volume of Specimen Status
Unstained tissue slides Unstained slides and consecutive cut H&E 10 slides,
10 microns thick
Preferred
Paraffin embedded tissue Paraffin block 1 block Preferred
Tissue (Snap-frozen) Tissue cassette 50 mg Alternate
Tissue (Snap-frozen) Cryogenic tube 50 mg Alternate
OCT-embedded tissue Tissue cassette 50 mg Alternate
OCT-embedded tissue Cryogenic tube 50 mg Alternate
Tissue (Fresh) Tissue culture transport media 50 mg Alternate
Tissue (Fresh) Sterile container with saline 50 mg Alternate
Tissue scrolls (FFPE) Sterile container 10-15 scrolls,
5-10 microns thick
Alternate
DNA
*Must be extracted in a
CLIA approved lab
Microcentrifuge tube Contact IGM lab Alternate


Minimum Volume

Specimen TypeType of ContainerVolume of SpecimenStatus
Unstained tissue slidesUnstained slides and consecutive cut H&E10 slides,
10 microns thick
Preferred
Paraffin embedded tissueParaffin block1 blockPreferred
Tissue (Snap-frozen)Tissue cassette30 mgAlternate
Tissue (Snap-frozen)Cryogenic tube30 mgAlternate
OCT-embedded tissueTissue cassette30 mgAlternate
OCT-embedded tissueCryogenic tube30 mgAlternate
Tissue (Fresh)Tissue culture transport media30 mgAlternate
Tissue (Fresh)Sterile container with saline30 mgAlternate
Tissue scrolls (FFPE)Sterile container10-15 scrolls,
5-10 microns thick
Alternate
DNA
*Must be extracted in a
CLIA approved lab
Microcentrifuge tubeContact IGM labAlternate


Inpatient Specimen Preparation

Unstained slides: Keep at room temperature
                          Protect from heat
                          Must accompany H&E slide from adjacent section
                          Samples decalcified with a strong acid are not accepted. EDTA-based decalcification                                      methods (such as Formical) are acceptable.
                        
Paraffin embedded tissue: Keep at room temperature
                                       Protect from heat

Tissue (Snap-frozen): Freeze immediately after collection
                                 Transport to laboratory as soon as possible

OCT-embedded tissue: Freeze immediately after collection
                                  Transport to laboratory as soon as possible

Tissue (Fresh): Do not add fixative
                         Do not formalin fix the sample
                         Transport to laboratory as soon as possible
                         Keep at room temperature or refrigerate

Tissue scrolls: Must accompany H&E slide from adjacent section
                     Protect from heat, Keep at room temperature

Outpatient Specimen Preparation

Unstained slides: Keep at room temperature
                          Protect from heat
                          Must accompany H&E slide from adjacent section
                          Samples decalcified with a strong acid are not accepted. EDTA-based decalcification                                      methods (such as Formical) are acceptable.
                        
Paraffin embedded tissue: Keep at room temperature
                                       Protect from heat

Tissue (Snap-frozen): Freeze immediately after collection
                                 Transport to laboratory as soon as possible

OCT-embedded tissue: Freeze immediately after collection
                                  Transport to laboratory as soon as possible

Tissue (Fresh): Do not add fixative
                       Do not formalin fix the sample
                       Transport to laboratory as soon as possible
                       Keep at room temperature or refrigerate

Tissue scrolls: Must accompany H&E slide from adjacent section
                      Protect from heat, Keep at room temperature

InLab Processing

Send to the Institute for Genomic Medicine (IGM) Lab with all submitted paperwork. For Non-EPIC lab orders, lab staff to order GENSP in Sunquest.

Stability

Unstained slides: Room temperature 12 months

Paraffin embedded tissue: Room temperature 12 months

Tissue (Snap-frozen): Frozen 36 months

OCT-embedded tissue: Frozen 36 months

Tissue (Fresh): Refrigerated 3 days
Tissue (Fresh): Room temperature 4 hours

Tissue scrolls (FFPE): Room temperature 12 months

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 or slide specimen, please submit 10-15 FFPE scrolls or slides (5-10 microns thick) and and adjacent H&E slide, or use this Tissue Scroll Calculator tool to determine the thickness and number of tissue scrolls to send to the laboratory (approximately 300mm2 at 10 microns thickness).

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 or slides, an H&E slide from a consecutive cut is also 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

81524

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