Ordering Recommendations

Determine DNA variants and their allele frequencies in genes commonly mutated in myeloid malignancies and related disorders, at diagnosis, relapse and during remission.  This assay serves as a primary approach and a complement to morphology, immunophenotyping by flow cytometry and cytogenetic workups.

Performing Lab

Genomic Services - Molecular Diagnostics

Performed

Run 1x per week, or as needed, day shift only

Methodology

DNA extraction and Next Generation DNA sequencing (NGS) on the Illumina platform

Reported

6-14 days

Additional Information

This Myeloid Multi Gene Panel (MMGP) Next Generation Sequencing test detects and determines the variant allele frequency (VAF) of DNA variants in exons and flanking splice sites in 52 genes (listed below) that are commonly mutated in myeloid malignancies. Pathogenicity of the detected DNA variants are reported based on established criteria in databases such as ClinVar and COSMIC, while Variants of Unknown Significance (VUS) are reported based on their potential disruption of gene and/or protein function and whether they are unlisted or occur at very low allelic frequencies in general population databases such as GnomAD. 

This assay is particularly relevant for the detection of DNA variants at diagnosis of suspected myeloid malignancies and for minimal residual disease (MRD) monitoring at relapse and during remission. The sensitivity of mutation detection of this assay routinely  down to 1% variant allele frequency (VAF) includes FLT3-ITD and other variants, which can also be reported at < 1% when monitoring for previously detected variants in the same patient.

Myeloid Multi Gene Panel 
ABL1, ASXL1, BCOR, BCORL1, BRAF, CALR, CBL, CDKN2A, CEBPA, CSF3R, CUX1, DDX41, DNMT3A, ETV6, EZH2, FLT3, GATA2, GNAS, HRAS, IDH1, IDH2, JAK2, JAK3, KIT, KMT2A, KRAS, MPL, NF1, NPM1, NRAS, PHF6, PIGA, PPM1D, PRPF8, PTEN, PTPN11, RAD21, RRAS2, RUNX1, SETBP1, SF3B1, SH2B3, SMC3, SRSF2, STAG2, STAT3, STAT5B, TET2, TP53, U2AF1, WT1 and ZRSR2.

 

Reflex Testing

To determine the FLT3 ITD allele ratio, an automatic reflex FLT3 assay by capillary electrophoresis (CE) will be ordered (with an additional charge) if a FLT3 ITD is detected and the FLT3 CE assay was not previously ordered on the same specimen. To skip this reflex test, please call the lab directly at (415)514-8488 or email ClinLabMDx@ucsf.edu.

Synonyms

  • MYEBL
  • MYENB
  • Acute myeloid leukemia (AML)
  • Chronic myeloid leukemia (CML)
  • Myeloproliferative disorders (MPD)
  • Myelodysplastic syndromes (MDS)
  • Next Generation Sequencing (NGS)

Sample Type

Tumor sample: EDTA whole blood, Bone marrow aspirate and FFPE tissue

Germline sample: Buccal swabs 

Collect

Lavender top (EDTA)

Preferred Volume

Tumor Sample
Blood: 3 mL
Bone marrow aspirate: 3 mL
FFPE: 10 micron sections x5 on uncharged, unstained, glass slides

Germline Sample
Collect 4-6 cytobrushes/cotton swabs on each side of the mouth, place swabs in transport tubes, 2 swabs per tube.
 

Minimum Volume

Tumor Sample
Blood: 2 mL
Bone marrow aspirate: 2 mL
FFPE: 10 micron sections x3 on uncharged, unstained, glass slides

Germline Sample
Collect 2-4 cytobrushes/cotton swabs on each side of the mouth, place swabs in transport tubes, 2 swabs per tube.
 

Remarks

Do not collect sample in heparin. Keep sample refrigerated for overnight or longer storage.

Stability (from collection to initiation)

Refrigerated 1 week, frozen at -20C unacceptable.

Storage/Transport Temperature

Refrigerated 

Unacceptable Conditions

Heparinized sample submitted. 

Test Code

MYEBL: Blood
MYENB: Non-blood

Performing Lab

Genomic Services - Molecular Diagnostics

Preferred Volume

Tumor Sample
Blood: 3 mL
Bone marrow aspirate: 3 mL
FFPE: 10 micron sections x5 on uncharged, unstained, glass slides

Germline Sample
Collect 4-6 cytobrushes/cotton swabs on each side of the mouth, place swabs in transport tubes, 2 swabs per tube.
 

Minimum Volume

Tumor Sample
Blood: 2 mL
Bone marrow aspirate: 2 mL
FFPE: 10 micron sections x3 on uncharged, unstained, glass slides

Germline Sample
Collect 2-4 cytobrushes/cotton swabs on each side of the mouth, place swabs in transport tubes, 2 swabs per tube.
 

Unacceptable Conditions

Heparinized sample submitted. 

Stability (from collection to initiation)

Refrigerated 1 week, frozen at -20C unacceptable.

Storage/Transport Temperature

Refrigerated 

Reference Interval

Negative

Additional Information

This Myeloid Multi Gene Panel (MMGP) Next Generation Sequencing test detects and determines the variant allele frequency (VAF) of DNA variants in exons and flanking splice sites in 52 genes (listed below) that are commonly mutated in myeloid malignancies. Pathogenicity of the detected DNA variants are reported based on established criteria in databases such as ClinVar and COSMIC, while Variants of Unknown Significance (VUS) are reported based on their potential disruption of gene and/or protein function and whether they are unlisted or occur at very low allelic frequencies in general population databases such as GnomAD. 

This assay is particularly relevant for the detection of DNA variants at diagnosis of suspected myeloid malignancies and for minimal residual disease (MRD) monitoring at relapse and during remission. The sensitivity of mutation detection of this assay routinely  down to 1% variant allele frequency (VAF) includes FLT3-ITD and other variants, which can also be reported at < 1% when monitoring for previously detected variants in the same patient.

Myeloid Multi Gene Panel 
ABL1, ASXL1, BCOR, BCORL1, BRAF, CALR, CBL, CDKN2A, CEBPA, CSF3R, CUX1, DDX41, DNMT3A, ETV6, EZH2, FLT3, GATA2, GNAS, HRAS, IDH1, IDH2, JAK2, JAK3, KIT, KMT2A, KRAS, MPL, NF1, NPM1, NRAS, PHF6, PIGA, PPM1D, PRPF8, PTEN, PTPN11, RAD21, RRAS2, RUNX1, SETBP1, SF3B1, SH2B3, SMC3, SRSF2, STAG2, STAT3, STAT5B, TET2, TP53, U2AF1, WT1 and ZRSR2.

 

CPT Codes

81450

LDT or Modified FDA

Yes

Ordering Recommendations

Determine DNA variants and their allele frequencies in genes commonly mutated in myeloid malignancies and related disorders, at diagnosis, relapse and during remission.  This assay serves as a primary approach and a complement to morphology, immunophenotyping by flow cytometry and cytogenetic workups.

Test Code

MYEBL: Blood
MYENB: Non-blood

Performing Lab

Genomic Services - Molecular Diagnostics

Performed

Run 1x per week, or as needed, day shift only

Methodology

DNA extraction and Next Generation DNA sequencing (NGS) on the Illumina platform

Remarks

Do not collect sample in heparin. Keep sample refrigerated for overnight or longer storage.

Collect

Lavender top (EDTA)

Sample Type

Tumor sample: EDTA whole blood, Bone marrow aspirate and FFPE tissue

Germline sample: Buccal swabs 

Preferred Volume

Tumor Sample
Blood: 3 mL
Bone marrow aspirate: 3 mL
FFPE: 10 micron sections x5 on uncharged, unstained, glass slides

Germline Sample
Collect 4-6 cytobrushes/cotton swabs on each side of the mouth, place swabs in transport tubes, 2 swabs per tube.
 

Minimum Volume

Tumor Sample
Blood: 2 mL
Bone marrow aspirate: 2 mL
FFPE: 10 micron sections x3 on uncharged, unstained, glass slides

Germline Sample
Collect 2-4 cytobrushes/cotton swabs on each side of the mouth, place swabs in transport tubes, 2 swabs per tube.
 

Unacceptable Conditions

Heparinized sample submitted. 

Reference Interval

Negative

Synonyms

  • MYEBL
  • MYENB
  • Acute myeloid leukemia (AML)
  • Chronic myeloid leukemia (CML)
  • Myeloproliferative disorders (MPD)
  • Myelodysplastic syndromes (MDS)
  • Next Generation Sequencing (NGS)

Storage/Transport Temperature

Refrigerated 

Stability (from collection to initiation)

Refrigerated 1 week, frozen at -20C unacceptable.

Reported

6-14 days

Reflex Testing

To determine the FLT3 ITD allele ratio, an automatic reflex FLT3 assay by capillary electrophoresis (CE) will be ordered (with an additional charge) if a FLT3 ITD is detected and the FLT3 CE assay was not previously ordered on the same specimen. To skip this reflex test, please call the lab directly at (415)514-8488 or email ClinLabMDx@ucsf.edu.

Additional Information

This Myeloid Multi Gene Panel (MMGP) Next Generation Sequencing test detects and determines the variant allele frequency (VAF) of DNA variants in exons and flanking splice sites in 52 genes (listed below) that are commonly mutated in myeloid malignancies. Pathogenicity of the detected DNA variants are reported based on established criteria in databases such as ClinVar and COSMIC, while Variants of Unknown Significance (VUS) are reported based on their potential disruption of gene and/or protein function and whether they are unlisted or occur at very low allelic frequencies in general population databases such as GnomAD. 

This assay is particularly relevant for the detection of DNA variants at diagnosis of suspected myeloid malignancies and for minimal residual disease (MRD) monitoring at relapse and during remission. The sensitivity of mutation detection of this assay routinely  down to 1% variant allele frequency (VAF) includes FLT3-ITD and other variants, which can also be reported at < 1% when monitoring for previously detected variants in the same patient.

Myeloid Multi Gene Panel 
ABL1, ASXL1, BCOR, BCORL1, BRAF, CALR, CBL, CDKN2A, CEBPA, CSF3R, CUX1, DDX41, DNMT3A, ETV6, EZH2, FLT3, GATA2, GNAS, HRAS, IDH1, IDH2, JAK2, JAK3, KIT, KMT2A, KRAS, MPL, NF1, NPM1, NRAS, PHF6, PIGA, PPM1D, PRPF8, PTEN, PTPN11, RAD21, RRAS2, RUNX1, SETBP1, SF3B1, SH2B3, SMC3, SRSF2, STAG2, STAT3, STAT5B, TET2, TP53, U2AF1, WT1 and ZRSR2.

 

CPT Codes

81450

LDT or Modified FDA

Yes
Ordering

Ordering Recommendations

Determine DNA variants and their allele frequencies in genes commonly mutated in myeloid malignancies and related disorders, at diagnosis, relapse and during remission.  This assay serves as a primary approach and a complement to morphology, immunophenotyping by flow cytometry and cytogenetic workups.

Performing Lab

Genomic Services - Molecular Diagnostics

Performed

Run 1x per week, or as needed, day shift only

Methodology

DNA extraction and Next Generation DNA sequencing (NGS) on the Illumina platform

Reported

6-14 days

Additional Information

This Myeloid Multi Gene Panel (MMGP) Next Generation Sequencing test detects and determines the variant allele frequency (VAF) of DNA variants in exons and flanking splice sites in 52 genes (listed below) that are commonly mutated in myeloid malignancies. Pathogenicity of the detected DNA variants are reported based on established criteria in databases such as ClinVar and COSMIC, while Variants of Unknown Significance (VUS) are reported based on their potential disruption of gene and/or protein function and whether they are unlisted or occur at very low allelic frequencies in general population databases such as GnomAD. 

This assay is particularly relevant for the detection of DNA variants at diagnosis of suspected myeloid malignancies and for minimal residual disease (MRD) monitoring at relapse and during remission. The sensitivity of mutation detection of this assay routinely  down to 1% variant allele frequency (VAF) includes FLT3-ITD and other variants, which can also be reported at < 1% when monitoring for previously detected variants in the same patient.

Myeloid Multi Gene Panel 
ABL1, ASXL1, BCOR, BCORL1, BRAF, CALR, CBL, CDKN2A, CEBPA, CSF3R, CUX1, DDX41, DNMT3A, ETV6, EZH2, FLT3, GATA2, GNAS, HRAS, IDH1, IDH2, JAK2, JAK3, KIT, KMT2A, KRAS, MPL, NF1, NPM1, NRAS, PHF6, PIGA, PPM1D, PRPF8, PTEN, PTPN11, RAD21, RRAS2, RUNX1, SETBP1, SF3B1, SH2B3, SMC3, SRSF2, STAG2, STAT3, STAT5B, TET2, TP53, U2AF1, WT1 and ZRSR2.

 

Reflex Testing

To determine the FLT3 ITD allele ratio, an automatic reflex FLT3 assay by capillary electrophoresis (CE) will be ordered (with an additional charge) if a FLT3 ITD is detected and the FLT3 CE assay was not previously ordered on the same specimen. To skip this reflex test, please call the lab directly at (415)514-8488 or email ClinLabMDx@ucsf.edu.

Synonyms

  • MYEBL
  • MYENB
  • Acute myeloid leukemia (AML)
  • Chronic myeloid leukemia (CML)
  • Myeloproliferative disorders (MPD)
  • Myelodysplastic syndromes (MDS)
  • Next Generation Sequencing (NGS)
Collection

Sample Type

Tumor sample: EDTA whole blood, Bone marrow aspirate and FFPE tissue

Germline sample: Buccal swabs 

Collect

Lavender top (EDTA)

Preferred Volume

Tumor Sample
Blood: 3 mL
Bone marrow aspirate: 3 mL
FFPE: 10 micron sections x5 on uncharged, unstained, glass slides

Germline Sample
Collect 4-6 cytobrushes/cotton swabs on each side of the mouth, place swabs in transport tubes, 2 swabs per tube.
 

Minimum Volume

Tumor Sample
Blood: 2 mL
Bone marrow aspirate: 2 mL
FFPE: 10 micron sections x3 on uncharged, unstained, glass slides

Germline Sample
Collect 2-4 cytobrushes/cotton swabs on each side of the mouth, place swabs in transport tubes, 2 swabs per tube.
 

Remarks

Do not collect sample in heparin. Keep sample refrigerated for overnight or longer storage.

Stability (from collection to initiation)

Refrigerated 1 week, frozen at -20C unacceptable.

Storage/Transport Temperature

Refrigerated 

Unacceptable Conditions

Heparinized sample submitted. 
Processing

Test Code

MYEBL: Blood
MYENB: Non-blood

Performing Lab

Genomic Services - Molecular Diagnostics

Preferred Volume

Tumor Sample
Blood: 3 mL
Bone marrow aspirate: 3 mL
FFPE: 10 micron sections x5 on uncharged, unstained, glass slides

Germline Sample
Collect 4-6 cytobrushes/cotton swabs on each side of the mouth, place swabs in transport tubes, 2 swabs per tube.
 

Minimum Volume

Tumor Sample
Blood: 2 mL
Bone marrow aspirate: 2 mL
FFPE: 10 micron sections x3 on uncharged, unstained, glass slides

Germline Sample
Collect 2-4 cytobrushes/cotton swabs on each side of the mouth, place swabs in transport tubes, 2 swabs per tube.
 

Unacceptable Conditions

Heparinized sample submitted. 

Stability (from collection to initiation)

Refrigerated 1 week, frozen at -20C unacceptable.

Storage/Transport Temperature

Refrigerated 
Result Interpretation

Reference Interval

Negative

Additional Information

This Myeloid Multi Gene Panel (MMGP) Next Generation Sequencing test detects and determines the variant allele frequency (VAF) of DNA variants in exons and flanking splice sites in 52 genes (listed below) that are commonly mutated in myeloid malignancies. Pathogenicity of the detected DNA variants are reported based on established criteria in databases such as ClinVar and COSMIC, while Variants of Unknown Significance (VUS) are reported based on their potential disruption of gene and/or protein function and whether they are unlisted or occur at very low allelic frequencies in general population databases such as GnomAD. 

This assay is particularly relevant for the detection of DNA variants at diagnosis of suspected myeloid malignancies and for minimal residual disease (MRD) monitoring at relapse and during remission. The sensitivity of mutation detection of this assay routinely  down to 1% variant allele frequency (VAF) includes FLT3-ITD and other variants, which can also be reported at < 1% when monitoring for previously detected variants in the same patient.

Myeloid Multi Gene Panel 
ABL1, ASXL1, BCOR, BCORL1, BRAF, CALR, CBL, CDKN2A, CEBPA, CSF3R, CUX1, DDX41, DNMT3A, ETV6, EZH2, FLT3, GATA2, GNAS, HRAS, IDH1, IDH2, JAK2, JAK3, KIT, KMT2A, KRAS, MPL, NF1, NPM1, NRAS, PHF6, PIGA, PPM1D, PRPF8, PTEN, PTPN11, RAD21, RRAS2, RUNX1, SETBP1, SF3B1, SH2B3, SMC3, SRSF2, STAG2, STAT3, STAT5B, TET2, TP53, U2AF1, WT1 and ZRSR2.

 
Administrative

CPT Codes

81450

LDT or Modified FDA

Yes
Complete View

Ordering Recommendations

Determine DNA variants and their allele frequencies in genes commonly mutated in myeloid malignancies and related disorders, at diagnosis, relapse and during remission.  This assay serves as a primary approach and a complement to morphology, immunophenotyping by flow cytometry and cytogenetic workups.

Test Code

MYEBL: Blood
MYENB: Non-blood

Performing Lab

Genomic Services - Molecular Diagnostics

Performed

Run 1x per week, or as needed, day shift only

Methodology

DNA extraction and Next Generation DNA sequencing (NGS) on the Illumina platform

Remarks

Do not collect sample in heparin. Keep sample refrigerated for overnight or longer storage.

Collect

Lavender top (EDTA)

Sample Type

Tumor sample: EDTA whole blood, Bone marrow aspirate and FFPE tissue

Germline sample: Buccal swabs 

Preferred Volume

Tumor Sample
Blood: 3 mL
Bone marrow aspirate: 3 mL
FFPE: 10 micron sections x5 on uncharged, unstained, glass slides

Germline Sample
Collect 4-6 cytobrushes/cotton swabs on each side of the mouth, place swabs in transport tubes, 2 swabs per tube.
 

Minimum Volume

Tumor Sample
Blood: 2 mL
Bone marrow aspirate: 2 mL
FFPE: 10 micron sections x3 on uncharged, unstained, glass slides

Germline Sample
Collect 2-4 cytobrushes/cotton swabs on each side of the mouth, place swabs in transport tubes, 2 swabs per tube.
 

Unacceptable Conditions

Heparinized sample submitted. 

Reference Interval

Negative

Synonyms

  • MYEBL
  • MYENB
  • Acute myeloid leukemia (AML)
  • Chronic myeloid leukemia (CML)
  • Myeloproliferative disorders (MPD)
  • Myelodysplastic syndromes (MDS)
  • Next Generation Sequencing (NGS)

Storage/Transport Temperature

Refrigerated 

Stability (from collection to initiation)

Refrigerated 1 week, frozen at -20C unacceptable.

Reported

6-14 days

Reflex Testing

To determine the FLT3 ITD allele ratio, an automatic reflex FLT3 assay by capillary electrophoresis (CE) will be ordered (with an additional charge) if a FLT3 ITD is detected and the FLT3 CE assay was not previously ordered on the same specimen. To skip this reflex test, please call the lab directly at (415)514-8488 or email ClinLabMDx@ucsf.edu.

Additional Information

This Myeloid Multi Gene Panel (MMGP) Next Generation Sequencing test detects and determines the variant allele frequency (VAF) of DNA variants in exons and flanking splice sites in 52 genes (listed below) that are commonly mutated in myeloid malignancies. Pathogenicity of the detected DNA variants are reported based on established criteria in databases such as ClinVar and COSMIC, while Variants of Unknown Significance (VUS) are reported based on their potential disruption of gene and/or protein function and whether they are unlisted or occur at very low allelic frequencies in general population databases such as GnomAD. 

This assay is particularly relevant for the detection of DNA variants at diagnosis of suspected myeloid malignancies and for minimal residual disease (MRD) monitoring at relapse and during remission. The sensitivity of mutation detection of this assay routinely  down to 1% variant allele frequency (VAF) includes FLT3-ITD and other variants, which can also be reported at < 1% when monitoring for previously detected variants in the same patient.

Myeloid Multi Gene Panel 
ABL1, ASXL1, BCOR, BCORL1, BRAF, CALR, CBL, CDKN2A, CEBPA, CSF3R, CUX1, DDX41, DNMT3A, ETV6, EZH2, FLT3, GATA2, GNAS, HRAS, IDH1, IDH2, JAK2, JAK3, KIT, KMT2A, KRAS, MPL, NF1, NPM1, NRAS, PHF6, PIGA, PPM1D, PRPF8, PTEN, PTPN11, RAD21, RRAS2, RUNX1, SETBP1, SF3B1, SH2B3, SMC3, SRSF2, STAG2, STAT3, STAT5B, TET2, TP53, U2AF1, WT1 and ZRSR2.

 

CPT Codes

81450

LDT or Modified FDA

Yes