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www.integratedoncology.com
Registered trademarks are property of its individual entity. ©2018 Laboratory Corporation of America® Holdings. All rights reserved.
onc-970-v1-0218L18341-0218-1
Your single-source laboratory solution.
IntelliGEN® MyeloidNEXT GENERATION
SEQUENCING PANEL
Lab Locations
ArizonaIntegrated Oncology5005 South 40th StreetPhoenix, AZ 85040800-710-1800Fax 800-481-4151
New YorkIntegrated Oncology521 West 57th Street, Sixth FloorNew York, NY 10019800-447-5816 Fax 212-258-2143
North CarolinaLabCorp Center for Molecular Biology and Pathology1912 Alexander DriveResearch Triangle Park, NC 27709800-345-4363Fax 919-361-7798
TennesseeIntegrated Oncology201 Summit View Drive, Suite 100Brentwood, TN 37027800-874-8532 Fax 615-370-8074
More than 490,000 tests performed on 225,000+ patients annually
1,600 contractual relationships with plans, payors, and other health care organizations across the US, some of which are on an exclusive basis
Integrated with more than 700 electronic medical records (EMR) and practice management systems
Menu of more than 450 genetic, pathology, IHC, and FISH tests, including 15 oncology-specific pharmacogenetic tests
Staff of more than 75 pathologists, PhDs, and genetic counselors dedicated to oncology and familial cancer testing
More than 65 oncology- and pathology-specific publications and presentations since 2013
answersaccess
actions
REFERENCES: 1. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines
in Oncology. Myelodysplastic Syndromes (Version 1.2018) Available at https://www. nccn.org/professionals/physician_gls/pdf/mds.pdf. Accessed February 9, 2018.
2. Mohamedali AM, et al., High concordance of genomic and cytogenetic aberrations between peripheral blood and bone marrow in Myelodysplastic syndrome (MDS). Leukemia 2015; 29:1928–1938.
3. Swerdlow, Steven H., et al., WHO classification of tumours of haematopoietic and lymphoid tissues. International Agency for Research on Cancer, 2017.
4. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. Acute Myeloid Leukemia (Version 3.2017) Available at https://www.nccn.org/professionals/ physician_gls/pdf/aml.pdf. Accessed February 9, 2018.
5. RYDAPT® (midostaurin). Novartis Pharmaceuticals Corporation, East Hanover, NJ; 2017. 6. IDHIFA® (enasidenib). Celgene Corporation, Summit, NJ; 2017 7. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology.
Myeloproliferative Neoplasms (Version 2.2018). Available at https://www.nccn.org/professionals/physician_gls/pdf/mpn.pdf. Accessed February 9, 2018.
8. Clara JA, Sallman, DA, Padron, E, Clinical management of myelodysplastic syndrome/myeloproliferative neoplasm overlap syndromes. Cancer Biol Med 2016. doi:10.20892/j.issn.2095-3941.2016.0043.
9. GLEEVEC® (imatinib mesylate). Novartis Pharmaceuticals Corporation East Hanover, NJ; 2017. 10. ZELBORAF® (vemurafenib). Genentech USA, Inc., A Member of the Roche Group, S. San Francisco, CA; 2017. 11. Vectibix® (panitumumab). Amgen Inc., Thousand Oaks, CA; 2009.
Next Generation Sequencing in Myeloid Malignancies
Gene*Association
MDS AML MPN
ABL19 l lASXL1 l l lBCOR l l lBCORL1 lBRAF10 lCALR lCBL lCDKN2A l lCEBPA lCSF3R l lCUX1 l lDNMT3A l l lETV6 l l lEZH2 l l lFBXW7
FLT35 lGATA1 lGATA2 l lIDH1 l l lIDH26 l l l
IntelliGEN Myeloid Panel Genes
Specimen Requirements
Specimen Preferred: Bone marrow. Alternate: Whole blood, extracted DNA or cell pellets (from whole blood or bone marrow).
Volume 1-2 mL bone marrow, TBD, 3-5 mL whole blood
Container Lavender-top (EDTA) tube or green-top (sodium heparin) tube
Gene*Association
MDS AML MPN
IKZF1 l lJAK2 l lJAK3 lKDM6A l l lKIT9 lKMT2A lKRAS11 lMPL lNF1 l lNOTCH1
NPM1 lNRAS l lPDGFRA9 lPHF6 lPML lPTEN lPTPN11 lRAD21 lRUNX1 l l lSETBP1 l l l
Gene*Association
MDS AML MPN
SF3B1 l l lSMC1A l lSMC3 l lSRSF2 l lSTAG2 l lTET2 l l lTP53 l lU2AF1 l lWT1 lZRSR2 l l
Genes associated with FDA approved therapies
l Frequently mutated in MDS
l Diagnostic and/or prognostic significance in AML
l Diagnostic and/or prognostic significance in MPN
The IntelliGEN® Myeloid panel is a next generation sequencing (NGS) assay that evaluates 50 genes known to be associated with myeloid malignancies.
The panel identifies somatic mutations useful in providing diagnostic, prognostic, and predictive information for patients with myeloid malignancies, including Myelodysplastic Syndromes (MDS), Acute Myeloid Leukemia (AML), and Myeloproliferative Neoplasms (MPN).
Myeloproliferative Neoplasms (MPN)
Somatic mutations in JAK2, CALR, and MPL have been identified in patients suspected of having MPN and are now used for diagnosis of these diseases.7
Other mutations are recognized by NCCN® as having prognostic significance in MPN.7
The incorporation of NGS platforms into the clinical management of MDS/MPN syndromes is likely to play an integral role in the diagnosis, prognosis and treatment of this unique group of complex hematologic malignancies.8
Myelodysplastic Syndromes (MDS)
Several studies have indicated that >80% of patients with MDS harbor at least 1 somatic mutation suggestive of clonal hematopoiesis.1
NCCN Guidelines® identify mutations in 23 genes frequently associated with MDS which may be useful in differential diagnosis and prognostic stratification.1
Combining mutation evaluation by NGS and copy number variant (CNV) assessment by SNP array has been shown to increase the diagnostic yield for MDS from 54% to 86% in the associated study population.2
Acute Myeloid Leukemia (AML)
WHO classification of AML includes:l several mutations that define specific disease subtypes: NPM1, CEBPA, RUNX1.3
l other mutations associated with adverse prognosis: KIT, FLT3, CEPBA, NPM1, RUNX1, KM2A, WT1, TET2, ASXL1.3
NCCN Guidelines® recognize the clinical utility of multiplex gene panels for assessment of additional mutations as prognostic indicators in AML, to guide therapy, and eligibility for clinical trials.4
Two mutations are specifically used to predict response to novel targeted treatments:l FLT3 for midostaurin in newly diagnosed AML 5
l IDH2 for enasidenib in relapsed, refractory AML6*identification of mutations should always be used within the context of clinical findings and bone marrow evaluation
Next Generation Sequencing in Myeloid Malignancies
Gene*Association
MDS AML MPN
ABL19 l lASXL1 l l lBCOR l l lBCORL1 lBRAF10 lCALR lCBL lCDKN2A l lCEBPA lCSF3R l lCUX1 l lDNMT3A l l lETV6 l l lEZH2 l l lFBXW7
FLT35 lGATA1 lGATA2 l lIDH1 l l lIDH26 l l l
IntelliGEN Myeloid Panel Genes
Specimen Requirements
Specimen Preferred: Bone marrow. Alternate: Whole blood, extracted DNA or cell pellets (from whole blood or bone marrow).
Volume 1-2 mL bone marrow, TBD, 3-5 mL whole blood
Container Lavender-top (EDTA) tube or green-top (sodium heparin) tube
Gene*Association
MDS AML MPN
IKZF1 l lJAK2 l lJAK3 lKDM6A l l lKIT9 lKMT2A lKRAS11 lMPL lNF1 l lNOTCH1
NPM1 lNRAS l lPDGFRA9 lPHF6 lPML lPTEN lPTPN11 lRAD21 lRUNX1 l l lSETBP1 l l l
Gene*Association
MDS AML MPN
SF3B1 l l lSMC1A l lSMC3 l lSRSF2 l lSTAG2 l lTET2 l l lTP53 l lU2AF1 l lWT1 lZRSR2 l l
Genes associated with FDA approved therapies
l Frequently mutated in MDS
l Diagnostic and/or prognostic significance in AML
l Diagnostic and/or prognostic significance in MPN
The IntelliGEN® Myeloid panel is a next generation sequencing (NGS) assay that evaluates 50 genes known to be associated with myeloid malignancies.
The panel identifies somatic mutations useful in providing diagnostic, prognostic, and predictive information for patients with myeloid malignancies, including Myelodysplastic Syndromes (MDS), Acute Myeloid Leukemia (AML), and Myeloproliferative Neoplasms (MPN).
Myeloproliferative Neoplasms (MPN)
Somatic mutations in JAK2, CALR, and MPL have been identified in patients suspected of having MPN and are now used for diagnosis of these diseases.7
Other mutations are recognized by NCCN® as having prognostic significance in MPN.7
The incorporation of NGS platforms into the clinical management of MDS/MPN syndromes is likely to play an integral role in the diagnosis, prognosis and treatment of this unique group of complex hematologic malignancies.8
Myelodysplastic Syndromes (MDS)
Several studies have indicated that >80% of patients with MDS harbor at least 1 somatic mutation suggestive of clonal hematopoiesis.1
NCCN Guidelines® identify mutations in 23 genes frequently associated with MDS which may be useful in differential diagnosis and prognostic stratification.1
Combining mutation evaluation by NGS and copy number variant (CNV) assessment by SNP array has been shown to increase the diagnostic yield for MDS from 54% to 86% in the associated study population.2
Acute Myeloid Leukemia (AML)
WHO classification of AML includes:l several mutations that define specific disease subtypes: NPM1, CEBPA, RUNX1.3
l other mutations associated with adverse prognosis: KIT, FLT3, CEPBA, NPM1, RUNX1, KM2A, WT1, TET2, ASXL1.3
NCCN Guidelines® recognize the clinical utility of multiplex gene panels for assessment of additional mutations as prognostic indicators in AML, to guide therapy, and eligibility for clinical trials.4
Two mutations are specifically used to predict response to novel targeted treatments:l FLT3 for midostaurin in newly diagnosed AML 5
l IDH2 for enasidenib in relapsed, refractory AML6*identification of mutations should always be used within the context of clinical findings and bone marrow evaluation
www.integratedoncology.com
Registered trademarks are property of its individual entity. ©2018 Laboratory Corporation of America® Holdings. All rights reserved.
onc-970-v1-0218L18341-0218-1
Your single-source laboratory solution.
IntelliGEN® MyeloidNEXT GENERATION
SEQUENCING PANEL
Lab Locations
ArizonaIntegrated Oncology5005 South 40th StreetPhoenix, AZ 85040800-710-1800Fax 800-481-4151
New YorkIntegrated Oncology521 West 57th Street, Sixth FloorNew York, NY 10019800-447-5816 Fax 212-258-2143
North CarolinaLabCorp Center for Molecular Biology and Pathology1912 Alexander DriveResearch Triangle Park, NC 27709800-345-4363Fax 919-361-7798
TennesseeIntegrated Oncology201 Summit View Drive, Suite 100Brentwood, TN 37027800-874-8532 Fax 615-370-8074
More than 490,000 tests performed on 225,000+ patients annually
1,600 contractual relationships with plans, payors, and other health care organizations across the US, some of which are on an exclusive basis
Integrated with more than 700 electronic medical records (EMR) and practice management systems
Menu of more than 450 genetic, pathology, IHC, and FISH tests, including 15 oncology-specific pharmacogenetic tests
Staff of more than 75 pathologists, PhDs, and genetic counselors dedicated to oncology and familial cancer testing
More than 65 oncology- and pathology-specific publications and presentations since 2013
answersaccess
actions
REFERENCES: 1. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines
in Oncology. Myelodysplastic Syndromes (Version 1.2018) Available at https://www. nccn.org/professionals/physician_gls/pdf/mds.pdf. Accessed February 9, 2018.
2. Mohamedali AM, et al., High concordance of genomic and cytogenetic aberrations between peripheral blood and bone marrow in Myelodysplastic syndrome (MDS). Leukemia 2015; 29:1928–1938.
3. Swerdlow, Steven H., et al., WHO classification of tumours of haematopoietic and lymphoid tissues. International Agency for Research on Cancer, 2017.
4. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. Acute Myeloid Leukemia (Version 3.2017) Available at https://www.nccn.org/professionals/ physician_gls/pdf/aml.pdf. Accessed February 9, 2018.
5. RYDAPT® (midostaurin). Novartis Pharmaceuticals Corporation, East Hanover, NJ; 2017. 6. IDHIFA® (enasidenib). Celgene Corporation, Summit, NJ; 2017 7. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology.
Myeloproliferative Neoplasms (Version 2.2018). Available at https://www.nccn.org/professionals/physician_gls/pdf/mpn.pdf. Accessed February 9, 2018.
8. Clara JA, Sallman, DA, Padron, E, Clinical management of myelodysplastic syndrome/myeloproliferative neoplasm overlap syndromes. Cancer Biol Med 2016. doi:10.20892/j.issn.2095-3941.2016.0043.
9. GLEEVEC® (imatinib mesylate). Novartis Pharmaceuticals Corporation East Hanover, NJ; 2017. 10. ZELBORAF® (vemurafenib). Genentech USA, Inc., A Member of the Roche Group, S. San Francisco, CA; 2017. 11. Vectibix® (panitumumab). Amgen Inc., Thousand Oaks, CA; 2009.
