Lab Locations
Accupath Diagnostic Laboratories, Inc. Esoterix Genetic Laboratories, LLC
201 Summit View Drive, Suite 100
Brentwood, TN 37027
5005 South 40th Street
Phoenix, AZ 85040
3 Forest Parkway
Shelton, CT 06484
Darzalex
®
is a registered trademark of Johnson & Johnson Corporation.
LeukoStrat
®
is a registered trademark of Invivoscribe Technologies, Inc.
SARCLISA
®
is a registered trademark of Sanofi.
Accupath Diagnostic Laboratories, Inc. and Esoterix Genetic Laboratories, LLC are subsidiaries of Laboratory Corporation of America Holdings, using the brand Labcorp and Labcorp Oncology.
©2022 Laboratory Corporation of America
®
Holdings. All rights reserved.
onc-711-v25 06072022
Flow Cytometry
¬
Peripheral blood/bone marrow panel (HNA)
24
¬
antibodies
CD2, CD3, CD4, CD5, CD7, CD8, CD10, CD11b, CD13, CD14,
CD16, CD19, CD20, CD23, CD57, CD33, CD34, CD38, CD45,
CD56, CD64, HLA-DR, kappa light chain, lambda light chain
Tissue/fluids panel (HNA)
21
¬
antibodies
CD2, CD3, CD4, CD5, CD7, CD8, CD10, CD11b, CD19, CD20,
CD23, CD30, CD38, CD43, CD45, CD56, CD57, FMC-7,
HLA-DR, kappa light chain, lambda light chain
PNH Evaluation
CD14, CD15, CD24, CD45, CD64, FLAER.
CD59 and CD235a may be added at discretion of reviewing
pathologist
¬
Additional antibodies may be added if determined to be medically necessary to render a diagnosis in the opinion of the reviewing pathologist.
Markers performed determined by testing facility.
FISH
(disease state profile OR individual probes)
ALL (Adult)
BCR/ABL1, t(9;22)
KMT2A (MLL)
MYC
6
21q
ALL (Pediatric)
BCR/ABL1,t(9;22)
4
10
17
KMT2A (MLL)
CDKN2A (p16)
TCF3 (E2A)
ETV6/RUNX1, t(12;21)
AML
PML/RARA, t(15;17)
CBFB, inv(16)
RUNX1T1/RUNX1, t(8;21)
5q
7q
KMT2A (MLL)
CLL
TP53 (17p-)
ATM (11q-)
CCND1/IGH, t(11;14)
13q14 (DLEU)
12
MPN/CML
20q
8
9
13q14 (DLEU)
BCR/ABL1, t(9;22)
Multiple Myeloma
Monosomy 13/13q-
TP53 (17p-)
7
9
15
CCND1/IGH, t(11;14)
CKS1B (1q21)
FGFR3/IGH, t(4;14)
IGH/MAF, t(14;16)
NHL
ALK
BCL6
CCND1/IGH, t(11;14)
IGH/BCL2, t(14;18)
IGH/MYC, t(8;14)
MALT1
TCRA/D
Aggressive B-cell (ABC) Lymphoma
BCL2
BCL6
MYC
MDS
5q
7q
20q
8
MPN with Eosinophilia
FGFR1
PDGFRA
PDGFRB
Morphologic Evaluation Common Components (Please include patient CBC report)
• Peripheral Blood Interpretation (85060) • Clot (88305)
• Bone Marrow Aspirate Smear & Interpretation (85097)
• Core (88305)
• Decalcifi cation (88311)
• Additional Studies/Special Stains (88313) – Iron and Reticulin
• IHC Global marker number (88342) varies but typically 0-4
Diagnostic Test Reflex Criteria Based on Flow Cytometry or Surgical Pathology Consultation Findings
Disease Category Timing Findings Tests to Perform
AML
Initial Diagnosis Diagnostic or suspicious for AML with RUNX1T1/RUNX1 t(8;21), CBFB inv (16),
or PML/RARA t(15;17), acute myelomonocytic, or acute monocytic/monoblastic
leukemia
FISH probes for RUNX1T1/RUNX1 t(8;21), CBFB inv(16), or PML/
RARA t(15;17) or MLL respectively, as indicated; NGS myeloid panel
+ FLT3 testing for patients <60 years; discuss necessity of testing with
client or place comment in report for patients >= 60 years
B-cell lymphoma
Initial Diagnosis
Findings suspicious or diagnostic for B-cell lymphoma, but with equivocal fi ndings
with regard to subclassifi cation (for tissue cases 5% or more abnormal B-cells by fl ow
cytometry; for peripheral blood/bone marrow cases, 10% or more abnormal B-cells)
NHL FISH probes and molecular assays as indicated
Large B-cell lymphoma or
Burkitt lymphoma
Initial Diagnosis Abnormal B-cells diagnostic or suspicious for large B-cell lymphoma or Burkitt
lymphoma
FISH probes for MYC, BCL6, and BCL2 translocations and cytogenetic
karyotyping, as indicated; refl ex to 11q FISH probe (BCL1 and
ATM) for MYC, BCL6, BCL2 negative cases suspicious for Burkitt
lymphoma, as indicated
Eosinophilia
Initial Diagnosis Peripheral blood with 1.0K/µL or more eosinophils FISH probes for PDGFRA, PDGFRB, and FGFR1
Hairy Cell Leukemia (HCL)
Initial Diagnosis CD103+ monoclonal B-cells (5% or more) inconclusive for HCL BRAF mutation
Lymphoplasmacytic
Lymphoma (LPL)
Initial Diagnosis Monoclonal B-cells (10% or more) with features indicating LPL in
differential diagnosis
MYD88 mutation
Mantle cell lymphoma (MCL)
Initial Diagnosis Monotypic B-cells (5% or more) diagnostic or suspicious of MCL FISH probe for CCND1/IGH t(11;14)
Mastocytosis
Initial Diagnosis Atypical mast cells by fl ow cytometry High-sensitivity KIT D816V mutation analysis for mast cell disease
CML
Initial Diagnosis Flow cytometric findings suspicious for CML FISH for BCR/ABL1
MDS/MPN
Initial Diagnosis Findings suspicious for MDS/MPN (CMML, aCML, etc.) NGS myeloid panel for patients <60 years; discuss necessity of
testing with client or place comment in report for patients >= 60 years
T-cell lymphoma/leukemia
Initial Diagnosis Atypical T-cells diagnostic or suspicious for T-cell lymphoma/leukemia TCR gene rearrangement ; ALK FISH probe for CD30+ cases, as
indicated; cytogenetic karyotyping if material adequate
+
LeukoStrat
®
CDx FLT3 Mutation performed by The Laboratory for Personalized Molecular Medicine (LabPMM
®
)
‡
Informed consent is required for non-oncology genetics testing for New York state patients.
IntelliGEN
®
(for genes evaluated, refer to oncology.labcorp.com)
Prognostic Test Reflex Criteria
Disease Category Timing Findings (Morphology, Flow cytometry, FISH and/or karyotyping) Tests to Perform
ALL
Initial Diagnosis ALL Pediatric FISH Profi le (<22 years) or Adult FISH Profi le (>22
years); Reveal
®
SNP Array
AML
Initial Diagnosis AML or borderline AML FISH probes for RUNX1T1/RUNX1 t(8;21), CBFB inv(16), or PML/
RARA t(15;17) or MLL respectively, as indicated; NGS myeloid panel
+ FLT3 testing for patients <60 years; discuss necessity of testing
with client or place comment in report for patients >= 60 years
AML
Relapse Findings indicative of relapse NGS myeloid panel <60 years; discuss necessity of testing with
client or place comment in report for patients >= 60 years
CLL (peripheral blood/bone
marrow)
Initial Diagnosis CD5+ neoplasm with classic or variant CLL features; >5K/uL circulating
monoclonal B-cells or 10% or more marrow based monoclonal B-cells
CLL FISH profi le or CLL SNP array with FISH probe for CCND1/IGH
t(11;14), ZAP70/CD38/CD49d assay, and IgVH mutation analysis
CLL (peripheral blood/bone
marrow)
Follow-up* Features of refractory disease or disease progression/transformation FISH probe for TP53 (17p-) deletion, TP53 mutation analysis, and
SNP array
CML
Initial Diagnosis Compatible or diagnostic fi ndings for CML Quantitative BCR/ABL1 assay and cytogenetics
CML
Follow-up* Prior diagnosis of CML Quantitative BCR/ABL1 assay; if features of progression, discuss
addition of NGS myeloid panel with client or place comment in report
MPN
Initial Diagnosis Morphologic features of MPN, but negative for JAK2 V617F, CALR, and MPL
mutations
NGS myeloid panel for patients <60 years; discuss necessity of
testing with client or place comment in report for patients >= 60 years
MPN
Follow-up* History of MPN, currently with features of progression (increased blasts or
dysplastic features)
Discuss addition of NGS myeloid panel with client or place comment
in report
MDS
Initial Diagnosis Morphologic diagnosis of MDS with normal cytogenetic karyotype NGS myeloid panel for patients <60 years; discuss necessity of
testing with client or place comment in report for patients >= 60 years
Plasma cell neoplasia
Initial Diagnosis 5% or more neoplastic plasma cells by morphology or 1% or more
by fl ow cytometry
Myeloma FISH profi le
Plasma cell neoplasia
Follow-up* Features of disease progression FISH probes for TP53 (17p-), CKS1B (1q21), Monosomy 13/13q-
SLL
Initial Diagnosis SLL identifi ed in tissue sample by fl ow cytometry with 10% or more
neoplastic cells
CLL FISH profi le or CLL SNP array with FISH probe for CCND1/IGH
t(11;14), IgVH mutation analysis
*recommendation for follow-up evaluation requires that prior material was evaluated in an IO facility
SERUM - Multiple Myeloma Cascade, Protein Electrophoresis (SPE) reflex to Immunofixation (sIFE) and Free Light Chain (sFLC)
for interpretation, refer to www.labcorp.com
B2A
8310075583
Patient, client, and billing information is requested for timely
processing of this case. Medicare and other third party payors
require that services be medically necessary for coverage,
and generally do not cover routine screening tests.
When ordering tests that are subject to ABN guidelines,
Administrative Contractor (MAC), CMS, or
Symbols Legend
@ = Subject to Medicare medical necessity guidelines
^ = Medicare deems investigational. Medicare does not pay for services it deems investigational.
refer to the policies published by your Medicare
www.LabCorp.com/MedicareMedicalNecessity.