Clinical Test Menu

Flow Cytometry
Anatomic Pathology
Karyotype
FISH
Molecular Diagnostics
Completeâ„ Program

Flow Cytometry

Lymphoid Panel

Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (2 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the diagnosis of leukemia and lymphoma and for post-treatment follow-up.
CPT Codes88184; 88185 (x16); 88189
TAT1-2 days

Myeloid/Lymphoid/Acute Leukemia Panel

Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (2 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the diagnosis of leukemia, lymphoma, plasma cell neoplasms, and evaluation of myeloid maturation.
CPT Codes"Myeloid/Lymphoid: 88184; 88185 (x28); 88189
With Acute Add-On: 88184; 88185(x34); 88189"
TAT1-2 days

Multiple Myeloma Panel

Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (2 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the clinical management of patients with multiple myeloma.
CPT Codes88184; 88185 (x22); 88189
TAT1-2 days

ZAP-70 Panel

Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (2 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the prognosis of chronic lymphocytic leukemia (CLL).
CPT Codes88184; 88185 (x4); 88187
TAT1-2 days

PNH Test

Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (2 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the diagnosis of PNH and monitoring response to therapy.
CPT Codes88184; 88185 (x7); 88187
TAT1-2 days

Our flow cytometry department also tests for a selection of individual antibodies. If you want more information please contact us at 888.334.4988

Anatomic Pathology

Tests in the area of Morphology include both histology and cytology. We offer a full immunohistochemistry library with over 180 antibodies. For the full list, please click here CGI Immunohistochemistry Library.

IHC

MethodologyImmunohistochemistry (IHC)
Specimen Requirements4-5μm thick FFPE sections on positively coated slides at room temp.
CPT Codes88342
TAT2-4 days

Karyotype

Karyotyping enables genome-wide detection of aberrations at low resolution that have a diagnostic and prognostic significance.

Karyotype with reflex to Fluorescence in situ Hybridization (FISH) as necessary

MethodologyG-banding
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temp.
CPT Codes88237; 88262; 88280; 88291
TAT5-7 days

FISH

Hemotologic Tumors

Acute Lymphocytic Leukemia (ALL) B-ALL PEDIATRIC/ADULT

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temp.
Clinical IndicationsFor the diagnosis and prognosis of acute lymphocytic leukemia (ALL).
CPT Codes88271(13); 88275(6); 88291
TAT3-5 days
  • 11q23 (MLL-Break Apart)
  • t(9;22) (BCR/ABL/ASS)
  • 17p13 (TP53)
  • t(12;21) (ETV6/RUNX1)
  • 9p21 (CDKN2A[p16])
  • CEP4,10, 17

Acute Lymphocytic Leukemia (ALL) T-ALL

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temp.
Clinical IndicationsFor the diagnosis and prognosis of acute lymphocytic leukemia (ALL).
CPT Codes88271(2); 88275; 88291
TAT3-5 days
  • 14q11 (TCR-Alpha/Delta Break Apart)

Acute Myeloid Leukemia (AML)

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the diagnosis, subtyping and prognostic stratification of acute myeloid leukemia (AML) patients.
CPT Codes88271(8); 88275(4); 88291
TAT3-5 days
  • 11q23 (MLL-Break Apart)
  • t(8;21) (ETO/AML1) [M2]
  • t(15;17) (PML/RARA) [M3]
  • inv(16) (CBFB-Break Apart) [M4, Eos]

Anaplastic Large Cell Lymphoma (ALCL)

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temp.
Clinical IndicationsFor the prognosis of anaplastic large cell lymphoma (ALCL).
CPT Codes88271(2); 88275; 88291
TAT3-5 days
  • 2p23 (ALK-Break Apart)

BM Transplant Monitoring

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the monitoring of patients who received opposite-sex bone marrow transplantation for chronic myelogenous leukemia (CML), acute myeloid leukemia (AML), myeloproliferative disorder (MPD), myelodysplastic syndrome (MDS), and acute lymphoid leukemia (ALL).
CPT Codes88271(2); 88275; 88291
TAT3-5 days
  • CEP X/Y

Chronic Lymphocytic Leukemia (CLL)

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the diagnosis and prognosis of chronic lymphocytic leukemia (CLL).
CPT Codes88271(9); 88275(4); 88291
TAT3-5 days
  • 11q22.3 (ATM)/17p13 (TP53)
  • CEP12/13q14 (D13S319)/13q34
  • CEP6/6q23 (c-MYB)
  • t(11;14)(CCND1/IGH)

Chronic Myelogenous Leukemia (CML)

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the diagnosis of chronic myelogenous leukemia (CML).
CPT Codes88271(3); 88275(1); 88291
TAT3-5 days
  • t(9;22) (BCR/ABL/ASS)

CML in blast crisis

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the diagnosis of chronic myelogenous leukemia (CML).
CPT Codes88271(5); 88275(3); 88291
TAT3-5 days
  • t(9;22) (BCR/ABL/ASS)
  • 17p13 (TP53)
  • CEP8

Multiple Myeloma (MM) with purified plasma cells (PPC)

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the diagnosis and prognosis of multiple myeloma.
CPT Codes88271(15); 88275(7); 88291
TAT7-10 days
  • 13q14/13q34
  • 17/17p13 (TP53)
  • 1p/1q
  • D5S23/D5S72/CEP9/CEP15
  • t(4;14) (FGFR3/IGH)
  • t(11;14) (CCND1/IGH)
  • t(14;16) (lGH/MAF)

Also Available:

  • IGH-Break Apart
  • CEP7/CEP11
  • t(6;14) (CCND3/IGH)
  • t(14;20) (IGH/MAFB)

Myelodysplastic Syndrome (MDS)

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the diagnosis, prognosis, monitoring of response to therapy or progression of disease of myelodysplastic syndrome (MDS).
CPT Codes88271(8); 88275(4); 88291
TAT3-5 days
  • 5q15.2/5q31
  • CEP7/7q31
  • CEP8
  • 20q12
  • 11q23 (MLL-Break Apart)

Myeloproliferative Disease (MPD)

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the diagnosis of myeloproliferative disease (MPD) or for monitoring response to therapy or progression of the disease.
CPT Codes88271(4); 88275(2); 88291
TAT3-5 days
  • 4q12 (FIP1L1/CHIC2/PDGFRA)
  • 5q33 (PDGFRB-Break Apart)
  • BCR/ABL (BCR/ABL/ASS)
  • CEP8/CEP9

Non-Hodgkin’s Lymphoma (NHL)

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temp.
Clinical IndicationsFor the diagnosis and prognosis of non-Hodgkin lymphoma (NHL).
CPT Codes88271(11); 88275(5); 88291
TAT3-5 days
  • Burkitt: t(8;14) (MYC/IGH)
  • DLBCL: 3q27 (BCL6-Break Apart)
  • Follicular: t(14;18) (IGH/BCL2)
  • Mantle: t(11;14) (CCND1/IGH)
  • MALT Lymphoma: MALT1-Break Apart

Also Available:

  • IGH-Break Apart
  • c-MYC-Break Apart

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Solid Tumors

ALK-Break Apart (NSCLC)

FDA approved test.
MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements3-5 µm thick FFPE sections on positively coated slides at room temp.
Clinical IndicationsNSCLC
CPT Codes88368(2)
TAT5-7 days

PathVysion® (HER2/neu)(Breast)

FDA approved test.
MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements3-5 µm thick FFPE sections on positively coated slides at room temp.
Clinical Indications88368(2)
CPT Codes88368(2)
TAT5-7 days

UroVysion® (Bladder)

FDA approved test.
MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements25-50 ml urine in a suitable container. Same day shipping or PreservCyt® should be used if the specimen will remain in transit for more than a day to ensure stability.
Clinical Indicationsbladder cancer
CPT Codes88120; 88121
TAT3-5 days

Hematologic Tumors

ABL Kinase Domain Mutation Analysis (CML)

MethodologyPCR, sequencing
Analytical Sensitivity20%
Specimen Requirements1 Lavender/EDTA tube peripheral blood or bone marrow (3-5 ml) at room temp. or 2-8°C within 48 hours after collection.
Clinical IndicationsFor monitoring patients with chronic myeloid leukemia (CML).
CPT Codes81403
TAT7-10 days

B-Cell Clonality (IGH) (Lymphoma)

MethodologyPCR, fragment analysis
Analytical Sensitivity1-3%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C or 30-50 μm total FFPE sections at room temp.
Clinical IndicationsFor the diagnosis of lymphomas.
CPT Codes81261
TAT7-10 days

BCR/ABL Qualitative (CML)

MethodologyReal-time PCR
Analytical Sensitivity1 tumor cell/ 100,000 normal cells
Specimen Requirements1 Lavender/EDTA tube peripheral blood or bone marrow (3-5 ml) at room temp. or 2-8°C within 48 hours after collection.
Clinical IndicationsFor the diagnosis of acute lymphoblastic leukemia (ALL) and chronic myeloid leukemia (CML).
CPT Codes81206, 81207
TAT3-5 days

BCR/ABL Quantitative Major(p210) & Minor(p190) (CML)

MethodologyReal-time PCR
Analytical Sensitivity1 tumor cell/ 100,000 normal cells
Specimen Requirements1 Lavender/EDTA tube peripheral blood or bone marrow (3-5 ml) at room temp. or 2-8°C within 48 hours after collection.
Clinical IndicationsFor monitoring patients with acute lymphoblastic leukemia (ALL) and chronic myeloid leukemia (CML).
CPT Codes81206 (major); 81207 (minor)
TAT3-5 days

c-KIT Mutation Analysis (Exon 8 and 17) (AML)

MethodologyPCR, sequencing
Analytical Sensitivity20%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis of patients with acute myeloid leukemia (AML).
CPT Codes81404
TAT7-10 days

c-KIT Mutation Analysis (System Mastocytosis) (D816) (MPN)

MethodologyPCR, sequencing
Analytical Sensitivity0.25%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis of patients with myeloproliferative neoplasms (MPN).
CPT Codes81402
TAT7-10 days

CEBPA Mutation Analysis (AML)

MethodologyPCR, sequencing
Analytical Sensitivity20%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis of patients with acute myeloid leukemia (AML).
CPT Codes81403
TAT7-10 days

FLT3 Mutation Analysis (AML)

MethodologyPCR, sequencing
Analytical Sensitivity10%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis and clinical management of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
CPT Codes81263
TAT7-10 days

IGHV Mutation Analysis (CLL)

MethodologyPCR, sequencing
Analytical Sensitivity10%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis and clinical management of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
CPT Codes81263
TAT7-10 days

JAK2 V617F Mutation Analysis (MPN)

MethodologyPCR, sequencing
Analytical Sensitivity1%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the diagnosis of patients with myeloproliferative neoplasms (MPN).
CPT Codes81270
TAT3-5 days

JAK2 Exon 12 Mutation Analysis (MPN)

MethodologyPCR, sequencing
Analytical Sensitivity20%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the diagnosis of patients with myeloproliferative neoplasms (MPN).
CPT Codes81403
TAT7-10 days

MatBA®-CLL/SLL Array-CGH (CLL, SLL)

MethodologyArray-CGH
Analytical Sensitivity30-40%
Specimen Requirements1 Lavender/EDTA tube peripheral blood or bone marrow aspirate with minimum 2-3ml or 3-5 FFPE sections at 10 μm thickness on regular slides at room temp.
Clinical IndicationsFor the risk stratification and prognosis of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
CPT Codes81479
TAT10-14 days

MatBA®-DLBCL Array-CGH (DLBCL)

MethodologyArray-CGH
Analytical SensitivityFFPE: 60-70%
Fresh-Frozen tissue: 50-60%"
Specimen Requirements"FFPE block: containing ≥ 70% tumor. Minimum size: 2 mm x 2 mm tumor area, shipped at room temperature.
Fresh-Frozen tissue: 0.2 cm3 min. (in OCT is acceptable) containing ≥ 50% tumor. Stored at -80°C /-20°C, shipped on dry ice.
FFPE block or fresh-frozen specimen: incisional or excisional biopsy."
Clinical IndicationsFor the risk stratification and prognosis of diffuse large B-cell lymphoma (DLBCL).
CPT Codes81479
TAT10-14 days

MPL 515/505 Mutation Analysis (MPN)

MethodologyPCR, bi-directional sequencing
Analytical Sensitivity20%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the diagnosis of patients with myeloproliferative neoplasms (MPN).
CPT Codes81403
TAT7-10 days

NOTCH 1 Mutation Analysis (CLL)

MethodologyPCR, bi-directional sequencing
Analytical Sensitivity20%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
CPT Codes81479
TAT7-10 days

NPM1 Mutation Analysis (AML)

MethodologyPCR, sequencing
Analytical Sensitivity5%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis of patients with acute myeloid leukemia (AML).
CPT Codes81310
TAT7-10 days

SF3B1 Mutation Analysis (CLL)

MethodologyPCR, bi-directional sequencing
Analytical Sensitivity20%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis of chronic lymphocytic leukemia (CLL).
CPT Codes81479
TAT7-10 days

T-Cell Clonality (TCRβ) (Lymphoma)

MethodologyPCR, fragment analysis
Analytical Sensitivity1-3%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C or 30-50 μm total FFPE sections at room temp.
Clinical IndicationsFor the diagnosis of lymphoma.
CPT Codes81340
TAT7-10 days

T-Cell Clonality (TCRγ) (Lymphoma)

MethodologyPCR, fragment analysis
Analytical Sensitivity1-3%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C or 30-50 μm total FFPE sections at room temp.
Clinical IndicationsFor the diagnosis of lymphoma.
CPT Codes81342
TAT7-10 days

TP53 Mutation Analysis (CLL, DLBCL)

MethodologyPCR, bi-directional sequencing
Analytical Sensitivity25%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis of chronic lymphocytic leukemia (CLL) and diffuse large B-cell lymphoma (DLBCL).
CPT Codes81404
TAT7-10 days

Solid Tumor

BRAF Mutation Analysis (CRC)

MethodologyPCR, Pyrosequencing
Analytical Sensitivity6%
Specimen RequirementsFFPE Block or 3-5 FFPE sections at 10 μm thickness containing at least 20% of tumor cells on regular unstained slides at room temp. with H&E slides.
Clinical IndicationsFor the clinical management of patients with colorectal cancer (CRC), hairy cell leukemia (HCL), melanoma, thyroid cancer
CPT Codes81210
TAT7-10 days

EGFR Mutation Analysis (NSCLC)

MethodologyPCR, Pyrosequencing
Analytical Sensitivity5.8-17%
Specimen RequirementsFFPE Block or 3-5 FFPE sections at 10 μm thickness containing at least 20% of tumor cells on regular unstained slides at room temp. with H&E slides.
Clinical IndicationsFor the clinical management of patients with non-small cell lung cancer (NSCLC).
CPT Codes81235
TAT7-10 days

KRAS Mutation Analysis (CRC, NSCLC)

MethodologyPCR, Pyrosequencing
Analytical Sensitivity12%
Specimen RequirementsFFPE Block or 3-5 FFPE sections at 10 μm thickness containing at least 20% of tumor cells on regular unstained slides at room temp. with H&E slides.
Clinical IndicationsFor the clinical management of patients with colorectal cancer (CRC) and non-small cell lung cancer (NSCLC).
CPT Codes81275
TAT7-10 days

NRAS Mutation Analysis (CRC, Melanoma, Thyroid cancer)

MethodologyPCR, sequencing
Analytical Sensitivity10%
Specimen RequirementsFFPE Block or 3-5 FFPE sections at 10 μm thickness containing at least 20% of tumor cells on regular unstained slides at room temp. with H&E slides.
Clinical IndicationsFor the clinical management of patients with leukemias, colorectal, melanoma, and thyroid cancers.
CPT Codes81404
TAT7-10 days

UroGenRAâ„¢-Kidney Array CGH (Kidney Cancer)

MethodologyArray-CGH
Analytical Sensitivity40%
Specimen Requirements"For both biopsies and resected specimens, a minimum of 70% tumor population is preferred.
Biopsy: Min. 3-4 needle/core biopsies (18-gauge needle) placed in a cryovial containing saline, transport frozen.
Resected specimen: A minimum of 0.2x0.2x0.2cm tissue, snap-frozen in a cryovial and transported in frozen condition."
Clinical IndicationsFor the diagnosis and subtyping of renal cortical neoplasms.
CPT Codes81479
TAT10-14 days

Array-CGH

MatBA®-CLL/SLL Array-CGH (CLL, SLL)

MethodologyArray-CGH
Analytical Sensitivity30-40%
Specimen Requirements1 Lavender/EDTA tube peripheral blood or bone marrow aspirate with minimum 2-3ml or 3-5 FFPE sections at 10 μm thickness on regular slides at room temp.
Clinical IndicationsFor the risk stratification and prognosis of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
CPT Codes81479
TAT10-14 days

MatBA®-DLBCL Array-CGH (DLBCL)

MethodologyArray-CGH
Analytical SensitivityFFPE: 60-70%
Fresh-Frozen tissue: 50-60%"
Specimen Requirements"FFPE block: containing ≥ 70% tumor. Minimum size: 2 mm x 2 mm tumor area, shipped at room temperature.
Fresh-Frozen tissue: 0.2 cm3 min. (in OCT is acceptable) containing ≥ 50% tumor. Stored at -80°C /-20°C, shipped on dry ice.
FFPE block or fresh-frozen specimen: incisional or excisional biopsy."
Clinical IndicationsFor the risk stratification and prognosis of diffuse large B-cell lymphoma (DLBCL).
CPT Codes81479
TAT10-14 days

UroGenRAâ„¢-Kidney Array-CGH (Kidney Cancer)

MethodologyArray-CGH
Analytical Sensitivity40%
Specimen Requirements"For both biopsies and resected specimens, a minimum of 70% tumor population is preferred.
Biopsy: Min. 3-4 needle/core biopsies (18-gauge needle) placed in a cryovial containing saline, transport frozen.
Resected specimen: A minimum of 0.2x0.2x0.2cm tissue, snap-frozen in a cryovial and transported in frozen condition."
Clinical IndicationsFor the diagnosis and subtyping of renal cortical neoplasms.
CPT Codes81479
TAT10-14 days

CLL Completeâ„ 

CD38 (flow)

MethodologyFlow cytometry
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (2 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the prognosis of chronic lymphocytic leukemia (CLL).
CPT Codes88184 or 88185; 88187
TAT1-2 days

FISH Panel

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the diagnosis and prognosis of chronic lymphocytic leukemia (CLL).
CPT Codes88271(9); 88275(5); 88291
TAT3-5 days

IGHV Mutation Analysis

MethodologyPCR, sequencing
Analytical Sensitivity10%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis and clinical management of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
CPT Codes81263
TAT7-10 days

Karyotype

MethodologyG-banding
Specimen Requirements1 Green/NaHeparin tube (3-5 ml) peripheral blood or bone marrow at room temp.
CPT Codes88237; 88262; 88280; 88291
TAT5-7 days

MatBA®-CLL/SLL Array-CGH (CLL, SLL)

MethodologyArray-CGH
Analytical Sensitivity30-40%
Specimen Requirements1 Lavender/EDTA tube peripheral blood or bone marrow aspirate with minimum 2-3ml or 3-5 FFPE sections at 10 μm thickness on regular slides at room temp.
Clinical IndicationsFor the risk stratification and prognosis of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
CPT Codes81479
TAT10-14 days

NOTCH1 Mutation Analysis

MethodologyPCR, bi-directional sequencing
Analytical Sensitivity20%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
CPT Codes81479
TAT7-10 days

SF3B1 Mutation Analysis

MethodologyPCR, bi-directional sequencing
Analytical Sensitivity20%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis of chronic lymphocytic leukemia (CLL).
CPT Codes81479
TAT7-10 days

TP53 Mutation Analysis

MethodologyPCR, bi-directional sequencing
Analytical Sensitivity25%
Specimen Requirements1 Lavender/EDTA tube peripheral blood or bone marrow (3-5 ml) at room temp. or 2-8°C within 48 hours after collection.
Clinical IndicationsFor the prognosis of chronic lymphocytic leukemia (CLL) and diffuse large B-cell lymphoma (DLBCL).
CPT Codes81404
TAT7-10 days

ZAP-70 (flow)

MethodologyFlow cytometry
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (2 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the prognosis of chronic lymphocytic leukemia (CLL).
CPT Codes88184 or 88185; 88187
TAT1-2 days

DLBCL Completeâ„ 

MatBA®-DLBCL Array-CGH (DLBCL)

MethodologyArray-CGH
Analytical SensitivityFFPE: 60-70%
Fresh-Frozen tissue: 50-60%"
Specimen Requirements"FFPE block: containing ≥ 70% tumor. Minimum size: 2 mm x 2 mm tumor area, shipped at room temperature.
Fresh-Frozen tissue: 0.2 cm3 min. (in OCT is acceptable) containing ≥ 50% tumor. Stored at -80°C /-20°C, shipped on dry ice.
FFPE block or fresh-frozen specimen: incisional or excisional biopsy."
Clinical IndicationsFor the risk stratification and prognosis of diffuse large B-cell lymphoma (DLBCL).
CPT Codes81479
TAT10-14 days

SETRAâ„¢:Six Gene Expression Treatment Response Assay

Specimen RequirementsFFPE block containing ≥ 70% tumor. Minimum size: 2 mm x 2 mm tumor area, shipped at room temperature.
Clinical IndicationsFor the risk stratification and prognosis for diffuse large B-cell lymphoma.

Karyotype

MethodologyG-banding
Specimen Requirements1 Green/NaHeparin tube (3-5 ml) peripheral blood or bone marrow at room temp.
CPT Codes88237; 88262; 88280; 88291
TAT5-7 days

TP53 Mutation Analysis

MethodologyPCR, bi-directional sequencing
Analytical Sensitivity25%
Specimen Requirements1 Lavender/EDTA tube peripheral blood or bone marrow (3-5 ml) at room temp. or 2-8°C within 48 hours after collection.
Clinical IndicationsFor the prognosis of chronic lymphocytic leukemia (CLL) and diffuse large B-cell lymphoma (DLBCL).
CPT Codes81404
TAT7-10 days

FISH Panel

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the diagnosis and prognosis of chronic lymphocytic leukemia (CLL).
CPT Codes88271(9); 88275(5); 88291
TAT3-5 days

B-Cell Clonality

MethodologyPCR, fragment analysis
Analytical Sensitivity1-3%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C or 30-50 μm total FFPE sections at room temp.
Clinical IndicationsFor the diagnosis of lymphomas.
CPT Codes81261
TAT7-10 days

GCB vs. Non-GCB Subtyping (IHC)

MethodologyIHC
Specimen RequirementsFFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice
CPT Codes88342
TAT2-4 days
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