CGI Complete

CGI's Complete™ Program

Cancer Genetics' Complete™ offering is a unique suite of common and proprietary tests that assists clinicians in determining the best treatment options to improve patient outcomes. Each program integrates the latest diagnostic and prognostic biomarkers across multiple methodologies. CGI offers Complete™ testing for a number of hematological neoplasms and solid tumor cancers, including CLL/SLL, DLBCL, MCL, MPN, colorectal, lung, and breast cancers.

CGI’s Complete Testing for DLBCL

Diffuse large B-cell lymphoma (DLBCL) is a clinically, pathologically, and genetically heterogenous disease – meaning that patients display a diverse range of clinical symptoms, pathological presentation, and genetic mutations. DLBCL accounts for ~40% of all Non-Hodgkin’s Lymphoma (NHL) cases, and is the most aggressive form of lymphoma. While DLBCL is an immunochemo-sensitive disease, only about 60% of patients are cured. Therefore, risk stratification is highly desirable for DLBCL patients in order to differentiate those who are likely to have refractory disease or relapse from those who may be cured with the standard therapy.
CGI’s Complete™ testing for DLBCL integrates the latest diagnostic and prognostic molecular markers, including CGI’s proprietary MatBA®-DLBCL, in order to risk stratify individual patients for disease progression, response to treatment, and overall prognosis.


» DLBCL Complete™

DLBCL Complete™ Work-Up
Physicians can order tests individually or allow CGI directors to perform a panel evaluation as determined necessary.

New Diagnosis



Diagnostic & Prognostic Assessment

Morphology

Immunophenotyping (Flow, IHC)

B-Cell Clonality(Molecular Dx)

FISH - NHL Panel(Cytogenetics)

Karyotyping (Cytogenetics)


Prognostic & Theranostic Assessment

Proliferation Index by Ki-67 (IHC)

MYC Expression (IHC)

GCB/Non-GCB Subtyping (IHC)

TP53 Mutation Analysis (Molecular Dx)

MatBA®-DLBCL (Molecular Dx)

SETRA™* (Molecular Dx)

Monitoring, Disease Progression & Recurrence


Prognostic & Theranostic Assessment

TP53 Mutation Analysis (Molecular Dx)

MatBA®-DLBCL (Molecular Dx)

SETRA™* (Molecular Dx)

MYC, Ki-67l (IHC)

Karyotyping (Cytogenetics)

Specimen RequirementsFFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice
TAT2-4 days
MethodologyIHC
Specimen RequirementsFFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice
CPT Codes88342
TAT2-4 days
MethodologyIHC
Specimen RequirementsFFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice
CPT Codes88342
TAT2-4 days
MethodologyIHC
Specimen RequirementsFFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice
CPT Codes88342
TAT2-4 days
MethodologyIHC
Specimen RequirementsFFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice
CPT Codes88342
TAT2-4 days
The lymphoid panel determines expression levels of cell surface antigens by flow cytometry that provide diagnostic information for the diagnosis and for monitoring therapy. This panel includes CD2, CD3, CD4, CD5, CD7, CD8, CD10, CD11b, CD11c, CD13, CD14, CD15, CD16, CD19, CD20, CD22, CD23, CD33, CD34, CD38, CD45, CD56, CD57, CD64, CD71, CD117, HLA-DR, sKappa, sLambda.
MethodologyFlow cytometry
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 (x17); 88189
TAT1-2 days
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
The presence of a TP53 mutation is associated with shorter survival and resistance to chemotherapy.
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 Codes81405
TAT7-10 days
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
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
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 diffuse large B-cell lymphoma (DLBCL)
CPT Codes88271(9); 88275(5); 88291
TAT3-5 days