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 CLL/SLL

CGI’s Complete testing program for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) integrates the latest diagnostic and prognostic molecular markers, including CGI’s proprietary array-CGH based panel, MatBA®-CLL/SLL, and our NGS-based panel, Focus::CLL™.

Accurate prognostication of CLL patients is essential in order to determine the most effective course of treatment. CLL patients tend to display significant clinical heterogeneity -some patients have aggressive disease requiring careful active monitoring or treatment at diagnosis, while others exhibit a more indolent (slowly progressing) course of disease.

Risk stratification based on clinical stage, fitness and comorbidities, and molecular prognostic markers is highly recommended at diagnosis in order to determine the most appropriate strategy for clinical management. Prior to the start of treatment, risk stratification is indicated for age- and risk-adapted chemoimmunotherapy and overall patient survival prediction. Depending on the patient’s age and the underlying biology of the disease, risk stratification may also be recommended throughout the course of the disease.


»CLL Complete™

Physicians can order tests individually or allow CGI directors to perform a panel evaluation as determined necessary.

CLL Complete Work Flow

New Diagnosis or Disease Monitoring

Risk Stratification

Morphology

Immunophenotyping (Flow, IHC)

CD38, Zap-70 (Flow Cytometry)

MatBA®-CLL/SLL (Molecular Dx)

FISH - CLL Panel (Cytogenetics)

IGHV Mutation Analysis (Molecular Dx)

TP53 Mutation Analysis (Molecular Dx)

NOTCH1 Mutation Analysis (Molecular Dx)

SF3B1 Mutation Analysis (Molecular Dx)

Karyotype (Cytogenetics)


Relapse or Prior to Treatment

Risk Stratification Therapy Guidance

MatBA®-CLL/SLL (Molecular Dx)

TP53 Mutation Analysis (Molecular Dx)

FISH - CLL Panel (Cytogenetics)

Karyotype (Cytogenetics)


The lymphoid panel determines expression levels of cell surface antigens by flow cytometry that provide diagnostic information for CLL. Zap-70 is an independent prognostic marker of CLL that is also used as a surrogate marker for IGHV mutation analysis. A high level of the ZAP-70 protein correlates with an aggressive form of the disease.
CGI's flow testing for CLL includes the following: CD2, CD3, CD4, CD5, CD7, CD8, CD10, CD11c, CD19, CD20, CD23, CD38, CD45, CD56, CD57, Kappa, Lambda, Zap70
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
Mature B-cell neoplasms exhibit clonal genomic alterations that have diagnostic and prognostic significance. Once such type of alteration is gain or loss of genomic loci, which in the current test is assayed by array-comparative genomic hybridization (array-CGH) permitting the simultaneous detection of gain and loss at multiple loci. Loci being assessed by MatBA®-CLL/SLL are 1p, 2p, 3q, 4q, 5p, 6q, 7p, 7q, 8p, 8q, 11q (ATM), 12q, 13 (MIR15A/16-1), 17p (TP53), 17q, 18p, 18q, and 19p.
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
The Focus::CLL™ NGS panel assists in the prognosis of CLL/SLL patients. Multiplexed sequencing by synthesis is performed using the MiSeq System (Illumina). This panel includes selected exons of the TP53, NOTCH1, SF3B1, BIRC3, ATM, MYD88, and Card11 genes.
MethodologyNext Generation Sequencing
Analytical Sensitivity5%
Specimen RequirementsOne Lavender (EDTA) tube of peripheral blood or bone marrow aspirate. Minimum: 2-3 mL. Shipped at room temperature.
Clinical IndicationsFor the risk stratification and prognosis of Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma
CPT Codes81450
TAT10-14 days
Detection of hyper-mutation in the IGHV gene serves as an independent prognostic marker. Patients with the hyper-mutated IGHV gene exhibit a better overall survival than those with un-mutated IGHV. Utilization of IGHV3-21 regardless of IGHV mutation status is associated with an unfavorable outcome.
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
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 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 breast cancer, chronic lymphocytic leukemia (CLL) and diffuse large B-cell lymphoma (DLBCL).
CPT Codes81405
TAT7-10 days
Mutational NOTCH1 activation in CLL diagnosis is an independent predictor of poor survival and a shorter time to progression.
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 mutations are independent predictors that occur in 10-15% of CLL patients. They are indicative of shorter time to treatment, and a poorer overall survival.
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
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
FISH analysis provides high sensitivity information about key genomic alterations and prognostic markers, such as the loss of 17p (TP53), 11q (ATM), 13q, and 6q, along with the gain of chromosome 12. The translocation t(11;14) is also evaluated to rule out Mantle Cell Lymphoma.
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