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 Myelorproliferative Neoplasms (MPN)

Myeloproliferative neoplasms (MPN) correspond to a group of blood cancers that include chronic myelogenous leukemia (CML), primary myelofibrosis (PMF), polycythemia vera (PV), essential thrombocythemia (ET), hyper eosinophilia and mast cell disorders. Most cases develop slowly, and some MPNs can progress to leukemia. In addition to the patient’s general clinical features, the treatment depends upon the MPN subtype, therefore determining the right MPN subtype is critical.

By offering the most comprehensive testing panel available, CGI’s MPN Complete™ Program can help in determining the best personalized course of action for the patient. Tests being offered in the Complete™ Programs include biomarkers that rely on various methodologies and that have diagnostic and prognostic significance for each patient.


MPN Complete™

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

MPN Complete Work Flow 050715

This workup is intended as a guide for the comprehensive suite of diagnostic tests included in MPN Complete™ to diagnose and monitor Myeloproliferative Neoplasms (MPNs). Physicians can order tests individually or allow CGI pathologists and directors to determine a panel evaluation as deemed necessary. Tests offered through CGI’s Complete™ Programs are also available via Digital Pathology.

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
TAT1-2 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
Methodologyreal time PCR
Analytical Sensitivity1 tumor cell/100,000 normal cells
Specimen Requirements1 Lavender/EDTA tube PB or BM (3-5 ml) shipped at room temperature.
Clinical IndicationsThis assay utilizes quantitative PCR to diagnose CML as well as monitor CML patients for therapeutic response, minimal residual disease (MRD), and early relapse.
CPT Codes81206 (major); 81207 (minor)
TAT3-5 days
MethodologyPCR, sequencing
Analytical Sensitivity1%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temperature or 2-8°C.
Clinical IndicationsThe JAK2 V617F mutation is used to diagnose or confirm the diagnosis of PV, ET or PMF. It is found in 90% of patients with PV and in nearly 50% of patients with ET or PMF.
CPT Codes81270
TAT3-5 days
MethodologyPCR, sequencing
Analytical Sensitivity20%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temperature or 2-8°C.
Clinical IndicationsThe JAK2 Exon 12 mutation is used to diagnose or confirm the diagnosis of PV in JAK2 V617F mutation negative patients.
CPT Codes81403
TAT7-10 days
MethodologyPCR, Bi-directional sequencing
Analytical Sensitivity10%
Specimen Requirements
Clinical Indications
CPT Codes81479
TAT5-7 days
MethodologyPCR, Bi-directional sequencing
Analytical Sensitivity20%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temperature or 2-8°C.
Clinical IndicationsSomatic mutations of codons 515 and 505 in the MPL virus oncogene are clonal markers of ET and PMF. The markers are used to diagnose these two diseases and is often ordered as a reflexed test when JAK2 V617F and CALR mutations are negative.
CPT Codes81402
TAT7-10 days
MethodologyPCR, sequencing
Analytical Sensitivity0.25%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temperature or 2-8°C.
Clinical IndicationsThe c-KIT D816 mutation can assist with the initial diagnosis of systemic mastocytosis (SM) and treatment response to imatinib therapy.
CPT Codes81402
TAT7-10 days
Designed for acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and myeloproliferative neoplasms (MPN), Focus::Myeloid™ is a unique NGS panel with 54 biomarkers that provides actionable information for improved diagnosis, prognosis, and risk stratification.
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 diagnosis, prognosis, and risk stratification of Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Myeloproliferative Neoplasms (MPN)
CPT Codes81455
TAT10-14 days
MethodologyFluorescence in situ Hybridization (FISH)
Specimen RequirementsFluorescence in situ hybridization (FISH)
1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsThe MPN FISH panel, including PDGFRα and PDGFRβ Probes, provides diagnostic and predictive information in MPN cases with eosinophilia. FISH for BCR-ABL1 detects both cryptic and noncryptic BCR-ABL1 translocations in suspected CML cases.
CPT Codes88271(4); 88275(2); 88291
TAT3-5 days