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 Breast Cancer

Breast cancer subtyping is critical to determining the appropriate targeted therapy option for each patient. By offering the most comprehensive testing panel available, CGI’s Breast Complete™ program can help determine the best personalized course of action for each patient.

Genetic AlterationsFrequencyWhat the Biomarker Tells Us
ER/PR70% of invasive breast cancersPositive status is indicative of poor prognosis, but also of an increased response rate to endocrine therapy (tamoxifen).
Her215-20% of invasive breast cancersPositive status is indicative of a proor prognosis and an increased response to Her2-targeted treatment Herceptin® (trastuzumab) but not to endocrine-based therapies.
Ki67~25%Higher levels of Ki-67 are indicative of higher recurrence rate.
EGFRPositive statuse indicates possible response to anti-EGFR therapies.

»Breast Complete

breast complete workupThis workup is intended as a guide for the comprehensive suite of diagnostic tests included in Lung Complete™ to diagnose and monitor lung cancer. Physicians can order tests individually or allow CGI pathologists and directors to determine a panel evaluation as determined necessary. Tests offered through CGI’s Complete™ Programs are also available via Digital Pathology.
MethodologyIHC
Specimen RequirementsFFPE block/H&E slide at room temperature
Clinical IndicationsFor the diagnosis and subtyping of breast cancer.
CPT Codes88342
TAT1-2 days
MethodologySanger Sequencing
Analytical Sensitivity10-12%
Specimen RequirementsFFPE block or 5-10 FFPE sections at 10 µm thickness on positively coated slides shipped at room temperature, with H&E slide(s).
Submit 15 sections for small biopsies.
Clinical IndicationsFor the clinical management of patients with breast cancer and non-small cell lung cancer (NSCLC).
CPT Codes81235
TAT5-7 days
MethodologyIHC
Specimen RequirementsFFPE block or Ten 4-5 μm thick unstained sections on positively coated slides
Clinical IndicationsFor the clinical management of patients with breast cancer and assessment of patients for whom Herceptin® or other HER2-targeted treatment is being considered.
CPT Codes88342
TAT2-4 days
MethodologyDual ISH
Specimen RequirementsFFPE block or Ten 4-5 μm thick unstained sections on positively coated slides
Clinical IndicationsFor the clinical management of patients with breast cancer and assessment of patients for whom Herceptin® or other HER2-targeted treatment is being considered.
CPT Codes
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 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
MethodologyIHC
Specimen Requirements3-5 µm thick FFPE sections on positively coated slides at room temp.
Clinical IndicationsGastric
CPT Codes88342, 88360, 88361
TAT1-3 days
FDA approved test.