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 Colorectal Cancer

Colorectal cancer (CRC) is the third most commonly diagnosed cancer in the U.S. with 140,000 new cases per year and the third leading cause of cancer death in both men and women with 50,000 deaths per year. In 2012, there were ~1.2 million Americans living with a history of CRC. The risk of CRC increases with age as 90% of new CRC cases and 93% of deaths occur in people over the age of 50.

Lynch Syndrome is an inherited disorder that increases the risk of CRC and increases the risk of developing the disease at a younger age. Approximately 3-5% of CRCs are caused by Lynch Syndrome.

CGI’s CRC Complete™ Program assists in determining the best personalized course of action for the patient by predicting overall prognosis and treatment response. CRC Complete™ also risk stratifies patients for likelyhood of developing Lynch Syndrome leading to earlier CRC screening and diagnosis for those identified as high risk.


»CRC Complete

CRC Complete Workup

This workup is intended as a guide for the comprehensive suite of diagnostic tests included in Lung Complete™ to diagnose and monitor colorectal cancer (CRC). 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
Analytical Sensitivity--
Specimen RequirementsFFPE block/H&E slide at room temperature
Clinical IndicationsFor the diagnosis of breast cancer.
CPT Codes88342
TAT1-2 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
MethodologyPCR-Fragment analysis
Analytical Sensitivity5%
Specimen RequirementsFFPE block or Ten 4-5 μm thick sections on positively coated slides at room temperature
Clinical IndicationsFor the diagnosis of Lynch Syndrome and prognostication of sporadic CRC.
CPT Codes81301
TAT5-7 days
MethodologyIHC
Analytical Sensitivity---
Specimen RequirementsFFPE block or Ten 4-5 μm thick sections on positively coated slides at room temperature
Clinical IndicationsPatients with melanoma, papillary thyroid cancer, or NSCLC who are being considered for treatment with BRAF or MEK inhibitors, as well as patients with CRC and others who are being considered for treatment with EGFR antagonists cetuximab and panitumumab.
CPT Codes88342
TAT2-4 days
MethodologyPCR, Pyrosequencing
Analytical Sensitivity5%
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, 81276
TAT5-7 days
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
TAT5-7 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 colorectal cancer (CRC) and lung cancer.
CPT Codes81404
TAT7-10 days
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 Codes81311
TAT7-10 days