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 Non Small Cell Lung Cancer

Non-small cell lung cancer (NSCLC) accounts for about 85% of all lung cancers, with more than 185,000 new cases diagnosed in the US each year. It is estimated that ~40% of lung cancer tumors are driven by certain genetic mutations that could be targets for specific drugs. Genetic testing for these mutations can provide important insight into a patient’s disease, and help determine an individual’s diagnosis, prognosis, and whether they are likely to respond to certain treatments.

Genetic AlterationsFrequencyWhat the Biomarker Tells Us
EGFR mutations10-35%Sensitizing mutations benefit from erlotinib, gefitinib & afatinib targeted therapies.
ALK rearrangements
c-MET amplifications
ROS1 rearrangements
3-7%
2-4%
1%
Genetic alterations benefit from crizotinib targeted therapy.
KRAS mutations15-25%Prognostic of poor survival independent of therapy & predicts lack of benefit from EGFR TKIs.

» Lung Complete™

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

This 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.

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
Methodologyreal time PCR
Analytical SensitivityExon 19: 1.4-13.4%
Exon 21: 4%
Specimen RequirementsFFPE block or 3-5 FFPE sections at 10 μm thickness containing at least 20% of tumor cells evaluated on H&E slides shipped at room temperature.
Clinical IndicationsEGFR mutations predict sensitivity or resistance to EGFR TKI treatments such as erlotinib and gefitinib. The most common EGFR mutations that show higher rates of response to EGFR TKIs, include the deletion of exon 19 and the L858R point mutation in exon 21. The predicted response rate to erlotinib is ~82-83% and to gefitinib is ~71-73% for these EGFR TKI sensitive mutations. The T790M point mutation in exon 20 is the most common mechanism of acquired resistance to EGFR TKIs.
CPT Codes81235, 88381 (macrodissected)
TAT3-5 days
FDA approved test.
MethodologyReal-Time PCR
Analytical Sensitivity12%
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 IndicationsThe KRAS mutation predicts resistance to EGFR tyrosine kinase inhibitors and is associated with a poor overall survival independent of therapy.
CPT Codes81275
TAT5-7 days
MethodologyFluorescence in situ Hybridization (FISH)
Specimen RequirementsFFPE block or 3-5 FFPE sections at 3-5 µm thickness on positively coated slides shipped at room temperature, with H&E slide(s).
Clinical IndicationsThe ALK Break Apart DNA-FISH probe identifies rearrangements of the ALK gene which indicated resistance to EGFR tyrosine kinase inhibitor therapy. Patients with ALK gene rearrangements can benefit from ALK tyrosine kinase inhibitors such as crizotinib. The predicted response rate to crizotinib is>60%.
CPT Codes88377
TAT5-7 days
FDAFDA approved test.
MethodologyFluorescence in situ Hybridization (FISH)
Specimen RequirementsFFPE block or 3-5 FFPE sections at 3-5 µm thickness on positively coated slides shipped at room temperature, with H&E slide(s).
Clinical IndicationsROS1 gene rearrangements are similar to ALK gene rearrangements. Similarly, patients with ROS1 gene rearrangements can benefit from ALK TKIs. The predicted response rate to crizotinib in patients with ROS1 gene rearrangements is 57.1%.
CPT Codes88377
TAT5-7 days