Technology Agnostic, Methodologically Complete

The unique needs for oncology diagnostics are evolving as quickly as our understanding of these diseases. At Cancer Genetics, we know that clinicians, patients, and their families rely on us to provide the most advanced testing available. For that reason, we offer testing across a number of technology platforms, and ensure that all of the most relevant tests are available to our customers.

Through our CLIA-certified, CAP-accredited clinical laboratory, we offer comprehensive testing for both solid tumor and hematological cancers. We utilize an expansive range of tests and technologies to provide the most comprehensive profile for each patient we serve.

Jump to test: Bladder | Brain | Breast | Cervical | Colon | Colorectal | Lung | Gastric | Kidney | Melanoma | Thyroid


Solid Tumors

»Bladder Cancer

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements25-50 ml urine in a suitable container. Same day shipping or PreservCyt® should be used if the specimen will remain in transit for more than a day to ensure stability.
Clinical Indicationsbladder cancer
CPT Codes88120
TAT3-5 days
FDA approved test.

»Brain Cancer

MethodologyFluorescence in situ hybridization (FISH)
Specimen RequirementsFFPE block or three 4 μm thick unstained sections on positively coated slides at room temperature.
Clinical Indicationsbrain cancer
CPT Codes88377x2
TAT5-7 days
MethodologyReal-Time PCR
Specimen RequirementsOne unbaked, unstained 4 μm section and ten unbaked, unstained 10 μm sections on positively charged glass slides or FFPE tissue block at room temperature.
Clinical IndicationsFor the prognosis and risk stratification for treatment of patients with glioblastoma.
CPT Codes81403
TAT5-7 days
MethodologySanger Sequencing
Specimen RequirementsOne unbaked, unstained 4 μm section and ten unbaked, unstained 10 μm sections on positively charged glass slides or FFPE tissue block at room temperature.
Clinical IndicationsFor the diagnosis and prognosis of glioma and the prognosis and risk stratification of acute myeloid leukemia (AML).
CPT Codes81403x2
TAT5-7 days
MethodologyReal-Time Methylation Specific PCR
Specimen RequirementsOne unbaked, unstained 4 μm section and ten unbaked, unstained 10 μm sections on positively charged glass slides or FFPE tissue block at room temperature.
Clinical IndicationsFor the prognosis and risk stratification for treatment of patients with glioblastoma.
CPT Codes81287
TAT5-7 days
MethodologyFluorescence in situ hybridization (FISH)
Specimen RequirementsFFPE block or three 4 μm thick unstained sections on positively coated slides at room temperature.
Clinical Indicationsbrain cancer and breast cancer
CPT Codes88377
TAT5-7 days


»Breast Cancer

Click here for information about CGI’s Breast Complete™ testing program.

MethodologyIHC
Specimen RequirementsFFPE block/H&E slide at room temperature
Clinical IndicationsFor the diagnosis and subtyping of breast cancer.
CPT Codes88342
TAT1-2 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.
CPT Codes88342
TAT2-4 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
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 IndicationsPerformed on lung and breast cancer patients’ samples for prognostic implications.
CPT Codes88377
TAT5-7 days
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MethodologyFluorescence in situ hybridization (FISH)
Specimen RequirementsFFPE block or three 4 μm thick unstained sections on positively coated slides at room temperature.
Clinical Indicationsbreast cancer and gastric cancer
CPT Codes88377
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 IndicationBreast
CPT Codes88342, 88360, 88361
TAT1-3 days
FDA approved test.
MethodologyFluorescence in situ hybridization (FISH)
Specimen RequirementsFFPE block or three 4 μm thick unstained sections on positively coated slides at room temperature.
Clinical Indicationsbrain cancer and breast cancer
CPT Codes88377
TAT5-7 days


»Cervical Cancer

MethodologyFluorescence in situ hybridization (FISH)
Specimen RequirementsLiquid cytology in PreservCyt or SurePath. Specimens should be sent within 3 weeks after collection. Specimens may be shipped at room temperature (≤ 25˚C) but shipping at 4˚C is recommended. Specimens shall not be frozen. Specimen volume recommended >10 mL.
Clinical IndicationsCervical Cancer
CPT Codes88377x2
TAT7-10 days

»Colon Cancer

MethodologyReal-Time PCR
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 selection of patients with lung, colon, or gastric cancer who might benefit from platinum-based therapies.
CPT Codes81479
TAT5-7 days
MethodologyReal-Time PCR
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 IndicationsPredicts the combination of therapeutic agents for patients with lung, colon, or gastric cancer.
CPT Codes81401
TAT5-7 days


»Colorectal Cancer

Click here for information about CGI’s CRC Complete™ Testing Program

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
MethodologyReal-Time PCR
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 prognosis of patients with advanced non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).
CPT Codes81479
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 breast cancer and non-small cell lung cancer (NSCLC).
CPT Codes81235
TAT5-7 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-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
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
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
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
MethodologySanger Sequencing
Specimen RequirementsFFPE block or three 4 μm thick unstained sections on positively coated slides at room temperature.
Clinical IndicationsFor patients with colorectal cancer (CRC) who are being considered for treatment with irinotecan.
CPT Codes81350
TAT5-7 days
MethodologyReal-Time PCR
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 temperature with H&E slides.
Clinical IndicationsIdentifies patients with colorectal cancer (CRC) who are likely to respond to vascular endothelial growth factor inhibition.
CPT Codes81479
TAT5-7 days


»Lung Cancer

Click here for information about CGI’s Lung Complete™ testing program.

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
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.
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, and lung cancer
CPT Codes81210
TAT5-7 days
MethodologyReal-Time PCR
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 prognosis of patients with advanced non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).
CPT Codes81479
TAT5-7 days
MethodologyReal-Time PCR
Analytical SensitivityExon 19: 1.4-13.4%
Exon 21: 4%
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 IndicationsPredicts sensitivity or resistance to EGFR tyrosine kinase inhibitor treatments such as erlotinib and gefitinib for patients with non-small cell lung cancer (NSCLC).
CPT Codes81235
TAT3-5 days
FDAFDA-Approved test
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
MethodologyReal-Time PCR
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 patients with non-small cell lung cancer (NSCLC) who are being considered for treatment with crizotinib (XALKORI®).
CPT Codes81401
TAT5-7 days
MethodologyReal-Time PCR
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 selection of patients with lung, colon, or gastric cancer who might benefit from platinum-based therapies.
CPT Codes81479
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 IndicationsPerformed on lung and breast cancer patients’ samples for prognostic implications.
CPT Codes88377
TAT5-7 days
MethodologySanger Sequencing
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 patients with non-small cell lung cancer (NSCLC) and others who are candidates for trastuzumab (Herceptin®) or afatinib (Gilotrif®) therapy.
CPT Codes81479
TAT5-7 days
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 IndicationsPatients with NSCLC or colorectal carcinomas being consider for treatment with tyrosine kinase inhibitors.
CPT Codes88377
TAT5-7 days
MethodologyQualitative Immunohistochemical Assay
Specimen RequirementsFFPE block or a minimum of 3 FFPE sections at 3-5 µm thickness on positively coated slides shipped at room temperature.
Clinical IndicationNon-Small Cell Lung Cancer (NSCLC)
CPT Codes88342
TAT3 days
FDA approved test
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
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 Indicationslung cancer and thyroid cancer
CPT Codes88377
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 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
MethodologyReal-Time PCR
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 patients with non-small cell lung cancer (NSCLC) and others who are being considered for treatment with crizotinib (XALKORI®).
CPT Codes81479
TAT5-7 days
MethodologyReal-Time PCR
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 IndicationsPredicts the combination of therapeutic agents and selects patients with lung cancer who might benefit from gemcitabine-based therapies.
CPT Codes81479
TAT5-7 days
MethodologyReal-Time PCR
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 IndicationsPredicts the combination of therapeutic agents for patients with lung, colon, or gastric cancer.
CPT Codes81401
TAT5-7 days

 


»Gastric Cancer

MethodologyReal-Time PCR
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 selection of patients with lung, colon, or gastric cancer who might benefit from platinum-based therapies.
CPT Codes81479
TAT5-7 days
MethodologyFluorescence in situ hybridization (FISH)
Specimen RequirementsFFPE block or three 4 μm thick unstained sections on positively coated slides at room temperature.
Clinical Indicationsbreast cancer and gastric cancer
CPT Codes88377
TAT5-7 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.
MethodologyReal-Time PCR
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 IndicationsPredicts the combination of therapeutic agents for patients with lung, colon, or gastric cancer.
CPT Codes81401
TAT5-7 days


»Kidney Cancer

MethodologyArray-CGH
Analytical Sensitivity40%
Specimen Requirements"For both biopsies and resected specimens, a minimum of 70% tumor population is preferred.
Biopsy: Min. 3-4 needle/core biopsies (18-gauge needle) placed in a cryovial containing saline, transport frozen.
Resected specimen: A minimum of 0.2x0.2x0.2cm tissue, snap-frozen in a cryovial and transported in frozen condition."
Clinical IndicationsFor the diagnosis and subtyping of renal cortical neoplasms.
CPT Codes81479
TAT10-14 days

»Melanoma

MethodologyRT-qPCR
Analytical Sensitivity5%
Specimen RequirementsFormalin-fixed paraffin-embedded (FFPE) tissue containing >20% of tumor cells. 3-5 FFPE sections at 10 μm thickness. Stored and transported at room temperature.
Clinical IndicationsAids in the assessment of patients with melanoma for whom Zelboraf™ treatment is being considered.
CPT Codes81210
TAT3-5 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
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


»Thyroid Cancer

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
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
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 Indicationslung cancer and thyroid cancer
CPT Codes88377
TAT5-7 days


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