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: Flow Cytometry | Anatomic Pathology | Karyotype | FISH | Molecular Diagnostics | Complete™


» Flow Cytometry

Our flow cytometry department also tests for a selection of individual antibodies.
If you want more information please contact us at 888.334.4988

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 (x16); 88189
TAT1-2 days
MethodologyFlow Cytometry
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube PB (10 ml) or BM (3 ml) at room temperature.
Clinical IndicationsFor the prognosis and monitoring of patients with chronic lymphocytic leukemia (CLL).
CPT Codes88184, 88185(8), 88188
TAT1-2 days
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (2 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the clinical management of patients with multiple myeloma.
CPT Codes88184; 88185 (x22); 88189
TAT1-2 days
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, lymphoma, plasma cell neoplasms, and evaluation of myeloid maturation.
CPT Codes"Myeloid/Lymphoid: 88184; 88185 (x28); 88189
With Acute Add-On: 88184; 88185(x34); 88189"
TAT1-2 days
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (2 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the diagnosis of PNH and monitoring response to therapy.
CPT Codes88184; 88185 (x7); 88187
TAT1-2 days
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (2 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the prognosis of chronic lymphocytic leukemia (CLL).
CPT Codes88184; 88185 (x4); 88187
TAT1-2 days


» Anatomic Pathology

Tests in the area of Morphology include both histology and cytology. We offer a full immunohistochemistry library with over 180 antibodies. For the full list, please click here CGI Immunohistochemistry Library.

MethodologyImmunohistochemistry (IHC)
Specimen Requirements4-5μm thick FFPE sections on positively coated slides at room temp.
CPT Codes88342
TAT2-4 days

» Karyotype

Karyotyping enables genome-wide detection of aberrations at low resolution that have a diagnostic and prognostic significance.

MethodologyG-banding
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temp.
CPT Codes88237; 88262; 88280; 88291
TAT5-7 days

» FISH

Hematological Malignancies

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temp.
Clinical IndicationsFor the diagnosis and prognosis of acute lymphocytic leukemia (ALL).
CPT Codes88271(13); 88275(6); 88291
TAT3-5 days
  • 11q23 (MLL-Break Apart)
  • t(9;22) (BCR/ABL/ASS)
  • 17p13 (TP53)
  • t(12;21) (ETV6/RUNX1)
  • 9p21 (CDKN2A[p16])
  • CEP4,10, 17

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temp.
Clinical IndicationsFor the diagnosis and prognosis of acute lymphocytic leukemia (ALL).
CPT Codes88271(2); 88275; 88291
TAT3-5 days
  • 14q11 (TCR-Alpha/Delta Break Apart)

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the diagnosis, subtyping and prognostic stratification of acute myeloid leukemia (AML) patients.
CPT Codes88271(8); 88275(4); 88291
TAT3-5 days
  • 11q23 (MLL-Break Apart)
  • t(8;21) (ETO/AML1) [M2]
  • t(15;17) (PML/RARA) [M3]
  • inv(16) (CBFB-Break Apart) [M4, Eos]

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temp.
Clinical IndicationsFor the prognosis of anaplastic large cell lymphoma (ALCL).
CPT Codes88271(2); 88275; 88291
TAT3-5 days
  • 2p23 (ALK-Break Apart)

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the monitoring of patients who received opposite-sex bone marrow transplantation for chronic myelogenous leukemia (CML), acute myeloid leukemia (AML), myeloproliferative disorder (MPD), myelodysplastic syndrome (MDS), and acute lymphoid leukemia (ALL).
CPT Codes88271(2); 88275; 88291
TAT3-5 days
  • CEP X/Y

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the diagnosis and prognosis of chronic lymphocytic leukemia (CLL).
CPT Codes88271(9); 88275(4); 88291
TAT3-5 days
  • 11q22.3 (ATM)/17p13 (TP53)
  • CEP12/13q14 (D13S319)/13q34
  • CEP6/6q23 (c-MYB)
  • t(11;14)(CCND1/IGH)

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the diagnosis of chronic myelogenous leukemia (CML).
CPT Codes88271(3); 88275(1); 88291
TAT3-5 days
  • t(9;22) (BCR/ABL/ASS)

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the diagnosis of chronic myelogenous leukemia (CML).
CPT Codes88271(5); 88275(3); 88291
TAT3-5 days
  • t(9;22) (BCR/ABL/ASS)
  • 17p13 (TP53)
  • CEP8

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the diagnosis and prognosis of multiple myeloma.
CPT Codes88271(15); 88275(7); 88291
TAT7-10 days
  • 13q14/13q34
  • 17/17p13 (TP53)
  • 1p/1q
  • D5S23/D5S72/CEP9/CEP15
  • t(4;14) (FGFR3/IGH)
  • t(11;14) (CCND1/IGH)
  • t(14;16) (lGH/MAF)

Also Available:

  • IGH-Break Apart
  • CEP7/CEP11
  • t(6;14) (CCND3/IGH)
  • t(14;20) (IGH/MAFB)

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the diagnosis, prognosis, monitoring of response to therapy or progression of disease of myelodysplastic syndrome (MDS).
CPT Codes88271(8); 88275(4); 88291
TAT3-5 days
  • 5q15.2/5q31
  • CEP7/7q31
  • CEP8
  • 20q12
  • 11q23 (MLL-Break Apart)

MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the diagnosis of myeloproliferative disease (MPD) or for monitoring response to therapy or progression of the disease.
CPT Codes88271(4); 88275(2); 88291
TAT3-5 days
  • 4q12 (FIP1L1/CHIC2/PDGFRA)
  • 5q33 (PDGFRB-Break Apart)
  • BCR/ABL (BCR/ABL/ASS)
  • CEP8/CEP9


MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temp.
Clinical IndicationsFor the diagnosis and prognosis of non-Hodgkin lymphoma (NHL).
CPT Codes88271(11); 88275(5); 88291
TAT3-5 days

  • Burkitt: t(8;14) (MYC/IGH)
  • DLBCL: 3q27 (BCL6-Break Apart)
  • Follicular: t(14;18) (IGH/BCL2)
  • Mantle: t(11;14) (CCND1/IGH)
  • MALT Lymphoma: MALT1-Break Apart

Also Available:

  • IGH-Break Apart
  • c-MYC-Break Apart

Solid Tumors

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
MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements3-5 µm thick FFPE sections on positively coated slides at room temp.
Clinical IndicationsNSCLC
CPT Codes88377
TAT5-7 days
FDA approved test.
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
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
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
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
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.
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
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 sections at 3-5 μm thickness on positively coated slides at room temperature.
Clinical Indicationslung cancer
CPT Codes88377
TAT5-7 days
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.


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»Molecular Diagnostics

Hematological Malignancies

MethodologyPCR, sequencing
Analytical Sensitivity20%
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 monitoring patients with chronic myeloid leukemia (CML).
CPT Codes81170
TAT7-10 days
MethodologyPCR, fragment analysis
Analytical Sensitivity1-3%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C or 30-50 μm total FFPE sections at room temp.
Clinical IndicationsFor the diagnosis of lymphomas.
CPT Codes81261
TAT7-10 days
MethodologyReal-time PCR
Analytical Sensitivity1 tumor cell/ 100,000 normal cells
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 diagnosis of acute lymphoblastic leukemia (ALL) and chronic myeloid leukemia (CML).
CPT Codes81206, 81207
TAT3-5 days
MethodologyReal-time PCR
Analytical Sensitivity1 tumor cell/ 100,000 normal cells
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 monitoring patients with acute lymphoblastic leukemia (ALL) and chronic myeloid leukemia (CML).
CPT Codes81206 (major); 81207 (minor)
TAT3-5 days
MethodologyPCR, sequencing
Analytical Sensitivity20%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis of patients with acute myeloid leukemia (AML).
CPT Codes81272
TAT7-10 days
MethodologyPCR, sequencing
Analytical Sensitivity0.25%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis of patients with myeloproliferative neoplasms (MPN).
CPT Codes81273
TAT7-10 days
MethodologyPCR, bi-directional sequencing
Analytical Sensitivity10%
Specimen Requirements2-3 ml peripheral blood or bone marrow in an EDTA tube (Lavender-top). Specimen should be stored, transported at room temperature or 2-8°C.
Clinical IndicationsET, PMF
CPT Codes81219
TAT5-7 days
MethodologyPCR, sequencing
Analytical Sensitivity20%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis of patients with acute myeloid leukemia (AML).
CPT Codes81218
TAT7-10 days
MethodologyPCR, sequencing
Analytical Sensitivity10%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis and clinical management of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
CPT Codes81245
TAT7-10 days
MethodologyPCR, sequencing
Analytical Sensitivity10%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis and clinical management of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
CPT Codes81263
TAT7-10 days
MethodologyPCR, sequencing
Analytical Sensitivity1%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the diagnosis of patients with myeloproliferative neoplasms (MPN).
CPT Codes81270
TAT3-5 days
MethodologyPCR, sequencing
Analytical Sensitivity20%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the diagnosis of patients with myeloproliferative neoplasms (MPN).
CPT Codes81403
TAT7-10 days
MethodologyPCR, bi-directional sequencing
Analytical Sensitivity20%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the diagnosis of patients with myeloproliferative neoplasms (MPN).
CPT Codes81403
TAT7-10 days
MethodologyPCR, pyrosequencing
Analytical Sensitivity5%
Specimen Requirements2-3 ml peripheral blood or bone marrow in an EDTA tube (Lavender-top). Specimen should be stored, transported at room temperature or 2-8°C.
Clinical IndicationsLymphoma
CPT Codes81479
TAT5-7 days
Mutational NOTCH1 activation in CLL diagnosis is an independent predictor of poor survival and a shorter time to progression.
MethodologyPCR, bi-directional sequencing
Analytical Sensitivity20%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
CPT Codes81479
TAT7-10 days
MethodologyPCR, sequencing
Analytical Sensitivity5%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis of patients with acute myeloid leukemia (AML).
CPT Codes81310
TAT7-10 days
SF3B1 mutations are independent predictors that occur in 10-15% of CLL patients. They are indicative of shorter time to treatment, and a poorer overall survival.
MethodologyPCR, bi-directional sequencing
Analytical Sensitivity20%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis of chronic lymphocytic leukemia (CLL).
CPT Codes81479
TAT7-10 days
MethodologyPCR, fragment analysis
Analytical Sensitivity1-3%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C or 30-50 μm total FFPE sections at room temp.
Clinical IndicationsFor the diagnosis of lymphoma.
CPT Codes81340
TAT7-10 days
MethodologyPCR, fragment analysis
Analytical Sensitivity1-3%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C or 30-50 μm total FFPE sections at room temp.
Clinical IndicationsFor the diagnosis of lymphoma.
CPT Codes81342
TAT7-10 days
MethodologyPCR, bi-directional sequencing
Analytical Sensitivity25%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis of chronic lymphocytic leukemia (CLL) and diffuse large B-cell lymphoma (DLBCL).
CPT Codes81405
TAT7-10 days

Array-CGH

Mature B-cell neoplasms exhibit clonal genomic alterations that have diagnostic and prognostic significance. Once such type of alteration is gain or loss of genomic loci, which in the current test is assayed by array-comparative genomic hybridization (array-CGH) permitting the simultaneous detection of gain and loss at multiple loci. Loci being assessed by MatBA®-CLL/SLL are 1p, 2p, 3q, 4q, 5p, 6q, 7p, 7q, 8p, 8q, 11q (ATM), 12q, 13 (MIR15A/16-1), 17p (TP53), 17q, 18p, 18q, and 19p.
MethodologyArray-CGH
Analytical Sensitivity30-40%
Specimen Requirements1 Lavender/EDTA tube peripheral blood or bone marrow aspirate with minimum 2-3ml or 3-5 FFPE sections at 10 μm thickness on regular slides at room temp.
Clinical IndicationsFor the risk stratification and prognosis of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
CPT Codes81479
TAT10-14 days
MethodologyArray-CGH
Analytical SensitivityFFPE: 60-70%
Fresh-Frozen tissue: 50-60%"
Specimen Requirements"FFPE block: containing ≥ 70% tumor. Minimum size: 2 mm x 2 mm tumor area, shipped at room temperature.
Fresh-Frozen tissue: 0.2 cm3 min. (in OCT is acceptable) containing ≥ 50% tumor. Stored at -80°C /-20°C, shipped on dry ice.
FFPE block or fresh-frozen specimen: incisional or excisional biopsy."
Clinical IndicationsFor the risk stratification and prognosis of diffuse large B-cell lymphoma (DLBCL).
CPT Codes81479
TAT10-14 days
MethodologyArray-CGH
Analytical Sensitivity50-60%
Specimen RequirementsFFPE block: containing ≥ 60% tumor. Minimum size: 2 mm x 2 mm tumor area, shipped at room temperature.
Fresh-Frozen tissue: 0.2 cm3 minimum (in OCT is acceptable) containing ≥50% tumor. Stored at -80°C /-20°C, shipped on dry ice.
FFPE block or fresh-frozen specimen from incisional or excisional biopsy.
Clinical IndicationsAssists in the prognosis of follicular lymphoma (FL)
CPT Codes81479
TAT10-14 days
MethodologyArray-CGH
Analytical SensitivityFFPE: 60-70%
Fresh-frozen: 50-60%
Peripheral blood: 30-40%
Specimen RequirementsFFPE block: containing ≥ 60% tumor. Minimum size: 2 mm x 2 mm tumor area, shipped at room temperature.
Fresh-Frozen tissue: 0.2 cm3 minimum (in OCT is acceptable) containing ≥50% tumor. Stored at -80°C /-20°C, shipped on dry ice.
Peripheral blood: Minimum 3-5 ml, shipped at room temperature.
Clinical IndicationsMCL
CPT Codes81479
TAT10-14 days
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

Solid Tumor

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
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
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
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
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
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
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
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
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
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
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
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
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
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

Next-Generation Sequencing

The Focus::CLL™ NGS panel assists in the prognosis of CLL/SLL patients. Multiplexed sequencing by synthesis is performed using the MiSeq System (Illumina). This panel includes selected exons of the TP53, NOTCH1, SF3B1, BIRC3, ATM, MYD88, and Card11 genes.
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 risk stratification and prognosis of Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma
CPT Codes81450
TAT10-14 days
MethodologyNext Generation 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). Please submit 15 sections for small biopsies. The tumor tissue must be ≥ 20% tumor cells for accurate test results.
Clinical IndicationsThis assay can be used to provide treatment guidance for solid tumors such as lung, colon, skin, breast, and bladder cancers and diagnosis/prognosis use in thyroid cancer.
CPT Codes81445
TAT7-10
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

Tissue of Origin

MethodologyGene Expression
Specimen RequirementsFFPE block containing at least 1 mm2 of tumor tissue by area and an H&E stained slide if possible. Unstained slides of at least 5 μm thickness (10 μm thickness preferred) that contain no less than 1 mm2 of tumor tissue.
Clinical IndicationsDetermines the tissue of origin of 58 morphologic subtypes from 15 of the most common tumor types: thyroid, breast, non-small cell lung, pancreas, gastric, colorectal, liver, bladder, kidney, non-Hodgkin’s lymphoma, melanoma, ovarian, sarcoma, testicular germ cell, and prostate.
CPT Codes81504
TAT5-11 days
FDA-Cleared Test
MethodologyGene Expression
Specimen RequirementsFFPE block containing at least 1 mm2 of tumor tissue by area and an H&E stained slide if possible. Unstained slides of at least 5 μm thickness (10 μm thickness preferred) that contain no less than 1 mm2 of tumor tissue.
Clinical IndicationsDetermines tissue of origin between Endometrial and Ovarian cancer.
CPT Codes81504
TAT5-11 days
MethodologyGene Expression
Specimen RequirementsFFPE block containing at least 1 mm2 of tumor tissue by area and an H&E stained slide if possible. Unstained slides of at least 5 μm thickness (10 μm thickness preferred) that contain no less than 1 mm2 of tumor tissue.
Clinical IndicationsDistinguishes between squamous cell carcinoma of the Head & Neck and squamous cell carcinoma of the lung.
CPT Codes81504
TAT5-11 days


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»Complete™ Program

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

»AML Complete


AML Complete Work Flow
This workup is intended as a guide for the comprehensive suite of diagnostic tests included in AML Complete™ to diagnose and monitor AML. 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
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
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
MethodologyPCR, sequencing
Analytical Sensitivity20%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis of patients with acute myeloid leukemia (AML).
CPT Codes81403
TAT7-10 days
MethodologyPCR, sequencing
Analytical Sensitivity10%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis and clinical management of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
CPT Codes81263
TAT7-10 days
MethodologyPCR, sequencing
Analytical Sensitivity20%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis of patients with acute myeloid leukemia (AML).
CPT Codes81404
TAT7-10 days
MethodologyPCR, sequencing
Analytical Sensitivity5%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis of patients with acute myeloid leukemia (AML).
CPT Codes81310
TAT7-10 days
MethodologyG-banding
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temp.
CPT Codes88237; 88262; 88280; 88291
TAT5-7 days
MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the diagnosis, subtyping and prognostic stratification of acute myeloid leukemia (AML) patients.
CPT Codes88271(8); 88275(4); 88291
TAT3-5 days

» CLL Complete™

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

Specimen RequirementsFFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice
TAT2-4 days
MethodologyFlow cytometry
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (2 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the prognosis of chronic lymphocytic leukemia (CLL).
CPT Codes88184 or 88185; 88187
TAT1-2 days
MethodologyFlow cytometry
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (2 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the prognosis of chronic lymphocytic leukemia (CLL).
CPT Codes88184 or 88185; 88187
TAT1-2 days
Mature B-cell neoplasms exhibit clonal genomic alterations that have diagnostic and prognostic significance. Once such type of alteration is gain or loss of genomic loci, which in the current test is assayed by array-comparative genomic hybridization (array-CGH) permitting the simultaneous detection of gain and loss at multiple loci. Loci being assessed by MatBA®-CLL/SLL are 1p, 2p, 3q, 4q, 5p, 6q, 7p, 7q, 8p, 8q, 11q (ATM), 12q, 13 (MIR15A/16-1), 17p (TP53), 17q, 18p, 18q, and 19p.
MethodologyArray-CGH
Analytical Sensitivity30-40%
Specimen Requirements1 Lavender/EDTA tube peripheral blood or bone marrow aspirate with minimum 2-3ml or 3-5 FFPE sections at 10 μm thickness on regular slides at room temp.
Clinical IndicationsFor the risk stratification and prognosis of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
CPT Codes81479
TAT10-14 days
The Focus::CLL™ NGS panel assists in the prognosis of CLL/SLL patients. Multiplexed sequencing by synthesis is performed using the MiSeq System (Illumina). This panel includes selected exons of the TP53, NOTCH1, SF3B1, BIRC3, ATM, MYD88, and Card11 genes.
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 risk stratification and prognosis of Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma
CPT Codes81450
TAT10-14 days
Detection of hyper-mutation in the IGHV gene serves as an independent prognostic marker. Patients with the hyper-mutated IGHV gene exhibit a better overall survival than those with un-mutated IGHV. Utilization of IGHV3-21 regardless of IGHV mutation status is associated with an unfavorable outcome.
MethodologyPCR, sequencing
Analytical Sensitivity10%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis and clinical management of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
CPT Codes81263
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
Mutational NOTCH1 activation in CLL diagnosis is an independent predictor of poor survival and a shorter time to progression.
MethodologyPCR, bi-directional sequencing
Analytical Sensitivity20%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
CPT Codes81479
TAT7-10 days
SF3B1 mutations are independent predictors that occur in 10-15% of CLL patients. They are indicative of shorter time to treatment, and a poorer overall survival.
MethodologyPCR, bi-directional sequencing
Analytical Sensitivity20%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis of chronic lymphocytic leukemia (CLL).
CPT Codes81479
TAT7-10 days
MethodologyG-banding
Specimen Requirements1 Green/NaHeparin tube (3-5 ml) peripheral blood or bone marrow at room temp.
CPT Codes88237; 88262; 88280; 88291
TAT5-7 days
FISH analysis provides high sensitivity information about key genomic alterations and prognostic markers, such as the loss of 17p (TP53), 11q (ATM), 13q, and 6q, along with the gain of chromosome 12. The translocation t(11;14) is also evaluated to rule out Mantle Cell Lymphoma.
MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the diagnosis and prognosis of chronic lymphocytic leukemia (CLL).
CPT Codes88271(9); 88275(5); 88291
TAT3-5 days

» 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
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
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.

» 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

» DLBCL Complete™

DLBCL Complete™ Work-Up
Physicians can order tests individually or allow CGI directors to perform a panel evaluation as determined necessary.

New Diagnosis



Diagnostic & Prognostic Assessment

Morphology

Immunophenotyping (Flow, IHC)

B-Cell Clonality(Molecular Dx)

FISH - NHL Panel(Cytogenetics)

Karyotyping (Cytogenetics)


Prognostic & Theranostic Assessment

Proliferation Index by Ki-67 (IHC)

MYC Expression (IHC)

GCB/Non-GCB Subtyping (IHC)

TP53 Mutation Analysis (Molecular Dx)

MatBA®-DLBCL (Molecular Dx)

SETRA™* (Molecular Dx)


Monitoring, Disease Progression & Recurrence


Prognostic & Theranostic Assessment

TP53 Mutation Analysis (Molecular Dx)

MatBA®-DLBCL (Molecular Dx)

SETRA™* (Molecular Dx)

MYC, Ki-67l (IHC)

Karyotyping (Cytogenetics)

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
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
MethodologyIHC
Specimen RequirementsFFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice
CPT Codes88342
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
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 (x16); 88189
TAT1-2 days
MethodologyArray-CGH
Analytical SensitivityFFPE: 60-70%
Fresh-Frozen tissue: 50-60%"
Specimen Requirements"FFPE block: containing ≥ 70% tumor. Minimum size: 2 mm x 2 mm tumor area, shipped at room temperature.
Fresh-Frozen tissue: 0.2 cm3 min. (in OCT is acceptable) containing ≥ 50% tumor. Stored at -80°C /-20°C, shipped on dry ice.
FFPE block or fresh-frozen specimen: incisional or excisional biopsy."
Clinical IndicationsFor the risk stratification and prognosis of diffuse large B-cell lymphoma (DLBCL).
CPT Codes81479
TAT10-14 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 (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C.
Clinical IndicationsFor the prognosis of chronic lymphocytic leukemia (CLL) and diffuse large B-cell lymphoma (DLBCL).
CPT Codes81405
TAT7-10 days
MethodologyPCR, fragment analysis
Analytical Sensitivity1-3%
Specimen Requirements1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temp. or 2-8°C or 30-50 μm total FFPE sections at room temp.
Clinical IndicationsFor the diagnosis of lymphomas.
CPT Codes81261
TAT7-10 days
MethodologyG-banding
Specimen Requirements1 Green/NaHeparin tube (3-5 ml) peripheral blood or bone marrow at room temp.
CPT Codes88237; 88262; 88280; 88291
TAT5-7 days
FISH analysis provides high sensitivity information about key genomic alterations and prognostic markers, such as the loss of 17p (TP53), 11q (ATM), 13q, and 6q, along with the gain of chromosome 12. The translocation t(11;14) is also evaluated to rule out Mantle Cell Lymphoma.
MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the diagnosis and prognosis of chronic lymphocytic leukemia (CLL).
CPT Codes88271(9); 88275(5); 88291
TAT3-5 days

» MDS Complete™

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

MDS Complete Work Flow 050715

This work up is intended as a guide for the comprehensive suite of diagnostic tests included in MDS Complete™ to diagnose and monitor MDS. Physicians can order tests individually or allow CGI pathologists and directors to determine a panel evaluation as determined necessary.

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
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
MethodologyG-banding
Specimen Requirements1 Green/NaHeparin tube (3-5 ml) peripheral blood or bone marrow at room temp.
CPT Codes88237; 88262; 88280; 88291
TAT5-7 days
MethodologyFluorescence in situ hybridization (FISH)
Specimen Requirements1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood or bone marrow at room temp.
Clinical IndicationsFor the diagnosis, prognosis, monitoring of response to therapy or progression of disease of myelodysplastic syndrome (MDS).
CPT Codes88271(8); 88275(4); 88291
TAT3-5 days

» 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

» 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