Displaying 1 - 20 of 20 tests
CancerTYPE ID® with reflex to NeoTYPE® Cancer Profile

CancerTYPE ID is a proprietary molecular cancer classifier used to identify unknown or unclear tumor types and subtypes in patients with metastatic cancer. When ordered through NeoGenomics, classification with CancerTYPE ID is followed by tumor profiling for actionable biomarkers using the NeoTYPE® Cancer Profile most appropriate for the tumor type identified by Cancer TYPE ID. Tech-only options for FISH and IHC within the NeoTYPE Cancer Profile are available.

CancerTYPE ID is performed and billed separately by NeoGenomics’ contracted reference laboratory, Biotheranostics, Inc., an independent CLIA-licensed and CAP-accredited reference laboratory. The test uses quantitative RT-PCR to measure the expression of 92 genes in the patient’s specimen and classifies the tumor by matching the gene expression profile to a database of more than 2000 known tumor types and subtypes. Using this technology, CancerTYPE ID can identify 50 different tumor types and subtypes, covering >95% of all solid tumors based on incidence.1 The test reports a main cancer type with the highest probability, as well as a list of tumor types that may be ruled out with 95% confidence. 

CancerTYPE ID may be ordered as a stand-alone test directly from Biotheranostics, Inc. Please see www.cancertypeid.com.   

Molecular
CD31CD31 is a 130kDa transmembrane glycoprotein that is shared by vascular lining cells, megakaryocytes and platelets. This marker is highly restricted to endothelial neoplasms among all tumors of the soft tissue and its sensitivity is excellent. 100% of angiosarcomas and hemangiomas are CD31 positive. However, Kaposi’s sarcoma (KS) is labeled more consistently by CD34 than by CD31. CD31 has also been used as a prognostic marker measuring tumor angiogenesis. CD31 also stains histiocytes. Immunohistochemistry (IHC)
CD68CD68 is an antibody directed against lysosomes. It is important for identifying macrophages in tissue sections. It stains macrophages in a wide variety of human tissues, including Kupffer cells and macrophages in the red pulp of the spleen, lamina propria of the gut, lung alveoli, and bone marrow. This antibody reacts with myeloid precursors and peripheral blood granulocytes. It shows strong granular cytoplasmic staining of chronic and acute myeloid leukemia and also reacts with true histiocytic neoplasia. It also stains granular cell tumors and some cases of melanoma, renal cell carcinoma, and pleomorphic sarcoma. Tumors of lymphoid origin are usually not stained. Immunohistochemistry (IHC)
CK OSCARAnti-cytokeratin clone OSCAR (CK OSCAR) demonstrates a broad spectrum of cytokeratin reactivity. In normal tissues, OSCAR is reactive with most epithelial types, including bile ducts and hepatocytes in liver, bladder epithelium, breast ducts, bronchial epithelium, endometrium, intestinal epithelium of stomach, duodenum, ileum, colon, rectum, pancreas, ovarian epithelium, pancreatic acini, pituitary acini, pneumocytes, prostate, thyroid, skin (positive on the basal layer and negative on the superficial layers of squamous epithelium), and apocrine and sweat glands. In tumors, OSCAR is reactive with most carcinomas, including breast, transitional cell (TCC), renal cell (RCC), lung adenocarcinoma, lung small cell, lung squamous cell, endometrial, prostate, ovarian, hepatocellular (HCC), colorectal CA, stomach and thyroid. It is negative in certain normal tissues, including brain, lymphocytes and all cells of hematolymphoid origin, muscle, brain, nerves, endothelium and in certain tumors including most melanomas, sarcomas, lymphomas, primitive neuroectodermal tumors (PNET)/Ewings and gastrointestinal stromal tumors (GIST). Positivity has been seen on some dendritic cells in lymph nodes, some endothelia, and some muscle cells. Immunohistochemistry (IHC)
EGFR Mutation Analysis

Bi-directional sequencing of exons 18-21 of the EGFR gene for detection of EGFR-activating mutations and TKI resistance mutations (including T790M) in these exons. Tumor enrichment is performed before extraction. Testing is approved for specimens from the state of New York.

Molecular
InhibinAnti-Inhibin alpha is an antibody against a peptide hormone which has a demonstrated utility in differentiating between adrenocortical tumors and renal cell carcinoma. This antibody stains most adrenal tumors but no cases of renal cell carcinomas (RCC). Sex cord stromal tumors of the ovary, as well as trophoblastic tumors, also demonstrate cytoplasmic positivity with this antibody. Immunohistochemistry (IHC)
INSM1

INSM1 is a transcription factor that is a sensitive and specific marker for neuroendocrine tumors.  It is a nuclear stain, and is as good if not better than synaptophysin and is superior to chromogranin. It is rarely expressed on adenocarcinoma or squamous cell carcinomas without neuroendocrine differentiation. 

Immunohistochemistry (IHC)
Microsatellite Instability Analysis (MSI)

PCR and fragment analysis of paired normal and tumor tissue to determine microsatellite instability (MSI) at the standard five NCI-recommended loci. Positive results are reported as MSI-high (at least two markers are unstable) or MSI-low (one marker is unstable).

Molecular
MMR Panel by IHC (MLH1, MSH2, MSH6, PMS2)

A well-defined subtype of colorectal cancer (CRC) is characterized by deficiencies in the mismatch repair (MMR) pathway. MMR status may impact prognosis and benefit of adjuvant chemotherapy. MLH1, MSH2, MSH6, and PMS2 protein expression (as assessed by IHC) and microsatellite instability analysis (MSI) assessed by PCR are well-established tools to screen for Lynch syndrome (LS), and such testing is recommended for all new colorectal cancer diagnoses. MMR IHC and molecular MSI testing also serve as companion diagnostic tests in a wide range of solid tumors for selection of certain immuno-oncology therapies.

Immunohistochemistry (IHC)
NeoARRAY™ SNP/Cytogenetic Profile

The NeoARRAY SNP/Cytogenetic Profile is available for hematological, solid tumor, and pregnancy loss indications. With the best genome-wide coverage available, this test employs an enhanced SNP microarray with over 2.6 million SNP and non-polymorphic markers for detection of copy number variants (deletions, duplications, and amplifications) and loss of heterozygosity or uniparental disomy (LOH or UPD) in any chromosome. Sensitivity and specificity for detection of copy number variants >400 kb is >99%. Testing may not reliably detect abnormalities present in less than 20% of the cells tested. Balanced rearrangements, including translocations and inversions, are not detectable by this method. Clients may request NeoARRAY on POC as the sole test, or they may order POC cytogenetics with reflex to NeoARRAY if the POC culture fails or if cytogenetic results are normal. For reflex orders, if there is no cell attachment or growth after 14 days in culture, a cytogenetics failure report will be issued and NeoARRAY will be performed. If there is limited cell attachment after 14 days in culture, NeoGenomics will contact the client for instructions. When array testing is not performed, a fee will be charged for DNA extraction (which is performed upon specimen receipt).

Molecular
NeoARRAY™ SNP/Cytogenetic Profile

The NeoARRAY SNP/Cytogenetic Profile is available for hematological, solid tumor, and pregnancy loss indications. With the best genome-wide coverage available, this test employs an enhanced SNP microarray with over 2.6 million SNP and non-polymorphic markers for detection of copy number variants (deletions, duplications, and amplifications) and loss of heterozygosity or uniparental disomy (LOH or UPD) in any chromosome. Sensitivity and specificity for detection of copy number variants >400 kb is >99%. Testing may not reliably detect abnormalities present in less than 20% of the cells tested. Balanced rearrangements, including translocations and inversions, are not detectable by this method. Clients may request NeoARRAY on POC as the sole test, or they may order POC cytogenetics with reflex to NeoARRAY if the POC culture fails or if cytogenetic results are normal. For reflex orders, if there is no cell attachment or growth after 14 days in culture, a cytogenetics failure report will be issued and NeoARRAY will be performed. If there is limited cell attachment after 14 days in culture, NeoGenomics will contact the client for instructions. When array testing is not performed, a fee will be charged for DNA extraction (which is performed upon specimen receipt).

Cytogenetics
NeoLAB™ Solid Tumor Monitor - Liquid Biopsy

The NeoLAB™ Solid Tumor Monitor is a blood test that uses cell-free circulating tumor DNA (ctDNA) or RNA in combination with next-generation sequencing (NGS) to detect mutations in the following 48 genes: ABL1, AKT1, ALK, APC, ATM, BRAF, CDH1, CDKN2A, CSF1R, CTNNB1, EGFR, ERBB2, ERBB4, FBXW7, FGFR1, FGFR2, FGFR3, FLT3, GNA11, GNAQ, GNAS, HNF1A, HRAS, IDH1, JAK2, JAK3, KDR, KIT, KRAS, MET, MLH1, MPL, NOTCH1, NPM1, NRAS, PDGFRA, PIK3CA, PTEN, PTPN11, RB1, RET, SMAD4, SMARCB1, SMO, SRC, STK11, TP53, and VHL. The EGFR T790 mutation is tested at high sensitivity (10^-4). Test orders include summary interpretation of all results together. NOTE: One-time baseline molecular testing at NeoGenomics on the solid tumor is required. Please see details in Specimen Requirements.

Molecular
NeoTYPE® Discovery Profile for Solid Tumors

This profile analyzes 334 biomarkers through a combination of next-generation sequencing (NGS), other molecular methods, FISH, and IHC as listed below. Test orders include summary interpretation of all results to help guide treatment decisions. If Pan-TRK IHC is expressed or indeterminate, NTRK NGS Fusion Profile for NTRK1 fusions, NTRK2 fusions, and NTRK3 fusions will be added by reflex.

  • FISH (9 FISH): ALK, BRAF,  HER2, MET, MYC, PDGFRA amplifications, PTEN, RET, ROS1 (tech-only available)
  • IHC (2 biomarkers): PD-L1 22C3, Pan-TRK (tech-only available for PD-L1) PD-L1 IHC, Pan-TRK IHC
  • NGS (322 genes + 1 biomarker): ABL1, ABL2, ACVR1B, AKT1, AKT2, AKT3, ALK, AMER1, APC, AR, ARAF, ARFRP1, ARID1A, ARID1B, ARID2, ASXL1, ATM, ATR, ATRX, AURKA, AURKB, AXIN1, AXL, BAP1, BARD1, BCL2, BCL2L1, BCL2L2, BCL6, BCOR, BCORL1, BLM, BRAF, BRCA1, BRCA2, BRD4, BRIP1, BTG1, BTK, C11orf30, CARD11, CBFB, CBL, CCND1, CCND2, CCND3, CCNE1, CD274, CD79A, CD79B, CDC73, CDH1, CDK12, CDK4, CDK6, CDK8, CDKN1A, CDKN1B, CDKN2A, CDKN2B, CDKN2C, CEBPA, CHD2, CHD4, CHEK1, CHEK2, CIC, CREBBP, CRKL, CRLF2, CSF1R, CTCF, CTNNA1, CTNNB1, CUL3, CXCR4, CYLD, DAXX, DDR2, DICER1, DNMT3A, DOT1L, EGFR, EP300, EPCAM, EPHA3, EPHA5, EPHA7, EPHB1, ERBB2, ERBB3, ERBB4, ERG, ERRFI1, ESR1, EZH2, FAM46C, FANCA, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCL, FAS, FAT1, FBXW7, FGF10, FGF14, FGF19, FGF23, FGF3, FGF4, FGF6, FGFR1, FGFR2, FGFR3, FGFR4, FH, FLCN, FLT1, FLT3, FLT4, FOXL2, FOXP1, FRS2, FUBP1, GABRA6, GATA1, GATA2, GATA3, GATA4, GATA6, GID4, GLI1, GNA11, GNA13, GNAQ, GNAS, GPR124, GRIN2A, GRM3, GSK3B, H3F3A, HGF, HNF1A, HRAS, HSD3B1, HSP90AA1, IDH1, IDH2, IGF1R, IGF2, IKBKE, IKZF1, IL7R, INHBA, INPP4B, IRF2, IRF4, IRS2, JAK1, JAK2, JAK3, JUN, KAT6A, KDM5A, KDM5C, KDM6A, KDR, KEAP1, KEL, KIT, KLHL6, KMT2A, KMT2C, KMT2D, KRAS, LMO1, LRP1B, LYN, LZTR1, MAGI2, MAP2K1, MAP2K2, MAP2K4, MAP3K1, MCL1, MDM2, MDM4, MED12, MEF2B, MEN1, MET, MITF, MLH1, MPL, MRE11A, MSH2, MSH6, MTOR, MUTYH, MYC, MYCL, MYCN, MYD88, NBN, NF1, NF2, NFE2L2, NFKBIA, NKX2-1, NOTCH1, NOTCH2, NOTCH3, NPM1, NRAS, NSD1, NTRK1, NTRK2, NTRK3, NUP93, PAK3, PALB2, PARK2, PAX5, PBRM1, PDCD1LG2, PDGFRA, PDGFRB, PDK1, PIK3C2B, PIK3CA, PIK3CB, PIK3CG, PIK3R1, PIK3R2, PLCG2, PMS2, POLD1, POLE, PPP2R1A, PRDM1, PREX2, PRKAR1A, PRKCI, PRKDC, PRSS8, PTCH1, PTEN, PTPN11, QKI, RAC1, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD54L, RAF1, RANBP2, RARA, RB1, RBM10, RET, RICTOR, RNF43, ROS1, RPTOR, RUNX1, RUNX1T1, SDHA, SDHB, SDHC, SDHD, SETD2, SF3B1, SLIT2, SMAD2, SMAD3, SMAD4, SMARCA4, SMARCB1, SMO, SNCAIP, SOCS1, SOX10, SOX2, SOX9, SPEN, SPOP, SPTA1, SRC, STAG2, STAT3, STAT4, STK11, SUFU, SYK, TAF1, TBX3, TERC, TERT, TET2, TGFBR2, TNFAIP3, TNFRSF14, TOP1, TOP2A, TP53, TSC1, TSC2, TSHR, U2AF1, VEGFA, VHL, WISP3, WT1, XPO1, ZBTB2, ZNF217, ZNF703, Tumor Mutation Burden (TMB)
Molecular
NeoTYPE® Other Solid Tumor Profile

This profile analyzes 29 biomarkers through a combination of next-generation sequencing (NGS), FISH, and IHC as listed below. Test orders include summary interpretation of all results to help guide treatment decisions. If Pan-TRK IHC is expressed or indeterminate, NTRK NGS Fusion Profile for NTRK1 fusions, NTRK2 fusions, and NTRK3 fusions will be added by reflex.

  • NGS (24 genes + 1 biomarker): AKT1, BRAF, EGFR, FGFR1, FGFR2, FGFR3, GNAS, HRAS, IDH1, IDH2, JAK3, KIT, KRAS, MET, NOTCH1, NRAS, PDGFRA, PIK3CA, PTEN, PTPN11, SMAD4, SMO, SRC, TP53  and Tumor Mutation Burden (TMB)
  • FISH (2 FISH): MET, PTEN (tech-only available)
  • IHC (2 biomarker): PD-L1, Pan-TRK (tech-only available for PD-L1)
Molecular
NeoTYPE® Precision Profile for Solid Tumors

This Profile analyzes 51 biomarkers through a combination of next-generation sequencing (NGS) and IHC as listed below. Test orders include summary interpretation of all results to help guide treatment decisions. If Pan-TRK IHC is expressed or indeterminate, NTRK NGS Fusion Profile for NTRK1 fusions, NTRK2 fusions, and NTRK3 fusions will be added by reflex.

  • NGS (48 genes + 1 biomarker): ABL1, AKT1, ALK, APC, ATM, BRAF, CDH1, CDKN2A, CSF1R, CTNNB1, EGFR, ERBB2, ERBB4, FBXW7, FGFR1, FGFR2, FGFR3, FLT3, GNA11, GNAQ, GNAS, HNF1A, HRAS, IDH1, JAK2, JAK3, KDR, KIT, KRAS, MET, MLH1, MPL, NOTCH1, NPM1, NRAS, PDGFRA,  PIK3CA, PTEN, PTPN11, RB1, RET, SMAD4, SMARCB1, SMO, SRC, STK11, TP53, VHL and Tumor Mutation Burden (TMB)
  • IHC (2 biomarkers): PD-L1 22C3, Pan-TRK (tech-only available for PD-L1)
     
Molecular
pHistone H3 (PHH3)Phosphohistone H3 (PHH3) is a marker of cells in the late G2-M phase of the cell cycle. It is not expressed in apoptotic cells which may be confused with mitotic figures on a routine H&E stained slide. PHH3 can be used as a surrogate of mitotic activity or as an independent prognostic marker in breast carcinomas. Immunohistochemistry (IHC)
SF1SF1 is expressed in all steroidogenic tissues, including the adrenal cortex, testicular Sertoli cells, and Leydig cells, ovarian theca, hypothalamus, and anterior pituitary. SF1 is highly valuable marker to determine adrenocortical origin. Immunohistochemistry (IHC)
SynaptophysinAntibody to synaptophysin reacts with neuroendocrine neoplasms of neural as well as epithelial types. In combination with chromogranin A and NSE antibodies, the antibody to synaptophysin is very useful in the identification of normal neuroendocrine cells and neuroendocrine neoplasms. Immunohistochemistry (IHC)
TP53 Mutation Analysis

Bi-directional sequencing of TP53 exons 4-9.

Molecular
VimentinVimentin is the major intermediate filament in a variety of mesenchymal cells, including endothelial cells, all fibroblastic cells, macrophages, Sertoli cells, melanocytes, lymphocytes and ovarian granulosa cells. Vimentin is found in all types of sarcomas and lymphomas. Positive staining for vimentin is seen in most cells of fibrosarcomas, liposarcomas, malignant fibrous histocytomas, angiosarcomas, chondrosarcomas and lymphomas. All melanomas and Schwannomas are strongly vimentin-positive. Immunohistochemistry (IHC)