Displaying 1 - 70 of 70 tests
Alcian BlueSpecial stain. Alcian blue is intended to identify weakly sulfated mucins in tissue samples. Immunohistochemistry (IHC)
BerEP4Ber-EP4 recognizes two glycoproteins of 34 and 49 kDa present on the surface and the cytoplasm of all epithelial cells except the superficial layers of squamous epithelial, hepatocytes and parietal cells. It does not label mesothelial cells and rarely marks mesotheliomas. It shows a broad spectrum of reactivity with human epithelial cells including simple epithelia and basal layers of stratified non-keratinized squamous epithelium and epidermis. Ber-EP4 reportedly distinguishes adenocarcinomas from pleural mesotheliomas. Immunohistochemistry (IHC)
BG8This antibody is specific for the Lewis Y (Type 2 Chain) carbohydrate antigen. Lewis Y has been evaluated as a clinical marker for the diagnosis and prognosis of cholangiocarcinoma, hepatocellular carcinoma and breast cancer. It was also shown that BG8 reacts predominantly with lung adenocarcinomas and is negative focally or weakly positive in epithelial mesotheliomas. Immunohistochemistry (IHC)
BRAF Mutation Analysis

Bi-directional sequencing of exon 15 of the BRAF gene, which includes qualitative detection of V600 mutations E, K, D, and others, plus other significant exon 15 mutations.  For solid tumors, tumor enrichment is performed before extraction. Expanded coverage for BRAF exons 11 & 15 is available in the RAS/RAF Panel. Testing is available separately or in combination with HRAS, KRAS, and NRAS in the RAS/RAF Panel. Testing is approved for specimens from the state of New York. 

Molecular
CAM 5.2Anti-Cytokeratin (CAM 5.2) has a primary reactivity with human keratin proteins that correspond to Moll`s peptides #7 and #8, Mr 48 and 52 Kd. Cytokeratin 8 is present on secretory epithelia of normal human tissue but not on stratified squamous epithelium. CAM 5.2 stains most epithelial derived tissue, including liver, renal tubular epithelium, hepatocellular and renal cell carcinomas. CAM 5.2 may not react with some squamous cell carcinomas. Immunohistochemistry (IHC)
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
CD163CD163 antigen is restricted in its expression to the monocytic/macrophage lineage. It is present on all circulating monocytes and most tissue macrophages except those found in the mantle zone and germinal centers of lymphoid follicles, interdigitating reticulum cells and Langerhans cells. Immunohistochemistry (IHC)
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)
CEA (Mono)Carcinoembryonic antigen (CEA) is usually demonstrated as a linear labeling of the apical poles of cells lining the glandular lumen and occasionally as weak staining near the apex of normal colonic epithelial cells. Tumors tend to display an increased cytoplasmic staining. In specific cases, CEA can be useful in tumor diagnosis. Pancreatic carcinomas, testicular tumors, gallbladder neoplasms and granular cell myoblastomas all stain positive for CEA, while malignant tumors of brain, prostate, skin, lymphoreticular tissues, hepatocellular carcinomas, esophageal squamous cell carcinomas and mesothelioma fail to stain for CEA. Immunohistochemistry (IHC)
CEA (Poly)Polyclonal carcinoembryonic antigen (CEA) antibody stains a larger percentage of cholangiocarcinomas compared to hepatocellular carcinomas. Approximately 95% of olangiocarcinomas are stained diffusely and strongly with polyclonal CEA, whereas show a canalicular staining pattern with this antibody. Immunohistochemistry (IHC)
CK HMW (CK903/34BE12)CK903 (34betaE12) is a high molecular weight cytokeratin present in all squamous epithelium and their carcinomas. This antibody recognizes cytokeratins 1, 5, 10 and 14 that are found in complex epithelia. There has been no reactivity with cells derived from simple epithelia, mesenchymal tumors, lymphomas, melanomas, neural tumors and neuroendocrine tumors. One useful application is the identification of the basal cell layer in prostate tissue in the determination of carcinoma. Immunohistochemistry (IHC)
CK20Cytokeratin 20 (CK20) positivity is seen in the majority of adenocarcinomas of the colon, mucinous ovarian carcinomas, transitional cell, and Merkel cell carcinomas, and frequently in adenocarcinomas of the stomach, bile system and pancreas. CK7/CK20 immunostaining patterns may be helpful in separating pulmonary from colonic adenocarcinomas. Immunohistochemistry (IHC)
CK5/6D5/16 B4 clone of CK5/6 antibody reacts strongly with cytokeratins 5 and 6. Cytokeratin 5/6 have been found valuable for the distinction between low differentiated squamous cell carcinoma and adenocarcinoma. It labels mesothelioma, and epithelial basal cells in prostate and tonsil. No reactivity with other mesodermally derived tissues, such as muscle and connective tissues, has been observed. Anti-CK 5/6 has also been found useful in the differential diagnosis of atypical proliferations of the breast. Immunohistochemistry (IHC)
CK7Cytokeratin 7 (CK7) antibody reacts with proteins that are found in most ductal, glandular and transitional epithelium of the urinary tract and bile duct epithelial cells. CK7 distinguishes between lung and breast epithelium that stain positive, and colon and prostate epithelial cells that are negative. It also reacts with many benign and malignant epithelial lesions, e.g. adenocarcinomas of the ovary, breast and lung. Transitional cell carcinomas are positive and most prostate cancers are negative. This antibody does not recognize other intermediate filament proteins. Immunohistochemistry (IHC)
cMETThe cMET tyrosine kinase receptor, normally expressed by epithelial cells, is overexpressed and amplified in a variety of human tumors, including non-small cell lung carcinoma (NSCLC). High levels of intratumor cMET expression have been associated with a more aggressive biology and a worse prognosis in NSCLC. Engelman et al. reported that cMET amplification induced resistance to gefitinib in a gefitinib-sensitive lung cancer cell line. Moreover, cMET inhibition with a cMET tyrosine kinase inhibitor (PHA-665,752) restored gefitinib sensitivity. Immunohistochemistry (IHC)
CMV

In situ hybridization for detection of cytomegalovirus (CMV) RNA.

In Situ Hybridization (ISH)
DesminDesmin is an intermediate filament protein of both smooth and striated muscles. Antibody to desmin reacts with striated (skeletal and cardiac) as well as smooth muscle cells. Anti-desmin antibody is useful in identification of tumors of myogenic origin. It reacts with leiomyosarcomas (smooth muscle) as well as rhabdomyosarcomas (striated muscle). Immunohistochemistry (IHC)
ERCC1The Excision Repair Cross-Complementing Rodent Repair Deficiency, Complementation Group 1 (ERCC1) polypeptide is required for nucleotide excision repair (NER) of damaged DNA. Elevated levels of ERCC1 have also been reported in cisplatin-resistant cells. Immunohistochemistry (IHC)
H. PyloriThis antibody reacts with H. pylori on the surface and in the cytoplasm of epithelial cells of stomach biopsies. Studies have shown that H. pylori plays an important role in the etiology of chronic active gastritis and the development of peptic ulcer disease. Immunohistochemistry can provide rapid detection of this bacterium. Immunohistochemistry (IHC)
HER2 Breast

This test uses the Ventana PATHWAY anti-HER-2/neu antibody (clone 4B5) for the semi-quantitative detection of HER-2 antigen in sections of FFPE normal and neoplastic tissue. The test is FDA-approved with the indication as an aid in the assessment of breast cancer patients for whom Herceptin treatment is considered. Staining is performed according to the package insert. Scoring for breast cases is performed according to ASCO/CAP 2013 guidelines. Scoring for gastroesophageal and other tissues is according to the 2010 ToGA trial standards.
HER2 is an oncogene that is over-expressed in a variety of cancers including some breast carcinomas. The expected breast cancer overexpression rate varies based on the grade and type of cancer. Known artifacts, such as edge artifact, tissue retraction and tissue crush may give the false impression of overexpression. Care should be taken to avoid assessing these areas, especially in needle core biopsies that generally harbor all of these artifacts.

Immunohistochemistry (IHC)
HER2 Gastric & Non-Breast

Probes: HER2 (17q11.2-q12) | 17 (Cen 17)
Disease(s): Gastric cancer, gastroesophageal junction (GEJ) cancer, esophageal adenocarcinoma, and others

FISH
HRAS Mutation Analysis

Bi-directional sequencing of HRAS exons 2 and 3 which includes sites of common activating mutations in codons 12, 13, 59 and 61.

Molecular
HSV I/II

This antibody cocktail reacts with Herpes Simplex Virus (HSV) type 1- or type 2-specific antigens and with antigens common to both types. The antibodies react with all the major glycoproteins present in the viral envelope and at least one core protein as determined by crossed immunoelectrophoresis. Neither antibody cross-reacts with cytomegalovirus or Epstein-Barr virus. The cocktail is well suited for the detection of HSV in human cellular material obtained from superficial lesions or biopsies and for the early identification of HSV in infected tissue cultures.

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)
Ki67

Ki67 is a nuclear protein that is expressed in proliferating cells. Ki67 is preferentially expressed during late G1, S, M, and G2 phases of the cell cycle, while cells in the G0 (quiescent) phase are negative for this protein. Increased proliferative activity is associated with more aggressive tumor and decreased disease-free survival period.
Note: Computer-assisted image analysis for Ki-67 is only validated for breast cancer and neuroendocrine carcinoma.

Immunohistochemistry (IHC)
KRAS Exon 4 Mutation Analysis

Bi-directional sequencing of exon 4 of the KRAS gene corresponding to amino acids  R97 through Q150.  Codon 117 and 146 mutations are detected. For solid tumors, tumor enrichment is performed before extraction.  This test may be ordered separately or by reflex after standard KRAS Mutation Analysis. Testing is available separately or in combination with BRAF, HRAS and NRAS in the RAS/RAF Panel. Testing is approved for specimens from the state of New York.

Molecular
KRAS Mutation Analysis

Bi-directional sequencing of exons 2 and 3 of the KRAS gene. High-sensitivity sequencing is used for enhanced detection of mutations in codons 12, 13, 59, and 61.  For solid tumors, tumor enrichment is performed before extraction. Testing is available separately or in combination with BRAF, HRAS and NRAS in the RAS/RAF Panel. Testing is approved for specimens from the state of New York.  

Molecular
MesothelinMesothelin is a 40kDa cell surface glycoprotein selectively expressed by mesothelial cells and malignant mesotheliomas, as well as by non-mucinous ovarian carcinomas, breast carcinomas, pancreatic carcinomas, and squamous tumors of the esophagus and cervix. Immunohistochemistry (IHC)
MET (c-MET) Mutation Analysis

Bi-directional Sanger sequencing of MET is performed using PCR primers designed to target hotspot mutations in exons 14, 16, 17 and 19.

Molecular
MET FISHProbes: MET (7q31) | Centromere 7
Disease(s): Multiple solid tumor cancers including lung (NSCLC), gastric, esophageal, endometrial
FISH
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
MLH1MLH1, a mismatch repair protein involved in maintaining the integrity of genetic information, alongside MSH2, MSH6 and PMS2. During DNA replication, strand misalignment can occur resulting in alterations to microsatellite repeats, often referred to as microsatellite instability (MSI). These defects in DNA repair pathways have been linked to human carcinogenesis. Mutations in the MLH1 gene have been reported to be found in tumors with MSI, such as some forms of colon cancer eg. Hereditary nonpolyposis colon cancer (HNPCC), a subset of sporadic carcinomas and breast cancer. Loss of expression of MLH1 has also been reported in acute lymphoblastic leukemia, endometrial carcinoma, gastric carcinoma and ovarian carcinoma. Immunohistochemistry (IHC)
MSAMuscle Specific Actin (MSA) antibody recognizes the alpha and gamma isotypes of skeletal, cardiac, and smooth muscle cells. It is non-reactive with other mesenchymal cells and all epithelial cells except for myoepithelium. This antibody is useful in the identification of tumors with muscle differentiation and detection of myoepithelial cells. Immunohistochemistry (IHC)
MUC1

Mucin 1 (MUC1) is a high molecular weight glycoprotein that is found on the apical surface of many glandular epithelia, including the gastrointestinal, respiratory, urinary, reproductive tracts and some hematopoietic cell lineages. MUC1 has been implicated in progression of numerous types of cancer, including breast, colon, lung, gastric and pancreatic cancers. MUC1 expression in tumors is greatly increased and accompanied by altered aberrant expression patterns that become more diffuse when compared to the normal apically restricted pattern.

Immunohistochemistry (IHC)
MUC2Mucin 2 (MUC2) expression is detected in human tissues such as normal colon, breast, prostate, and salivary gland, as well as in gastrointestinal, colonic, breast and prostate neoplasia. This antibody labels MUC2 in normal colon and colonic carcinomas where it produces intense perinuclear staining in goblet cells. Immunohistochemistry (IHC)
MUC5Mucin 5 (MUC5) is expressed in gastric mucosa, and in gall bladder epithelium. MUC5 antibody is recommended for use as part of a panel of antibodies for the characterization of mucin expression and in differentiation of intestinal metaplasia as well as gastric and pancreaticobiliary carcinomas. Immunohistochemistry (IHC)
MUC6MUC6 is expressed mucopeptic neck cells and pyloric glands of the gastric mucosa. MUC6 antibody is recommended for use as part of a panel of antibodies in differentiation of gastric cancer. Immunohistochemistry (IHC)
MucicarmineSpecial stain. Mucicarmine staining is used to identify epithelial mucins, namely acid mucopolysaccharides. Staining is useful to distinguishing mucin negative undifferentiated squamous cell lesions from mucin positive adenocarcinomas. In addition, this product will stain the mucopolysaccharide capsule of Cryptococcus neoformans. 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).

Cytogenetics
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
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
NeoSITE™ BE Barrett's Esophagus FISH Panel

Probes: MYC (8q24) | p16 (CDKN2A at 9p21) | HER2 (ERBB2 at 17q12) | ZNF217 (20q13)
This 4-probe FISH assay is performed on cytology brushings from Barrett esophagus to determine patterns of chromosomal gain and loss suggestive of esophageal adenocarcinoma/high-grade dysplasia vs. low grade dyplasia/non-dysplastic tissue. Sensitivity is 86% and specificity is 67% for differentiating the high-risk from the low-risk groups. Sensitivity and specificity are higher when only nodules rather than the entire esophagus are brushed. Cells from nodular surfaces will be tested first (if available) and reported as a final result if positive, or testing will reflex to the pan brushing sample if negative.
Testing is approved for specimens from the state of New York.
Disease(s): Barrett's esophagus, esophageal adenocarcinoma.

FISH
NeoTYPE Discovery Profile for Solid Tumors

This test is performed by sequencing the entire coding regions of the genes listed unless another method is noted. ABL1, ABL2, ACVR1B, AKT1, AKT2, AKT3, ALK, AMER1 (FAM123B), 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, CYLD, DAXX, DDR2, DICER1, DNMT3A, DOT1L, EGFR, EP300, EPHA3, EPHA5, EPHA7, EPHB1, ERBB2, ERBB3, ERBB4, ERG, ERRF11, 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 (C17orf39), 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 (MYST3), KDM5A, KDM5C, KDM6A, KDR, KEAP1, KEL, KIT, KLHL6, KMT2A (MLL), KMT2C (MLL3), KMT2D (MLL2), KRAS, LMO1, LRP1B, LYN, LZTR1, MAGI2, MAP2K1 (MEK1) , MAP2K2 (MEK2) , MAP2K4 (MEK4), MAP3K1 (MEKK) , MCL1, MDM2, MDM4, MED12, MEF2B, MEN1, MET, MITF, MLH1, MPL, MRE11A, MSH2, MSH6, MTOR, MUTYH, MYC, MYCL (MYCL1), 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, ALK FISH, BRAF FISH, HER2 FISH, MET FISH, c-MYC FISH, PDGFRA Amplification FISH, PTEN FISH, RET FISH, ROS1 FISH and PD-L1 IHC. Tumor Mutation Burden (TMB) testing is performed with all Discovery Profiles. Test orders include summary interpretation of all results together.

Molecular
NeoTYPE Esophageal Tumor Profile

This test is performed by sequencing the entire coding regions of the genes listed unless another method is noted. AKT1, BRAF, CTNNB1, ERBB2, ERBB4, FGFR1, FGFR2, FGFR3, HRAS, JAK3, KIT, KRAS, MET, Microsatellite Instability (MSI). NOTCH1, NRAS, PDGFRA, PIK3CA, PTEN, SMAD4, SMO, SRC, TP53, HER2 FISH, MET FISH, PTEN FISH and PD-L1 IHC. MSI is performed by fragment analysis. Tumor Mutation Burden (TMB) testing and individual genes from a validated list of genes can be added. Test orders include summary interpretation of all results together. FISH components of NeoTYPE Profiles may be ordered as "Tech-Only" by pathology clients who wish to perform the professional component.

Molecular
NeoTYPE Gastric Tumor Profile

This test is performed by sequencing the entire coding regions of the genes listed unless another method is noted. AKT1, BRAF, EGFR, ERBB2, ERBB4, FGFR1, FGFR2, FGFR3, HRAS, JAK3, KIT, KRAS, MET, Microsatellite Instability (MSI), NOTCH1, NRAS, PDGFRA, PIK3CA, PTEN, SMAD4, SMO, SRC, TP53, HER2 FISH, MET FISH, PTEN FISH and PD-L1 IHC. MSI is performed by fragment analysis. Tumor Mutation Burden (TMB) testing and individual genes from a validated list of genes can be added. Test orders include summary interpretation of all results together. FISH components of NeoTYPE Profiles may be ordered as "Tech-Only" by pathology clients who wish to perform the professional component.

Molecular
NeoTYPE GI Predictive Profile

This test is performed by sequencing of select exons of the genes listed unless another method is noted: BRAF, HRAS, KRAS, Microsatellite Instability Analysis (MSI), NRAS, HER2 FISH, PD-L1 IHC. MSI is performed by fragment analysis. Tumor Mutation Burden (TMB) testing and individual genes from a validated list of genes can be added. Test orders include summary interpretation of all results together. FISH components of NeoTYPE Profiles may be ordered as "Tech-Only" by pathology clients who wish to perform the professional component.

Molecular
NeoTYPE Other Solid Tumor Profile

This test is performed by sequencing the entire coding regions of the genes listed unless another method is noted. AKT1, BRAF, EGFR, FGFR1, FGFR2, FGFR3, GNAS, HRAS, IDH1, IDH2, JAK3, KIT, KRAS, MET, NOTCH1, NRAS, PDGFRA, PIK3CA, PTEN, PTPN11, SMAD4, SMO, SRC, TP53, MET FISH, PTEN FISH, and PD-L1 IHC. Tumor Mutation Burden (TMB) testing and individual genes from a validated list of genes can be added. Test orders include summary interpretation of all results together. FISH components of NeoTYPE Profiles may be ordered as "Tech-Only" by pathology clients who wish to perform the professional component.

Molecular
NeoTYPE Precision Profile for Solid Tumors

The NeoTYPE Precision Profile for Solid Tumors utilizes next-generation sequencing 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, VHL and PD-L1 IHC. This test is performed by sequencing the enitre coding regions of the genes listed unless another method is noted. Tumor Mutation Burden testing can be added. Test orders include summary interpretation of all results together.

Molecular
NOTCH1 Mutation Analysis

Bi-directional sequencing of exons 26, 27, and 34 is performed for detection of sequence variant mutations. Testing can be performed on plasma when adequate leukemic cells are not available.

Molecular
NRAS Exon 4 Mutation Analysis

Bi-directional sequencing of NRAS exon 4 is performed using PCR primers designed to target hotspot mutations in codons 117 and 146, among other regions in exon 4. Testing is available separately or in combination with BRAF, KRAS and HRAS in the RAS/RAF Panel. Testing is approved for specimens from the state of New York.

Molecular
NRAS Mutation Analysis

Bi-directional sequencing of NRAS exons 2 and 3 which includes sites of common activating mutations in codons 12, 13, 59, and 61. Testing is approved for specimens from the state of New York.

Molecular
p21p21 is a cyclin dependent protein kinase inhibitor and is a member of a family of proteins that functions to slow down cell division. p21 is found in t cells as they transitions from G1 phase to S phase. Low nuclear expression of p21 has been associated with poor prognosis in colon and prostate carcinomas. Immunohistochemistry (IHC)
p27p27 (KIP1) belongs to the family of cell cycle regulators that cause cell cycle arrest in G1 phase. p27 promotes apoptosis, plays a role in terminal differentiation of some tissues and mediates chemosensitivity in solid tumors. Decreased p27 KIP1 expression in tumors is associated with a more aggressive tumor phenotype such as poor histologic grade, presence of lymphovascular invasion and higher growth fraction. These findings have been validated on various cancers such as breast, colon, esophagus, stomach, lung and prostate. Immunohistochemistry (IHC)
p40p40 antibody recognizes ΔNp63—a p63 isoform. It is equivalent to p63 in sensitivity for squamous cell carcinoma, but it is markedly superior to p63 in specificity, which eliminates a potential pitfall of misinterpreting a p63-positive adenocarcinoma as squamous cell carcinoma. These findings strongly support the routine use of p40 for the diagnosis of pulmonary squamous cell carcinoma. Immunohistochemistry (IHC)
p53The product of the p53 gene is a nuclear phosphoprotein that regulates cell proliferation. Excess accumulation of the mutant p53 gene product results in inactivation of its tumor suppressor function and cellular transformation. Overexpression of mutant p53 gene has also been associated with high proliferative rates and poor prognosis in breast, colon, lung, and brain cancer, as well as in some leukemias and lymphomas. Immunohistochemistry (IHC)
Pan-CytokeratinMonoclonal antibodies AE1 and AE3 recognize the acidic and basic subfamilies of cytokeratin, respectively, thus the combination of these two antibodies can be used to detect almost all human epithelia. In surgical pathology, it is an important marker for carcinoma as well as some special tumor types which have an epithelial component or differentiation. This cocktail has been used to differentiate epithelial from non-epithelial tumors. Immunohistochemistry (IHC)
PD-L1 22C3 FDA (KEYTRUDA®) for Gastric/GEA

PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1, Clone 22C3 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) gastric or gastroesophageal junction adenocarcinoma (GEJ, GEA) tissue using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying patients with metastatic gastric or GEJ cancer for treatment with KEYTRUDA® (pembrolizumab).

For cervical cancer, please order PD-L1 22C3 FDA (KEYTRUDA®) for Cervical. For urothelial (bladder) carcinoma, please order PD-L1 22C3 FDA (KEYTRUDA®) for Urothelial Carcinoma. For non-small cell lung carcinoma (NSCLC), please order PD-L1 22C3 FDA (KEYTRUDA®) for NSCLC.

Stain-only (tech-only) testing is available to clients who have completed the test kit manufacturer’s online interpretation training.

Immunohistochemistry (IHC)
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)
PIK3CA Mutation Analysis

Bi-directional sequencing of PIK3CA exons 1, 9, and 20 which are the most commonly-mutated regions of the gene.

Molecular
PPM1D Mutation Analysis

PPM1D (Protein Phosphatase, Mg2+/Mn2+ Dependent 1D) Mutation Analysis is performed by next-generation sequencing (NGS) of all coding regions of the PPM1D gene. Germline and somatic mutation testing is available. Note: For germline testing (blood sample), patient and physician or genetic counselor signatures on the NeoGenomics Consent for Hereditary Cancer Genetic Testing form are required. Testing will be put on hold until signatures are received.

Molecular
PTEN Mutation Analysis

Bi-directional sequencing of all exons (1-9) of the PTEN gene. For solid tumors, enrichment is performed before extraction. This assay does not detect large deletions.

Molecular
SmoothelinSmoothelin is a novel cytoskeletal protein that reacts with the 59 kDa and 100 kDa proteins corresponding to Smoothelin A and B, respectively, which are exclusively found in smooth muscle cells (SMC). Cells with SMC-like characteristics, such as myofibroblasts and myoepithelial cells, as well as skeletal and cardiac muscle do not contain Smoothelin. Smoothelin is exclusively expressed in fully differentiated (contractile) smooth muscle cells and could be used as a tool to differentiate muscularis propria from muscularis mucosa. Immunohistochemistry (IHC)
Thrombomodulin (TM)Thrombomodulin (TM) is a plasma membrane-related glycoprotein that has anticoagulant activity. TM antigen is found in several cell types, including megakaryocytes, mesangial cells, synovial cells, mesothelial cells, endothelial cells, and some squamous epithelial cells and their associated tumors. TM antibody labels most mesotheliomas with thick membranous staining pattern and about half of pulmonary adenocarcinomas, showing cytoplasmic immunostaining. Thrombomodulin is also a marker of urinary bladder epithelium. Immunohistochemistry (IHC)
TP53 Mutation Analysis

Bi-directional sequencing of TP53 exons 4-9.

Molecular
Tumor Mutation Burden

Tumor Mutation Burden (TMB) testing at NeoGenomics measures the number of non-synonymous DNA coding sequence changes per megabase of sequenced DNA. Testing is performed routinely within the NeoTYPE™ Discovery Profile, can be added to any of the NeoTYPE Solid Tumor Profiles, and is available as a stand-alone test. Results are reported as low, high intermediate, and high upper quartile in reference to the median genomic TMB value determined across a wide variety of tumor types in an internal validation study. TMB is also called tumor mutational burden or tumor mutation load (TML). 

Molecular
UGT1A1 Genotyping

Lengths of the TA repeat polymorphism in the promoter region of the UTG1A1 gene are determined by fragment analysis using capillary electrophoresis. The alleles detected include the common normal allele *1 (with 6 TA repeats) and the common abnormal allele *28 (7 repeats). The patient's genotype is reported along with the associated high, intermediate, or low risk for toxicity from the drug irinotecan (Camptosar®).

Molecular
Universal Fusion/Expression Profile

The Universal Fusion/Expression Profile is a targeted RNA sequencing panel that utilizes next-generation sequencing (NGS) to detect all relevant fusion transcripts in 1,385 genes associated with hematologic or solid tumor cancers. It is especially useful for testing patients with rare diseases. Learn more about the Universal Fusion/Expression Profile. See the full 1,385 gene list here.

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)
Warthin StarrySpecial stain. Warthin Starry stain is intended to identify Helicobacter pylori in tissue samples. Immunohistochemistry (IHC)