Displaying 1 - 60 of 60 tests
Alcian BlueSpecial stain. Alcian blue is intended to identify weakly sulfated mucins in tissue samples. Immunohistochemistry (IHC)
ARAndrogen receptor (AR) is responsible for the regulation of the growth of the prostate epithelial cells. In untreated prostate carcinoma, AR positive cells are more likely to be responsive to hormonal therapy. In patients with hormone refractory prostate carcinoma, the presence of AR has a negative prognostic impact. It is also commonly expressed in salivary duct carcinoma. Immunohistochemistry (IHC)
BCA-225This antibody recognizes a human breast carcinoma associated glycoprotein BCA-225 (220-225kD). This protein differs in size and distribution from other breast carcinoma antigens. It does not react with benign or malignant gastrointestinal tissues. It can be used to identify skin carcinomas with sweat gland and sebaceous differentiation. 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)
Breast Triple Stain (CK5 + p63 + CK 8/18)The combination of CK5 + P63 + CK8/18 (Breast Triple Stain) can be useful in distinguishing ductal carcinoma in situ (DCIS) from microinvasive breast carcinoma. This multiplex can decipher between a radial scar and infiltrating carcinoma. P63 (nuclear brown) and CK5/6 (cytoplasmic brown) stain myoepithelial cells, whereas CK8/18 labels the cytoplasm (red) of all ductal or lobular epithelium. Immunohistochemistry (IHC)
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)
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)
Chromosome Analysis

A wide variety of abnormalities can be identified, providing both diagnostic and prognostic information. Acute leukemias, lymphomas and chronic myeloid and lymphoid disorders are examined cytogenetically in order to establish the exact nature of the acquired genetic change. Rearrangements, also known as translocations, inversions, and deletions, can usually be detected under a light microscope. In most leukemias and lymphomas, changes in chromosome number (ploidy) or chromosome structure (rearrangements) are often observed.
 

Cytogenetics
CK AE1/AE3Monoclonal 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)
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)
COX2Cyclooxygenase-2 (COX-2) plays a role in tumorigenesis through stimulating epithelial cell proliferation, inhibiting apoptosis, stimulating angiogenesis, enhancing cell invasiveness, mediating immune suppression, and by increasing the production of mutagens. COX-2 is expressed in breast cancer, transitional cell carcinoma of the bladder, high-grade endometrioid carcinoma, and ovarian cancer. Overexpression of COX-2 is associated with poor prognosis in cervical cancers after radiation and concurrent chemotherapy. Immunohistochemistry (IHC)
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)
DNA Ploidy/Cell Cycle Analysis – POC/Solid Tumors

Available as a global test only. DNA stain propidium iodide (PI) is used to determine S-phase cell cycle fraction and DNA index as indicators of DNA ploidy. Products of conception (POC) and solid tumors are accepted for this test. Please see DNA Ploidy/Cell Cycle Analysis – Heme for other indications.

Flow Cytometry
E-CadherinE Cadherin is an adhesion protein that is expressed in cells of epithelial lineage. It stains positively in glandular epithelium, as well as adenocarcinomas of the lung, G.I. tract and ovary. It is useful in distinguishing adenocarcinoma from mesothelioma. It is also positive in some thyroid carcinomas. Breast carcinomas with ductal and lobular features show two staining patterns: (1) complete or almost complete lack of membrane staining in lobular carcinomas and (2) uniform membrane expression throughout the tumor in ductal carcinomas. Immunohistochemical detection of ECadherin expression can be a useful diagnostic tool for the differentiation of ductal and lobular carcinomas of the breast. Immunohistochemistry (IHC)
EREstrogen Receptor (ER) belongs to a superfamily of nuclear hormone receptors and is expressed in about 85% of invasive breast cancers. There are two known isoforms of estrogen receptor, ERα and ERß. It is a weak prognostic factor but a strong predictive factor for response to endocrine therapies, both in adjuvant and metastatic settings. The primary indication to assess ER in breast cancer is to predict response to hormonal therapies such as tamoxifen, other selective estrogen receptor modulators (SERMs) and aromatase inhibitors. In univariate analysis, moderate to strong staining in even 1% of the invasive tumor cells is associated with significant improvement in disease-free survival compared to those patients whose tumor lacks ER expression. Immunohistochemistry (IHC)
GATA3GATA3 (GATA binding protein 3) is a member of the GATA family of transcription factors. Among several other roles, GATA3 is involved in luminal cell differentiation in the mammary gland and appears to control a set of genes involved in the differentiation and proliferation of breast cancer. The expression of GATA3 is associated with the expression of estrogen receptor-alpha (ER) in breast cancer. GATA3 has been shown to be a novel marker for bladder cancer. GATA3 stains almost all of urothelial carcinomas, but stained no prostate or renal carcinomas. Immunohistochemistry (IHC)
GCDFP15This antibody is specific to a 15kDa monomer protein called Gross Cystic Disease Fluid Protein-15 (GCDFP-15). GCDFP15 is expressed in apocrine epithelia, lacrimal, ceruminous and Moll’s glands, as well as in numerous serous cells of the submandibular, tracheal, bronchial, sublingual and minor salivary glands. It can be of use in the identification of breast carcinoma, salivary duct carcinoma and apocrine epithelia. 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 Breast Cancer

Probes: HER2 (17q11.2-q12) | 17 (Cen 17
Disease(s): Breast cancer

FISH
HER2 Breast Equivocal FISH Panel

Probes: TP53 (17p13.1) | SMS Critical Region (SMSCR) (17p11.2) | Centromere 17 | RARA (17q21.1
Disease(s): Breast cancer
Testing is performed only on a global basis at this time.

FISH
HER2 Dual ISHThe FDA approved Ventana Medical Systems’ (Ventana) INFORM HER2 Dual ISH DNA Probe set is intended to determine HER2 gene status by enumeration of the ratio of theHER2 gene to Chromosome 17 in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. The INFORM HER2 Dual ISH DNA Probe set is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. In Situ Hybridization (ISH)
Hereditary Cancer Comprehensive Panel

Next-gen sequencing of all coding regions and intron-exon boundaries is performed concurrently for the following 73 genes: AKT1, APC, ATM, ATR, BAP1, BARD1, BMPR1A, BRCA1, BRCA2, BRIP1, CDH1, CDK4, CDKN2A, CEBPA, CHEK1, CHEK2, CTNNA1, EPCAM, ETV6, FAM175A, GALNT12, GATA2, GEN1, GREM1, HOXB13, KLLN, MEN1, MLH1, MRE11A, MSH2, MSH6, MUTYH, MYH1, MYH2, MYH3, MYH4, MYH6, MYH7, MYH8, MYH9, MYH10, MYH11, MYH13, MYH14, MYH15, NBN, NTRK1, PALB2, PIK3CA, PMS2, POLD1, POLE, PPM1D, PRSS1, PTEN, RAD50, RAD51, RAD51C, RAD51D, RET, RUNX1, SDHB, SDHC, SDHD, SMAD4, STK11, TERC, TERT, TP53, TP53BP1, VHL, WT1, and XRCC2. Note: 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
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)
MammaglobinMammaglobin is a breast-associated glycoprotein. In normal breast tissue, this antibody labels breast ductal and lobular epithelial cells. In tumor cells, they are reactive with all types of breast adenocarcinoma regardless of tumor differentiation and type. Adenocarcinomas from other organs rarely express mammaglobin. Mammaglobin can help in the identification of primary sites of carcinomas. 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
MOC31Monoclonal antibody MOC31 recognizes a membrane glycoprotein of 40kDa present on epithelial cells but not on mesothelial cells. MOC31 reacts with most adenocarcinomas of various origins, typically with strong staining pattern. Only rare cases of mesotheliomas show focal or weak staining. MOC31 antibody does not label liver as well as hepatocellular carcinoma, therefore, it will be helpful in the differential diagnosis of liver metastases versus hepatocellular carcinomas. 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)
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).

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
NeoTYPE Breast Tumor Profile

This test is performed by sequencing of the entire coding regions of the genes listed unless another method is noted. AKT1, BRAF, BRCA1, BRCA2, CTNNB1, EGFR, ERBB2, ERBB4, FGFR1, FGFR2, FGFR3, HRAS, KIT, KRAS, MET, NRAS, PIK3CA, PTEN, SMAD4, SMO, SRC, TP53, HER2 FISH, 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. Note - Samples with equivocal HER2 FISH results will be reflexed to the Equivocal Breast FISH Panel. BRCA1/2 testing will be performed unless opted out.

Molecular
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, 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 (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 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
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.

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.

Molecular
p120 CateninP120 Catenin is a tyrosine kinase which binds to E-cadherin within the cell membrane. It is detectable in the cell membranes of a wide variety of cells, but predominates in virtually all types of epithelia. When E-cadherin is absent, P120ctn moves to the cell cytoplasm. P120ctn can be useful in the diagnostic distinction between lobular (cytoplasmic staining pattern) and ductal (membranous) breast neoplasia. Immunohistochemistry (IHC)
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)
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)
PgR

Progesterone Receptor (PR) belongs to a superfamily of nuclear hormone receptors. Estrogen Receptor (ER) induces PR expression, therefore, PR status serves as an indicator of an intact ER pathway. There are two known isoforms of PR; PR? and PRß. The current assays in clinical breast cancer measure both isoforms. PR is expressed in about 60-70% of invasive breast cancers. It is a weak prognostic factor by itself but a modest predictive factor that adds to the predictive value of ER for response to endocrine therapies, both in adjuvant and metastatic settings. The primary indication to assess PR in breast cancer is to predict response to hormonal therapies, such as tamoxifen, other selective estrogen receptor modulators (SERMs) and aromatase inhibitors.

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
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
RRM1

RRM1 is crucial for DNA synthesis and damage repair. High levels of RRM1 are associated with G2 cell cycle arrest and increased apoptosis in vitro.

Immunohistochemistry (IHC)
TOP2AProbes: TOP2A (17q21-q22) | Cen 17 (17p11.1-q11.1)
Disease(s): Breast cancer
Note: Available as a global test only.
FISH
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)