Our IHC Menu

Antibody AE1/AE3

Billing (level 1 or 2 or multi) 1

Alternate Name–

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description Results aid in the classification of normal and neoplastic tissue as epithelial in origin.

Antibody AFP

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description Positive staining with anti-AFP is seen in hepatocytes of fetal liver and hepatoma. In conjunction with elevated serum levels, AFP has been immunohistochemically demonstrated in yolk sac tumor of gonadal and extragonadal sites, in hepatic malignancies, and a few other neoplasms.

Antibody Arginase-1

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic/Nuclear

Test Description Arginase-1 is intended to aid in the identification and differentiation of hepatocellular carcinoma within the context of an antibody panel.

Antibody bcl-2

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description bcl-2 may be used to aid in the identification of follicular lymphomas and diffuse large cell lymphomas, and to differentiate follicular lymphomas from reactive lymph nodes.

Antibody bcl-6

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Nuclear

Test Description bcl-6 is a transcriptional regulator gene which codes for a 706-amino-acid nuclear zinc finger protein. Antibodies to this protein stain the germinal center cells in lymphoid follicles, the follicular cells and interfollicular cells in follicular lymphoma, diffuse large B-cell lymphomas, and Burkitt’s lymphoma, and the majority of the Reed-Sternberg cells in nodular lymphocyte predominant Hodgkin’s Disease

Antibody Ber-EP4

Billing (level 1 or 2 or multi) 1

Alternate Name Ep-CAM

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description In conjunction with other markers, Ep-CAM can be used as an aid in determining neoplasms of epithelial origin, such as distinguishing between lung adenocarcinoma and mesothelioma. Ber-EP4 is not expressed in mesothelial cells, hepatocytes or lymphocytes.

Antibody BRCA-1

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Nuclear

Test Description The BRCA-1 antibody gene codes for a nuclear phosphoprotein that plays a role in maintaining genomic stability and acts as a tumor suppressor. Findings suggest that BRCA-1 antibody plays a protective role in epithelial cells undergoing high levels of proliferation in association with differentiation. Additional studies have shown that the complete loss of BRCA-1 nuclear expression and the correlation with poor prognostic markers in breast cancer imply that the altered BRCA-1 phenotype may provide an added prognostic parameter for breast cancer and could be applied as a potential rapid screening technique for BRCA-1 mutations.

Antibody Breast Triple

Billing (level 1 or 2 or multi) Multiplex

Alternate Name –

Regulatory Status LDT

Staining Pattern Cytoplasmic/Nuclear

Test Description Breast triple stain

Antibody CA-IX

Billing (level 1 or 2 or multi) 1

Alternate Name Carbonic Anhydrase IX

Regulatory Status IVD

Staining Pattern Membranous

Test Description Data suggest consistent immunoreactivity for anti-CA IX in clear cell renal cell carcinoma (RCC) making it a useful marker for this type of tumor.

Antibody CA125

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Membranous/Cytoplasmic

Test Description CA-125 antibody reacts with epithelioid malignancies of the ovary, papillary serous carcinoma of the cervix, adenocarcinoma of the endometrium, clear cell adenocarcinoma of the bladder, and epithelioid mesothelioma.

Antibody CA19-9

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description CA19-9 antigen is highly expressed in gastrointestinal (gastric, pancreatic, and colonic) adenocarcinomas and salivary gland mucoepidermoid carcinomas. Anti-CA19-9 antibody is usually not reactive with breast, kidney, and prostate carcinomas.

Antibody Calponin-1

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description Calponin has been found to be useful in differentiating benign sclerosing lesions of the breast from carcinoma. Calponin positivity has also been noted in malignant myoepithelioma and pleomorphic adenoma of salivary gland origin, as well as angiomatoid malignant fibrous histiocytoma.

Antibody Calretinin

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic/Nuclear

Test Description Anti-calretinin labels mesothelial and Leydig cells under normal and neoplastic conditions. Anti-calretinin has been shown to be useful in differentiating mesothelioma from adenocarcinomas of the lung and other sources.

Antibody CAM 5.2

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description This antibody may be used to aid in the identification of tumors of epithelial origin such as colorectal, pancreatic, and non-small cell lung cancer and in distinguishing carcinomas from other malignant tumors of non-epithelial origin.

Antibody CD10

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Membranous/Cytoplasmic

Test Description CD10 may be used to aid in the identification of Burkitt’s lymphoma and follicular germ cell lymphoma, and in the classification of some carcinomas such as renal cell carcinoma. 

Antibody CD117

Billing (level 1 or 2 or multi) 2

Alternate Name c-KIT

Regulatory Status IVD

Staining Pattern Cytoplasmic/Membranous

Test Description c-KIT is indicated as an aid in the diagnosis of GIST within the context of the patient’s clinical history, tumor morphology, and other diagnostic tests. C-KIT may be used after the diagnosis of GIST as an aid in the selection of GIST patients who may qualify for imatinib mesylate (Gleevec®/Glivec®) therapy.

Antibody CD138

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Membranous

Test Description Anti-CD138/syndecan-1 is a useful marker for labeling normal and neoplastic plasma cells and plasmacytoid lymphomas. Various forms of Hodgkin’s disease have also shown positive staining with this antibody.

Antibody CD15

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic/Membranous

Test Description CD15 is a mouse monoclonal antibody (IgM, kappa) directed against a carbohydrate epitope present on most granulocytic cells.

Antibody CD163

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic/Membranous

Test Description CD163 was recently identified as an acute phase-regulated transmembrane protein whose function is to mediate the endocytosis of haptoglobin-hemoglobin complexes. This receptor is expressed on the surface of monocytes (low expression) and tissue macrophages [also known as histiocytes] (high expression).

Antibody CD20

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Membranous

Test Description CD20 is intended for use to qualitatively identify cells of B lymphocytic lineage1 by light microscopy.

Antibody CD3

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Membranous

Test Description Anti-CD3 is considered to be a pan-T-cell marker and reacts with an antigen present at the surface and in the cytoplasm of T lymphocytes. Anti-CD3 is widely used for the identification of immature and mature T-cell malignancies.

Antibody CD30

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Membranous/Cytoplasmic

Test Description CD30 is intended for laboratory use in the detection of the CD30 protein in formalin-fixed, paraffin-embedded tissue. Positive staining results may aid in the identification of classical Hodgkin lymphoma and anaplastic large cell lymphoma.

Antibody CD31

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic/Membranous

Test Description CD31 is expressed by stem cells of the hematopoietic system and is primarily used to identify and concentrate these cells for experimental studies as well as for bone marrow transplantation. Endothelial cells also express this marker, therefore, antibodies to CD31 have been used as a tool to identify the vascular origin of neoplasms. CD31 has shown to be highly specific and sensitive for vascular endothelial cells. Staining of nonvascular tumors (excluding hematopoietic neoplasms) has not been observed.

Antibody CD34

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Membranous

Test Description This antibody is intended for use to qualitatively identify CD34 by light microscopy in sections of formalin fixed, paraffin embedded tissue

Antibody CD4

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Membranous

Test Description CD4 is intended for the qualitative detection of CD4 in sections of formalin-fixed, paraffin-embedded normal and neoplastic human tissues. CD4 is present on helper-inducer T lymphocytes that recognize antigen in the context of MHC class 2 molecules. CD4 positive staining results may aid in identifying T-cell lymphomas and in identifying the T helper-inducer cell subset of T lymphocytes in normal tissues.

Antibody CD44

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Membranous

Test Description CD44 is a type I transmembrane receptor protein expressed in several cell types including T and B lymphocytes, monocytes, granulocytes, erythrocytes, fibroblasts, epithelial, and mast cells and may be used to detect the CD44 standard and variant proteins in a variety of neoplastic tissues, including squamous cell and urothelial carcinoma.

Antibody CD45

Billing (level 1 or 2 or multi) 1

Alternate Name LCA

Regulatory Status IVD

Staining Pattern Membranous

Test Description CD45 (LCA) may be used to aid in the identification of normal and abnormal cells of leukocytic lineage and as an aid in the diagnosis of anaplastic tumors. CD45 specifically binds to antigens located on the membrane of leukocytes. Staining is most consistent for lymphocytic cells with less consistent reaction in other leukocytes (macrophages/ histiocytes/myeloid cells).

Antibody CD5

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Membranous/Cytoplasmic

Test Description CD5 expressed on the plasma membrane of virtually all human T cells and the B1a subset of human B cells found in the follicular mantle zones, bone marrow and peripheral blood. Staining CD5 is commonly used as part of several IHC panels to determine T cell and B cell sub-classifications. CD5 may be used to aid in the identification of T cell lymphomas, and certain B cell lymphomas, including mantle cell lymphoma.

Antibody CD56

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic/Membranous

Test Description Use of this antibody is indicated as an aid in the identification of neural/neurodendocrine tissues, natural killer (NK) cells, NK-like T-cells, and diagnosis of related neoplasms within the context of an antibody panel,

Antibody CD68

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic/Membranous

Test Description CD68 reacts with a 110 KD intracellular glycoprotein associated with the cell membrane of macrophages and some myeloid elements.1,2,3,4 Unexpected antigen expression or loss of expression may occur, especially in neoplasms. Occasionally stromal elements surrounding heavily stained tissue or cells will show immunoreactivity.

Antibody CD99

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Membranous

Test Description CD99 is directed against human CD99 expressed on T lymphocytes, cortical thymocytes, granulosa cells of the ovary, pancreatic islet cells, CNS ependymal cells and Sertoli’s cells. CD99 shows a plasma membrane location. This antibody may be used as part of a panel to aid in the identification of Ewing’s sarcoma and related peripheral neuroectodermal tumors.

Antibody CDX2

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Nuclear

Test Description CDX-2 has been useful to establish GI origin of metastatic adenocarcinomas and carcinoids and is especially useful to distinguish metastatic colorectal adenocarcinoma from lung adenocarcinoma. However, mucinous carcinomas of the ovary also stain positively with this antibody, which limits the usefulness of this marker in the distinction of metastatic colorectal adenocarcinoma versus mucinous carcinoma of the ovary.

Antibody CEA(M)

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Nuclear

Test Description The human carcinoembryonic antigen antibody (CEA) family consists of glycophosphatidyl inositol (GPI) linkage and transmembrane linkage members. Studies suggest the GPI-linked members tend to be up regulated in human tumors, whereas the transmembrane-linked members tend to be down regulated. CEA (CD66e) [COL-1], a GPI-linked member, shows no detectable reactivity for other CEA members. [COL-1] may be useful in aiding the detection of early foci of gastric carcinoma and distinguishing pulmonary adenocarcinomas from mesothelioma. Studies have shown it stains many types of adenocarcinoma, but does not stain benign glands, stroma, or malignant prostatic cells.

Antibody CEA(P)

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Nuclear

Test Description The human carcinoembryonic antigen antibody (CEA) family consists of glycophosphatidyl inositol (GPI) linkage and transmembrane linkage members. Studies suggest the GPI-linked members tend to be up regulated in human tumors, whereas the transmembrane-linked members tend to be down regulated. CEA (CD66e) [COL-1], a GPI-linked member, shows no detectable reactivity for other CEA members. [COL-1] may be useful in aiding the detection of early foci of gastric carcinoma and distinguishing pulmonary adenocarcinomas from mesothelioma. Studies have shown it stains many types of adenocarcinoma, but does not stain benign glands, stroma, or malignant prostatic cells.

Antibody Chromogranin-A

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description It is generally accepted that the co-expression of certain keratins and chromogranin mean neuroendocrine lineage. The presence of strong chromogranin staining and absence of keratin staining should raise the possibility of paraganglioma. The co-expression of chromogranin and NSE is typical of neuroendocrine neoplasms.

Antibody Ck 17

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description This antibody may be used to aid in the identification of squamous cell carcinomas in various tissues including the cervix, lung, and oral cavity.

Antibody Ck 20

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description Anti-Cytokeratin 20 is useful in the identification of specific types of these epithelial cells under normal hyperplastic and neoplastic conditions. Cytokeratin 20 has been detected in adenocarcinomas of the colon, stomach and biliary tract. Merkel cell carcinomas have shown reactivity. In contrast, carcinomas of the breast are generally non-reactive.

Antibody Ck 5&6

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description Cytokeratin 5 & cytokeratin 6 are type II high molecular weight keratins that are expressed in a broad range of normal tissues including breast, prostate, mesothelium, skin and esophagus. Anti-Cytokeratin 5 & 6 is a useful immunohistochemical marker in the identification of mesothelioma and lung squamous cell carcinoma.

Antibody Ck 7

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description Cytokeratin 7 labeling can help distinguish between lung, breast carcinomas, and urothelial carcinomas that typically stain positive, and colon and prostate carcinomas that typically lack CK7 expression. CK 7 is a common marker of primary lung adenocarcinomas (almost all cases) with a lower specificity since it is also observed in other primary lung carcinomas and non-pulmonary carcinomas. Anti-cytokeratin 7 has also been useful in the differential diagnosis of ovarian neoplasms. This antibody does not recognize intermediate filament proteins.

Antibody CK 8&18

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description Cytokeratins 8 & 18 can be found in most simple epithelium, e.g. thyroid, female breast, gastrointestinal tract, and respiratory tract. Adenocarcinomas and most non-keratinizing squamous carcinomas will stain, but keratinizing squamous carcinomas will not. This antibody is used when attempting to demonstrate the presence of Paget cells; there is very little keratin 18 in the normal epidermis so this will only stain Paget cells. This approach facilitates the interpretation using immunostains and is more sensitive than mucin histochemistry.

Antibody Ck HMW

Billing (level 1 or 2 or multi) 1

Alternate Name 34BetaE12

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description Anti-Cytokeratin, 34betaE12 is an antibody to high molecular weight cytokeratin that reacts with all squamous and ductal epithelium and stains carcinomas. Anti-Cytokeratin, 34betaE12 does label myoepithelial cells and has been shown to be useful in distinguishing prostatic adenocarcinoma from hyperplasia of the prostate. This antibody has also been useful in separating benign from malignant intraductal breast proliferations.

Antibody Ck Oscar

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description This antibody stains cytokeratins present in normal and abnormal human tissues and has shown high sensitivity in the recognition of epithelial cells, making it a useful marker for identifying several types of carcinoma.

Antibody Desmin

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description Anti-Desmin (DE-R-11) may be used to aid in the identification of cells of normal and abnormal myocytic lineage as an aid in diagnosis of anaplastic tumors. CONFIRM anti-Desmin (DE-R-11) specifically binds to antigens located in the cytoplasm of myocytic cells.

Antibody DOG1

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic/Membranous

Test Description This antibody is used as an aid in the identification and diagnosis of gastrointestinal stromal tumors (GIST) within the context of an antibody panel, the patient’s clinical history, and other diagnostic tests evaluated by a qualified pathologist.

Antibody EGFR

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic/Membranous

Test Description This primary antibody is designed to qualitatively detect the presence of the internal domain of EGFR via light microscopy in formalin fixed, paraffin embedded tissue. This antibody is directed against the internal domain of the human Epidermal Growth Factor Receptor (also called EGFR, ErbB1 or HER 1).

Antibody EMA

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic/Membranous

Test Description This antibody may be used to aid in the identification of epithelial membrane antigen in adenocarcinomas derived from secretory epithelia, malignant mesothelioma, renal cell carcinomas and meningiomas.

Antibody ER

Billing (level 1 or 2 or multi) 2

Alternate Name –

Regulatory Status IVD

Staining Pattern Nuclear

Test Description Anti-ER (SP1) is directed against an epitope present on human ER alpha protein located in the nucleus of ER positive normal and neoplastic cells. CONFIRM anti- ER (SP1) is indicated as an aid in the management, prognosis, and prediction of therapy outcome of breast cancer. The clinical interpretation of any staining, or the absence of staining, must be complemented by morphological studies and evaluation of proper controls. 

Antibody ERG

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Nuclear/Cytoplasmic

Test Description This antibody exhibits a nuclear staining pattern and may be used to aid in the identification of prostate adenocarcinomas through the detection of truncated ERG.

Antibody GATA-3

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Nuclear

Test Description GATA3 expression is primarily seen in breast carcinoma and urothelial carcinoma.  Anti-GATA3 can also be useful in the identification of unknown primary carcinoma when carcinomas of the breast or bladder are a possibility.

Antibody GCDFP-15

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description GCDFP-15 (EP1582Y) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin embedded tissue sections using IHC test methods. Use of this antibody is indicated, subsequent to clinical differential diagnosis, as an aid in the identification of GCDFP-15 within the context of an antibody panel.

Antibody GLUT-1

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Membranous

Test Description Use of this antibody is indicated as an aid in the identification and diagnosis of tumors within the context of an antibody panel, the patient’s clinical history, and other diagnostic tests evaluated all by a qualified pathologist.

Antibody Glycophoris-A

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Membranous

Test Description Glycophorin A is a sialoglycoprotein present on human red blood cells and their precursors. Anti-Glycophorin A has been used to characterize erythroid cell development and in the diagnosis of erythroid leukemias.

Antibody Glypican-3

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic/Membranous

Test Description Anti-Glypican 3 is directed against the heparan sulfate proteoglycan, glypican 3. This antibody may be used to aid in the differentiation of hepatocellular carcinoma from normal liver or benign lesions.

Antibody HCG

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status –

Staining Pattern –

Test Description –

Antibody H. Pylori

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Bacteria

Test Description Immunohistochemical techniques using a Helicobacter pylori antibody can distinguish it from other types of curved bacteria. There is evidence showing that these bacteria may play a significant role in peptic ulcer disease. A study has suggested that Helicobacter pylori infection is a risk factor for colorectal polyps in children.

Antibody HER2/Neu

Billing (level 1 or 2 or multi) 2

Alternate Name –

Regulatory Status IVD

Staining Pattern Membranous

Test Description It is indicated as an aid in the assessment of breast cancer patients for whom Herceptin treatment is considered. Note: All of the patients in the Herceptin clinical trials were selected using a clinical trial assay. None of the patients in those trials were selected using PATHWAY anti-HER-2/neu (4B5). PATHWAY anti-HER-2/neu (4B5) was compared to PATHWAY HER-2 (clone CB11) Primary Antibody on an independent sample set and found to provide acceptably concordant results. The actual correlation of PATHWAY anti-HER-2/neu (4B5) to clinical outcome has not been established.

Antibody HMB45

Billing (level 1 or 2 or multi) 1

Alternate Name Melanosome

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description Anti-Melanosome (HMB45) is a mouse monoclonal antibody (IgG1, kappa) directed against an oncofetal antigen present within immature melanosomes in the cytoplasm of activated and neoplastic melanocytes. 

Antibody HSA

Billing (level 1 or 2 or multi) 1

Alternate Name HEP-Par1

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description Anti-Hepatocyte Specific Antigen recognizes both benign and malignant liver derived tissues including such tumors as hepatoblastoma, hepatocellular carcinoma, and hepatic adenoma. It recognizes both normal adult and fetal liver tissue. The typical pattern is a granular cytoplasmic staining. This antibody is useful in differentiating hepatocellular carcinomas with adenoid features from adenocarcinomas, either primary in the liver or metastatic lesions to the liver. In recognizing hepatoblastoma, it is useful in differentiating this entity from other small round cell tumors.

Antibody HSV1

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status ASR

Staining Pattern –

Test Description –

Antibody HSV2

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status ASR

Staining Pattern –

Test Description –

Antibody Inhibin

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description Anti-Inhibin alpha is an antibody against a peptide hormone which has demonstrated utility in the differentiation between adrenal cortical tumors and renal cell carcinoma. Sex cord stromal tumors of the ovary as well as trophoblastic tumors also demonstrate cytoplasmic positivity with this antibody. This antibody has been used to make the differential diagnosis of intra-uterine vs. ectopic pregnancy in endometrial curettings.

Antibody Kappa

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description When dealing with B-cell neoplasms, the determination of light chain ratios remains the centerpiece. Most B-cell lymphomas express either kappa or lambda light chains, whereas reactive proliferations display a mixture of kappa and lambda positive cells. If only a single light chain type is detected, a lymphoproliferative disorder exists.

Antibody Ki67

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Nuclear

Test Description The Ki-67 antigen is a nuclear, non-histone protein that is present in proliferating cells. In general, Ki-67 is a good marker of proliferating cell populations. Anti-Ki-67 labeling index has been shown to be a good marker to grade neoplasms including:  colon carcinoma, breast carcinoma, and  lymphoma.

Antibody Lambda

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description B-cells. Anti-lambda staining is seen in B-cell follicles of human lymphoid tissue. When dealing with B-cell neoplasms, the determination of light chain ratios remains helpful. Most B-cell lymphomas express either kappa or lambda light chains, whereas reactive proliferations display a mixture of kappa and lambda positive cells. If only a single light chain type is detected, a lymphoproliferative disorder is very likely.

Antibody Mammaglobin

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description Use of this antibody is indicated as an aid in identification of substantial proportion of primary and metastatic breast carcinomas within the context of an antibody panel, the patient’s clinical history and other diagnostic tests evaluated by a qualified pathologist.

Antibody Melan A

Billing (level 1 or 2 or multi) 1

Alternate Name MART-1

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description This antibody is designed to qualitatively detect the presence of melan A by light microscopy in sections of formalin-fixed, paraffin-embedded tissue. Positive staining may aid in the classification of melanoma.

Antibody MOC-31

Billing (level 1 or 2 or multi) 1

Alternate Name Ep-CAM/Epithelial Specific Antigen

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description Immunoreactivity with the antibody to Ep-CAM has been seen in the majority of epithelial neoplasms, whereas most non-epithelial neoplasms do not show Ep-CAM expression. Ep-CAM is not expressed in mesothelial cells, hepatocytes, and lymphocytes. In conjunction with other markers, Ep-CAM can be used as an aid in determining neoplasms of epithelial origin, such as distinguishing between lung adenocarcinoma and mesothelioma.

Antibody MSA

Billing (level 1 or 2 or multi) 1

Alternate Name Muscle Specific Actin

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description This antibody recognizes actin of skeletal, cardiac, and smooth muscle cells. It is not reactive with other mesenchymal cells except for myoepithelium. Actin can be resolved on the basis of its isoelectric points into three distinctive components: alpha, beta, and gamma in order of increasing isoelectric point. Non-muscle cells such as vascular endothelial cells and connective tissues are non-reactive. Also, neoplastic cells of non-muscle-derived tissue such as carcinomas, melanomas, and lymphomas are negative.

Antibody Napsin A

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description Use of this antibody is indicated, subsequent to clinical differential diagnosis, as an aid in the identification of napsin A protein over-expression in various lung adenocarcinomas within the context of an antibody panel.

Antibody NKX3.1

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Nuclear

Test Description A recent study showed that NKX3.1 staining was highly sensitive and specific for high-grade prostatic adenocarcinomas. The sensitivity for identifying metastatic prostatic adenocarcinomas overall was 98.6% (68/69 cases positive) for NKX3.1, and 94.2% (65/69 cores positive) for PSA. The specificity of NKX3.1 was 99.7% (1/349) in various cancers. NKX3.1 stains nuclei in both normal and prostate cancer, thus providing a robust stain that is easy-to-interpret, similar to other transcription factors such as TTF-1 or CDX2.

Antibody NSE

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description Use of this antibody is indicated, subsequent to clinical differential diagnoses of diseases, as an aid in the identification of neuroendocrine neoplasms within the context of antibody panels.

Antibody P120

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Membranous/Cytoplasmic

Test Description Anti-p120 catenin (98) Mouse Monoclonal Primary Antibody is directed against human juxtamembrane protein p120 expressed as a part of the cell-cell adhesion complex in epithelial tissues. Cytoplasmic accumulation of p120 is associated with lobular breast carcinoma whereas ductal neoplasms retain membranous localization.

Antibody P16

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cervical Carcinoma

Test Description CINtec® Histology is a qualitative immunohistochemistry (IHC) test using mouse monoclonal anti-p16 antibody clone E6H4, and is intended for use in the light microscopic assessment of the p16INK4a protein in formalin-fixed, paraffin-embedded (FFPE) cervical punch biopsy tissues using OptiView DAB IHC Detection Kit on a VENTANA BenchMark ULTRA instrument.

Antibody P40

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Nuclear

Test Description P40 (BC28) Mouse Monoclonal Primary Antibody [anti-p40 (BC28)] is intended for laboratory use in the detection of p40 protein in formalin-fixed, paraffin-embedded tissue.

Antibody P504S

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status ASR

Staining Pattern –

Test Description –

Antibody P53

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Nuclear

Test Description Anti-p53 (DO-7) primary antibody is a mouse monoclonal antibody (IgG1, kappa) directed against human p53. The antibody is intended for laboratory use to qualitatively identify by light microscopy wild type and mutant p53 in sections of formalin fixed, paraffin embedded tissue.

Antibody P63

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Nuclear

Test Description p63 is detected in prostatic basal cells in normal prostate; however, it is negative in malignant tumors of the prostate gland. Thus p63 antibody may be a valuable tool in the differential diagnosis of benign and malignant tumors of prostate gland and can be used in a panel of antibodies such as HMW CK [34ßE12], PSA and PSAP. p63 may play a significant role in prostate development by maintaining a prostate stem cell population. Striated muscle staining may be observed with p63.

Antibody Pan-CK

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description Anti-Pan Keratin (AE1/AE3/PCK26) Primary Antibody may be used to aid in the identification of normal and abnormal epithelial cells and to determine the lineage of poorly differentiated malignant tumors.

Antibody PAX-2

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Nuclear

Test Description Gnarra et al. showed PAX-2 expression in renal carcinoma cell lines and underlined its potential role in cell proliferation in these lines.1 Mazal et al. demonstrated PAX-2 nuclear expression in 88% of clear cell renal cell carcinomas as well as 18% of papillary renal cell carcinoma, and 13% of chromophobe renal cell carcinomas. More recently, Chivukula et al. demonstrated utility in distinguishing ovarian serous papillary carcinoma (anti-PAX-2 positive) from breast carcinoma (anti-PAX-2 negative).

Antibody PAX-8

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Nuclear

Test Description PAX-8 can be useful for marking several types of carcinoma including ovarian serous carcinoma, clear cell renal cell carcinoma, and papillary thyroid carcinoma.  Additionally, PAX-8 is not found in the epithelial cells of the breast, lung, mesothelium, stomach, colon, pancreas and other sites.

Antibody PIN-4

Billing (level 1 or 2 or multi) Multiplex

Alternate Name –

Regulatory Status LDT

Staining Pattern Cytoplasmic/Nuclear

Test Description Prostate triple stain

Antibody PLAP

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description Anti-PLAP antibody immunoreacts with germ cell tumors and can discriminate between these and other neoplasms. Somatic neoplasms e.g. breast, gastrointestinal, prostatic and urinary cancers may also immunoreact with antibodies to PLAP. Anti-PLAP positivity in conjunction with keratin negativity favors seminoma over carcinoma. Germ cell tumors are usually keratin positive, but they regularly fail to stain with anti-EMA, whereas most carcinomas stain with anti-EMA. Anti-PLAP has been useful in the diagnosis of gestational trophoblastic disease. This antibody has shown cross-reaction with human intestinal alkaline phosphatase.

Antibody Pneumocystis

Billing (level 1 or 2 or multi) 1

Alternate Name PCP

Regulatory Status ASR

Staining Pattern Membranous

Test Description –

Antibody Podoplanin

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description Podoplanin is a transmembrane mucoprotein (38 kd) recognized by the D2-40 monoclonal antibody. Podoplanin is selectively expressed in lymphatic endothelium as well as lymphangiomas, Kaposi sarcomas and in a subset of angiosarcomas with probable lymphatic differentiation. Podoplanin has also been shown to be expressed in epithelioid mesotheliomas hemangioblastomas and seminomas.

Antibody PR

Billing (level 1 or 2 or multi) 2

Alternate Name –

Regulatory Status IVD

Staining Pattern Nuclear

Test Description Anti-PR (1E2) is directed against an epitope present on human progesterone receptor protein located in the nucleus of PR positive normal and neoplastic cells. Anti-PR (1E2) is indicated as an aid in the management, prognosis, and prediction of therapy outcome of breast carcinoma.

Antibody PSA

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description Anti-Prostate Specific Antigen (PSA)Primary Antibody is a rabbit polyclonal antibody (lg) directed against both free and bound human prostate specific antigen (PSA).

Antibody PSAP

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description Anti-PSAP reacts with prostatic acid phosphatase in the glandular epithelium of normal and hyperplastic prostate, carcinoma of the prostate, and metastatic cells of prostatic carcinoma. This marker may be helpful in pinpointing the site of origin in cases of metastatic carcinoma of the prostate, and is considered a more sensitive marker than PSA. However, it also offers less specificity.

Antibody RCC

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic/Membranous

Test Description This antibody immunoreacts with approximately 90% of primary renal cell carcinomas and approximately 85% of metastatic renal cell carcinomas. Other tumors that may react with this antibody are parathyroid adenoma, an occasional breast carcinoma. Nephroblastoma, oncocytoma, mesoblastic nephroma, transitional cell carcinoma, and angiomyolipoma are not labeled with this antibody.

Antibody S-100

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description This antibody is intended for use to qualitatively identify S100 protein by light microscopy in sections of formalin fixed, paraffin embedded tissue 

Antibody SATB2

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Nuclear

Test Description SATB2 is a good marker for identifying a carcinoma of colorectal origin when working on a tumor of unknown primary. Another potential utility of SATB2 is to identify neuroendocrine neoplasms/carcinomas of the left colon and rectum because SATB2 is usually negative in other neuroendocrine neoplasms of the GI tract, pancreas, and lung.

Antibody SMA

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description Smooth Muscle Actin is a part of the actin family of proteins which are highly conserved and form microfilaments. These filaments are one of the major components of the cytoskeleton. Anti-smooth muscle actin immunohistochemical reactivity is seen in smooth muscle cells, myofibroblasts and myoepithelial cells.

Antibody SMMHC

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cyotplasmic

Test Description It is helpful in distinguishing between benign sclerosing breast lesions and infiltrating carcinomas in difficult cases since it strongly stains the myoepithelial layer in the benign lesions while it is negative in the infiltrating carcinomas.

Antibody Smoothelin

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic/Nuclear

Test Description Use of this antibody is indicated as an aid in the distinction of terminally differentiated smooth muscle cells, smooth muscle neoplasms of the gastrointestinal tract and other organs, and staging of bladder carcinoma within the context of an antibody panel

Antibody Sox-10

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Nuclear

Test Description SOX-10 (SP267) Rabbit Monoclonal Primary Antibody is intended for laboratory use in the detection of the SOX-10 protein in formalin-fixed, paraffin-embedded tissue stained.

Antibody Synaptophisin

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description This antibody identifies normal neuroendocrine cells and neuroendocrine neoplasms. Diffuse, finely granular, cytoplasmic staining is observed, which probably correlates with the distribution of the antigen within neurosecretory vesicles. The expression of synaptophysin is independent of the presence of NSE or other neuroendocrine markers. Anti-synaptophysin is an independent, broad-range marker of neural and neuroendocrine differentiation.

Antibody TAG-72

Billing (level 1 or 2 or multi) 1

Alternate Name B72.3

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description Tumor associated glycoprotein (TAG)-72 is a high molecular weight glycoprotein that is present on the surface of many neoplastic cells, including adenocarcinomas of the breast, colon, and lung. TAG-72 is found in lung adenocarcinoma and is absent in mesothelioma, making the TAG-72 antibody useful in distinguishing adenocarcinoma from mesothelioma.

Antibody Thyroglobulin

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description Anti-Thyroglobulin antibody reacts with human thyroglobulin as demonstrated by a single band of immunoblotting in a lysate of human thyroid tissue. The vast majority of follicular carcinomas of the thyroid will give positive immunoreactivity for thyroglobulin even though sometimes only focal. Poorly differentiated carcinomas of the thyroid are frequently thyroglobulin negative. Adenocarcinomas of other than thyroid origin do not react with this antibody.

Antibody TTF-1

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Nuclear

Test Description TTF-1 immunostaining is useful in the differentiation between pulmonary and nonpulmonary origin of adenocarcinomas in malignant effusions.8 TTF-1 staining is very reliable in discerning whether a brain metastasis has arisen from a pulmonary or nonpulmonary site, particularly when dealing with adenocarcinomas and large-cell carcinomas.

Antibody Vimentin

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Cytoplasmic

Test Description This antibody is intended for use to qualitatively identify vimentin by light microscopy in sections of formalin fixed, paraffin embedded tissue.

Antibody WT-1

Billing (level 1 or 2 or multi) 1

Alternate Name –

Regulatory Status IVD

Staining Pattern Nuclear

Test Description WT1 is detected in tumor cells of Wilms’ Tumor (also  known as nephroblastoma) and mesothelioma. Additionally, WT1 expression has been found in ovarian serous carcinomas and some breast carcinomas.