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Identifies a transcription factor associated with tuft cell differentiation. POU2F3 is useful in identifying tuft cell–variant small cell lung carcinoma and other tumors showing tuft cell lineage. It helps distinguish this subtype from classic neuroendocrine tumors, as POU2F3 expression is typically non–neuroendocrine and marks a distinct molecular subtype with therapeutic and diagnostic relevance.
Preferentially expressed antigen in melanoma (PRAME) is detected in approximately 90% of melanoma subtypes, while it is negative in roughly 85% of cutaneous melanocytic nevi. Immunohistochemical detection of PRAME is useful as an adjunct diagnostic tool to help distinguish malignant melanoma from benign melanocytic lesions.
Preferentially expressed antigen in melanoma (PRAME) is detected in approximately 90% of melanoma subtypes and is negative in about 85% of cutaneous melanocytic nevi. This red-labeled immunostain is useful for supporting the diagnosis of melanoma by distinguishing malignant melanocytic lesions from benign nevi.
Identifies a 750 amino acid type II membrane glycoprotein with folate hydrolase and neuropeptidase activity expressed in normal and malignant prostatic epithelium and in a subset of non-prostatic tissues. In prostate cancer, PSMA expression correlates with disease progression, with the highest levels expressed in hormone-refractory and metastatic disease. Expression has also been reported on the neovasculature of a variety of non-prostatic solid tumors.
Identifies a tumor suppressor protein frequently lost or mutated in many cancers, including breast, prostate, and endometrial tumors, and in Cowden syndrome–associated lesions. Loss of PTEN expression can serve as a prognostic and predictive marker, correlating with more advanced disease in breast and prostate cancer. PTEN loss has also been associated with predicting response to Herceptin in HER2-positive breast cancers.
Identifies parathyroid hormone (PTH), produced by parathyroid glands and expressed in normal parathyroid tissue, parathyroid adenomas, and primary or secondary parathyroid hyperplasia. This marker is useful in evaluating parathyroid lesions and in the differential diagnosis of autoimmune disorders affecting the parathyroid gland, including conditions associated with anti-PTH antibodies and hypoparathyroidism.
Detects expression of tropomyosin receptor kinase A, B, and C proteins arising from the NTRK 1, 2, and 3 genes, respectively. NTRK gene rearrangements occur in many different tumor types, often at low frequency, including lung non-small cell carcinomas, colorectal and other GI-related adenocarcinomas, breast carcinomas, melanoma, renal cell carcinomas, and adult brain tumors. IHC screening is not recommended in neuroendocrine tumors, GISTs, gliomas, or adult sarcomas, as these tissues so positive staining in the absence of an NTRK translocation. Instead, molecular testing (i.e. NGS or FISH) for an NTRK gene fusion is recommended to confirm the presence of an NTRK gene fusion. Patients having a tumor harboring an NTRK gene fusion may be responsive to NTRK inhibitor therapy.
Identifies pancreatic polypeptide–producing cells located mainly in the pancreatic islets. It is useful for detecting PP-cell neoplasms, including pancreatic neuroendocrine tumors that produce pancreatic polypeptide, and for characterizing islet cell differentiation in pancreatic lesions.
Identifies a capsid protein of human parvovirus B19 and is used to detect cells infected with the virus.
Identifies a transcription factor critical for kidney development. In normal adult tissue, its expression is limited mainly to the nuclei of collecting ducts and, to a lesser extent, distal tubules. It is present during early renal organogenesis and is expressed in Wilms’ tumor and renal cell carcinoma, making it a useful marker for diagnosing renal cell carcinoma.
Identifies a B-cell–specific activator protein (BSAP) present throughout B-cell maturation until the plasma cell stage. PAX5 shows strong expression in most immature and mature B-cell neoplasms, as well as in nodular lymphocyte–predominant Hodgkin lymphoma. In classical Hodgkin lymphoma, staining is typically weaker, and plasma cell neoplasms are largely negative. This marker is highly specific for the B-cell lineage and does not label T cells.
Identifies a cytolytic protein stored in the granules of cytotoxic T lymphocytes (CTLs), which enables these cells to destroy targets presenting foreign antigens. Perforin is highly expressed in CD8⁺ T cells and, to a lesser degree, in γ/δ T cells and NK cells. It can be useful for detecting activated CTLs in conditions such as severe graft-versus-host disease, chronic renal rejection, peripheral T-cell lymphomas, and in identifying NK-cell lymphomas.
This test evaluates the cellular components of peripheral blood through smear analysis. It provides important insights for detecting blood disorders and guiding treatment.
Available as global and tech-only. Markers are CD19, CD20, CD38, CD45, CD56, CD117, CD138, ckappa, clambda.
CLINICAL SIGNIFICANCE: Useful to aid in diagnosis of plasma cell and B cell neoplasms.
Identifies Pneumocystis jirovecii, the organism responsible for Pneumocystis pneumonia (PCP). This stain highlights cysts and trophic forms within lung tissue and is useful for diagnosing PCP, particularly in immunocompromised patients.
Identifies a 40kDa O-linked sialoglycoprotein expressed by a variety of tissues, including fetal testes and testicular germ cell tumors. Podoplanin is a marker of lymphatic endothelium, as well as neoplasms such as Kaposi's sarcoma. In the context of epithelial tumors, it has been demonstrated to be a highly sensitive marker of mesothelium and mesothelioma, complementing other markers such as calretinin and the Wilms tumor gene product. In neoplastic tissue, immunostaining of lymphatic endothelium can be useful in identifying lymphatic invasion of primary tumors.
Identifies a nuclear hormone receptor regulated by estrogen receptor (ER) activity and used as a marker of an intact ER pathway. Progesterone receptor (PR) is expressed in 60–70% of invasive breast cancers and provides additional predictive value alongside ER for determining response to endocrine therapies, including tamoxifen, SERMs, and aromatase inhibitors. Its primary clinical use is to help predict benefit from hormonal treatment in both early-stage and metastatic breast cancer.
Identifies a growth factor produced by the anterior pituitary that is essential for mammary gland development and function. This marker is useful for detecting prolactin-secreting pituitary tumors, regardless of whether galactorrhea is present.
Identifies Keratin 5/14, p63, and P504S to aid in the diagnosis of prostatic intraepithelial neoplasia (PIN) and prostate carcinoma, particularly in challenging or limited tissue samples. P504S highlights prostate adenocarcinoma and atypical adenomatous hyperplasia, while p63 and high–molecular weight cytokeratin mark the basal cells of normal and benign prostate glands, which are absent in malignancy.
Identifies a 100 kDa glycoprotein found in high concentration in prostate tissue and its secretions. It is specific for benign and malignant prostatic epithelial cells, with negative staining in prostatic stroma, urethra, and basal cells. PSAP expression may be lost in inflamed or infarcted tissue and in areas of squamous metaplasia. Nearly all metastatic prostatic carcinomas retain PSAP expression, making it a reliable marker for confirming prostatic origin.
Identifies a glycoprotein localized to the cytoplasm of acinar and ductal epithelial cells of normal, benign, and malignant prostate tissue. It is a highly sensitive and specific marker for metastatic prostate adenocarcinoma. PSA produced by prostate cancer is immunologically and biochemically similar to that of normal prostate. Because it does not react with non-prostatic tumors, PSA is valuable for determining whether an isolated metastasis is of prostatic origin.
Detects antibodies associated with Reticulin (RAG), which may be present in certain autoimmune or gastrointestinal disorders. RAG antibodies can support the evaluation of conditions such as celiac disease or other immune-mediated enteropathies when used alongside clinical findings and additional serologic markers.
Identifies the RB tumor suppressor protein, a key negative regulator of the cell cycle. Loss of RB function leads to uncontrolled cell proliferation. RB abnormalities are seen in a wide range of cancers, including breast, colon, prostate, kidney, nasopharyngeal tumors, and leukemias.
Identifies the ROS1 proto-oncogene, which is highly expressed in various tumor cells. ROS1 gene rearrangements produce constitutively active fusion proteins found in ~1–2% of lung adenocarcinomas and are associated with strong responses to tyrosine kinase inhibitors such as crizotinib and ALK inhibitors. This antibody is useful as an alternative or complementary test to ROS1 FISH for detecting ROS1-rearranged lung adenocarcinomas.
Identifies renal cell carcinoma (RCC) antigen. In normal kidney, staining is localized along the brush border of proximal tubules. RCC antigen is also seen on the luminal surfaces of breast ducts and lobules, epididymal epithelium, within parathyroid cytoplasm, and focally in thyroid colloid. Most primary and metastatic renal cell carcinomas express this marker, while other normal tissues do not show cross-reactivity.
Identifies S100, a nuclear and cytoplasmic protein expressed in a broad range of tumors. It stains Schwannomas, ependymomas, astrocytomas, nearly all benign melanocytic lesions, melanomas, and their metastases. S100 is also present in Langerhans cells of the skin and interdigitating reticulum cells in lymph node paracortex.
Identifies S100P, a member of the S100 protein family, with increased expression in various tumors including pancreatic, lung, breast, and ovarian carcinomas. It is present in many pancreatic ductal carcinomas but absent in benign pancreatic ducts and acinar glands.
Detects antibodies targeting the nucleocapsid protein of SARS-CoV-2, indicating recent or prior COVID-19 infection.
Acts as a marker for colorectal and appendiceal carcinomas, tumors with osteoblastic differentiation such as osteosarcoma, and renal/urothelial tumors. It stains colonic and osteogenic cells and their neoplasms, making it useful in the evaluation of carcinoma of unknown primary.
Identifies the succinate dehydrogenase complex subunit B (SDHB), a mitochondrial protein. Loss of SDHB expression by IHC indicates a mutation in any SDH subunit (SDHA, SDHB, SDHC, or SDHD) and is used in the evaluation of paragangliomas, pheochromocytomas, and gastrointestinal stromal tumors (GISTs) associated with SDH deficiency.
SF1 is expressed in all steroidogenic tissues, including the adrenal cortex, testicular Sertoli and Leydig cells, ovarian theca cells, hypothalamus, and anterior pituitary. Nuclear SF1 staining helps distinguish sex cord-stromal tumors (SCST) from non-sex cord-stromal tumors and is a valuable marker for determining adrenocortical origin. It is best used as part of a panel with other SCST markers, such as inhibin and calretinin.
SFRP1 (Secreted Frizzled-Related Protein 1) is a modulator of the Wnt signaling pathway, acting as a tumor suppressor in various tissues. Its expression can be altered in multiple cancers, including breast, colorectal, and prostate carcinomas, and it is useful in studies evaluating tumor differentiation, progression, and Wnt pathway activity.
Loss of SMAD4 expression helps identify pancreatic ductal adenocarcinoma and some ampullary and colonic tumors, making it a useful marker in the evaluation of carcinomas of unknown primary.
Identifies SOX10, a nuclear transcription factor expressed in nerve sheath tumors and melanomas, including conventional, spindle, and desmoplastic subtypes. Also seen in myoepithelial tumors of salivary gland and soft tissue, and diffusely in schwannoma, neurofibroma, and granular cell tumors. More specific than S100.
Identifies SOX10, a highly specific and sensitive nuclear transcription factor expressed in nerve sheath tumors and melanomas, including conventional, spindle, and desmoplastic types. It is also seen in salivary gland and soft tissue tumors with myoepithelial differentiation, and is diffusely expressed in schwannoma, neurofibroma, and granular cell tumors. SOX10 is more specific than S100 and rarely expressed in other mesenchymal or epithelial tumors.
Identifies a transcription factor expressed in almost all cases of mantle cell lymphoma (MCL) including cyclin D1-negative MCL. Routine use of anti-SOX11 in cases of suspected CD5+ diffuse large B cell lymphoma might help identify additional cases of cyclin D1-negative blastoid MCL. It is not expressed in potential MCL mimics such as atypical chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular lymphoma, and marginal zone lymphoma.
Identifies the SS18-SSX fusion protein resulting from the t(X;18)(p11.2;q11.2) translocation, which is characteristic of synovial sarcoma. Detection by IHC or molecular methods helps confirm the diagnosis of synovial sarcoma and distinguish it from other soft tissue tumors.
Identifies STAT6, a transcription factor normally in the cytoplasm that translocates to the nucleus upon activation. Nuclear STAT6 immunoreactivity serves as a surrogate marker for NAB2-STAT6 gene fusions, which are characteristic of solitary fibrous tumors/hemangiopericytomas, aiding in their identification.
Identifies SV40 large T antigen in human tissues. This antibody is used to detect cells infected with SV40 and is primarily applied in the evaluation of tumors and lesions associated with SV40 infection.
Identifies a zinc-finger transcription factor essential for maintaining embryonic cell pluripotency through modulation of OCT4. It is a highly sensitive and specific marker for germ cell tumors, including seminoma, embryonal carcinoma, yolk sac tumor, and choriocarcinoma, with occasional positivity in a subset of gastric carcinomas.
Identifies a peptide expressed by intestinal neuroendocrine cells and carcinoid tumors, useful for detecting normal and neoplastic enteroendocrine cells.
Identifies smooth muscle and myoepithelial cells, staining the muscularis propria and muscularis mucosae of the GI tract, uterine myometrium, vascular media, salivary gland myoepithelium, and similar tissues. It does not stain skeletal or cardiac muscle, endothelium, connective tissue, epithelium, or nerves. Useful in detecting leiomyomas, leiomyosarcomas, and mesenchymal tumors with myofibroblastic differentiation.
Identifies a component of smooth muscle myosin, a protein expressed in cells and tumors showing smooth muscle or myoepithelial differentiation. This antibody reacts with human visceral and vascular smooth muscle cells and myoepithelial cells and is useful in distinguishing between benign sclerosing breast leasons and infiltrating carcinomas because it strongly stains the myoepithelial layer in the benign lesions while being negative in the infiltrating carcinomas.
Identifies smoothelin, a cytoskeletal protein specific to smooth muscle cells. It helps distinguish true smooth muscle from cells with smooth muscle-like features, such as myofibroblasts, myoepithelial cells, and skeletal or cardiac muscle, and can differentiate muscularis propria from muscularis mucosa.
RNA-based next-generation sequencing to detect clinically relevant information on translocations and expression of more than 60 cancer-specific genes, including ALK, ROS1, RET,NTRK1, NTRK2, NTRK3, BRAF, CIC, EWSR1, PD-L1, and others. This also covers screening for sarcoma translocations and aids in sarcoma diagnosis and classification. Other genes of clinical relevance are reported including MYC,PD-L1, and more.
RNA-based next-generation sequencing targeting the transcriptome sequencing of more than 1600 genes to provide a comprehensive evaluation of cancer. The test is designed to detect microsatellite instability (MSI), tumor mutation burden (TMB), homologous recombination repair (HRR) mutations, and homologous recombination deficiency (HRD). Other notable features include evaluation for MET exon 14skipping, EGFRvIII, AR-V7, TERT promoter mutations, DYPD gene polymorphism for prediction of toxicity to fluoropyrimidine therapy, and RNA levels of CTLA4, PD-L1, and PD-L2. It can also detect gene expression levels that correlate to immunophenotype, gene amplifications, alternative splicing, HLA class I genotyping, viral infections (EBV, HPV, TTV), T-cell and B-cell Clonality and MGMT methylation.
DNA-based next-generation sequencing designed to target abnormalities in single-nucleotide and indels in434 genes, associated with cancers of the lung, pancreas, brain, colon, breast,ovary, endometrium, thyroid, head and neck, and soft tissue (sarcoma and GIST).In addition, the test is designed to detect microsatellite instability (MSI),tumor mutation burden (TMB) and homologous recombination deficiency(HRD). The provided information helps in determining prognosis, designing a therapeutic approach and predicting response to therapy.
Identifies somatostatin, a peptide hormone produced by neuroendocrine cells in the pancreas, gastrointestinal tract, and central nervous system. This antibody is used to detect normal and neoplastic somatostatin-producing cells, including neuroendocrine tumors.
Identifies the somatostatin receptor 2A (SSTR2A), a receptor for somatostatin-14 and -28. Overexpression in neuroendocrine tumors is useful for diagnosis and may guide therapeutic decisions.
ClearLLab 10C Standard Leukemia/Lymphoma Panel – 27 markers; Available as global and tech-only. Markers are CD2, CD3, CD4, CD5, CD7, CD8, CD10, CD11b, CD13, CD14, CD15, CD16, CD19, CD20, CD33, CD34, CD38, CD45, CD56, CD64, CD117, CD123, CD200, HLA-DR, Kappa, Lambda, TCR-γδ.
CLINICAL SIGNIFICANCE: Useful to aid in diagnosis of leukemia and lymphoma, and for post-treatment follow-up.
Flow cytometry, also known as flow immunophenotyping or fluorescence activated cell count (FACS) is a technology that can rapidly count, sort, and analyze different cell types by creating a fluid suspension of cells with labeled targets to pass through an electronic detection system. This technique is widely used in diagnostics, biomarker detection, evaluating gene expression, and measuring both new and total synthesized DNA, allowing for simultaneous analysis of multiple physical and biochemical properties with one sample.
Our 10-color flow cytometry technique provides a precise characterization of various cell populations, improves detection of low-level abnormalities, and increases success with smaller specimens, delivering more specific and meaningful results for you and your patients.
For the standard leukemia / lymphoma panel we use the ClearLLab 10C system which is an integrated FDA cleared and CE-marked IVD leukemia and lymphoma (L&L) immunophenotyping solution for lymphoid and myeloid lineages using the dry DURA Innovations technology. ClearLLab Control Cells are the first application specific control cells for L&L immunophenotyping.
Our hematopathologist and Chief Medical Officer, Dr. Adrian Padurean Palmer, was one of the four principal investigators instrumental in Beckman Coulter’s ClearLLab 10C system application and FDA approval. *
*Hedley BD, Cheng G, Keeney M, Kern W,Padurean A, Luider J, Chin-Yee I, Lowes LE, Rohrbach J, Ortega R, Smit A, Lo K, Magari R, Tejidor L. A Multi-center Study Evaluation of the ClearLLab 10C Panels. Cytometry B Clin Cytom. 2021 Mar;100(2):225-234. (https://pubmed.ncbi.nlm.nih.gov/32667744/ )
Identifies Surfactant Protein A, a protein expressed by type II pneumocytes in the lung. SP-A is a sensitive and specific marker for pulmonary adenocarcinomas and can be used to help confirm lung origin in metastatic tumors. It may also be useful in evaluating lung tissue in certain interstitial lung diseases.
Identifies neural and neuroendocrine cells and their tumors, as well as certain epithelial neoplasms. It demonstrates higher sensitivity than chromogranin A in high-grade neuroendocrine carcinomas and is also expressed in PNET/ES and other tumors with neural differentiation.
Identifies a pituitary-specific transcription factor involved in the development and differentiation of corticotroph and melanotroph cells. T-PIT expression is restricted to these cell types in the anterior pituitary and is useful in the classification of pituitary adenomas, particularly those producing ACTH.
Identifies a chemokine involved in the recruitment of T cells and the regulation of immune responses. It is expressed in the thymus and by activated dendritic cells, and may be useful in studies of immune-mediated diseases and certain hematolymphoid neoplasms.
Identifies a protein expressed in the cytoplasm and nucleus of immature T cells, T-cell prolymphocytic leukemia, and various B-cell neoplasms, including CLL/SLL and blastic plasmacytoid dendritic cell tumors. It is used to help distinguish B-cell lymphomas from T-cell lymphomas, CD30+ anaplastic large cell lymphoma, multiple myeloma, and marginal zone B-cell lymphoma.
Identifies the alpha/beta chain of the T-cell receptor, expressed on normal T lymphocytes and most T-cell neoplasms. It is present on thymocytes and the majority of peripheral α/β T cells, but negative in normal B cells, B-cell neoplasms, anaplastic large cell lymphoma, and NK/T-cell neoplasms.
Identifies a specialized DNA polymerase present in immature pre-B and pre-T lymphoid cells, as well as most precursor B- and T-lymphoblastic leukemias/lymphomas. Useful for distinguishing lymphoblastic lymphoma from Burkitt lymphoma, with occasional aberrant expression in some acute myeloid leukemias.
Identifies a helix-loop-helix transcription factor that is a sensitive and specific marker for Xp11 translocation renal cell carcinoma. It is also expressed in alveolar soft part sarcoma, which involves a rearrangement at 17q25 and Xp11.2.
Identifies a cytoplasmic protein with a coarse granular pattern found in cytotoxic T cells and NK cells, as well as neoplasms derived from these lineages, including most anaplastic large cell lymphomas. It also labels granular lymphocytic leukemias, hepatosplenic T-cell lymphomas, intestinal T-cell lymphomas, NK-like T-cell lymphomas, NK-cell lymphomas, nasal T/NK-cell lymphomas, subcutaneous T-cell lymphomas, and pulmonary angiocentric lymphomas of T or NK phenotype. B-cell lymphomas, Hodgkin lymphoma, and lymphoblastic leukemias are negative.
Identifies a transducing-like enhancer (TLE) protein, expressed in immature epithelial cells undergoing differentiation. This antibody is a highly specific marker for synovial sarcoma and helps distinguish it from other sarcomas, including histologically similar tumors like malignant peripheral nerve sheath tumor.
Bi-directional sequencing analysis of TP53 gene in exons 4-9. TP53 mutations are detected in at least 50% of all adult tumors and are generally associated with a poor prognosis. It aids in prognosis and/or therapy selection in patients with chronic lymphocytic leukemia (CLL) and germline mutations in TP53 are the cause of Li-Fraumeni Syndrome.
Identifies a nuclear transcription factor expressed in breast tissue and breast carcinomas. It is a sensitive and specific marker for tumors of breast origin and can aid in distinguishing metastatic breast carcinoma from other carcinomas.
Identifies a pituitary hormone that stimulates thyroid growth and hormone production. This antibody labels thyrotropic cells of the pituitary and is used for classifying pituitary adenomas, distinguishing primary versus metastatic pituitary tumors, and differentiating primary from secondary hypo- or hyperthyroidism.
Identifies a nuclear transcription factor primarily expressed in lung and thyroid neoplasms. It is present in most lung carcinomas (non-neuroendocrine and endocrine) and nearly all thyroid carcinomas except anaplastic types. This marker is useful in distinguishing primary from metastatic carcinomas, particularly in the lung.
Identifies thyroid transcription factor-1 (TTF-1) and Napsin A, both of which are expressed in lung adenocarcinomas. This cocktail is useful for confirming pulmonary origin in metastatic or primary lung tumors and helps differentiate lung adenocarcinomas from squamous cell carcinomas and non-pulmonary tumors.
Identifies both thyroid transcription factor-1 (TTF-1) and surfactant proteins in lung and thyroid tissues. This dual marker is useful for confirming lung or thyroid origin in neoplasms, including primary lung adenocarcinomas, thyroid carcinomas, and other TTF-1–positive tumors.
Identifies a plasma membrane-associated glycoprotein expressed on endothelial cells and in other cell types, including megakaryocytes, mesangial cells, synovial cells, mesothelial cells, and some squamous epithelia. It serves as a marker for endothelial cells, vascular neoplasms, urinary bladder epithelium, and aids in distinguishing mesothelioma from adenocarcinoma. In mesotheliomas, staining is typically thick and membranous, while approximately half of pulmonary adenocarcinomas show cytoplasmic staining.
Identifies Thymidylate Synthase (TS), a protein targeted by fluoropyrimidine chemotherapies. TS expression can help predict response to 5-FU–based treatments in breast, colorectal, gastric, head, and neck cancers.
Identifies thyroglobulin, a dimeric protein produced by the thyroid gland. It is useful for confirming metastatic papillary and follicular thyroid carcinomas, though combining thyroglobulin staining with TTF-1 and PAX-8 expression is generally more reliable due to occasional nonspecific staining.
Identifies Toxoplasma gondii, an intracellular protozoan parasite that can infect various tissues in vertebrates. It is useful for detecting tissue infection and aiding in the diagnosis of toxoplasmosis.
Identifies a serum protein produced by the liver and choroid plexus, which is a component of certain amyloid subtypes and can serve as a marker for choroid plexus tumors.
Detects the spirochete bacterium Treponema pallidum, the causative agent of syphilis. May also cross-react with Borrelia burgdorferi (Lyme disease).
Detects Treponema pallidum in tissue, the spirochete responsible for syphilis. May show cross-reactivity with Borrelia burgdorferi (Lyme disease). Staining is visualized in red.
Identifies a transmembrane glycoprotein expressed on the surface of a variety of epithelial cells and epithelial-derived tumors. Trop-2 is frequently overexpressed in several carcinomas, including breast, colorectal, and pancreatic cancers, and can be useful in tumor characterization and as a potential therapeutic target.
Identifies a serine proteinase found in the secretory granules of mast cells, commonly used to detect mast cell tryptase. Shows lesser reactivity in basophils.
Identifies tyrosinase, a copper-containing enzyme critical for melanin production, expressed in melanocytic cells and tumors. Mutations in this gene are associated with forms of albinism, and it serves as a target for cytotoxic T-cell recognition in melanoma. Staining detects both melanotic and amelanotic melanoma variants.
PCR with capillary electrophoresis assays to detect mutations in the coding sequence of the UGT1A1 gene due to variations in the number of TA repeats in the TATA box of the UGT1A1 gene promoter. This test can report the following alleles: (TA)5 (UGT1A1*36),(TA)6 (UGT1A1*1), (TA)7 (UGT1A1*28), and (TA)8 (UGT1A1*37).
The UGT1A1 activity is responsible for the metabolic inactivation of SN-38 (active form of Irinotecan, also known as Camptosar® or CPT-11), therefore these mutations increase the risk of toxicity following its administration, due to the presence of elevated levels of unconjugated SN-38.
Several clinical studies have shown that individuals who are homozygous, and potentially those who are heterozygous, for the UGT1A1 (TA)7 promoter allele (UGT1A1*28) are at increased risk for the development of a significant adverse response to the standard dose of Irinotecan.
The result provides valuable information to initiate or modify treatment in a broad spectrum of solid tumors, e.g. metastatic cancer of the colon or rectum. The variants have also been reported in patients with disorders of bilirubin metabolism, such as Crigler-Najjar Types I and II, as well as Gilbert syndrome.
Synonyms: Gilbert Syndrome,Uridine Diphosphate Glucuronyltransferase 1A1 Promoter Genotyping, Irinotecan Sensitivity Analysis
Identifies a transmembrane protein specific to urothelial cells, serving as a marker of transitional cell epithelium and tumors. In normal urothelium, UPIII is expressed on the luminal surface of superficial cells. It is highly specific but only moderately sensitive for detecting urothelial carcinomas and may reflect malignant potential.
Identifies Vascular Endothelial Growth Factor (VEGF), a signaling protein that stimulates angiogenesis by promoting proliferation and migration of endothelial cells. It is expressed in a variety of normal and neoplastic tissues and can serve as a marker for tumor angiogenesis and potential response to anti-angiogenic therapies.
Used to identify vasoactive intestinal peptide (VIP)–producing tumors, such as VIPomas, in patients presenting with chronic diarrheal disorders.
Identifies cells infected with varicella-zoster virus (VZV), a human herpesvirus responsible for chickenpox (varicella) and shingles (herpes zoster). Primary infection causes chickenpox, which can lead to complications such as encephalitis or pneumonia.
A histochemical stain used to visualize elastic fibers in tissues. Elastic fibers appear black, while other tissue elements, such as collagen and cytoplasm, are counterstained in contrasting colors. It is commonly employed to assess vascular structures, skin, lung, and connective tissue for elastic fiber distribution and integrity.
Identifies villin, an actin-binding protein present in human renal epithelial cells, used as a marker for gastrointestinal tract–derived carcinomas. Along with CDX2, villin is a highly specific and moderately sensitive marker for colorectal and other GI tract (pancreatobiliary) carcinomas, typically showing a brush border pattern. A subset of lung adenocarcinomas may also express villin.
Identifies vimentin, the primary intermediate filament protein in various mesenchymal cells, including endothelial cells, fibroblasts, macrophages, Sertoli cells, melanocytes, lymphocytes, and ovarian granulosa cells. Vimentin is expressed in most sarcomas and lymphomas and can be co-expressed with cytokeratin in some carcinomas, though lineage-specific markers like TTF-1 or PAX-8 are preferred in these cases. Strong positivity is seen in fibrosarcomas, liposarcomas, malignant fibrous histiocytomas, angiosarcomas, chondrosarcomas, melanomas, and Schwannomas.
Identifies the Wilms tumor 1 (WT1) protein, a marker expressed in ovarian serous carcinomas and mesotheliomas. It is useful in panels to differentiate mesothelioma from adenocarcinoma and to aid in the subclassification of ovarian carcinomas.
Detects the C-terminal portion of the Wilms tumor 1 (WT1) protein. Expressed in ovarian serous carcinomas and mesotheliomas, it is useful in panels for distinguishing mesothelioma from adenocarcinoma and for subclassifying ovarian carcinomas.
Identifies spirochete (Treponema pallidum), the causative agent of syphilis.
Identifies p15, a tumor suppressor protein involved in cell-cycle regulation through inhibition of cyclin-dependent kinases. Loss of p15 expression is associated with several hematologic malignancies, including acute myeloid leukemia, myelodysplastic syndromes, and some lymphomas. Assessment of p15 can help evaluate dysplasia, neoplastic transformation, and prognostic features in hematologic disorders.
Identifies a tumor suppressor gene that inhibits the progression of the cell cycle through the G1 phase. Overexpression of the p16 protein has been observed in CIN I, II, and III, where it can serve as a surrogate for the presence of high risk HPV types. The gene is also frequently deleted or mutated in tumors such as melanomas, gliomas, esophageal, pancreatic, lung, and urinary bladder carcinomas, and some types of leukemias. p16 overexpression can also serve as a prognostic marker in the context of head and neck squamous cell carcinomas.
Identifies a protein expressed in prostatic adenocarcinoma but absent in benign prostate tissue. It also stains premalignant lesions, including high-grade PIN and atypical adenomatous hyperplasia. This marker is positive in most prostate cancers and can also be expressed in other tumor types, such as hepatocellular carcinoma, breast carcinoma, pancreatic islet cell tumors, and desmoplastic small round cell tumors.