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INTRODUCTION: HER2, also known as epidermal growth factor receptor 2, neu, ERBB2 or CD340 is a proto-oncogene located in the human chromosome 17, band 21 that code a transmembrane glycoprotein (p185) with tyrosine-kinase activity. Because of its interaction and similarity to EGFR and other members of the epidermal growth factor receptor family, HER2 takes part in the differentiation of some cell-lines during embryogenesis after the interaction between mesenchyme–epithelium-neuroectoderm. It also has an influence on the migration, differentiation and interaction between numerous cells.
The overexpression of HER2 has been proven in over 20% of adenocarcinomas of different locations, including lung, uterus, gastrointestinal and urinary tract, breast and skin appendages in different studies. In case of breast and stomach cancers, the overexpression of this oncoprotein, which is associated with a worse prognosis, is related to the gene amplification and it is subsidiary of responding to treatment anti HER2 with Trastuzumab (Herceptin), the humanized monoclonal antibody able to block this growth receptor and for which purpose, similar results have been obtained in malignant neoplasias, such as ovarian, stomach and salivary gland carcinomas.
INTENDED USE: The HER2 FISH probe is designed to detect the number of copies of the gen ERBB2 (Her2/neu) in the 17q12 chromosome region. The probe CEN17 is designed to detect an alpha-satellite sequence of DNA located in the 17p11.1 region and allows identifying and counting the number of copies of chromosome 17.

PROBE DESCRIPTION: The Her2 FISH Probe labeled with the CytoOrange fluorochrome covers a chromosomal region which includes the entire ERBB2 gene. The CCP17 FISH Probe labeled with the CytoGreen fluorochrome is covering the alpha satellite region of the centromere of the chromosome 17 and is designed as a control to determine the number of copies per cell of the chromosome 17.

INTRODUCTION:Rearrangements of the ALK gene (also known as CD246 or NBLST3), initially discovered in anaplastic large cell lymphoma, have also been found in many types of malignant tumors, including B and T-cell lymphomas, plasmacytomas, neuroblastomas, esophageal, breast, kidney, colon, thyroid and lungcarcinomas, among others.A significant percentage of cases of non-small cell lung cancer (3-13%) show abnormalities of the ALK gene and are likely to targeted treatments withspecific tyrosine kinases inhibitors that show significant benefits as compared to conventional chemotherapy.
INTENDED USE: The ALK Break Apart FISH probe is designed to detect rearrangements in the ALK human gene located in the band of the chromosome 2p23.2. Aside from detecting breaks that can lead to translocation of parts of the gene, to its inversion or to its fusion with other genes, the probe can also be used to identify other aberrations of ALK such as deletions or amplifications.

PROBE DESCRIPTION:The 5’ centromeric fragment of the ALK Break Apart FISH probe labeled with the fluorochrome CytoGreen covers the 5’ and central sequences of the ALK gene. The 3’ telomeric fragment of the ALK Break apart FISH probe labeled with CytoOrange covers the 3’ end and the contiguous neighboring region. Both probes are designed to detect sequences in both sides in a mutual cut-off point that is located within the ALK gene.

INTRODUCTION:Rearrangements and abnormal expression of the BCL2 gene (also known as Bcl-2 or PPP1R50), are usually located in the follicular lymphoma, but they are also present in many other types of hematological and solid neoplasias. A particularly usual rearrangement is a reciprocal translocation of the IGH locus of the chromosome 14, present in up to 90% of follicular lymphomas and in up to 30% of diffuse large B-cell lymphomas.

INTENDED USE:The BCL2 Break Apart FISH probe is designed to detect rearrangements in the BCL2 human gene located in the chromosome band 18q21.33. Aside from detecting breaks (break-apart/split) that can lead to translocation of parts of the gene, to its inversion or to its fusion with other genes, the probe can also be used to identify other aberrations of BCL2 such as deletions or amplifications.

PROBE DESCRIPTION:The 5’ telomeric fragment of the BCL2 Break Apart FISH probe labeled with the fluorochrome CytoOrange covers sequences adjacent to the 5’ portion (beginning) of the BCL2. The 3’ centromeric fragment of the BCL2 Break apart FISH probe labeled with CytoGreen covers some distal sequences (3’ end) of the gene. Both marked loci are flanking sequences of the BCL2 gene, in which numerous cut-off points have been observed.

INTRODUCTION: Rearrangements of the BCL6 gene (also known as BCL5, LAZ3, BCL6A, ZNF51 or ZBTB27) have been described in lymphomas and B-cell leukemias. BCL6 is also unregulated in cases of multiple myeloma and several types of solid tumors. More than 30 different genes have been described as translocation pairs. In practice, the presence of the BCL6 translocation may have diagnostic value in follicular lymphomas grade 3B with negative BCL2 translocation, while in diffuse large B-cell lymphomas, along with BCL2 and MYC translocations, it presents a prognostic and therapeutic value.

INTENDED USE: The BCL6 Break Apart FISH probe is designed to detect rearrangements in the BCL6 human gene located in the chromosome band 3q27.3. Aside from detecting breaks that can lead to translocation of parts of the gene, to its inversion or to its fusion with other genes, the whole probe can also be used to identify other aberrations of BCL6, such as deletions or amplifications.

PROBE DESCRIPTION: The 5’ telomeric fragment of the BCL6 Break Apart FISH probe labeled with the fluorochrome CytoOrange covers some sequences adjacent to the 5’ portion (beginning) of the BCL6. The 3’ centromeric fragment of the BCL6 Break apart FISH probe labeled with CytoGreen covers some distal sequences (3’ end) of the gene. Both loci are flanking sequences of the BCL6 gene, in which numerous cut-off points have been observed.

INTRODUCTION: Rearrangements involving the IGH locus (or immunoglobulin heavy locus) have been observed in many types of leukemias and lymphomas. It represents the prototype for translocations in B-cell non-Hodgkin lymphomas, in which it has been detected in up to 50% of the cases, whereas reciprocal and specific translocations with different chromosomal loci have been characterized and considered as pathognomonic for different histological subtypes.

INTENDED USE: The IGH Break Apart FISH probe is designed to detect rearrangements in the human IGH locus located in the chromosome band 14q32.33. Aside from detecting breaks that can lead to translocation of parts of the locus, to its inversion or to its fusion with other genes, the probe can also be used to identify other aberrations of IGH such as deletions or amplifications.

PROBE DESCRIPTION: The telomeric 5’ Fragment of the IGH Break Apart FISH probe labeled with the fluorochrome CytoOrange covers the 5’ portion and the center of the locus of the IGH gene, whereas the centromeric 3’ fragment of the IGH Break Apart FISH probe labeled with CytorGreen covers some distal sequences (3’ end) of the gene.Both loci are flanking sequences of the BCL2 gene, in which numerous cut-off points have been observed.

INTRODUCTION: An abnormal expression of the MDM2 gene (also known as MDM2, hdm2 or ACTFS) has been described, generally associated by amplification of the same with a 7% of the human neoplastic processes. The neoplasms that more frequently show MDM2 gene amplification are atypical lipomatous tumors/well-differentiated liposarcomas, undifferentiated liposarcomas, intimal sarcomas and low-grade osteosarcomas (parosteal/intramedullary).

INTENDED USE: The MDM2/CEN12 FISH probe is designed to analyze the MDM2 human gene located in the band of the chromosome 12q15, in relation to the centromere of the Chromosome 12.

PROBE DESCRIPTION: The MDM2 FISH Probe labeled with the CytoOrange fluorochrome covers a chromosome region that includes the whole MDM2 gene. The CCP12 FISH Probe labeled with the CytoGreen fluorochrome is derived from the alpha satellite region of the centromere of the chromosome 12 and is designed as a control to determine the number of copies per cell of the chromosome 12.

INTRODUCTION: Rearrangements and abnormal expression of the MALT1 gene (also known as MLT, MLT1 or IMD12), in B-cell lymphomas and other malignant diseases have been described. There are two types of translocations that involve the MALT1 gene described in lymphomas: t(11;18)(q21;q21.32) that involves BIRC3/MALT1 (the most frequent) and t(14;18)(q32;q21.32) of the IGH/MALT1 genes. Up to 33% of the mucosa-associated lymphoid tissue B-cell lymphoma (MALT-type B-cell lymphoma) present translocation, whereas the vast majority of primary MALT lymphomas in lymph node or spleen are negative.

INTENDED USE: The MALT1 Break Apart FISH probe is designed to detect rearrangements in the MALT1 human gene located in the band of the chromosome 18q21.32. Aside from detecting breaks that can lead to translocation of parts of the gene, to its inversion or to its fusion with other genes, the probe can also be used to identify other aberrations of MALT1 such as deletions or amplifications.

PROBE DESCRIPTION:  The 5’ centromeric fragment of the MALT1 Break Apart FISH probe labeled with the fluorochrome CytoOrange covers the 5’ portion (beginning) of the MALT1 gene and some adjacent genomic sequences. The 3’ telomeric fragment of the MALT1 Break apart FISH probe labeled with CytoGreen covers the 3’ part (end) and the adjacent and inferior sequences of the gene. Both probes are flanking sequences of the MALT1 gene, in which variable cut-off points have been observed.

INTRODUCTION: Rearrangements and abnormal expression of the FUS gene (also known as TLS, ALS6, ETM4, FUS1, POMP75 or HNRNPP2) have been described in the alveolar rhabdomyosarcoma, prostate carcinoma and other types of tumors such as myxoid liposarcoma, low-grade fibromyxoid sarcoma or some cases of Ewing’s sarcoma.

INTENDED USE: The FUS Break Apart FISH probe is designed to detect rearrangements in the FUS human gene located in the band of the chromosome 16p11.2. Aside from detecting breaks that can lead to the translocation of parts of the gene, to its inversion or to its fusion with other genes, the probe can also be used to identify other aberrations of FUS such as deletions or amplifications.

PROBE DESCRIPTION: The 5’ telomeric fragment of the FUS Break Apart FISH probe labeled with the fluorochrome CytoOrange covers the 5’ portion (beginning) of the FUS gene and some adjacent genomic sequences. The 3’ centromeric fragment of the FUS Break apart FISH probe labeled with CytoGreen covers the center and the 3’ part (end) as well as the distal sequences of the gene. Both probes are flanking sequences in the FUS gene, in which variable cut-off points have been observed.