Vysis alk break apart fish probe kit pdf merge

This test utilizes a laboratory modification of the procedure for the vysis alk break apart fish probe kit, which is fdaapproved for the detection of alk gene rearrangement via fluorescence in situ hybridization fish in formalinfixed paraffinembedded ffpe nonsmall cell lung cancer nsclc tissue specimens. Only a technologist familiar with cytogenetic methods and trained for the fish technique can perform the assay. Vysis melanoma fish probe kit 1n8920 prostate cancer vysis lsi androgen receptor gene xq12 spectrumorange probe 5j4401 vysis myc spetrumorange fish probe kit 3n8720 vysis fish probes for solid tumors products are analyte specific reagents. Fluorescence in situ hybridization fish thermo fisher. The bottom inset image shows the alk and eml4 images merged, indicating that a separate orange signal is colocalised with a. High quality, directly labelled dna probes for fluorescence in situ hybridisation fish. Fda approves a new latestage lung cancer treatment. Ventana has demonstrated concordance of ventana alk d5f3 cdx assay with the abbott vysis alk break apart fish probe kit alk fish in determining the alk status of a patients nsclc.

The presence of anaplastic lymphoma kinase is detected using abbott moleculars abbott park, il, usa vysis alk break apart fish probe kit. Alk break apart fish probe kit abbott molecular was the reference. Phenopath now offering the fdaapproved a new fluorescence in situ hybridization fish testing protocol developed at phenopath. Probe description the spec erg dual color break apart probe is a mixture of two direct labeled probes hybridizing to the long arm of chromosome 21. Probe kit abbott molecular as a companion diagnostic test for. Eml4alk testing in nonsmall cell carcinomas of the lung. Vysis alk break apart fish probe kit en food and drug. Vysis fish probes for solid tumors ilex medical ltd. Assay interpretation can be technically challenging, and either splitting of the 5. Xl alk ba is a break apart probe with an orange labeled probe hybridizing to the proximal region within alk in 2p23 and a green labeled probe hybridizing distal to alk. Microcost analysis of alk rearrangement testing by fish. Alk evaluation in the world of multiplex testing annals of oncology.

Empire genomics dualcolored breakapart fish probes have helped thousands of clinicians and researchers quickly and reliably track gene translocations. Application of the comprehensive assessment of the value of diagnostic technologies framework to abbotts vysis alk break apart fish probe kit test open application pdf. Pdf detection of circulating tumor cells harboring a unique. The vysis alk break apart fish probe kit uses fluorescence in situ allowed to hybridize with the dna probes. Agilent expands catalog of surefish breakapart probes. The majority of fish probes available on the market use bac technology. The probes are constructed using the repeatfree technology that is based on subtractive hybridization, which specifically removes all repetitive elements from the probe. The htg edgeseq alkplus assay eu was tested against a cohort of nsclc samples previously tested by the vysis alk break apart fish probe kit. Alk iqfish breakapart probe part number reference artikelnr. In each case, 50 nonoverlapping nuclei were examined by fluorescence microscope bx51. A fish test that detects deletion of the lsi tp53, lsi atm, and lsi ds319 probe targets and gain of the d12z3 sequence. Vysis alk break apart fish probe kit molecular catalog.

Probe design of the vysis alk break apart fish kit. Alk rearranged, ros1rearranged and alk ros1 wildtype. Alk is a receptor tyrosine kinase of the insulin receptor family. Using spectrally distinct fluorophore labels for each hybridization probe, this approach gives you the power to resolve several genetic elements or multiple gene expression patterns through multicolor visual display.

The alk fish probe set is designed to detect rearrangements involving portions of the human alk gene located on chromosome band 2p23. The results from vysis alkros1 dual break apart probe kit was in 100% concordant to the previous alk and ros1 tests in all the three patients cohorts. Break apart fluorescence in situ hybridization fish is the fdaapproved assay for detecting anaplastic lymphoma kinase alk rearrangements in nonsmall cell lung cancer nsclc, identifying patients who can gain dramatic benefit from alk kinase inhibitors. Materials provided if you receive reagents that are in a condition contrary to label vysis alk break apart fish probe kit list no. Theyre designed to flank either side of a gene, so that in the event of a translocation, the two colors will split. Ros1 break apart fish probe kit introduction the ros1 break apart fish probe kit is designed to detect rearrangements in the human ros1 gene located on chromosome band 6q22. Fish aneuvysion realtime pcr realtime ctng realtime cmv realtime hbv realtime hcv realtime hcv genotype ii realtime hiv1 realtime sarscov2 sequencing viroseq hiv1 genotyping system fish pathvysion her2 dna probe kit urovysion vysis alk break apart fish probes kit vysis cll fish probe kit vysis egr1 fish probes kit realtime pcr. The vysis alk break apart fish probe kit detects rearrangements involving the alk gene via fish tests in nsclc tissue specimens. The vysis alk break apart fish probe kit is a qualitative test to detect rearrangements involving the alk gene via fluorescence in situ hybridization fish in. Another gene that can rearrange or combine with other genes is called ros1.

Multiplex fluorescence in situ hybridization fish enables you to assay multiple targets and visualize colocalized signals in a single specimen. In addition to revealing breaks, which can lead to translocation of parts of the gene, inversion, or its fusion to other genes, the probe set can also be used to identify. Abbott launched the vysis alk break apart fish probe test kit in the eu as a companion diagnostic to detect translocations in genes encoding anaplastic lymphoma kinase alk. Validation of breakapart and fusion myc probes using a. Alk break apart dnafish probe sonde break apart, bicolore h21002 vc s20ocwf procedure standard for fish remarque. Alkrearranged, ros1rearranged and alkros1 wildtype. Fluorescence in situ hybridization analysis of the alk. Nonsmall cell lung cancer with eml4alktranslocation in chinese. To see the complete range of cytocell fish probes and for full ordering information please visit the cytcoell website for your region.

The probechek alk negative control slides are intended for use as an assay control for appropriate hybridization conditions during routine use of the vysis alk break apart fish probe kit list no. The alk gene can fuse with one of 20 known alk gene rearrangement partners, the most common being t2. Vysis cll fish probe kit intended use the vysis cll fish probe kit is a test to detect deletion of the lsi tp53, lsi atm, and lsi ds319 probe targets and gain of the d12z3 sequence probe target via fluorescence in situ hybridization fish in peripheral blood specimens from patients with bcell chronic lymphocytic leukemia cll. Rearrangement of the alk locus on 2p23 has been implicated in the development of nsclc. Vysis fish chromosome search abbott molecular contact. Preliminary data in this regard suggests that only about 50% of the pcr positive results can be confirmed by fish, using the vysis alk break apart fish probe kit and defining. Overall, 93% agreement was achieved between the two methods. The vysis alk test is an fda proven companion diagnostic test with xalkori crizotinib as a treatment for non. Access the most uptodate vysis fish probe information, including viewing probe maps, hybridization images and ordering information. Vysis alk break apart fish probe kit abbott molecular contact. Mll break apart dnafish probe two color, break apart probe. Alk break apart dnafish probe two color, break apart probe. The resultant fusion proteins generated from alk gene rearrangement plays a vital role in driving the pathogenesis of several different types of cancer, such as.

Of the 12 alk positive cases, hybridization with vysis alk ros1 dual break apart probe kit was successful in 10 cases success rate 1012, 83% and of these 10 cases, all showed alk rearrangement 100% concordance with the results of vysis alk break apart fish probe kit. The 30alk and 50alk probes are located centromerically and telomerically to the alk breakpoint, respectively 8. The alk genetic status of each patient was evaluated by fish in representative tumor areas, with an lsi alk dualcolor, break apart rearrangement probe vysis alk break apart fish probe kit, abbott molecular inc. Each probe is sold in 20 test kits 20 slides 22x22 mm area and includes hybridization buffer. Microcosting of a commercial alk break apart fish assay. This means that 650011,000 patient in the usa alone would be eligible for treatment with crizotinib each year 110. We programmed a detailed model designed to assess the cost of performing fish testing for alk rearrangement and to enable sensitivity analysis of various cost inputs and laboratory practices. Pleas ot om roduct a o o al l arkets ontac ou oca epresentativ o vailability. Resistance mechanisms in lung cancer patients with egfr or alk. The alk breakapart fish probe kit detects rearrangement of the anaplastic lymphoma kinase alk gene in nsclc. A fish test that detects rearrangements involving the alk gene in nonsmall cell lung cancer tissue specimens. Fluorescence in situ hybridization was performed for alk rearrangement using the vysis alk break apart fish probe kit abbott laboratories, abbott park, il, usa according.

The vysis alk break apart fish probe kit is a qualitative test to detect rearrangements involving the alk gene via fluorescence in situ. The overall success rate using vysis alk ros1 dual break apart fish probe kit was 83% 3741 cases. This probe is intended for methanolaceticacid fixed cells and tissue sections. Alk break apart fish analysis detecting alkrearrangement. Visualizing fish hybridization evaluate hybridized ffpe nsclc tissue specimen. Automated fish analysis using dualfusion and breakapart. Mar 27, 2019 fish was performed on interphase nuclei on 3. Only biomarker testing can determine which patients have alk positive metastatic nsclc.

G1116008 intended use the alk iqfish breakapart probe is intended fo r the detection of rearrangements involving the alk gene by fluorescence in situ hybridization fish. The orange labeled probe hybridizes to an extended region at the abl1 locus on 9q34 and a green labeled probe hybridizes specifically to extended regions at the bcr gene on 22q11. Alk rearrangement by fish for lung cancer ucsf health. In 2011, the vysis break apart alk fluorescence in situ hybridization fish assay was approved by the united states food and drug administration as a companion diagnostic for detecting alk. The fda has approved crizotinib xalkori for treatment of patients with locally advanced or metastatic nsclc that is alkpositive. The fdaapproved vysis alk break apart fish probe consists of a 30alkprobe of approximately 300 kb labeled in spectrumorange and a 50alk probe of about 442 kb labeled in spectrumgreen. In 2011, the vysis break apart alk fluorescence in situ hybridization fish. The keysight 10073c passive probe is our most rugged 500 mhz probe. The vysis alk break apart fish probe kit uses fluorescence in situ hybridisation technology to detect chromosome 2p23 rearrangements. The user selects the appropriate areas for analysis in accordance with the alk kit.

In 2011 the vysis alk break apart fish probe kit was the first assay approved by the us fda as a companion diagnostic test for crizotinib, and this assay is used for the detection of rearrangements involving the alk gene in nsclc. Novel method for rapid fluorescence insitu hybridization. Vysis alk break apart fish probe kit hybridization conditions may be adversely affected by the use of 1. In the normal condition without rearrangements, two signals redgreen appear to be overlapped or fused leading to a yellow signal due to their proximity. Fish probes for prenatal, postnatal and preimplantation genetics. The probechek alk negative control slides should be assayed in. Alk fish can present technical challenges in evaluating the staining results. Alk fish shows positive results, with split 5 alk green and 3 alk red f and all channels merged in the. The vysis alk break apart fish probe kit is shipped on dry ice. Vysis lsi alk dual color break apart fish probe reagents other than those provided by abbott molecular. Fivemicron unstained ffpe sections were used for fish analysis.

Cytocell fluorescence in situ hybridisation fish probes. This kit contains a mixture of lsimyc spectrumorange probe and lsimyc spectrumgreen probe. If you receive reagents that are in a condition contrary to label recommendation, or that are damaged, contact abbott molecular technical services. Validation of alkros1 dual break apart fish probe probe. Diagnosis of fusion genes using targeted rna sequencing. The alk break apart dna fish probe is designed to detect the translocation between the alk gene located at 2p23 and one of at least 14 known translocation partner loci using fluorescence in situ hybridization fish. Vysis cll fish probe kit en food and drug administration. The vysis alk break apart fish probe kit detects rearrangements involving the alk gene via fluorescence in situ hybridization fish technology in nonsmall.

May, 20 detection of circulating tumor cells harboring a unique alk rearrangement in alk positive nonsmallcell lung cancer. The orange fluorochrome direct labeled probe hybridizes at 21q22. The probes are repeatfree, able to target specific sequences of interest, and use highfidelity oligos designed in silico. Validation of alkros1 dual break apart fish probe probe in. Fish for alk background information the food and drug administrations august 2011 approval of the targeted therapy crizotinib xalkori, pfizer, new york, n. Ros1 rearrangements using fluorescence in situ hybridization might be a helpful tool for the identification of patients likely to respond to ros1 kinase targeting therapies. If the test result indicates that the patients tumor is positive for alk gene rearrangements, then the patient may benefit from treatment with xalkori. Xl bcrabl1ass deletiondual fusion probe metasystems probes. Do not reconstitute or dilute with hybridization buffer.

Alk break apart dnafish probe sonde break apart, bicolore. The vysis alk break apart fish probe kit must be stored at 30c to 10c and protected from light. Vysis lsi alk break apart fish probe kit, spectrum orange probe, and spectrum green. The vysis alk break apart fish test commercially known as vysis alk test is a genetic test that determines the presence of the abnormal alk anaplastic lymphoma kinase gene, which causes cancer development and growth. Note that eml4 is normally on the opposite strand to alk, and that both probes on the alk gene red orange and green are close together, explaining. The probe is to be used on lung paraffinembedded tissue sections.

Genomic heterogeneity of alk fusion breakpoints in non. All the centers used the vysis alk break apart rearrangement probe abbott diagnostics, abbott park, il, but the prehybridization protocol was not the same in all referral. Kreatech fish probes are the latest advancement in dna in situ hybridization. Intrachromosomal re arrangements can yield subtle signal splitting. The fdaapproved vysis alk break apart fish probe consists of a 3.

The model was based on the manufacturers recommended procedure for use of the vysis alk break apart fish probe kit ivd and the associated ce. Identification of novel variant of eml4alk fusion gene in. The bottom inset image shows the alk and eml4 images merged, indicating that a separate orange signal is co localised with a. Jul 24, 2012 signal pattern of vysis alk break apart fish kit. Alk rearrangement testing by fish analysis in nonsmall. Abbotts alk test is now available in europe as a companion diagnostic test to aid in identifying patients for targeted lung cancer therapy. The vysis lsi alk break apart fish probe kit consists of two probes, vysis lsi 3.

Multivysion pb multicolor fish probe kit, 16, 18, 21, 22 8l6220 multivysion pgt multicolor fish probe kit, 18, 21, x, y 8l6910 probechek multivysion control slides 5j0701 microdeletion syndrome fish probes criduchat region probes vysis criduchat region probe lsi d5s23, d5s721 spectrumgreen 5j2025. The kit contains two differentially labeled locus specific probes lsp, one covering the 5 start portion of the alk gene and. Alk, ros1, ergrearrangement were detected by filteradaptedfish fafish. Fish for alk thinprep nsclc cleveland clinic laboratories.

Vysis alk break apart fish probe kit abbott molecular. Xalkori and the companion vysis alk break apart fish probe kit were approved ahead of the drugs sept. Mll break apart dnafish probe two color, break apart probe h11002 vc s20ocwf standard fish procedure note. Fluorescence in situ hybridization fish for detecting. Apr, 2016 new york genomeweb news abbott announced today that the us food and drug administration has granted premarket approved for the companys vysis cll fish probe kit as a companion diagnostic for abbvie and genentechs newly approved chronic lymphocytic leukemia cll drug venclexta venetoclax. Shipping conditions the vysis alk break apart fish probe kit is shipped on dry ice. Fish studies and interpretation were performed on interphase nuclei on ffpe tissue sections as previously described.

When using fish for detection of alk rearrangements, the alk break apart fish probe kit abbott molecular, des plaines, il has become a gold standard diagnostic for targeted therapy with an alk. March 2014agilent technologies introduced surefish alk, ros1, and ret breakapart translocation probes, expanding its offering of oligonucleotidebased fluorescent in situ hybridization products. Alk break apart fish probe kit cat no ctpac009 lung cancer diagnostic kit the alk fish probe set is designed to detect rearrangements involving portions of the human alk gene located on chromosome band 2p23. The 8q24 myc rearrangement is detected using the vysis lsimyc dual color break apart rearrangement probe kit abbott laboratories, des plaines, il usa. Analytical and performance characteristics are not established. Vysis alk break apart fish probe kit ivd, 20 assays, 06n38033, 00884999042728. Actionable biomarkers in metastatic nsclc az oncology id. Empire genomics alk fish probe is used to detect translocations of the alk gene and can be labeled in one of five colors, using standard nick translation protocols. The resultant fusion proteins generated from alk gene rearrangement plays a vital role in driving the pathogenesis of several different types of cancer, such. The vysis alk break apart fish probe kit consists of two probes adjacent to. Probe description the spec ros1 dual color break apart probe is a mixture of two direct labeled probes hybridizing to the 6q22.

This kit was used in the clinical studies of xalkori and was simultaneously approved by the fda with the product. The overall success rate using vysis alkros1 dual break apart fish probe kit was 83% 3741 cases. The hybridization of the probe with the cellular dna region is visible by direct detection using fluorescence microscopy. Membrane kit, standard, includes electrolyte 1 mil.