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The Vysis® AutoVysion™ System is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use with the Vysis® PathVysion® HER-2 DNA Probe Kit to aid in the detection and enumeration of FISH signals in interphase nuclei. and to determine the LSI® HER-2 to CEP® 17 signal ratio of the HER-2/neu gene via FISH in formalinfixed, paraffin-embedded human breast cancer tissue specimens. The AutoVysion System is intended to reduce overall hands-on time by performing automated enumeration. For a small percentage of samples (less than 7%) manual enumeration may be required. The Vysis® AutoVysion™ System is an adjunctive computer-assisted methodology to assist in the acquisition and measurement of images from microscope slides of formalin-fixed, paraffin-embedded breast cancer tissue sections for the presence of amplified HER-2/neu gene. The Vysis® AutoVysion™ System is intended for use as aid in determining HER-2/neu amplification status. in coniunction with optional manual visualization directly through the fluorescence microscope. When used with the Vysis® PathVysion® HER-2 DNA Probe Kit, the Vysis® AutoVysion™ System is indicated for use as a) an adjunct to existing clinical and pathologic information currently used as prognostic factors in stage II, node-positive breast cancer patients b) an aid to predict disease-free and overall survival in patients with stage II. node positive breast cancer treated with adjuvant cyclophosphamide, doxorubicin and 5-fluorouracil (CAF) chemotherapy; and, c) aid in the assessment of patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered (see HERCEPTIN package insert).

The Vysis® AutoVysion™ System consists of an automated fluorescence microscope with motorized scanning stage, a large-format monochrome CCD camera, computer and scanning and assay specific analysis software. The microscope is equipped with a mercury arc lamp for fluorescence epi-illumination; three single-pass fluorescence filter sets for DAPI, SpectrumGreen™ (SG) and SpectrumOrange™ (SO) and a triple-pass fluorescence filter set for DAPI/SG/SQ, all mounted in a motorized filter turret; 10x and 40x objectives in a motorized objective turret; 10x eyepieces; a CCD camera; and a motorized scanning stage that holds up to 8 slides. Images of single fluorescence colors are captured by the CCD camera and transferred to the computer. All functions are controlled by the System software.

The UroVysion Bladder Cancer Recurrence Kit (UroVysion Kit) is designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from subjects with transitional cell carcinoma of the bladder. Results from the UroVysion Kit are intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer.

The UroVysion Kit is based upon fluorescence in situ hybridization (FISH) DNA probe technology. The UroVysion probes are fluorescently labeled nucleic acid probes for use in in situ hybridization assays on urine specimens fixed on slides. The UroVysion Kit consists of a 4-color, four-probe mixture of DNA probe sequences homologous to specific regions on chromosomes 3, 7, 9, and 17. The UroVysion probe mixture consists of Chromosome Enumeration Probe (CEP®) 3 SpectrumRed™, CEP 7 SpectrumGreen™, CEP 17 SpectrumAqua™ and Locus Specific Identifier (LSI®) 9p21 SpectrumGold™.

The UroVysion Bladder Cancer Recurrence Kit (UroVysion Kit) is designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from subjects with transitional cell carcinoma of the bladder. Results from the UroVysion Kit are intended for use as a noninvasive method for monitoring for turnor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer.

The UroVysion Kit is based upon fluorescence in situ hybridization (FISH) DNA probe technology. The UroVysion probes are fluorescently labeled nucleic acid probes for use in in situ hybridization assays on urine specimens fixed on slides. . The UroVysion Kit consists of a 4-color, four-probe mixture of DNA probe sequences homologous to specific regions on chromosomes 3, 7, 9, and 17. The UroVysion probe mixture consists of Chromosome Enumeration Probe (CEP®) 3 SpectrumRed™, CEP 7 SpectrumGreen™, CEP 17 SpectrumAqua™, and Locus Specific Identifier (LSI®) 9p21 SpectrumGold TM .

The AneuVysion™ (CEP 18, X, Y-alpha satellite, LSI 13 and 21) Multicolor Probe Panel is intended to use CEP 18/X/Y probe to detect alpha satellite sequences in the centromere regions of chromosomes 18, X, and Y, and LSI 13/21 probe to detect the 13q14 region and the 21q22.13 to 21q22.2 region. The AneuVysion™ kit is indicated for use as an adjunct to standard cytogenetic metaphase analysis for identifying and enumerating chromosomes 13, 18, 21, X, and Y via fluorescence in situ hybridization (FISH) in metaphase cells and interphase nuclei obtained from amniotic fluid in subjects with presumed high risk pregnancies. It is not intended to be used as a stand alone assay for test reporting. FISH results are intended to be reported and interpreted only in conjunction with results of standard cytogenetic analysis, performed concurrently, utilizing the same patient specimen. FISH results should not be reported prior to standard cytogenetic results except in instances where reporting of FISH results alone is medically indicated or standard cytogenetic results are not available, e.g., culture failure. Reporting and interpretation of FISH should be consistent with professional standards of practice! This device is intended for use only with amniocyte cells; it is not intended for and has not been validated for use with other test matrices. This FISH assay will not detect the presence of structural chromosome abnormalities frequently associated with birth defects. This FISH assay will be performed in cytogenetics laboratories.

The AneuVysion™ kit is a combination of two DNA probe mixtures; CEP 18/X/Y and LSI 13/21. The CEP 18/X/Y probe is a mixture of directly labeled fluorescent DNA probes specific for the D18Z1, DXZ1 and DYZ3 regions of chromosomes 18, X, and Y respectively. The LSI 13/21 probe contains a mixture of unique DNA sequences that hybridize in the 13q14 region of chromosome 13, and unique DNA sequences complementary to the D21S259, D21S341, and D21S342 loci contained within the 21q22.13 to 21q22.2 region on the long arm of chromosome 21. The LSI 13 probe was created from a set of overlapping clones which contain the entire RB-1 gene as well as regions extending beyond the gene on both sides. The probe extends beyond the 180 kb RB-1 gene for 110-170 kb in the 5' direction and approximately 120 kb in the 3' direction; the entire probe is 410-470 kb. CEP 18/X/Y is an aqua, green, and orange tri-color probe mixture and LSI 13/21 is a green and orange dual-color probe mixture.

This assay is designed to provide a reliable method for the simultaneous detection and enumeration of X and Y chromosomes in interphase nuclei and metaphase spreads in bone marrow by fluorescence in situ hybridization (FISH).

The CEP X/Y probe is a combination of CEP X SpectrumOrange and CEP Y SpectrumGreen continuous DNA probes for the centromeric region of chromosome X and the satellite III DNA at the Yq12 region of chromosome Y.

The CEP 12 SpectrumOrange Direct Labeled Chromosome Enumeration DNA Probe Kit is designed to be an adjunct to standard cytogenetic analysis for in vitro diagnostic use in identifying and enumerating chromosome 12 via fluorescence in situ hybridization (FISH) in interphase nuclei of cells obtained from peripheral blood lymphocytes in patients with chronic lymphocytic leukemia (CLL). Results from the CEP 12 SpectrumOrange Direct Labeled Chromosome Enumeration DNA Probe Kit are intended for use in conjunction with standard cytogenetics and for further assessing the trisomy 12 status in normal and abnormal tissue specimens characterized by standard cytogenetics, in patients with and/or without clinical symptoms of CLL. It is not intended to be a stand alone assay for test reporting.

The CEP 12 SpectumOrange DNA Probe is a SpectumOrange fluorescent labeled DNA probe specific for the centromeric region of chronosome 12. This assey is designed IDN provide a rapid and reliable method for the desertion and quantification of chromosome 12 In interphase nuclei by fluorescence in situ hybridization (FISH).

This assay is designed to provide a method for the detection and quantification of chromosome 8 in both interphase nuclei and metaphase spreads by fluorescence in situ hybridization (FISH).

The CEP 8 SpectrumOrange DNA Probe is a SpectrumOrange fluorescent labeled DNA probe specific for the centromeric region of chromosome 8.