UroVysion^®

FDA Approved

Product Description

Probe Name	Probe Location	Fluorophore
Vysis^® CEP^® 3	3p11.1-q11.1 Alpha Satellite DNA	SpectrumRed ^TM
Vysis CEP 7	7p11.1-q11.1 Alpha Satellite DNA	SpectrumGreen ^TM
Vysis LSI^® p16	9p21	SpectrumGold ^TM
Vysis CEP 17	17p11.1-q11.1 Alpha Satellite DNA	SpectrumAqua ^TM

The UroVysion^® Bladder Cancer Kit (UroVysion Kit) is FDA approved and 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 persons with hematuria suspected of having bladder cancer. Results from the UroVysion Kit are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

The UroVysion Bladder Cancer Kit probes are directly labeled with one of the Vysis fluorophores; SpectrumRed, SpectrumGreen, SpectrumAqua or SpectrumGold. The UroVysion Bladder Cancer Kit consists of three alpha-satellite repeat sequence probes; CEP 3 SpectrumRed, CEP 7 SpectrumGreen, and CEP 17 SpectrumAqua that hybridize to the centromere regions of chromosomes 3, 7, and 17, respectively. In addition, a unique sequence probe, LSI p16 (9p21) SpectrumGold, is included that hybridizes to the p16 gene at 9p21. This probe set is premixed in Hybridization Buffer.

Probe Map

A diagram of the 9p21 region and sequence tagged sites (STS) known to be contained within this region. The yellow bar represents the approximately 190 kb region covered by the LSI p16 (9p21) probe.

Results of Hybridization

Determination of results is conducted by enumeration of CEP 3, 7 and 17, and LSI p16 (9p21) signals through microscopic examination of the nucleus.Hybridization is viewed using a fluorescence microscope equipped with appropriate excitation and emission filters allowing visualization of the red, green, aqua, and gold fluorescent signals. Samples hybridized with the UroVysion Bladder Cancer Kit will exhibit signals indicative of the copy number of chromosomes 3, 7, and 17 and of the p16 gene. Processing The UroVysion Bladder Cancer Kit can be used with the Vysis VP2000^TM ^TM Processor for specimen pretreatment and the HYBrite^TM Denaturation/ Hybridization unit for modular automation.

Vysis Microscope Filter Recommendations
UroVysion probe signals and DAPI counterstain should be viewed with the following Vysis filter sets:

DAPI single bandpass (DAPI counterstain)
Aqua single bandpass (chromosome 17)
Yellow single bandpass (p16 gene)
Red/Green dual bandpass (chromosomes 3 and 7)

An epi-fluorescence microscope equipped with a 100-watt mercury lamp is strongly recommended.An epi-fluorescence microscope enables a light source to transmit light through the viewing path, replacing the illuminator and condenser of the conventional wide field microscope. For this mode to function, the structures of interest are labeled with a fluorophore. Light from the source is collimated and directed into the tube of the microscope to a 45-degree mirror with an interference coating that lets in light at particular wavelengths and is transparent at other wavelengths (a dichroic mirror). This light is directed to the back of the objective and is focused into the sample. The objective functions as a condenser. Exciting light is absorbed by the fluorophore in the sample. The energy of the absorbed photon causes an electron in the dye molecule to jump to a higher energy orbital state. The electron rapidly jumps back to its ground orbital state, with the energy released becoming a photon of less energy compared to the exciting photon. The emitted photon has a color shifted toward red. The eyepiece collects the image in an identical manner as is transmitted in wide field microscopy.

Aneusomic interphase cell obtained from a sample showing two copies of chromosome 3 (red), four copies of chromosome 7 (green), five copies of chromosome 17 (aqua) and one copy of p16 gene (gold) after the UroVysion Bladder Cancer Kit (UroVysion Kit) hybridization.

References

Cairns, P. et al. (1995) Nat Genet 11:210-2.
Cajulis, RS. et al. (1997) Diagn Cytopathol 13:214-24.
Halling, KC. et al. (2000) J Urol 164, 1768-75.
Hopman, AHN. et al. (1991) Cancer Res 51:644-51.
Matsuyama, H. et al. (1994) Cancer Genet Cytogenet 77:118-24.
Meloni, AM. et al. (1993) Cancer Genet Cytogenet 71:105-18.
Sauter, G. et al. (1995) Cancer Genet Cytogenet 82:163-9.
Smeets, W. et al. (1993) Cancer Genet Cytogenet 71:97-9.
Sokolova, I. et al. (2001) Proceedings of the 92nd annual Meeting of AACR p. 357, Abstract No. 1923.
Waldman FM. et al. (1991) Cancer Res 51:3807-13.
Wheeless, LL. et al. (1994) Cytometry 17:319-26.

Order Information

Product Name	Package Size	Vysis Order Number	Abbott Order Number
UroVysion FDA Approved	20 Assays	30-161070	02J27-020
UroVysion FDA Approved	100 Assays	36-161070	02J27-095
UroVysion Export Only CE	20 Assays	32-161070	02J27-020
UroVysion Export Only CE	100 Assays	37-161070	02J27-099

The UroVysion Bladder Cancer 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 persons with hematuria suspected of having bladder cancer. Results from the UroVysion Kit are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.