Fluorescence In Situ Hybridization (FISH)
BioVantra offers a continually expanding selection of highly specialized diagnostic, prognostic, and predictive testing technologies and services to urologists whose patient populations require more advanced information for treating cancer and other complex diseases. In addition, with the advent of the human genome project, more sophisticated technologies are becoming a reality, offering increasing possibilities in personalized healthcare.
UroVysion
UroVysion is a fluorescence in situ hybridization assay designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus in urine specimens from persons suspected of having bladder cancer. Results from the assay are intended for use, in conjunction with current standard diagnostic procedures, as an aid for the initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.
UroVysion provides more significant insights during monitoring of bladder cancer, especially in patients where cytology and cystoscopy are negative, equivocal, or suspicious. UroVysion has a high negative predictive value providing confidence in the effectiveness of treatment plans. When used in patients undergoing Bacillus Calmette-Guerin (BCG) therapy, a UroVysion positive result indicates patients are 3-5 times more likely to have tumor recurrence.
UROVYSION HAS NO INTERFERENCE WITH BCG and 30 other possible urine constituents, microbial contaminants, preservatives, and therapeutic agents.
TMPRSS2-ERG
The fluorescence in situ hybridization (FISH) assay with TMPRSS2-ERG rearrangement probe is optimized to detect the deletion between TMPRSS2 and ERG at 21q22 associated with the TMPRSS2-ERG fusion in a triple-color deletion assay.
In addition, it also detects translocations involving the TMPRSS2 region such as ETV1 or ETV4.
Emerging data suggest that TMPRSS2-ERG fusion prostate cancer has a worse prognosis, i.e., higher tumor stage and tumor-specific death or metastases.
The assay results can aid in diagnosing and distinguishing patients with indolent disease from those with clinically relevant cancers, thereby allowing for conservative management (active surveillance and deferred intervention) or more aggressive primary and neoadjuvant or adjuvant treatment.
PTEN
PTEN (10q23) specific DNA Probe is optimized to detect copy numbers of the PTEN gene region at region 10q23. Deletions involving chromosome 10q23 frequently occur in prostatic carcinomas and other types of cancer. Thus, PTEN, mapping to this interval, has been identified as a tumor suppressor gene located in this region.
GuardianDx
The GuardianDx Assay is an OligoFISH probe panel designed to detect aneuploidy for chromosomes 7, 16, 18, and 20 via fluorescence in situ hybridization (FISH) in post-DRE urine specimens from males suspected of having prostate cancer. The GuardianDx assay utilizes whole urine collected following a digital rectal examination (DRE) consisting of three strokes per lobe and final central depression from base to apex. The DRE releases prostate cells through the prostate duct system into the prostatic urethra, allowing recovery in the first catch urine.
Specimen slides are prepared and hybridized using OligoFISH technology. This methodology allows chromosome enumeration in 15 minutes to 2 hours instead of 2 days required for traditional FISH.
The GuardianDx Assay highly correlates with positive and negative pathology findings, supporting their high specificity and accuracy compared to prostate biopsy results.
VesicaDx
The VesicaDx Assay is an OligoFISH probe panel designed to detect aneuploidy for chromosomes 3, 6, 7, and 20 via fluorescence in situ hybridization (FISH) in voided urine specimens from persons suspected of having bladder cancer.
Results from the assay are intended for use, in conjunction with current standard diagnostic procedures, as an aid for the initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.
The VesicaDx assay has excellent sensitivity for low-grade tumors compared to UroVysion.
Automated Fluorescent Scanning & Analysis of Target Cells in Suspension, Previously Stained with a Different Marker
Target FISH
BioVantra’s Target FISH (T-FISH) application provides a genetic content analysis (FISH) of a specific, pre-selected subset of target cells. First, the application scans slide stained with Papanicolaou stain, Immunofluorescent antibodies (IFL), or FISH probes to detect and select specific cell types/groups. Then, it rescans the same slides after de-staining and is stained again with different Immunofluorescent antibodies or FISH probes. Finally, the T-FISH application matches the two scans to present two images of the same cell for each cell in the sample (morphology/FISH or IFL/FISH or FISH/FISH).
Examples of Papanicolaou-stained urine cytology and corresponding UroVysion FISH (Chromosomes 3 in red, 7 in green, 17 in aqua, and 9p21 in gold)
a. Benign “umbrella” cell with pronounced reactive changes in a patient with irritative voiding symptoms. Highly increased number of all FISH signals due to repeated doubling of the genome (i.e., endoreplication), but no unbalanced copy number changes and no 9p21 deletion.
b. Sheets of mildly atypical urothelial cells in a voided urine sample. Normal FISH result (two copies per chromosome), consistent with reactive changes.
c. Atypical urothelial cells suspicious for high-grade urothelial carcinoma. Positive UroVysion FISH result with increased copy numbers of all three chromosomes and homozygous deletion of 9p21.
d. UroVysion FISH positive atypical urothelial cells with increased copy number of all five chromosomes but no 9p21 deletion.
