Bladder Cancer

Bladder Cancer

Bladder Cancer
Molecular Pathology Laboratory Network, Inc. (MPLN) has been on the forefront of laboratory medicine since its inception in 1989. We offer a continually expanding selection of tests in molecular oncology, infectious diseases and human genetics to hospitals, medical laboratories and private physician groups nationwide.
Bladder Cancer

Bladder Cancer Screen by Fluorescence in situ Hybridization

The Bladder Cancer Kit is designed to detect aneuploidy for chromosomes 3, 7, and 17 and loss or deletion of the 9p21 locus via fluorescence in situ hybridization (FISH).

The test is performed on urine specimens from individuals with hematuria or atypical cell morphology suspected of having bladder cancer or on urine from patients previously diagnosed with bladder cancer.

Bladder Cancer testing is a non-invasive method to aid in the initial diagnosis of bladder cancer and in the early detection of tumor recurrence in patients previously diagnosed with bladder cancer. The results of the Bladder Cancer assay should be interpreted in conjunction with standard diagnostic procedures.

Advantages of Bladder Cancer Testing

The Bladder Cancer Kit enumerates specific chromosome regions to detect cancer-associated genetic changes.

Testing provides information that is complementary to results obtained by cystoscopy.

Direct analysis of cytogenetic changes reduces subjectivity in the interpretation of test results.

Less subjectivity affords more accurate monitoring of bladder cancer.

More accurate monitoring provides more information for therapeutic decisions.

The first molecular cytogenetic test for monitoring the recurrence of bladder cancer. Utilizes DNA probes and fluorescence DNA probe technology.

Non-invasive – Cells for analysis are harvested from voided urine. As few as four cells with certain genetic changes identified by the Kit can indicate bladder cancer recurrence.

Highly sensitive for detecting higher stage, higher grade bladder cancer tumors (100% sensitive for stage T2 and Tis tumors). The Kit also detects lower-stage, low-grade tumors (94% sensitive for grade 3 tumors). High sensitivity means few false negatives.

Highly specific for cancer cells. In 275 patients (59 normal volunteers and 216 non-healthy subjects), the Kit showed 94.5% specificity. In healthy volunteers (smokers and non-smokers over age 50), the specificity was 100%. High specificity means fewer false positive results.

Results unaffected by Bacillus Calmette-Guérin (BCG) intravesical therapy.

Readily reimbursed by private and public payers. Bladder cancer testing detects abnormalities in chromosome copy numbers that can occur independently of significant changes in cell morphology, making it more sensitive than conventional urine cytology. Both tests look for cancer cells shed into the urine, but the Bladder Cancer Kit identifies potential cancer cells by detecting specific cytogenetic changes.

Bladder Cancer testing helps identify the presence of the following:

  • in situ tumors that lie flat against the bladder wall
  • Transitional Cell Carcinomas (TCCs)
  • Suspected tumor sites in patients receiving BCG immunotherapy (Often, the inflammation caused by BCG immunotherapy may mask or make it difficult to visualize a tumor. Bladder Cancer testing can help clinicians determine whether or not a site is cancerous.)
  • Other urinary tract-related cancers beyond the view of the cystoscope, including ureter, urethra, renal, or prostate, indicate that additional follow-up is warranted.

One Source

Coordinating laboratory tests and results within one facility, MPLN provides a single source for anatomic pathology, flow cytometry, cytogenetics, FISH, and molecular testing. Using one source for your laboratory testing provides simpler logistics for ordering, downstream testing, reporting, billing, and patient management.

Contact Us

For more information about how our Bladder Cancer Testing services can benefit your practice, contact a Client Services Specialist at 800.932.2943.

    Project Management

    Our project managers have strong scientific backgrounds and extensive experience in complex research-based clinical trials. They collaborate with our scientific operations, client services, and commercial operations teams to deliver high-quality, regulatory-compliant testing results on time at every project step.

    Key Features

    • Each study is assigned a dedicated and experienced project manager
    • Studies are typically set up within 6 to 8 weeks of contract signature
    • Project management software tools ensure timely deliveries
    • Onsite customer service teams efficiently resolve queries and deliver reports

    Benefits

    • Accelerated study setup time
    • Responsive communication with the scientific and operational team
    • Testing completed on time and within budget
    • Prompt reporting of critical study data

    Data Management

    The key to a successful clinical trial is accurate, clean, quality data. Our team of data managers provides you with data in customized formats exported to your data management teams from our in-house laboratory information system (LIS).

    Key Features

    • Access to dedicated and experienced data specialists upon contract award
    • Customized reports are agreed upon in study-specific data transfer agreement
    • In-house software development team for custom data solutions
    • Flexible data exports and data transfers

    Benefits

    • Real-time reports for your data and project teams to aid in patient management
    • Guaranteed data integrity and quality
    • Improved decision-making and enhanced patient safety
    • Timely access to accurate, clean data for intermediate or final database lock
    Genomic Solutions

    Genomic Solutions

    Genomic medicine, a vital tool in oncology and drug development by providing deeper, more personalized insights into each patient.
    Beyond informing drug target discovery, validation, and clinical development, it uncovers critical genetic markers that drive disease progression and influence individual treatment responses. This empowers healthcare professionals to create more precise, tailored treatment plans, optimizing medical management based on each patient’s unique genetic profile.

    DNA Solutions – WGS*, WGMS*, WES*, TSO-500 Comp, Pillar OncoReveal
    RNA Solutions – Total RNA-Seq*, RNA exome*, mRNA*
    Liquid Biopsy Solutions – TSO-500 ctDNA, PGDx elio™ plasma complete*

    Key Features

    • Targeted NGS panels, including FDA-approved assays with companion diagnostic designations
    • Customized bioinformatics and reporting solutions 
    • Robust assay designs to accommodate low-yielding biopsy material
    • Streamlined wet lab processes to meet screening window timelines

    Benefits

    • Identify variants along with key biomarker signatures
    • Save time and money by assessing multiple biomarkers in a single test
    • Enable targeted therapies with actionable, easy-to-interpret results
    • Assists in targeted patient stratification and recruitment
    • Accelerates the development of personalized medicine

    *Offered through fully accredited partner laboratories.
    Digital Pathology

    Digital Pathology

    Digital pathology revolutionizes clinical trials by enhancing accessibility, cost-efficiency, compliance, and data management. MPLN’s comprehensive digital pathology services streamline clinical research, allowing for improved patient outcomes and operational efficiency.

    Features:

    • Seamless access to digital slides and slide retrieval enables instant access to digital slides.
    • Cost-effective digital slide management streamlines logistics by reducing the need for physical slide storage and transportation.
    • Digital storage ensures slides remain in perfect condition over time.

    Benefits:

    • Allows key opinion leaders (KOL) and remote client pathologists to be utilized
    • Digital slides can be easily shared, allowing for faster, more collaborative decisions, including obtaining second opinions.
    • Reduces the costs associated with physical storage and transport of slides, improving trial efficiency.
    • Simplifies regulatory processes, ensuring quicker and more accurate FDA submissions and audit readiness.
    • Prevents slide degradation or breakage, maintaining the quality of research data for the long term.
    • Enables broader patient recruitment by facilitating decentralized clinical trials for wider geographic participation, increasing patient recruitment and diversity.
    Global Logistics

    Global Logistics

    Effective global logistics are the cornerstone of effective specialty laboratory testing supporting global clinical trials. With precious patient samples such as biopsy and bone marrow aspirates, ensuring samples reach the lab on time and within stability is paramount.

    Key Features

    • Partnerships with global specialist couriers and large integrators to support global studies and specialty shipping requirements
    • Ambient, refrigerated, frozen, and liquid nitrogen storage and shipment services available
    • Real-time or batched shipments based on your clinical trial’s individual needs
    • Secure, high-volume, redundant data storage solutions for digital pathology images
    • Expert advice for effective sample collection, handling, and transport
    • Accurate tracking and inventory for all clinical trial specimens

    Benefits

    • Safe and effective transport of specimens worldwide
    • Standardized procedures to reduce pre-analytical variability and ensure valid results
    • Centralized and harmonized specialty pathology testing supported
    • Reduced costs and maximized budgets with fully managed logistics from one trusted source
    • Readily available inventories, manifests, and shipments for timely study closeouts
    Multiplex IHC

    IHC & Multiplex IHC

    Our advanced technology enables simultaneous visualization of single or multiple biomarkers within the same tissue section, delivering comprehensive insights and precise diagnostics. With unmatched expertise and cutting-edge technology, our team supports you in understanding complex tissue microenvironments, aiding patient stratification and treatment response prediction.

    Features:

    • Simultaneously visualize multiple biomarkers within the same tissue section for deeper insights.
    • Advanced analysis of tissue microenvironments to assist in patient stratification and treatment response prediction.
    • Custom assay design and flexible testing to meet your unique research or clinical trial needs.
    • Detailed data analysis and interpretation are provided by our expert team to ensure accurate results.

    Benefits:

    • Allows enhanced information from small biopsy samples. (I.e. NSCLC)
    • Gain comprehensive insights that lead to more precise diagnostics and better patient outcomes.
    • Enhanced ability to identify patient subgroups and better predict treatment responses with greater accuracy.
    • Whether in biomarker discovery or clinical trials, our advanced technology supports a range of applications, helping you unlock the full potential of your tissue samples.
    Cytogenetics FISH

    Cytogenetics & FISH

    We offer a comprehensive range of chromosome analysis and fluorescent in situ hybridization (FISH) testing with industry-leading turnaround times and global coverage. Our board-certified lab directors and experienced cytogenetic technologists ensure accurate, efficient, and competitively priced testing with the highest quality of service.

    Features:

    • Extensive FISH menu of over 40 loci and disease-specific panels detecting gene amplifications, deletions, translocations, and inversions.
    • Testing is available on bone marrow, blood, and FFPE tissue samples.
    • Specialized Offerings:
      • Plasma cell enrichment for plasma disorders
      • Stat turnaround for PML::RARA and acute myeloid leukemia
      • Bladder cancer urine analysis
      • Custom FISH assay development
    • Comprehensive chromosome analysis testing for oncology, infertility, recurrent pregnancy loss, and congenital disorders.
    • Global coverage of equivocal CAP/CLIA services supporting clinical trials

    Benefits:

    • Rapid, precise results critical for diagnosis and treatment.
    • Expert-driven testing with Board-certified experts ensures the highest accuracy.
    • Tailored assays and solutions to meet unique clinical needs.
    • Faster diagnostics support timely treatment decisions.