What is the purpose of the Oncuria® Multiplex Immunoassay for Bladder Cancer Test?

The Oncuria® Multiplex Immunoassay for Bladder Cancer Test is the first-of-its-kind multiplex protein-based immunoassay to provide early detection, therapy choice, and disease monitoring of bladder cancer. This 10-biomarker test was developed to detect early stages of bladder cancer in patients presenting with hematuria or with a history of bladder cancer.

What are the Oncuria® Multiplex Immunoassay for Bladder Cancer Tests?

The Oncuria® Multiplex Immunoassay can be broken down into three tests: Oncuria® Detect, Oncuria® Monitor, and Oncuria® Predict. This immunoassay specializes in analyzing and monitoring a patient’s risk of developing bladder cancer and predict the response rate of patients to BCG therapy.

Oncuria® Detect: This test provides a highly sensitive and specified diagnosis without the need for invasive procedures by looking for biomarkers consistent with bladder cancer in patients with gross and micro-hematuria.

Oncuria® Monitor: Monitors for recurrences of bladder cancer in patients. Bladder cancer recurrence occurs in non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC) types. It is hard to know when the cancer will come back. Therefore, adequately scheduled surveillance is necessary following cancer treatment.

Oncuria® Predict:  Identifies patients who are likely to experience rapid failure with Bacillus Calmette-Guerin (BCG) therapy, a live attenuated tuberculosis vaccine that acts as a non-specific immune system stimulant, has proven to be the most successful adjuvant treatment for non-muscle invasive bladder cancer (NMIBC). BCG helps eradicate residual disease, reduce recurrence, and decrease cancer progression.

Who Should Receive Testing?

Bladder cancer is the sixth most common cancer in the US, and overall the ninth most deadliest cancer. Bladder cancer can vary in terms of severity, and early detection and treatment are essential for the best possible outcomes. It’s essential to consider getting testing, especially if you fall into one of the following categories:

• If you have a history of
  • smoking,
  • exposure to certain chemicals,
  • or a family history of bladder cancer
• Significantly for individuals who have a past history of bladder cancer.
• Accordingly for those with subtle or nonspecific symptoms, such as blood in the urine, frequent urination, or pelvic pain.
• Individuals wanting to know their potential response to Bacillus Calmette-Guerin (BCG) therapy to ensure the treatments efficacy.

Don’t wait for symptoms to worsen or become evident—in general you should consult with your healthcare provider to discuss your potential risk factors and create a screening plan tailored to your needs. Overall, early detection through regular screenings can significantly improve the chances of successful treatment and outcomes for bladder cancer.

Benefits of the Oncuria® Multiplex Immunoassay for Bladder Cancer Tests:

• Analyzes all 10 biomarkers to achieve a sensitivity of 93% and a specificity of 93% when 3 key clinical factors (age, race, and gender) were included in the clinical nomogram.
• Further predict a patients response to BCG therapy with Oncuria® Predict with high sensitivity and specificity results to better tailor treatment regimens.
• Significantly the Oncuria® Multiplex Immunoassay, requires only a urine sample for testing.
• Due to the assay examining multiple biomarkers simultaneously thus offering a comprehensive assessment of bladder cancer risk, stage, and progression.

Biomarkers:

• VEGF-A
• MMP-9
• IL-8
• ANG
• MMP-10
• CA9
• PAI-1, SERPIN E1
• SDC1
• APOE
• A1AT, SERPIN A1

Sample Type

• Urine

For Information regarding test pricing, please check under ‘Additional Information’ for cost breakdown for testing.