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NMP22® BladderChek®

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Introducing the only in-office Health Canada & FDA Approved Tumor marker for detecting and monitoring bladder cancer.

While the traditional method for testing for bladder cancer with cystoscopy alone is relatively reliable, it’s far from a perfect science.  Sensitivity is approximately 91%, and early-stage cancer can be misssed.  The NMP22® BladderChek® Test is a tumor marker test specifically designed for bladder cancer testing.  When used in conjunction with cystoscopy, it’s proven to increase sensitivity levels up to 99%, and negative predictive values up to 99.5%.

About half the size of a credit card, this disposable test is a rapid, accurate and cost-efficient way to diagnose more completely, and catch tumors before they become invasive or metastatic.

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How It Works

The NMP22® BladderChek® Test is a painless, noninvasive assay performed on a single urine sample that provides results during a patient visit.  It works by detecting levels of NMP22® protein, which are often elevated in patients with bladder cancer,

Be 99% sure, like never before

When combined with a cystoscopy, the NMP22® BladderChek® Test provides up to 99% sensitivity, as proven in clinical testing.  In fact, it’s the first and only way to achieve up to 99% sensitivity when diagnosing bladder cancer.  This minimizes the risk of misdiagnosis, and gives you greater confidence that cancer has been detected.

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It’s easy to be sure

Testing with NMP22® BladderChek® Test is as simple as 4 drops of urine and only 30 minutes.  Special sample handling or instruments are not required.

  1. Data derived from 510(k) K021231.
  2. JAMA, January 18, 2006
  3. FDA submission 510(K) K021231
  4. Data derived from PMA 940035 S003.
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Detect hidden and early stage cancers

The combination of cystoscopy and the NMP22® BladderChek® Test detected 10 of 11 lifethreatening cancers compared to 7 of 11 by cystoscopy alone.  And when compared with a voided urine cytology, the NMP22® BladderChek® Test detects:

  • 4x more nonmuscle-invasive bladder cancers
  • 4x more muscle-invasive cancers

What’s more, the NMP22® BladdrChek Test provides a negative predictive value op to 99.5% when combined with cystoscopy.  So, when you say “negative” you can be sure you’re positive.

  1. Data derived from 510(k) K021231.
  2. JAMA, January 18, 2006
  3. FDA submission 510(K) K021231
  4. Data derived from PMA 940035 S003.

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  1. Data derived from 510(k) K021231.
  2. JAMA, January 18, 2006
  3. FDA submission 510(K) K021231
  4. Data derived from PMA 940035 S003.

In-Office Usage Guide

Patient Test Procedure

1. Collect a voided urine sample in a plastic urine collection container.

2. Keep the urine sample, for up to 2 hours, at room temperature until the time of testing.

3. If the test is stored refrigerated, bring the test materials to room temperature (18-30°C, 64-86°F) before opening the foil pouch.

4. Open the foil pouch immediately prior to use. Discard the small desiccant pouch.

5. Fill the enclosed dropper with the patient’s urine sample and hold it upright above the sample well.

6. Allow 4 FULL drops (without air bubbles) to fall into the sample well.

7. Read the test results at 30 minutes, but NO LATER THAN 50 MINUTES. Read results as shown below, “Interpretation of Results”.

8. Discard used dropper and test device in a proper biohazard container.

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Interpretation of results:

1. Check the procedural Control (C) zone. A line must appear for the test to be valid.

2. Positive Result: Carefully observe the Test (T) zone of the device. ANY complete line in the Test (T) zone is a POSITIVE result when a Control (C) line is present. Neither the intensity nor the color of the Test (T) line should be compared to that of the line in the procedural Control (C) zone.

3.Negative Result: Carefully observe the Test (T) zone of the device. The absence of ANY colored line in the Test (T) zone is a NEGATIVE result if a Control (C) line is present.

4. Invalid Result: If no line appears in the procedural Control (C) zone, or if the Test (T) line is smeared or incomplete, the test is INVALID and must be repeated with a new device. The most common reason for an invalid result is failure to apply exactly 4 FULL drops, without air bubbles, of urine to the sample well.

Contact Us
Stellar Pharmaceuticals Inc.
544 Egerton St
London ON, N5W 3Z8
T: 1-900-752-6491
F: 413-716-3125
stell@pharma.com
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