ConfirmMDx for Prostate Cancer

As Many as 1 in 4 Men With a Negative Biopsy Actually Have Cancer1,2

A standard prostate biopsy only provides a limited evaluation by sampling less than 1% of your entire prostate.3  Prostate cancer can be present in one or more small tumors, and there is a risk the biopsy needle could have missed it.

Prostate biopsy sampling error

Why do I need ConfirmMDx?
If you have an elevated PSA test result and high risk factors you may have prostate cancer.  A prostate biopsy procedure is the best method for your urologist to determine if cancer is present.  Although 1 in 6 men are diagnosed with prostate cancer during their lifetime, the vast majority of men have a negative prostate biopsy result.4

Unfortunately, today’s “gold standard” for diagnosis, the prostate biopsy procedure, only provides a limited evaluation by sampling less than 1% of your entire prostate.4  Prostate cancer may be present in one or more small tumors, and there is a risk the biopsy needle could have missed it.

Your urologist may have concerns about your risk for undetected prostate cancer and recommend ConfirmMDx to determine your need for a repeat biopsy.

How does ConfirmMDx work?
ConfirmMDx works on the DNA level to help identify undetected cancers. The test is able to detect abnormal changes to DNA associated with the presence of prostate cancer.

Since these changes are at the molecular level, they cannot be seen by the standard microscopic evaluation traditionally used for all prostate biopsies.

Epigenetic Field Effect

ConfirmMDx for Prostate Cancer detects a field effect or halo associated with the presence of cancer at the DNA Level.  This halo around a tumor can be detected in prostate cells despite having a normal appearance under the microscope.

What is my benefit from ConfirmMDx?
ConfirmMDx can provide your urologist with actionable information that helps:

  • Confidently rule out prostate cancer-free men from undergoing unnecessary repeat biopsies.
  • Determine if you are at high risk for prostate cancer and may need a repeat biopsy and potential treatment.

When should I get ConfirmMDx?
If you had a negative prostate biopsy within the past 24 months, ask your urologist if ConfirmMDx is right for you. Your doctor can send the remaining tissue samples from your previous prostate biopsy for ConfirmMDx testing. You do not need a repeat biopsy or office visit for this test.

Where is ConfirmMDx performed?
Your urologist will submit your previously collected, prostate biopsy samples to MDxHealth for testing in its CAP and CLIA accredited laboratory in Irvine, CA.  The test results will be provided to your urologist.

For more information and to inquire about having the ConfirmMDx for Prostate Cancer test performed, please talk to your doctor.

References

  1. Welch HG et al: Detection of Prostate Cancer via Biopsy in the Medicare SEER Population During the PSA Era. J Natl Cancer Inst 2007;99: 1395 – 400.
  2. Pinsky PF et al: Repeat Prostate Biopsy in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. BJU International 99, no. 4 (April 2007): 775–779.
  3. Shen et al.: Three-Dimensional Sonography With Needle Tracking - Role in Diagnosis and Treatment of Prostate Cancer. J. Ultrasound Med. 2008; Jun; 27(6): 895-905.
  4. Ross et al., Cancer Epidemiol Biomarkers Prev. 2008. 17:636-644.