What is Confirm MDx?
Confirm MDx is a test that looks for prostate cancer at the molecular level.
It is most often used in patients who have had a negative biopsy but an abnormal DRE, elevated PSA, or another sign of prostate cancer. Confirm mdx is an important PCM test because traditional TRUS biopsies sample less than 1% of the prostate, which means that cancer can be missed. Confirm MDx screens for prostate cancer at a molecular level that is present anywhere in the prostate gland, helping to clarify and confirm biopsy results.
Confirm MDx Video
Learn more about the Confirm MDx tissued-based PCM and how it could provide more insights about prostate cancer risk after a negative biopsy.
Understanding Your Confirm MDx Results
The ConfirmMDx test can provide more information for patients who have a negative or inconclusive biopsy but there’s a high suspicion of prostate cancer. See a sample Confirm MDx results report and learn more about how to interpret this report. It’s important to always review the results of your Confirm MDx results with your healthcare provider first.
FAQs about Confirm MDx
Below is an initial list of frequently asked questions about Confirm MDx. You can also submit your question.
Prostate cancer biomarkers (PCMs) are molecules found in blood, tissue, or body fluids. PCMs are revolutionary new, non-invasive diagnostic tests that may help your healthcare provider decide if your prostate cancer is in fact low risk, if something more aggressive may be lurking in your prostate, or if there are hot spots in the prostate that may need to be re-evaluated upon biopsy. PCMs also can help you and your healthcare provider determine the most appropriate treatment for your cancer.
There are many factors that will make one prostate cancer marker test better suited for individual cases. Many times, individuals who have never had a biopsy or had low to intermediate grade prostate cancer (Gleason 3+3=6 or 3+4=7) diagnosed on a biopsy are well suited for blood or urine prostate cancer markers, whereas individuals who have persistently negative biopsies or a biopsy of intermediate to high grade cancer may benefit from tissue prostate cancer markers. Use this interactive questionnaire to see what tests may be right for you. Once you’ve completed the questionnaire, discuss the results with your healthcare provider. Also be sure to check out our Patient Journey section that may help you decide which test is right for you.
If you have a negative or atypical biopsy and are wanting more insights about prostate cancer risk, you might consider the tissue-based PCM test:
If your prostate biopsy has a Gleason Score of less than or equal to 7 or if your prostate biopsy has a Gleason Score greater than 7 and you have not yet undergone treatment (surgery or radiation), you and your healthcare provider might consider these tissue-based PCM tests:
If your prostate biopsy has a Gleason Score greater than 7 and you have already undergone treatment, please see Waypoint 4 for additional PCM tests to consider.
Men with a cancer-negative (HGPIN, ASAP, atypia) prostate biopsy may benefit from insights provided by the Confirm mdx test. Confirm mdx can be used immediately after biopsy to confirm negative results, determine a patient’s risk for clinically significant prostate cancer and to help inform the patient’s prostate cancer risk management plan or need for rebiopsy/MRI.
Confirm mdx detects the presence of hypermethylation (which is when certain molecules bind to areas of the genetic code, also known as the DNA) of three cancer specific genes: APC, RASSF1, and GSTP1. A positive test indicates you are at increased risk for clinically significant prostate cancer, your clinical risk factors need to be monitored more closely, or you may be a candidate for a re-biopsy. Results of the Confirm mdx test may also help you and your healthcare provider determine which area(s) of the prostate may be “hot spots” for prostate cancer, subsequently targeting these zone(s) of suspicion at the time of repeat biopsy.
While you should always discuss the results of your Confirm mdx test with your healthcare provider first, in general, test results are presented as negative or positive:
- Negative for hypermethylation: You have a ≤ 4% risk of having clinically significant prostate cancer.
- Positive for hypermethylation: You are at increased risk and should be monitored more closely or a re-biopsy/MRI should be considered.
- This result demonstrates three risk categories:
- Overall risk of finding prostate cancer upon repeat biopsy.
- Percent risk of having low-grade cancer upon repeat prostate biopsy.
- Percent risk of having clinically significant prostate cancer (greater than or equal to Gleason 7) upon repeat prostate biopsy.
- This result demonstrates three risk categories:
See a sample Confirm MDx results report and learn more about interpreting it.
Explore more information about Confirm MDx.