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Personalized Risk Assessment of Prostate Cancer

SelectMDx Testing

Learning you have elevated PSA can be alarming news, but elevated PSA does not mean you have clinically significant disease and require a biopsy or treatment. SelectMDx is a novel decision support tool and provides your urologist with additional important information on the likelihood of finding aggressive cancer upon biopsy.

How is the test performed?

Urine sample (first void urine, post-prostatic massage)

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Prostate-specific antigen (PSA) is a protein produced within the prostate gland. PSA is mostly found in semen, but small amounts can also be found in the blood of healthy men. PSA levels naturally increase as men age because the prostate naturally enlarges over time. . There are many reasons why PSA levels fluctuate, and higher levels may indicate the presence of prostate cancer or other prostate conditions (inflammation).

Prostate cancer is the most common cancer to affect Canadian men. Typically slow growing, prostate cancer can be present for many years before causing symptoms. Receiving news that you have an elevated PSA may be alarming, but it does not necessarily mean you require a biopsy or aggressive treatment. SelectMDx can help your physician determine whether you would benefit from a biopsy or simply require ongoing screening (active surveillance).

SelectMDx is a urine test that measures two cancer-related genetic biomarkers, HOXC6 and DLX1. Combined with other clinical factors like total PSA and age, the test produces a likelihood score of discovering clinically significant disease (defined as Gleason Score equal to or more than 7 [3+4 and 4+3]). This provides your urologist with another important piece of information to consider when recommending whether a biopsy is required and potentially avoid unnecessary procedures. The test has a very high negative predictive value, meaning that a low likelihood result is correct in the vast majority of men (Negative Predictive Value (NPV) of 98% for clinically significant cancer).

SelectMDx is recommended if a Prostate-Specific Antigen (PSA) test result has revealed PSA levels increased to between 4 – 10 ng/ml and/or you have had an abnormal digital rectal exam.

Your healthcare provider may order a SelectMDx test if you have:

  • elevated PSA levels
  • had an abnormal digital rectal exam
  • a family history of prostate cancer
  • other factors that may put you at elevated risk for prostate cancer such as age or ethnic background

SelectMDx is a two-part process for urine sample collection. First your physician must conduct a prostatic massage (via a digital rectal exam; DRE) to slough off cells from your prostate. Following this you must provide a urine sample which  is generally collected in your urologist’s office and delivered the same day to a LifeLabs Patient Service Centre along with a requisition completed by your physician.

Test results will be provided directly to your healthcare provider for discussion with you. The report will indicate the likelihood of prostate cancer (and clinically significant disease) upon biopsy.

SelectMDx is a well-validated decision support tool for patients with elevated PSA (validated on 4-10ng/ml). It has an NPV of 98% for clinically significant cancer. It produces a likelihood score for clinical significant disease defined as GS equal to or more than 7 (3+4 and 4+3), and therefore the test result is relevant to a clinical decision to perform a biopsy.

The test is a reverse-transcription PCR (RT-PCR) assay performed on urine specimens collected immediately following prostatic message from patients who are being considered for prostate biopsy. The test measures the urinary mRNA levels of DLX1 and HOXC6 biomarkers. Higher levels of DLX1 and HOXC6 mRNA are associated with an increased probability for clinically significant disease. The SelectMDx  likelihood score is calculated by combining DLX1 and HOXC6 mRNA levels with established clinical risk factors, including PSA, prostate volume, DRE, family history and age, is based on a clinical model that yields an area under the curve (AUC) of 0.87 (95% CI: 0.85 – 0.90). Performance is based on the presence of all relevant data elements (although minimally impacted by lack of PSA Density, Family History and DRE Findings). Results for patients on 5­-reductase inhibitors (5-ARIs) should be interpreted with caution.

Urine samples for SelectMDx must be collected following prostatic message. Urine samples are generally collected in a physician’s office and then delivered by the patient the same day to the nearest LifeLabs Patient Service Centre. The urine sample must be accompanied by a completed provincial third-party billing form, along with a requisition (clinical information is required for test reporting) MDx form. Please refer to test collection instruction for full details.

Results will be available to you within 10 business days of sample collection. Consult your urologist to review the results and decide on next steps.

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