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Helps identify patients at increased risk for aggressive disease, thereby aiding in the selection of men for prostate biopsy.

Measures biomarkers that help a physician determine if a patient is at higher or lower risk for prostate cancer and which men can safely avoid biopsy.

A non-invasive urine test (“liquid biopsy”), SelectMDx measures the expression of two mRNA cancer-related biomarkers (HOXC6 and DLX1).1 The test provides binary results that, when combined with the patient’s clinical risk factors, help the physician determine whether:

• The patient may benefit from a biopsy and early prostate detection, or

• The patient can avoid a biopsy and return to routine screening

SelectMDx


Overcomes Historical Prostate Cancer Screening Challenges for More Effective and Efficient Diagnosis


Overdosage, repeated biopsies and their complications make PSA an imperfect biomarker. An increased PSA may be caused by other factors other than cancer, such as infections, inflammation or benign prostatic hyperplasia (BPH).

The clinical utility of SelectMDx for Prostate Cancer is well-established:

• Men identified by the test as having a high likelihood of clinically significant cancer can, upon biopsy, be diagnosed and treated sooner.

• Men with low risk for prostate cancer can avoid biopsy and associated complications and continue to be monitored through urine tests.

• The test’s negative predictive value (NPV) is 98%, meaning if the test identifies a very low risk, the physician and patient can be 98% sure the patient does not have Gleason score ≥7 prostate cancer and avoid a biopsy.1

• The test has a very high predictive accuracy (AUC 0.87) for high-grade prostate cancer, which is significantly better than the Prostate Cancer Prevention Trial (PCPT) risk calculator version.1

• It is recognized as biomarker in prostate cancer diagnosis and it is mentioned in EAU 2018 guides3

References

1. Van Neste L, et al. (2016) Detection of High-grade Prostate Cancer Using a Urinary Molecular Biomarker-Based Risk Score. Eur Urol, Nov; 70(5): 740-748.

2. Govers TM, et al. (2018) Cost-Effectiveness of Urinary Biomarker Panel in Prostate Cancer Risk Assessment. J Urol. doi: 10.1016/j.juro.2018.07.034

3. Mottet N, et al. 2018 EAU Prostate Cancer Guidelines.

It is a test from initial tissue biopsy to identify the men with prostate cancer risk, clinically unidentified.

One biopsy out of four is fals-negative. Approximately 20-30% of the patients receive, after first biopsy, a fals-negative result.

Who should have the test and why?

– High risk patients, with a previous histopathologic negative result, may have an unidentified cancer (fals-negative biopsy result)

– To avoid repeted biopsies and useless screening procedures. Helps to reduce complications, patient anxiety and associated costs of all these procedures.


Copyright by AMS 2018. All rights reserved.