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SelectMDx -Actionable Molecular Diagnostic System for Prostate Cancer

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SelectMDx Helps Physicians 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:
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  • The patient may benefit from a biopsy and early prostate detection, or
  • The patient can avoid a biopsy and return to routine screening
Overcomes Historical Prostate Cancer Screening Challenges for More Effective and Efficient Diagnosis

Concerns about identifying patients with indolent prostate cancer and subsequent overtreatment have led to recommendations for eliminating the PSA test. An elevated PSA result could be caused by factors other than cancer, including infection, inflammation or benign prostatic hyperplasia.

An elevated PSA is considered the best risk stratifier for the early detection of prostate cancer, resulting in an increased likelihood for curative treatment. In contrast, delayed diagnosis can lead to poorer outcomes, lower quality of life, and higher healthcare costs.2

SelectMDx Increases Physician Confidence in Biopsy DecisionsIncluded in the National Comprehensive Cancer Network (NCCN) Guidelines
  • Biomarkers can improve the specificity of screening methods for clinically significant cancer.
  • Included in the 2020 NCCN Guidelines for Prostate Cancer Early Detection.
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, while men identified at very low risk may avoid biopsy.
  • The test’s negative predictive value (NPV) is 95%, meaning if the test identifies a very low risk, the physician and patient can be 95% sure the patient does not have Gleason score ≥7 (GS≥7) prostate cancer and avoid a biopsy.1,3
  • The test has a very high predictive accuracy (AUC 0.85) for high-grade prostate cancer, which is significantly better than the Prostate Cancer Prevention Trial (PCPT) risk calculator version 2.1,3

MDxHealth is regulated under the Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) as an accredited laboratory to perform high complexity clinical testing. The SelectMDx for Prostate Cancer test was developed, and its performance characteristics determined by MDxHealth. It has not been reviewed by the U.S. Food and Drug Administration. The FDA has determined such clearance or approval is not necessary. The test is intended for use as an aid to clinicians for patient management decisions about the need for a prostate biopsy in men with clinical risk factors suggesting an increased risk for prostate cancer. Use outside of this indication has not been validated by MDxHealth. Test results should be interpreted in conjunction with other laboratory and clinical data available to the clinician and relevant guidelines on the decision for biopsy. CLIA# 05D2033858; CAP# 8015399