SelectMDx for Prostate Cancer

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  

SelectMDx Clinical Pathway

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 How It Works

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 Treatment Decisions

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 98%, meaning if the test identifies a very low risk, the physician and patient can be 98% sure the patient does not have Grade Group ≥2 (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 2.1

Numerous Studies Verify the Test’s Validation, Clinical Utility and Cost Savings

Validation Study

Multicenter Study Using Two Independent Cohorts of Men Scheduled for Prostate Biopsy

Detection of High-grade Prostate Cancer Using a Urinary Molecular Biomarker–Based Risk Score

  • Before biopsy, post-DRE urine was collected and mRNA levels of several biomarkers were measured. The combination of HOXC6 and DLX1 had the highest predictive accuracy (AUC 0.76) for high-grade prostate cancer (Gleason score ≥7). From a previous study, it was also shown that these biomarkers have a higher predictive accuracy for high-grade prostate cancer than PCA3.
  • Subsequently, logistic regression models were developed and validated combining the biomarkers with clinical variables (PSA, PSA density, DRE, age, family history and prior biopsy).

Clinical Utility Studies

Study Involving 418 Men Undergoing Evaluation for Initial Biopsy

SelectMDx Impacts Prostate Biopsy Decision Making in Routine Clinical Practice

  • The study showed that SelectMDx had a significant impact on initial prostate biopsy decision-making. Biopsy rates in SelectMDx positive men were five-fold higher than in SelectMDx negative men.  In the subset of patients biopsied within three months of receiving test results, 27/71 biopsies performed on SelectMDx positive men were cancer positive, including 10 with high grade disease. In SelectMDx negative men, cancers were identified in 4/9 men biopsied within three months of testing, and all were low-grade disease. These results reflect the clinical utility of SelectMDx for biopsy decision-making in real world clinical practice.

Study of 144 Men Who Might Benefit from mpMRI

Assessment of an Established TRUS and a Urinary Biomarker-Based Risk Score as an Inclusion Criteria for Multiparametric MRI to Detect Clinically Significant Prostate Cancer 

  • All study participants had SelectMDx, mpMRI, and TRUS guided biopsy. The study showed that SelectMDx and mpMRI have great promise for the detection of clinically significant prostate cancer; and that SelectMDx and TRUS before mpMRI will result in a significant reduction of unnecessary mpMRI and, respectively, biopsy procedures. 

Cost-Effectiveness Study

SelectMDx Increases QALY and Cost Savings

Cost-Effectiveness of Urinary Biomarker Panel in Prostate Cancer Risk Assessment 

  • The study showed that Select MDx improves health outcomes and lowers costs in US men with elevated PSA. The expected mean QALY (Quality-Adjusted-Life-Year) per patient under the current standard was 10.796 at a cost of $11,060 over an 18-year horizon. SelectMDx resulted in an average 0.045 QALY gained at a cost-savings of $1,694 per patient. In a conservative estimate of 311,879 men per year undergoing biopsy, SelectMDx is expected to result in an incremental 14,035 QALY gained at a cost-savings of $528,323,026 for each yearly cohort. 

 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