MDxHealth SA, Herstal, Belgium, and Irvine, Calif, has announced the publication of data demonstrating the value of the SelectMDx liquid biopsy test for prostate cancer in guiding patient management for men under consideration for multiparametric magnetic resonance imaging (mpMRI).

The study results indicate the clinical utility of the test for guiding biopsy decisions in real-world clinical practice. Researchers from Belgium and the Netherlands presented the data this June at the Global Congress on Prostate Cancer (PROSCA) in Frankfurt, Germany.1

Jan Groen, PhD, MDxHealth.

Noninvasive techniques such as SelectMDx and mpMRI show great promise for the detection of prostate cancers that are clinically significant, enabling clinicians to avoid overdiagnosis and overtreatment of cancers with low malignant potential. Although several studies support the promise of MRI in this arena, there remains a lack of consensus on its diagnostic accuracy, and its adoption faces challenges due to the high cost of setting up, staffing, and maintaining an MRI unit. Upfront risk stratification could significantly lower the cost of mpMRI by excluding patients who are at very low risk for high-grade prostate cancer.

The study demonstrated that use of the SelectMDx liquid biopsy test for prostate cancer significantly reduces overdiagnosis and overtreatment, helping to identify patients who may forgo unnecessary MRI procedures.

“These new studies show the clinical utility of SelectMDx for biopsy decisionmaking in real-world clinical practice,” says Jan Groen, PhD, CEO of MDxHealth. “Significant results from multiple prior and ongoing studies on thousands of patients continue to support the value of SelectMDx as a tool to prevent unnecessary biopsy procedures in men demonstrating prostate cancer symptoms, benefiting patients and reducing the cost of public healthcare.”

“The use of genomic classifiers such as SelectMDx is set to revolutionize the way that we manage patients with prostate cancer, predicting with extreme accuracy the likely biopsy findings and allowing us to tailor our advice and investigations appropriately,” adds Christopher Eden, professor of urology at the Royal Surrey County Hospital and director of the Santis prostate cancer clinic in London.

In addition, two other relevant abstracts were presented at PROSCA. The first demonstrated the significant impact of SelectMDx tests on initial prostate biopsy decisionmaking in a community urology setting in the United States. Conducted at five community urology practices, the study sequentially enrolled 418 patients who received a SelectMDx test ordered by the treating urologist while undergoing consideration for an initial prostate biopsy. Results showed that biopsy rates in men testing positive with SelectMDx were five-fold higher than in men testing negative with SelectMDx. In the subset of patients biopsied within 3 months of receiving test results, 19 of 27 biopsies performed on SelectMDx-positive men were cancer positive, including 10 with high-grade disease. In SelectMDx-negative men, cancers were identified in 4 of 9 men biopsied, and all were low-grade disease.2

The second study demonstrated that SelectMDx testing improved the identification of patients at increased risk for high-grade prostate cancer on biopsy and showed that, even in circumstances where not all clinical factors are available, the performance of SelectMDx remains robust, maintaining sensitivity greater than 95%.3

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References
 

  1. Trooskens G. Assessment of a urinary TRUS/biomarker-based risk score as inclusion criteria for multiparametric MRI to detect clinically significant prostate cancer [abstract]. Presentation at the Global Congress on Prostate Cancer, Frankfurt, Germany, June 28–30, 2018. Available at: https://abstracts.mirrorsmed.org/abstracts/assessment-urinary-trusbiomarker-based-risk-score-inclusion-criteria-multiparametric-mri. Accessed July 25, 2018.
  1. Shore N. SelectMDx impacts prostate biopsy decisionmaking in routine clinical practice [abstract]. Presentation at the Global Congress on Prostate Cancer, Frankfurt, Germany, June 28–30, 2018. Available at: https://abstracts.mirrorsmed.org/abstracts/selectmdx-impacts-prostate-biopsy-decision-making-routine-clinical-practice. Accessed July 25, 2018.
  1. Trooskens G. Robust performance of a urinary molecular biomarker–based risk score to detect high-grade prostate cancer using optimized cascading models [abstract]. Presentation at the Global Congress on Prostate Cancer, Frankfurt, Germany, June 28–30, 2018. Available at: https://abstracts.mirrorsmed.org/abstracts/robust-performance-urinary-molecular-biomarker–based-risk-score-detect-high-grade-prostate. Accessed July 25, 2018.