Sunday, 25 August 2019

MDxHealth's SelectMDx Test Successfully Stratifies Men

27 June 2018 | News

Multiple SelectMDx Clinical Study Abstracts presented at 2018 Global Prostate Congress in Frankfurt, Germany

MDxHealth SA, announced the publication of positive data demonstrating the value of the SelectMDx liquid biopsy test for Prostate Cancer in guiding  patient management for men being considered for multiparametric MRI and the clinical utility in guiding biopsy decisions in real-world clinical practice.

Assessment of a urinary TRUS/biomarker-based risk score as inclusion criteria for multiparametric MRI to detect clinically significant prostate cancer

Non-invasive techniques like SelectMDx and Magnetic Resonance Imaging (MRI) show great promise for the detection of prostate cancers that are clinically significant, avoiding over-diagnosis and over-treatment of cancers with low malignant potential.

 

Although several studies support the promise of MRI in this arena, there remains a lack of consensus of its diagnostic accuracy, and its adoption faces further challenges due to the high cost of setting up, staffing and maintaining an MRI unit.

 

Upfront risk stratification could significantly lower the cost of multiparametric MRI (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 over-diagnosis and over-treatment, helping to identify patients who may forgo unnecessary MRI procedures.

 

The study was conducted at five U.S. community urology practices, which sequentially enrolled 418 patients who received a SelectMDx test while undergoing consideration for an initial prostate biopsy.

 

SelectMDx tests were ordered by the treating urologist for patient management (i.e., not as part of a planned or ongoing study), therefore reflecting real-world utility.

 

The study showed that SelectMDx had a significant impact on initial prostate biopsy decision-making in a U.S. community urology setting. Biopsy rates in men testing positive with SelectMDx were 5-fold higher than in men testing negative with SelectMDx.

 

In the subset of patients biopsied within 3 months of receiving test results, 19/27 biopsies performed on SelectMDx positive men were cancer positive, including 10 with high grade disease. In SelectMDx negative men, cancers were identified in 4/9 men biopsied, and all were low-grade disease.

 

Robust performance of a Urinary Molecular Biomarker–Based Risk Score to detect High-grade Prostate Cancer using optimised cascading models

 

The SelectMDx test results incorporate certain identified key clinical variables to improve the identification of patients at increased risk for high-grade PCa on prostate biopsy.

 

The study demonstrates that, even in circumstances where not all clinical factors are available, the performance of SelectMDx remains robust, maintaining a >95% sensitivity.

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