Of the more than 2 million prostate biopsies performed each year in the US and Europe, less than a third find cancer. Most of these men could have avoided a painful and invasive prostate biopsy procedure, with its associated complications and costs. SelectMDx for Prostate Cancer is a proprietary urine-based, molecular diagnostic test that offers a non-invasive ‘liquid biopsy’ method to assess a man’s risk for prostate cancer. SelectMDx helps identify men at increased risk of harboring aggressive, potentially lethal, prostate cancer who may benefit most from a prostate biopsy and earlier detection. The test delivers a negative predictive value (NPV) of 98% for clinically significant disease, helping to reduce unnecessary MRI procedures and invasive prostate biopsies by approximately 50%, thereby reducing healthcare costs.
Read more about the Select MDx liquid biopsy test
PSA testing is the current standard of care to determine if a patient should be selected for a prostate biopsy. However, since the test has a low-specificity for prostate cancer, it can lead to a considerable number of unnecessary, invasive procedures some of which find clinically insignificant tumors.
Researchers from leading universities in Belgium and The Netherlands used a decision-tree and mathematical model to evaluate diagnostic strategies that used SelectMDx versus PSA testing alone, to identify patients for transrectal ultrasound-guided biopsy (TRUSGB) procedures. Findings indicated that a diagnostic strategy that used SelectMDx with a cut-off sensitivity of 95.7% for high-grade prostate cancer, resulted in savings of €128 and a gain of 0.025 quality-adjusted life year (QALY)* per patient compared to using PSA alone.
“We know from our clinical validation studies that SelectMDx is a powerful predictor of high-grade prostate cancer and can help stratify patients for biopsy,” said Prof. Wim Van Criekinge, study investigator, Ghent University, Belgium and Chief Scientific Officer of MDxHealth. “However, it was interesting to see that adding SelectMDx on top of the current standard of care actually lowered healthcare costs.”
Patients selected for TRUSGB using PSA testing alone had a probability of 77% to undergo an unnecessary procedure versus 36% when using SelectMDx. Therefore, 41% of these unnecessary biopsies could be prevented. The probability to find a low-grade prostate cancer was also reduced by 7%.
