The SelectMDx test for prostate cancer reduces overdiagnosis and overtreatment in men at risk of prostate cancer compared to PSA testing alone, MDxHealth announced.
By cutting the number of unnecessary biopsies, the test brings down total costs per patient while improving quality of life, according to the Dutch study, “Cost-effectiveness of a new urinary biomarker-based risk score compared to standard of care in prostate cancer diagnostics: a decision analytical model,” which appeared in the journal BJU International.
The standard biomarker for prostate cancer is a PSA level above 3 ng/ml), but PSA testing has a low specificity for prostate cancer. In other words, PSA levels may be higher in the prostate due to other reasons, and can distort the diagnosis, leading to unnecessary, burdensome and expensive medical interventions.
MDxHealth says its SelectMDx test measures the probability of a man developing an aggressive form of the disease with 98 percent accuracy. The test uses urine samples to measure the expression levels of DLX1 and HOX6 biomarkers, and combines it with traditional clinical parameters like PSA.
Researchers at the Radboud University Medical Center in the Netherlands assessed the cost-effectiveness of the SelectMDx test to identify patients for transrectal ultrasound-guided biopsy (TRUSGB) and compared it to that of PSA testing. Cost-effectiveness was expressed in quality-adjusted life years (QALYs, a measure of how medical intervention interferes with a patient’s quality of life) and healthcare costs of both diagnostic strategies, simulating the course of patients over a period of 18 years.
Results showed that a diagnostic strategy using SelectMDx with a cut-off sensitivity of 95.7 percent for high-grade prostate cancer resulted in savings of €128 (about $135) and a gain of 0.025 QALY per patient compared to using PSA testing alone.
Indeed, men selected for TRUSGB after PSA testing alone were more likely to be submitted to an unnecessary procedure (77 percent) than those chosen by SelectMDx (36 percent). This means that 41 percent of unnecessary biopsies could be prevented. Also, the likelihood of finding a low-grade prostate cancer fell by 7 percent.
“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,” Wim Van Criekinge, the study’s author, said in a news release. “However, it was interesting to see that adding SelectMDx on top of the current standard of care actually lowered healthcare costs.”