MDxHealth has presented positive data designed to demonstrate the accuracy and decision-making value of its two prostate cancer tests, ConfirmMDx and SelectMDx.
The molecular diagnostics developer has highlighted a clinical utility study showing that ConfirmMDx had a significant positive impact on repeat prostate biopsy decision-making in a US community urology practice setting.
MDxHealth also presented data from a 1,956-patient clinical validation study that was intended to show how SelectMDx demonstrated high sensitivity and negative predictive value in detecting clinically significant prostate cancer.
“These genomic tests should be considered the standard of care for men and help guide their prostate cancer journey,” MDxHealth CEO Michael McGarrity declared in a statement. “The studies being presented at AUA’s 2019 Annual Meeting demonstrate that urologists can rely on the results of ConfirmMDx and SelectMDx as highly-accurate precision medicine tools.”
ConfirmMDx is a tissue test designed to improve the identification of men at risk for undetected clinically significant prostate cancer. The test “rules in” high-risk men who have had a previous negative biopsy result, may be harboring undetected cancer (a false-negative biopsy result), and therefore may benefit from a repeat biopsy and appropriate treatment. ConfirmMDx is also intended to rule out otherwise cancer-free men from undergoing unnecessary repeat biopsies and screening procedures.
Paul M. Yonover, MD, FACS, a urologist with UroPartners, which has more than 30 locations in the Chicagoland region, and colleagues, evaluated the clinical utility of ConfirmMDx in the management of patients being considered for repeat prostate biopsy. The researchers found that ConfirmMDx had a significant impact on the decision-making in a U.S. community urology setting: “Repeat biopsy rates in ConfirmMDx positive men were six-fold higher than in ConfirmMDx negatives.”
In the second study, Alexander Haese, MD, chief physician and faculty member at Martini-Klinik in Hamburg, Germany, led a research team in studying the generalizability of SelectMDx, a 2-gene, urine-based molecular test that combines mRNA biomarkers with clinical factors designed to risk-stratify patients for high-grade prostate cancer.
Haese and his colleagues found that SelectMDx showed high sensitivity and negative predictive value for detection of prostate cancer, supporting the use of the test to help guide initial prostate biopsy decision.
SelectMDx is a liquid biopsy test designed to measure the expression of two mRNA cancer-related biomarkers, HOXC6 and DLX1. The test provides binary results that, when combined with the patient’s clinical risk factors, are intended to help physicians determine whether their patients may benefit from a biopsy and early prostate detection, or can avoid a biopsy and return to routine screening
The company presented its data at poster sessions during the American Urological Association Annual Meeting (AUA 2019), which took place May 3-6 in Chicago.