Molecular test assesses bladder Ca risk in patients with hematuria
MDxHealth SA has launched the AssureMDx for Bladder Cancer test in the United States as a laboratory developed test. The noninvasive, urine-based test combines methylation and mutation biomarkers to assess the risk of bladder cancer in patients diagnosed with hematuria. The test has been validated to improve the standard of care by helping to rule out the risk of bladder cancer with a negative predictive value of 99%. Researchers found that the high negative predictive value could help as many as 77% of hematuria patients avoid undergoing a cystoscopy. Additionally, the test’s 93% sensitivity and 85% specificity can help physicians identify patients at an increased risk for bladder cancer who might benefit from cystoscopy. Testing will be performed at the MDxHealth CAP and CLIA-accredited laboratory facilities in Irvine, CA.
For more information, visit www.mdxhealth.com.