MDxHealth SA announced the commercial launch of its AssureMDx(TM) for Bladder Cancer test in the United States as a laboratory developed test (LDT). Testing will be conducted at the company's state-of-the-art CAP and CLIA accredited laboratory facilities in Irvine, California.
Each year in the United States, it is estimated that nearly 11 million patients are referred to a urologist for clinical evaluation due to hematuria (blood in urine). Hematuria is the most common symptom of bladder cancer, yet only 3% to 28% of hematuria patients are diagnosed with bladder cancer. The current standard of care for bladder cancer diagnosis is a cystoscopy, which is an invasive procedure where a cystoscope is inserted into the patient's urethra to visualize the bladder wall and to perform a biopsy if a lesion is identified. However, given the low prevalence of bladder cancer, the vast majority of hematuria patients could avoid the unnecessary discomfort and cost of cystoscopy, if cancer could be ruled out by a less intrusive method.
AssureMDx is a non-invasive, urine-based test, combining methylation and mutation biomarkers, to assess the risk of bladder cancer for patients diagnosed with hematuria. AssureMDx has been validated to improve upon the standard of care, helping rule out the risk of bladder cancer with a negative predictive value (NPV) of 99%. The high NPV led study investigators to report that the test could potentially spare as many as 77% of hematuria patients from undergoing a cystoscopy. Furthermore, the test's 93% sensitivity and 85% specificity can help doctors identify patients at increased risk for bladder cancer, who may benefit from cystoscopy.
"AssureMDx is our third molecular diagnostic test in the field of urology, and our second liquid biopsy test," stated Dr. Jan Groen CEO MDxHealth. "With AssureMDx, we continue to deliver on our mission to offer 'best in class' molecular tests that improve patient outcomes, while reducing healthcare costs."