TEST:

AssureMDx

"Photocure ASA...today announced the signing and successful completion of its acquisition of Vesica Health, a U.S. established precision diagnostics company advancing AssureMDx, a urine-based molecular test for the early detection of bladder cancer, in a transaction designed to expand Photocure’s position across the bladder cancer care continuum."

"VESICA HEALTH®...today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) to its AssureMDx test."

Urine-based biomarkers have the potential to improve early BC detection and surveillance while reducing reliance on invasive procedures and costs related to the disease. Future efforts should prioritize cost-effective, large-scale multicentric studies to facilitate the adoption of these biomarkers into routine practice.

"VESICA HEALTH®...today announced that its flagship test, AssureMDx, has been formally recognized in the newly updated American Urological Association (AUA) Guidelines for the evaluation of patients with microscopic hematuria. Hematuria—blood in the urine—is the most common presenting symptom of bladder cancer."

"VESICA HEALTH, INC...announced the launch of its laboratory-developed AssureMDx™ test...AssureMDx represents a significant leap forward in bladder cancer diagnostics, offering unparalleled accuracy and reliability backed by rigorous scientific validation."