DiaCarta announced that the Oncuria Bladder Cancer Tests, developed by Nonagen Bioscience and validated by DiaCarta as a lab developed test (LDT), at its CAP-accredited and CLIA-certified laboratory, received Medicare coverage effective Jan. 1, 2024.

Oncuria, a novel 10-biomarker urine test, has been developed as specific tests namely:

  • Oncuria-Detect: Designed for the detection of bladder cancer, providing accurate and reliable results to aid in early diagnosis and treatment planning.
  • Oncuria-Monitor: Enables the monitoring of bladder cancer recurrence, offering physicians valuable insights for disease management and surveillance.
  • Oncuria-Predict: Revolutionizes the prediction of BCG therapy response for non-muscle invasive bladder cancer (NMIBC) patients, empowering clinicians with personalized treatment strategies.

“The approval of Oncuria tests for reimbursement by CMS is a momentous milestone,” says Adam (Aiguo) Zhang, PhD, CEO and president of DiaCarta. “With the superior performance of Oncuria in clinical studies we look forward to continuing wide adoption of the Oncuria tests.”

By securing Medicare reimbursement for Oncuria, DiaCarta says it will continue to facilitate access to innovative diagnostic solutions for patients and healthcare providers nationwide.

Further reading: DiaCarta Launches OTC at Home Fecal Occult Blood Test

“It is great to see the clinical value of these tests being recognized by payers,” says Charles Rosser, MD, MBA, FACS, CEO of Nonagen Bioscience. “CMS’ coverage decision will enable more patients to benefit from the suite of Oncuria tests. I am especially excited for the expanded use of Oncuria Predict in helping to identify patients that may not respond to BCG treatment (BCG is a common first-line treatment for bladder cancer).”