DiaCarta Announces That the Oncuria® Bladder Cancer Tests Receive Medicare Coverage Effective January 1, 2024

PLEASANTON, Calif., March 4, 2024 /PRNewswire/ -- DiaCarta proudly 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, have received Medicare coverage effective January 1, 2024.

Oncuria, a novel 10-biomarker urine test, is the first of its kind that 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.

Dr. Adam (Aiguo) Zhang, CEO and President of DiaCarta, emphasized the significance of this achievement: "The approval of Oncuria® tests for reimbursement by CMS is a momentous milestone. With the superior performance of Oncuria in clinical studies we look forward to continuing wide adoption of the Oncuria tests."

Dr. Charles Rosser, CEO of Nonagen Bioscience, expressed his enthusiasm for the recognition of these tests by payers: "It is great to see the clinical value of these tests being recognized by payers. 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)."

This approval underscores DiaCarta's commitment to advancing precision medicine and improving patient outcomes in bladder cancer care. By securing Medicare reimbursement for Oncuria®, DiaCarta continues to facilitate access to innovative diagnostic solutions for patients and healthcare providers nationwide.

About DiaCarta:

DiaCarta is a leading molecular diagnostics company dedicated to advancing precision medicine through innovative solutions. With a focus on improving patient outcomes across various oncology indications, DiaCarta's portfolio of cutting-edge assays empowers clinicians with actionable insights for personalized treatment strategies. For more information, visit www.diacarta.com.

About Nonagen Bioscience

Nonagen Bioscience is a biotechnology company focused on globally reducing the burden of cancer with innovative diagnostics. As a physician-led company, Nonagen Bioscience is committed to bringing to market the best-in-class, noninvasive diagnostics for cancer detection, therapy choice, and disease monitoring, so patients can live better, longer lives. The Los Angeles-based company was founded in 2011 and is currently developing diagnostics for bladder, breast, and prostate cancers. For more information, visit www.nonagen.com.

Nonagen Contact:
Investor Relations - [email protected]

For media inquiries or further information, please contact:
Anne Vallerga PhD, MBA
VP, External Affairs
650-333-3152
[email protected]

SOURCE DiaCarta Inc