CMS establishes payment rate for Oncuria bladder cancer tests

The Centers for Medicare & Medicaid Services (CMS) have announced Medicare coverage for the Oncuria bladder cancer tests (Oncuria-Detect, Oncuria-Monitor, and Oncuria-Predict), according to news releases from Nonagen Biosciences and DiaCarta, the developer and manufacturer of the tests, respectively.^1,2

In a prior clinical trial of the test, Oncuria was shown to have a 93% sensitivity and a 93% specificity in detecting bladder cancer.

The CMS payment rate for the tests went into effect on January 1, 2024.

"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,” said Adam (Aiguo) Zhang, PhD, CEO and president of DiaCarta, in the news release.²

Oncuria works by detecting concentrations of 10 proteins associated with bladder cancer in urine samples, allowing it to be used across multiple indications. The established payment rate covers all 3 indications of the test: Oncuria-Detect, Oncuria-Monitor, and Oncuria-Predict.

Oncuria-Detect is indicated for the early detection of bladder cancer in patients who present with hematuria. Oncuria-Monitor is for the evaluation of recurrence in patients with a history of bladder cancer. Oncuria-Predict is to predict response to treatment in patients with non–muscle-invasive bladder cancer (NMIBC) who are being considered for intravesical BCG therapy.

The Oncuria Bladder tests can be reported using the Current Procedural Terminology Proprietary Laboratory Analyses codes 0365U for Oncuria-Detect, 0366U for Oncuria-Monitor, and 0367U for Oncuria-Predict. These codes went into effect on January 1, 2023.³

CEO and co-founder of Nonagen Bioscience Charles J. Rosser, MD, MBA, FACS, said in the news release, "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)."²

The Oncuria multiplex bladder cancer immunoassay was previously validated by DiaCarta as a laboratory-developed test.³ In a prior clinical trial of the test, Oncuria was shown to have a 93% sensitivity and a 93% specificity in detecting bladder cancer.⁴ The test also showed a positive predictive value of 0.65 and a negative predictive value of 0.99.

Additionally, the test demonstrated consistent sensitivity across multiple tumor types and grades. The sensitivity of the test in high-grade bladder cancer, low-grade bladder cancer, muscle-invasive bladder cancer, and NMIBC was 0.94, 0.89, 0.97, and 0.93, respectively.

Rosser concluded in the news release, “This marks a significant milestone in advancing bladder cancer care and underscores the pivotal role liquid biopsies play in transforming cancer care. Our suite of Oncuria bladder cancer tests is just one among only a handful of bladder cancer tests that have secured payment rates, and as the market continues to grow, this decision serves as a promising indicator for both Nonagen Bioscience and the broader spectrum of bladder diagnostic companies.”¹

References:

1. Nonagen receives Medicare payment rate for Oncuria Bladder Cancer Tests. News release. Nonagen Bioscience Corp. January 10, 2024. Accessed March 5, 2024. https://www.nonagen.com/news-briefs

2. DiaCarta announces that the Oncuria Bladder Cancer Tests receive Medicare coverage effective January 1, 2024. News release. DiaCarta Inc. March 4, 2024. Accessed March 5, 2024. https://www.prnewswire.com/news-releases/diacarta-announces-that-the-oncuria-bladder-cancer-tests-receive-medicare-coverage-effective-january-1-2024-302077696.html

3. DiaCarta completes Oncuria validation study with Nonagen Bioscience. News release. January 5, 2023. Accessed March 5, 2024. https://www.nonagen.com/news-briefs

4. Hirasawa Y, Pagano I, Chen R, et al. Diagnostic performance of Oncuria, a urinalysis test for bladder cancer. J Transl Med. 2021;19(1):141.doi:10.1186/s12967-021-02796-4