DiaCarta Announces That the Oncuria® Bladder Cancer Tests Receive Medicare Coverage Effective January 1, 2024
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 – investor@nonagen.com
For media inquiries or further information, please contact:
Anne Vallerga PhD, MBA
VP, External Affairs
650-333-3152
373739@email4pr.com
SOURCE DiaCarta Inc
DiaCarta Helps Communities Scale Up Their MPOX Testing Efforts with Its Simple, Reliable, and FDA-EUA-Approved MPOX Testing Kits
DiaCarta, Inc., an experienced in-vitro diagnostics (IVD) company that provided COVID-19 testing kits during the global pandemic, has expanded its focus to mpox detection and the detection of other infectious diseases.
DiaCarta and Capstone Health Alliance Collaborate to Bring Revolutionary Diagnostic Tests to Enhance Patient Care
DiaCarta, Inc., a pioneer in developing innovative molecular technologies to transform patient care by providing effective precision diagnostics using liquid biopsy in cancer and infectious diseases has established a strategic collaboration with Capstone Health Alliance, one of the largest regional group purchasing organizations (GPO) in the US healthcare sector. This new collaboration brings together powerful technologies to enhance patient care.
Florida Selects DiaCarta’s cfDNA Test (RadTox™) for Statewide Use to Detect Early Response of Cancer Treatment
DiaCarta, a leading molecular diagnostics company specializing in personalized patient care through liquid biopsy, proudly announced that Florida Health Department selected “using plasma DNA concentration (DiaCarta’s RadTox™ test) for early detection of treatment response and resistance” through the Casey DeSantis Florida Cancer Innovation Fund. This fund supports deployment of the RadTox™ test throughout the State of Florida to be performed between Radiotherapy or Chemotherapy doses for real time detection of treatment response or resistance. The results will be as a real time predictor of imaging data.
DiaCarta, Inc. and OncoAssure Ltd. Collaborate to Launch Prostate Cancer Lab Developed Test
DiaCarta, Inc. (“DiaCarta”), a pioneer in molecular diagnostic test development for cancer and infectious diseases, today announced that it has established a strategic collaboration with OncoAssure Ltd, an Irish medical diagnostics company. The focus of the collaboration is to commercialize OncoAssure’s groundbreaking Prostate test which is designed to identify patients with a lower risk of prostate cancer recurrence, guiding decisions on active surveillance or reduced monitoring post-treatment.
DiaCarta’s RadTox™ Test to Monitor Tumor Response Receives Medicare Coverage
DiaCarta, a leading molecular diagnostics company personalizing patient care through liquid biopsy, proudly announced that its revolutionary RadTox™ test, designed for tumor response monitoring, is now eligible for reimbursement from Medicare, effective January 1, 2024.