Irvine, California, December 2, 2024

Promis Diagnostics is proud to announce the completion of the American Medical Association (AMA) and Centers for Medicare & Medicaid Services (CMS) review process for its innovative EarlyTect® BCD Test, a cutting-edge diagnostic tool for bladder cancer detection. The process began in December 2023 when the test was submitted to the AMA for Proprietary Laboratory Analyses (PLA) code assignment. After a comprehensive three-month evaluation of its technical specifications, methodology, and clinical utility, the AMA assigned a PLA code, acknowledging the test’s distinct purpose, robust performance, and potential to enhance patient care.

The successful PLA code assignment enabled the test’s code to be forwarded to the CMS for pricing consideration under the Clinical Laboratory Fee Schedule (CLFS). In June 2024, Promis Diagnostics proposed pricing for the test during the CLFS Annual Public Meeting. CMS subsequently reviewed the test and announced its preliminary pricing determination of $192 in September 2024.
To ensure transparency and industry feedback, CMS opened a public comment period from October to November 2024, during which stakeholders provided input on the proposed pricing. In November 2024, CMS finalized the pricing for the EarlyTect® BCD Test at $192, making it one of 120 newly reviewed laboratory tests. This finalized price will be effective as of January 1, 2025, and reflected in the updated AMA CPT codebook.

Having achieved coding and payment milestones, the next crucial step is securing Medicare coverage through the MolDx program by demonstrating the test’s clinical utility. This involves presenting evidence on how the test improves diagnostic accuracy and guides treatment decisions for bladder cancer, leading to a Local Coverage Determination (LCD). An LCD will establish Medicare coverage criteria, ensuring broader access for patients and driving adoption in clinical practice. This step solidifies the test’s role in advancing bladder cancer diagnostics and improving patient outcomes.

The EarlyTect® BCD Test reflects Promis Diagnostics’ dedication to innovation and addressing critical unmet needs in bladder cancer detection. With the successful completion of coding and payment milestones, we look forward to the next step of securing Medicare coverage to expand access and adoption. We are confident that this groundbreaking diagnostic tool will play a pivotal role in improving patient care and clinical outcomes.