American Medical Association (AMA) Grants Promis Diagnostics’ EarlyTect® Bladder Cancer Detection, EarlyTect® BCD, a Dedicated CPT PLA Reimbursement Code

Irvine, California, April 2, 2024

  • Obtaining a CPT PLA code marks a key milestone in securing reimbursement from federal and
    private payers for, and expanding access to the innovative EarlyTest® BCD


Promis Diagnostics, Inc., today announced that the American Medical Association (AMA) has assigned a dedicated Current Procedural Terminology (CPT®) Proprietary Laboratory Analysis (PLA), 0452U, for the company’s urine-based bladder cancer detection test, EarlyTect® BCD. Receipt of this new CPT PLA code, which will be effective on July 1, 2024, is a significant step toward payer billing and payment, facilitating broader adoption of non-invasive, urine-based diagnosis of bladder cancer from patients with hematuria.

In the united States, bladder cancer is the 6th most common cancer and the tenth leading cause of cancer in 2023. The most common sign of bladder cancer is hematuria. however, about 10 percent of visible hematuria patients and only 2 to 5 percent with microscopic hematuria are diagnosed with bladder cancer.

The EarlyTect® BCD test is intended for qualitatively detecting a single epigenetic biomarker, PENK methylation, associated with bladder cancer in the urine DNA from patients with hematuria. Methylation of PENK is known to present highly frequently in the urine DNA of all patients with bladder cancers, while rarely or not at all in hematuria patients without the disease.

“Promis Diagnostics is committed to ensuring that our tests are widely accessible and receiving a dedicated CPT PLA code for EarlyTect® BCD is a critical milestone in our commercialization strategy,” said Sungwhan An, Ph.D., CEO. “With EarlyTest® BCD, we believe that expanding equitable access to bladder cancer diagnostics and improving patient health outcomes while reducing healthcare expenditure is possible.”


About Promis Diagnostics

Promis Diagnostics is a fully licensed and accredited specialized laboratory headquarters in Irvine, CA. We were founded to enable patients to lead healthier lives by providing actionable and affordable cancer early diagnostics options. Our specialization is discovering DNA methylation biomarkers and developing highly effective body fluidic-based cancer detection methods. We hold the highest standards of quality control and assurance. We are accredited by the College of American Pathologists (CAP) and certified through Clinical Laboratory Improvement Amendments (CLIA). We operate a state-of-the-art molecular laboratory providing cancer diagnostics. We are dedicated to consistently delivering high-quality services.