Value to Payors

The Impact of
Covering IsoPSA

Current prostate cancer screening methods can result in wasteful spending and patient dissatisfaction.

Inefficiencies in prostate cancer early detection result in significant and increasing costs to the US healthcare system as well as continued dissatisfaction for patients and providers.

Patients with increased baseline risk after screening are typically sent for further testing, such as MRI and biopsy to diagnose prostate cancer. However, 75% of prostate biopsy results are negative for cancer.

There is an opportunity to address these rising costs and unnecessary procedures through coverage of IsoPSA.

IsoPSA is a blood test for men ages 50 years and older with elevated PSA levels to further assess their risk of clinically significant prostate cancer and better triage the right patients to biopsy.

IsoPSA is a proprietary test exclusively performed by Cleveland Diagnostics. The test is:

  • Covered by Medicare: LCD – Prostate Cancer Detection with IsoPSA® (L39284) (cms.gov)
  • IsoPSA is included in many of the leading diagnostic guidelines, including:
    • (NCCN®) Early Prostate Cancer Detection
    • AUA/SUO Early Detection of Prostate Cancer
  • Assigned a unique CPT Code: PLA 0359U
  • Assigned a Z-Code: Z0008K
  • Included on the Clinical Laboratory Fee Schedule
Clinical study findings

Substantial clinical validation and proven clinical utility.

In an IsoPSA Clinical Utility study of 734 patients, test results were analyzed to affirm or modify provider recommendations for prostate biopsy and/or MRI1:

  • 60% change in recommendations for biopsy.
  • 90% of patients initially recommended for biopsy were not recommended for biopsy after clinicians received IsoPSA results ≤ 6.
  • 55% reduction in recommendations for prostate biopsy overall.

An IsoPSA Clinical Validation study of 888 patients demonstrated2:

  • IsoPSA outperformed total PSA and % free PSA on area under the ROC curve, specificity, and positive and negative predictive values at similar sensitivity.
  • Using the IsoPSA Index cutoff for csPCa (>6), an estimated 46% of biopsies could be avoided in low-risk patients.

A real-world study of 1,578 consecutive patients with elevated PSA confirmed IsoPSA’s ability to predict clinically significant prostate cancer (csPCa) at 12, 24, and 30 months.3 The study found:

  • IsoPSA has value as a reliable single-time test for assessing and predicting intermediate-term csPCA risk.
  • Low IsoPSA results can justify reducing, deferring, or avoiding further testing (MRI, biopsy, repeat PSA), minimizing burden and risk of missing csPCa.
  • Patients with high IsoPSA results warrant closer monitoring.

IsoPSA is gaining widespread adoption

IsoPSA is covered by Medicare (LCD by CGS Administrators, LLC), and a growing number of of commercial payors. The test is being adopted by a growing number of clinicians nationwide.

FOOTNOTES
1. Scovell J, et al., Urol. Pract 2022.
2. Klein, et al., Urol Oncol. 2022 Sep;40(9):408.e9-408.e18.
3. Abdallah, et al., Urology Jan15:S0090-4295(25)00031-7.