Summary:
A new study published in Urology confirms Cleveland Diagnostics’ IsoPSA test effectively differentiates between low- and high-risk prostate cancer patients, potentially reducing unnecessary biopsies while enhancing early detection.

Three Takeaways:

  1. Risk Stratification: IsoPSA reliably identifies low-risk patients who may safely avoid or delay invasive procedures and high-risk patients needing close monitoring.
  2. Long-Term Predictive Value: A low IsoPSA Index (≤6) was linked to sustained low prostate cancer risk over 30 months, while a high index (>6) indicated significant cancer risk.
  3. Clinical Impact: IsoPSA supports more precise and cost-effective prostate cancer care and is covered by Medicare and available nationwide.

Cleveland Diagnostics, Inc., a pioneering, commercial-stage oncology company developing highly accurate diagnostic tests, announced today the results of a new independent study published in Urology. The longitudinal study demonstrates the ability of the company’s IsoPSA prostate cancer test to help identify low-risk patients who can avoid or defer unnecessary interventions such as biopsy, while identifying high-risk patients who would benefit from closer monitoring. This successful study sets the tone for Cleveland Diagnostics’ strong presence at the upcoming American Urological Association’s 2025 Annual Meeting (AUA 2025).

IsoPSA Index Shows Prostate Cancer Risk

The study found that patients with a low IsoPSA Index (≤6) continued to have a lower risk of clinically significant prostate cancer (csPCa) up to 30 months after initial testing, while patients with a high IsoPSA Index (>6) had consistently much higher risk for csPCa at all time points evaluated. The predictive value of a low IsoPSA Index may help reduce potentially unnecessary biopsies or extend intervals between biopsies, allowing low-risk patients to avoid costs and associated risks (e.g., biopsy pain, infection, or sepsis). Conversely, nearly 50% of patients with a high IsoPSA Index developed csPCa within 30 months, highlighting the need for closer monitoring and follow-up of those patients. Study findings also reinforce IsoPSA’s ability to further refine biopsy decisions when paired with MRI.

“Studies such as this illustrate our commitment to advancing science-driven solutions that improve patient outcomes and optimize healthcare decision-making,” says Arnon Chait, PhD, president and CEO at Cleveland Diagnostics. “IsoPSA is rapidly setting a new standard for precision in prostate cancer care enhancing early detection by reducing unnecessary interventions for low-risk patients while ensuring high-risk patients receive the close monitoring they need.”

Most Common Men’s Cancer

Prostate cancer remains the second most common cancer in American men, with 1 in every 8 men diagnosed during their lifetime. This growing number of diagnoses emphasizes the importance of early and accurate risk assessment and testing for better patient outcomes. IsoPSA is a highly accurate blood test that provides greater insight into patients’ elevated PSA levels by analyzing PSA protein structure to determine if the proteins may have originated in cancer cells.

“In this large study of over 1,500 men with an elevated PSA, we found that a low IsoPSA is incredibly reassuring,” says Dr. Chris Weight, MD, center director for Urologic Oncology at Cleveland Clinic and contributing author. “We found that not only was there a very low risk for prostate cancer at the time of the low IsoPSA, but very few men (~4%) went on to develop prostate cancer in the following 2.5 years. This means that most men with an elevated PSA can feel comfortable forgoing further invasive testing if they also have a low IsoPSA.”

The physician-ordered IsoPSA test is one of the only prostate cancer tests to be covered by Medicare and a growing body of commercial payors. The test is available to order directly through Cleveland Diagnostics or at Quest Diagnostics clinics across the country.

“IsoPSA represents a major advancement in prostate cancer management. The findings from this most recent study support the critical role of innovative biomarker-driven approaches in both refining clinical decision making and improving resource allocation for physicians,” says Mark Stovsky, MD, Cleveland Diagnostics’ chief medical officer.

Featured Image: A technician runs a test using the IsoPSA in Cleveland Diagnostics’ CLIA lab. Image; Cleveland Diagnostics