Predictive Power of IsoPSA Is Sustained For Over Two Years
Data Strengthens Evidence for IsoPSA’s Accuracy in Prostate Cancer Detection & Patient Risk Assessment
CLEVELAND--(BUSINESS WIRE)--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 American Urological Association's 2025 Annual Meeting (AUA 2025), to be held April 26-29 in Las Vegas.
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.
This study and other research will be shared with urology leaders and innovators at this year’s AUA meeting, the leading conference in urology that centers on sharing new discoveries and fostering collaboration to advance the industry.
“Studies such as this illustrate our commitment to advancing science-driven solutions that improve patient outcomes and optimize healthcare decision-making,” said 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.”
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 1500 men with an elevated PSA, we found that a low IsoPSA is incredibly reassuring,” shared Dr. Chris Weight, 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."
“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," added Mark Stovsky, MD, Cleveland Diagnostics’ Chief Medical Officer.
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.
To learn more about IsoPSA, visit ClevelandDx.com.
About Cleveland Diagnostics, Inc.
Cleveland Diagnostics is changing the shape of cancer detection. The company has unlocked the diagnostic power of protein structure with its revolutionary IsoClear™ platform that enables novel diagnostics based on a single cancer-specific, protein structure-based assessment using easy to execute tests within the clinical lab setting. Learn more at ClevelandDx.com and IsoPSA.com.
Contacts
Media Contact:
Liz Robinson at CG Life
news@clevelanddx.com
Investor Contact:
David Holmes
Gilmartin Group
IR@ClevelandDx.com
332-330-1031
