TEST:

IsoPSA®

IsoPSA density performed comparably to PSA density and outperformed traditional clinical predictors of csCaP. In MRI-negative men, its high negative predictive value supports its use as a non-invasive tool to reduce unnecessary biopsies. IsoPSA density may serve as a valuable adjunct in contemporary prostate cancer diagnostic pathways and warrants further validation.

Commercially-available, noninvasive biomarker tests consistently outperformed PSA and PSA-based risk calculators for detection of csPCa. Clinical use of these tests appears to substantially reduce the proportion of unnecessary biopsies performed, while maintaining detection of the vast majority of significant cancers.

"Cleveland Diagnostics, Inc...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 risk of developing csPCa was smaller in patients with initial low vs high IsoPSA Indices over the ensuing 30 months, which supports using IsoPSA to safely avoid follow-up testing.

The contemporary literature further supports the proposed role of post-PSA biomarker testing to reduce the use of invasive biopsy while maintaining highly sensitive detection of GG ≥ 2 cancer. Questions remain regarding the optimal application of biomarkers in combination or in sequence with mpMRI.

" Join us on May 5th from 1: 30-2: 15 pm, as we discuss Drawbacks of conventional PSA screeningCurrent testing to further stratify risk for prostate cancer and their constraintsIn-depth look into IsoPSA and the key differentiators and advantagesReview of compelling IsoPSA clinical data and case studiesInteractive Q&A – Have your questions answered by Dr. Berger

"Cleveland Diagnostics...signed a distribution agreement with Dow BioMedica, a trusted distributor of life science solutions for biotechnology, clinical research organizations, and universities. Under this agreement, Dow BioMedica will exclusively distribute Cleveland Diagnostics’ IsoPSA prostate cancer test in Korea."

With a 24-month follow-up, 4. 3% of patients with normal IsoPSA developed csPCa, suggesting that a low baseline IsoPSA provides durable information about the 2-year risk of csPCa.

"Cleveland Diagnostics, Inc...announced the closing of over $75M in growth capital financing. The financing was led by Novo Holdings, a leading global life sciences investor, responsible for managing the assets of the Novo Nordisk Foundation, along with participation from existing investors as well as a credit facility from Symbiotic Capital. The financing will accelerate Cleveland Diagnostics’ commercial and corporate development goals....Cleveland Diagnostics’ portfolio of oncology related tests will be expanding beyond prostate cancer into additional indications in 2024."

With 24-month follow-up, 4.3% of patients with normal IsoPSA developed csPCa, suggesting that a low baseline IsoPSA provides durable information about the 2-year risk of csPCa.

In a real-world clinical setting, providers from diverse training backgrounds and practice settings readily adopted IsoPSA with substantial reductions in the rate of recommended prostate biopsies in patients with elevated PSA values (≥4 ng/ml). There was a high concordance between recommendation for or against prostate biopsy and the IsoPSA result.