TEST:

IsoPSA®

Sponsored by: IsoPSA We invite you to join us for our product theater "Breakthroughs In Prostate Cancer Risk Assessment: IsoPSA, a Novel Approach to Enhance Biopsy Decision-Making." 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.

Common BPH medications (5-ARI and α-blockers) do not negatively impact IsoPSA performance characteristics for the detection of prostate cancer including clinically actionable prostate cancer.

IsoPSA is highly sensitive for not only csCaP but also unfavorable histologic features including CF/IDC status. This association may not only help inform the need for biopsy but also refine treatment selection when considering active surveillance, focal therapy or whole gland treatments.

The combination of PI-RADS with IsoPSA ratios may help refine the biopsy decision-making process. In our cohort, a negative or equivocal MRI with a low IsoPSA may provide a low enough predicted probability to omit biopsy in such patients.

The performance of IsoPSA for detecting any prostate cancer and clinically actionable prostate cancer is unaffected by commonly used medications (5-ARI and α-blockers) for symptoms of benign prostatic hyperplasia.

"Cleveland Diagnostics, Inc...announced an agreement designed to expand patient access to Cleveland Diagnostics’ novel prostate cancer test, IsoPSA. Through an agreement with Quest Diagnostics...the nation’s leading provider of diagnostic information services, patients will be able to access IsoPSA and, once ordered by their physician, provide a blood specimen for testing at one of over 2,100 Quest Diagnostics patient service center locations nationwide later this year. With its national logistics network, Quest will transport the specimens to Cleveland Diagnostics’ laboratory for testing. The parties expect physicians will be able to begin offering the test to patients through Quest Diagnostics in the second quarter of 2023."

The combination of elevated IsoPSA with adverse PIRADS score (4-5) is associated with a 48% predicted probability of csPCa at biopsy with an AUC of 0.83, which was more accurate than either marker alone. A low IsoPSA in combination with a negative MRI resulted in a 98% chance of benign/indolent disease at biopsy. These findings may prove useful for the practicing Urologist and may help guide discussions regarding the need for biopsy when interpreting various IsoPSA/PIRADS combinations.

In 18-month follow-up, 1.1% of patients with normal IsoPSA developed csPCa compared to 28.5% of patients with high IsoPSA. In the cohort of patients with high IsoPSA and initially negative biopsy, 3.2% eventually developed csPCa, however, having a significantly higher IsoPSA than those who remained negative. The odds of having csPCa were 7 times higher with IsoPSA>10.