Cleveland Diagnostics Announces the Publication of Two Major IsoPSA® Studies

Prospective, multicenter clinical validation study and retrospective real-world outcomes study reaffirm significant improvement over standard of care tests and overall utility of IsoPSA in the detection of prostate cancer

Cleveland Diagnostics, Inc., a commercial-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, announced today the publication of two additional major clinical studies relating to its lead product, IsoPSA, for prostate cancer.

The first publication—appearing in the peer-reviewed journal, Urologic Oncology: Seminars and Original Investigations (the official journal of the Society of Urologic Oncology)—describes a large, prospective, multicenter clinical validation study led by Dr. Eric Klein, Emeritus Professor and Chair of the Glickman Urological & Kidney Institute at Cleveland Clinic. In this study, investigators validated the diagnostic performance and predictive value of IsoPSA for both high-grade and any prostate cancer in men age ≥ 50 with total PSA ≥ 4 ng/mL, confirming that IsoPSA outperforms standard of care tests (total and % free PSA) in discriminating the risk of prostate cancer on subsequent biopsy and demonstrating the test’s potential to both reduce unnecessary biopsies and to improve the risk-benefit ratio for early detection of prostate cancer.

In this study, a total of 888 patients being evaluated for prostate cancer were enrolled at eight leading academic and community healthcare centers in the United States to validate the clinical performance of IsoPSA. This study demonstrated significant improvements in diagnostic accuracy vs. standard of care tests and provided support for a novel clinical paradigm that not only incorporates the use of IsoPSA following elevated PSA results, but also prior to MRI during prostate biopsy decision making.

This study highlights key attributes that differentiate IsoPSA in the early detection of prostate cancer including the ability of IsoPSA to distinguish the risk of both high‐grade and any‐grade of prostate cancer, diagnostic accuracy across a broad range of triggering total PSA levels (4‐100 ng/mL) seen in clinical practice, and the consistent and substantial diagnostic performance of the test in both biopsy naïve and prior negative biopsy patient groups.

“Our clinical validation study reaffirms that IsoPSA is a valuable tool that can provide urologists with critical information needed to determine which patients need to go to biopsy and which do not,” said Dr. Klein. “I believe that IsoPSA will lead to fewer unneeded biopsies and reduce overdiagnosis of indolent prostate cancer and thereby reduce overtreatment.”

In the second study, published in Urology (the “Gold Journal”), Benidir, et al. describe a retrospective analysis of real-world data representing outcomes associated with IsoPSA use. In the study, investigators evaluated patients who went on to radical prostatectomy following elevated IsoPSA values which triggered biopsy.

“In real world applications, our study demonstrated that IsoPSA does not select for any particular adverse pathologic feature upon radical prostatectomy. IsoPSA is a reliable tool for the identification of clinically significant prostate cancer,” commented lead author Dr. Chris Weight of Cleveland Clinic.

As a non-biased, agnostic predictor of meaningful disease, IsoPSA was demonstrated to be valuable even in cases where biopsy histology and radiology may not accurately reflect the current biology of disease. Study investigators observed that many so-called “false positive” IsoPSA results may actually be true positives for high-grade cancer given that biopsies (the standard to which IsoPSA is compared in earlier prospective clinical studies) have been known to miss 20-30 percent of cancers. In this study, 99 percent of patients with IsoPSA indices greater than 6.0 (the IsoPSA threshold that triggers biopsy) had clinically significant prostate cancer on subsequent radical prostatectomy, the ultimate determinant of disease status.

“Cleveland Diagnostics is fully committed to supporting and publishing results from high quality studies. The clinical validation study adds to the already extensive stable of clinical evidence supporting IsoPSA, which indicates superior clinical performance and biopsy reductions,” said Arnon Chait, PhD, Chief Executive Officer at Cleveland Diagnostics. “The independent real-world outcomes study is another example of the growing number of key publications authored by clinicians using the test in their practices, and supports the use of IsoPSA earlier in the diagnostic paradigm. Due to data such as those highlighted in these two important new publications, we continue to see rapid clinical adoption of the test, and expect that IsoPSA will become an integral part of every urologist’s workflow.”

Together with the results of previously-published clinical validation, clinical utility, and cost effectiveness data, these new studies lend further support for the notion that IsoPSA has the ability to not only dramatically reduce the number of unnecessary procedures but also identify patients with clinically significant cancer that may even be missed by MRI and biopsy. This, in turn, could generate significant savings to the healthcare system and improve patient outcomes.

About IsoPSA

IsoPSA is a non-invasive, blood-based test that demonstrated in large, multicenter studies superior diagnostic accuracy compared to prostate-specific antigen (PSA), the current standard of care in prostate cancer diagnosis. Cleveland Diagnostics currently offers IsoPSA as a laboratory-developed test (LDT) conducted at its high-complexity, CLIA-certified, CAP-accredited laboratory in Cleveland, Ohio.

About Cleveland Diagnostics, Inc.

Cleveland Diagnostics, Inc. is a commercial-stage diagnostics company developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. The Company’s Solvent Interaction Analysis™ (SIA) technology investigates protein biomarkers at the structural level (as opposed to mere biomarker concentration) in blood, providing better and more direct insights regarding the protein origin on the cellular level, thus improving test specificity to the underlying disease process. Its portfolio of non-invasive cancer diagnostics will be expanding from prostate cancer to breast cancer and lung cancer, and certain other diseases. Please visit us at ClevelandDx.com.

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