CLEVELAND–(BUSINESS WIRE)–Cleveland Diagnostics, Inc., a commercial-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, today announced the publication of two additional major clinical studies for its lead product, IsoPSA , for prostate cancer.
The first publication, published in the peer-reviewed journal, Urological oncology: seminars and original investigations (the official journal of the Society of Urologic Oncology) – describes a large, multicenter, prospective clinical validation study led by Dr. Eric Klein, Professor Emeritus and Chairman of the Glickman Urological & Kidney Institute at the Cleveland Clinic. In this study, researchers validated the diagnostic performance and predictive value of IsoPSA for high-grade prostate cancer and for any prostate cancer in men aged ≥ 50 years 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 in subsequent biopsy and demonstrating the test’s potential both to reduce unnecessary biopsies and to improve the risk-benefit ratio for the early detection of prostate cancer.
In this study, a total of 888 patients evaluated for prostate cancer were enrolled at eight leading academic and community health centers in the United States to validate the clinical performance of IsoPSA. This study demonstrated significant improvements in diagnostic accuracy over standard of care tests and provided support for a new clinical paradigm that incorporates not only the use of IsoPSA after elevated PSA results, but also before MRI in prostate biopsy decision making.
This study highlights key attributes that differentiate IsoPSA in the early detection of prostate cancer, including IsoPSA’s ability to discriminate between high-grade and all-grade prostate cancer risk, diagnostic accuracy on a wide range of trigger total PSA levels (4-100 ng/mL) observed in clinical practice, and the consistent and substantial diagnostic performance of the test in the groups of biopsy-naïve and previously negative biopsy patients.
“Our clinical validation study reaffirms that IsoPSA is a valuable tool that can provide urologists with the critical information needed to determine which patients should undergo biopsy and which do not,” said Dr. Klein. “I believe IsoPSA will result in fewer unnecessary biopsies and reduce overdiagnosis of indolent prostate cancer and thereby reduce overtreatment.”
In the second study, published in Urology (the “Golden Journal”), Benidir, et al. describe a retrospective analysis of real-world data representing outcomes associated with the use of IsoPSA. In the study, investigators evaluated patients who underwent radical prostatectomy following elevated IsoPSA values that prompted a biopsy.
“In real-world applications, our study demonstrated that IsoPSA does not select for any particular undesirable pathological feature during radical prostatectomy. IsoPSA is a reliable tool for the identification of clinically significant prostate cancer,” commented lead author Dr. Chris Weight of the Cleveland Clinic.
As an unbiased and agnostic predictor of significant disease, IsoPSA has been shown to be useful even in cases where biopsy histology and radiology may not accurately reflect current disease biology. Study investigators observed that many so-called “false positive” IsoPSA results may in fact be true positives for high-grade cancer since biopsies (the standard to which IsoPSA is compared in previous prospective clinical studies ) are known to miss 20 to 30 percent of cancers. In this study, 99% of patients with IsoPSA scores greater than 6.0 (the IsoPSA threshold that triggers biopsy) had clinically significant prostate cancer at subsequent radical prostatectomy, the ultimate determinant of prostate cancer status. disease.
“Cleveland Diagnostics is fully committed to supporting and publishing the results of high quality studies. The clinical validation study adds to the already extensive body of clinical evidence supporting IsoPSA, which indicates superior clinical performance and biopsy reductions,” said Arnon Chait, PhD, CEO of Cleveland Diagnostics. “The independent real-world outcome study is another example of the growing number of key publications authored by clinicians using the test in their practice, 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 IsoPSA to 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 further support the idea that IsoPSA has the ability to not only significantly reduce the number of unnecessary procedures, but also identify patients with clinically significant disease. cancer that can even be missed by MRI and biopsy. This, in turn, could generate significant savings for the healthcare system and improve patient outcomes.
IsoPSA is a non-invasive blood test that has demonstrated in large, multi-center studies superior diagnostic accuracy compared to prostate-specific antigen (PSA), the current standard of care in the diagnosis of prostate cancer. Cleveland Diagnostics currently offers IsoPSA as a laboratory-developed test (LDT) performed at its highly complex, CLIA-certified, and CAP-accredited laboratory in Cleveland, Ohio.
About Cleveland Diagnostics, Inc.
Cleveland Diagnostics, Inc. is a commercial-stage diagnostics company that develops highly effective, laboratory-friendly, and affordable diagnostic tests using proprietary technology to improve cancer diagnosis. The Company’s Solvent Interaction Analysis™ (SIA) technology studies protein biomarkers at the structural level (as opposed to just the concentration of biomarkers) in blood, providing better and more direct insight into the origin of proteins at the cellular level, thus improving the specificity of the test at the underlying level. disease process. Its non-invasive cancer diagnostics portfolio will span from prostate cancer to breast cancer and lung cancer, as well as certain other diseases. Please visit us at ClevelandDx.com.