CLEVELAND--(BUSINESS WIRE)--Cleveland Diagnostics, Inc., a clinical-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, announced today the publication of a large real-world clinical utility study in Urology Practice, a peer-reviewed journal of the American Urological Association. The study, led by Dr. Eric Klein, Emeritus Professor and Chair of the Glickman Urological & Kidney Institute at Cleveland Clinic and Cleveland Clinic Lerner College of Medicine, found that the use of IsoPSA led to significant provider behavior modification and a 55 percent net reduction in prostate biopsy recommendations.
In the study, a diverse set of 38 providers from both community-based practices and academic locations within the Cleveland Clinic health system enrolled 900 men being evaluated for prostate cancer, readily adopted IsoPSA, and utilized IsoPSA results in their patient management decisions. IsoPSA results led to physicians changing their initial biopsy and MRI recommendations in two-thirds of the cases. In addition to the 55 percent reduction in biopsy recommendations subsequent to the test, IsoPSA also demonstrated both confirmatory and discriminatory power, most notably that providers changed their pre-test ‘biopsy’ recommendations to ‘no biopsy’ recommendations in 90 percent of the cases following receipt of patient IsoPSA results below the test’s threshold value.
“Caregivers are seeking better tools to help them determine with confidence which of their patients should or should not go on to biopsy,” said Dr. Mark Stovsky, Chief Medical Officer at Cleveland Diagnostics. “We expect that IsoPSA, our novel blood-based prostate cancer test, may fundamentally shift the diagnostic paradigm of prostate cancer, and improve patient care and outcomes.”
“We’re very pleased that providers are not only willing to insert IsoPSA into their current diagnostic workflow, but also change their behavior based on the test results,” said Arnon Chait, Chief Executive Officer at Cleveland Diagnostics. “Given the significant reduction in biopsy recommendations observed in this real-world study, the downstream savings to Medicare and commercial payors, and ultimately, the clinical benefits to patients are expected to be substantial.”
It is estimated that $4B is spent in the U.S. each year on unnecessary prostate biopsies. Given the results of this real-world study and previously published clinical validation and cost effectiveness studies, Cleveland Diagnostics believes that IsoPSA will reduce significantly the number of unnecessary procedures, thereby improving patient care while producing significant cost savings for the health care system.
IsoPSA is a non-invasive, blood-based test that demonstrated in a large, multicenter study 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 and IsoPSA.com.