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Cleveland Diagnostics Announces Publication of Multicenter IsoPSA Clinical Validation Study Demonstrating Improved Accuracy Over Prostate-Specific Antigen Test

May 7, 2019

CLEVELAND--(BUSINESS WIRE)--May 7, 2019--Cleveland Diagnostics, Inc., a clinical-stage company focused on developing next-generation diagnostic tests for the detection of cancers, today announced the online publication of results from a multicenter validation study of IsoPSA™, a novel structure-based prostate cancer assay, in Journal of Urology. The study validated the findings from a preliminary study published earlier in European Urology, demonstrating that the non-invasive, blood-based IsoPSA assay has superior diagnostic accuracy over the current gold standard, prostate-specific antigen (PSA), in detecting high-grade prostate cancer.

The study, led by Eric Klein, M.D., chairman of Cleveland Clinic’s Glickman Urological & Kidney Institute, involved leading researchers from Cleveland Clinic, Johns Hopkins, University of Texas Southwestern, Kaiser Permanente Northwest, Rabin Medical Center (Israel), and other academic and community clinical sites.

“We now have extensive clinical evidence that supports our technology and the ability of IsoPSA to meaningfully change the current clinical paradigm in prostate cancer diagnosis,” said Arnon Chait, Ph.D., CEO of Cleveland Diagnostics. “We continue to work towards the appropriate regulatory approvals to get IsoPSA into the hands of physicians as soon as possible.”

The multicenter study compared the diagnostic accuracy of Cleveland Diagnostics’ IsoPSA technology to that of PSA, the current standard of care in prostate cancer, in men scheduled for prostate biopsy. The results echoed those from a preliminary study, demonstrating that IsoPSA has much greater diagnostic performance than PSA in identifying which patients have high-grade disease.

“The superior clinical performance stems from the underlying technology, which effectively classifies proteins based on cancer-specific changes to their structure, rather than overall concentration in blood – which is not cancer-specific. This first-in-class scientific approach can be extended to a number of cancers and neurodegenerative diseases, which we are currently exploring,” said Chait. The results of the study show that IsoPSA could reduce unnecessary biopsies by at least 45 percent, saving men from unneeded invasive and expensive procedures that can sometimes lead to serious and lasting side effects. Future indications for IsoPSA could also include active surveillance and direct replacement of PSA for screening in the primary care environment, while still maintaining a similar cost structure.

Cleveland Diagnostics has several clinical collaborations around the world, including underserved areas in Africa and India. “A unique advantage of IsoPSA is that it does not require highly specialized or expensive equipment or reagents to run samples,” said Aimee Kestranek, Vice President of Operations at Cleveland Diagnostics. “We have set up clinical sites in a matter of hours due to the ease-of-use of the IsoPSA technology.”

Dr. Klein has no personal financial interest in the company.

About Cleveland Diagnostics, Inc.

Cleveland Diagnostics, Inc., is a clinical-stage biotechnology company developing technology to improve cancer diagnostics. Its Solvent Interaction Analysis (SIA) technology investigates biomarkers at the structural level as opposed to overall concentration, giving better insights as to the protein origin. Its portfolio of non-invasive cancer diagnostics include prostate cancer, breast cancer, and Alzheimer’s disease. Visit us at cleveland-diagnostics.com.

View source version on businesswire.com:https://www.businesswire.com/news/home/20190507005792/en/

CONTACT: Cleveland Diagnostics, Inc.

3615 Superior Ave #4407B

Cleveland, OH 44114

Erich Heise

Phone: 216.432.2700

info@cleveland-diagnostics.com

KEYWORD: UNITED STATES NORTH AMERICA OHIO

INDUSTRY KEYWORD: SURGERY HEALTH BIOTECHNOLOGY CLINICAL TRIALS HOSPITALS ONCOLOGY OTHER HEALTH RESEARCH OTHER SCIENCE SCIENCE GENERAL HEALTH

SOURCE: Cleveland Diagnostics, Inc.

Copyright Business Wire 2019.

PUB: 05/07/2019 11:24 AM/DISC: 05/07/2019 11:24 AM

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