Cleveland Diagnostics Announces Inclusion of IsoPSA® in National Comprehensive Cancer Network® Guidelines for Prostate Cancer Early Detection

NCCN® Guidelines now include IsoPSA to further define the probability of high-grade prostate cancer

CLEVELAND--(BUSINESS WIRE)--Cleveland Diagnostics, Inc., a clinical-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, announced today that its prostate cancer test, IsoPSA, has been added to the National Comprehensive Cancer Network (NCCN) Guidelines for Prostate Cancer Early Detection (version 1.2022). The NCCN panel now recommends the use of IsoPSA as an option to further define the probability of high-grade prostate cancer (Gleason score ≥ 3+4, Grade Group 2 or higher) prior to a first biopsy or after a negative biopsy.

“We are honored that NCCN, an organization that provides valuable guidelines based on the latest evidence and expert consensus, now includes our IsoPSA test in its guidelines for prostate cancer early detection,” said Arnon Chait, Ph.D., Chief Executive Officer at Cleveland Diagnostics. “The NCCN’s new recommendation highlights years of extensive clinical validation and clinical utility studies that all point to how IsoPSA could change the way prostate cancer is diagnosed and subsequently treated.”

“Most urologists follow NCCN prostate cancer guidelines as a standard in the diagnosis and treatment of the disease,” said Mark Stovsky, M.D., Chief Medical Officer at Cleveland Diagnostics. “We are pleased to have IsoPSA included in these guidelines as it will give urologists more insight into the best course of action for patients for which they are evaluating for prostate cancer.”

IsoPSA is a non-invasive, blood-based test that has demonstrated in large, multicenter studies superior diagnostic accuracy and clinical utility when compared to prostate-specific antigen (PSA), the current standard of care in prostate cancer, in men being considered for prostate biopsy.

“In the Introduction section of the new guidelines, the NCCN panel recognizes that maximizing early detection of prostate cancer will increase the detection of both indolent (slower-growing) and aggressive (faster-growing) prostate cancers,” adds Bob Rochelle, Chief Commercial Officer at Cleveland Diagnostics. “The panel also describes a goal of minimizing immediate treatment or overtreatment of indolent cancers by accurately characterizing the biology of detected cancer, and that there are some indolent cancers and benign prostate conditions that can be monitored rather than immediately treated. This is precisely the rationale for our IsoPSA test.”

About NCCN

NCCN is a not-for-profit alliance of thirty-one leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, equitable, and accessible cancer care so all patients can live better lives. The prostate cancer panel consists of an august group of reviewers including epidemiologists, internists, oncologists, pathologists, radiologists and urologists.

About Cleveland Diagnostics, Inc.

Cleveland Diagnostics, Inc., is a commercial-stage biotechnology company developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. Its Solvent Interaction Analysis™ (SIA) technology investigates protein biomarkers at the structural level (as opposed to overall 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, lung cancer and multicancer tests, to maximize clinical performance and efficiencies, reducing costs to payors and the healthcare system. Visit us at ClevelandDx.com.

Cleveland Diagnostics, Inc.
Bob Rochelle
Phone: (216) 432-2700, Ext. 2119
Bob.Rochelle@ClevelandDx.com