Articles from Cleveland Diagnostics, Inc.

Cleveland Diagnostics, Inc., a pioneering, commercial-stage precision oncology company, has appointed Rich Ramko to its Board of Directors. Ramko's extensive financial leadership across the biotech, pharmaceutical, medical device, and healthcare sectors will help support Cleveland Diagnostics as it advances commercialization of its IsoPSA® prostate cancer test and expands its proprietary IsoClear™ platform into new therapeutic areas.

Cleveland Diagnostics, Inc., a commercial-stage precision oncology company, recently received ISO 13485:2016 certification, the globally recognized standard for medical device quality management systems. The certification validates that Cleveland Diagnostics has implemented the manufacturing, quality, and operational infrastructure required to support scaled commercial production and distribution of its Class III IVD medical device, IsoPSA® Assay.

Cleveland Diagnostics, Inc., a pioneering, commercial-stage precision oncology company, has named Michael Iskra as its new Chief Executive Officer. Iskra brings more than 30 years of industry experience with large multinational companies, including Bayer, Siemens, and Ortho Clinical Diagnostics/QuidelOrtho. He will leverage his global market expertise and proven track record in strategy development, growth transformation, and building best-in-class customer experience teams to accelerate Cleveland Diagnostics’ next phase of innovation and commercial expansion.

Cleveland Diagnostics, Inc., a pioneering, commercial-stage precision oncology company, announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s IsoPSA® in vitro diagnostic (IVD) kit through the Premarket Approval (PMA) process. IsoPSA is a blood-based test indicated as an aid in the decision for prostate biopsy for men ≥ 50 years of age with elevated PSA levels.

Cleveland Diagnostics, Inc., a pioneering precision oncology company, relaunches its third annual PSA on PSA Campaign this September for Prostate Cancer Awareness Month with a powerful new message: Take the PSA Pledge.

Cleveland Diagnostics, Inc., a pioneering, commercial-stage oncology company developing highly accurate diagnostic tests, announced today the results of a new independent study published in Urology. The longitudinal study demonstrates the ability of the company’s IsoPSA® prostate cancer test to help identify low-risk patients who can avoid or defer unnecessary interventions such as biopsy, while identifying high-risk patients who would benefit from closer monitoring. This successful study sets the tone for Cleveland Diagnostics’ strong presence at the American Urological Association's 2025 Annual Meeting (AUA 2025), to be held April 26-29 in Las Vegas.

This September, cancer biotech company Cleveland Diagnostics, Inc. launches ‘A PSA on PSA.’

Cleveland Diagnostics, Inc., a cancer biotechnology company, today announced the appointment of a new independent director, Dara Grantham Wright, to its Board of Directors. Wright’s extensive experience in life science research and clinical diagnostics will be an asset to Cleveland Diagnostics as it expands commercialization of its IsoPSA® prostate cancer test, and brings new products to the market.

Cleveland Diagnostics, Inc., a clinical-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers announced the closing of over $75M in growth capital financing. The financing was led by Novo Holdings, a leading global life sciences investor, responsible for managing the assets of the Novo Nordisk Foundation, along with participation from existing investors as well as a credit facility from Symbiotic Capital. The financing will accelerate Cleveland Diagnostics’ commercial and corporate development goals.

Cleveland Diagnostics, Inc., a leading commercial-stage biotechnology company, is launching its inaugural Prostate Cancer Awareness Campaign this September: ‘A PSA on PSA.’

Cleveland Diagnostics, Inc., a commercial-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, has opened a new, state-of-the-art facility. The space will help Cleveland Diagnostics meet the burgeoning demand for its innovative prostate cancer test, IsoPSA, while also supporting the development of additional product and platform enhancements. Designed with expansion in mind, the new Cleveland-based facility provides ample room to grow its workforce and manufacturing space to accommodate increased test demand as patient accessibility and interest continue to rise.

Cleveland Diagnostics, Inc., a commercial-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, today announced an agreement designed to expand patient access to Cleveland Diagnostics’ novel prostate cancer test, IsoPSA.

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.

Cleveland Diagnostics, Inc., a commercial-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, announced today two significant developments regarding the reimbursement of its novel non-invasive, blood-based prostate cancer test, IsoPSA.

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.

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.

Cleveland Diagnostics, Inc., a commercial stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, today announced that the company has received support from JobsOhio, a private nonprofit economic development corporation with a mission to drive job creation and new capital investment in Ohio through business attraction, retention, and expansion. Under the agreement, Cleveland Diagnostics is subject to economic development requirements regarding Ohio-based job creation and retention.

Cleveland Diagnostics, Inc., a commercial stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, announced today that Eric Klein, MD, Chairman of the Glickman Urological & Kidney Institute at Cleveland Clinic, delivered two presentations at the annual meeting of the American Urological Association regarding the company’s prostate cancer test, IsoPSA.

Cleveland Diagnostics, Inc., a commercial-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, announced today that it has received Laboratory Accreditation from the College of American Pathologists (CAP) for its CLIA certified reference lab. The CAP Accreditation is awarded to laboratories that meet stringent requirements and maintain the highest standards of laboratory quality, accuracy, and consistency.