Cleveland Diagnostics Appoints New CEO

Cleveland Diagnostics Inc. has named Michael Iskra as its new CEO. Iskra has more than 30 years of industry experience with large multinational companies, including Bayer, Siemens, and Ortho Clinical Diagnostics/QuidelOrtho.

Iskra 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.

Iskra’s appointment occurs shortly after the company received U.S. Food and Drug Administration (FDA) premarket approval in December for its IsoPSA in-vitro diagnostic (IVD) kit. IsoPSA is a blood-based prostate cancer test designed to help with prostate biopsy decision-making among men ages 50 and older with elevated PSA levels. With FDA approval, the company can supply the IsoPSA IVD Assay as a kit to any clinical lab nationwide, significantly expanding test access.

“I am very excited to join Cleveland Diagnostics as we drive IVD expansion and build out the platform to the benefit of our business partners, caregivers, and their patients,” Iskra said. “The team has already proven success and laid groundwork for meaningful innovation that is changing the future of cancer care, and I am proud to carry that work forward with Arnon at my side.”

Under Iskra’s leadership, Cleveland Diagnostics will focus on scaling the IsoPSA IVD Assay kit’s commercial adoption, expanding access to the prostate cancer test, and driving broader clinical uptake.

“This organizational alignment reflects the strength of both our validated diagnostic assets and the broader potential of our platform,” Chief Innovation Officer Arnon Chait, Ph.D., stated. “Given the value that our technology can provide across the diagnostics ecosystem, and now with experienced commercial-stage company leadership in place, we are well-positioned to accelerate development of both our existing and next generation of tests.”

Since its inception in 2013, Cleveland Diagnostics has achieved a series of pivotal milestones, including the FDA breakthrough designation for its IsoPSA LDT in 2019, launch of the LDT product in 2020, several successful fundraises, a national distribution agreement with Quest Diagnostics in 2023, and the recent FDA approval of the IsoPSA IVD Assay—each a critical step in expanding patient access to its prostate cancer testing technology.

Cleveland Diagnostics is a precision oncology company striving to change the shape of cancer detection. The company has unlocked the diagnostic power of protein structure with its IsoClear platform that enables novel diagnostics based on a cancer-specific, protein structure-based assessment using easy-to-execute tests within the clinical lab setting.