Michael Iskra Appointed CEO of Cleveland Diagnostics to Drive Strategic & Accelerated Growth Following FDA Approval of Its IsoPSA Assay

Iskra brings decades of commercialization expertise with leading global healthcare organizations

Cofounding CEO Arnon Chait to remain with company as Chief Innovation Officer

CLEVELAND--(BUSINESS WIRE)--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.

This announcement comes on the heels of an FDA approval in December 2025 for Cleveland Diagnostics' IsoPSA® in vitro diagnostic (IVD) kit through the Premarket Approval (PMA) process. IsoPSA is a blood-based prostate cancer test indicated as an aid in the decision for prostate biopsy for men ≥ 50 years of age with elevated PSA levels. With FDA approval, the company will be able to 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,” said Iskra. “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 commercial adoption of the IsoPSA IVD Assay kit, expanding access to the novel prostate cancer test, and driving broader clinical uptake. With Dr. Chait serving in the new role of Chief Innovation Officer to focus on the development of the IsoClear® platform, the company now has a powerful and complementary leadership team in place to execute its strategy in 2026 and beyond.

“This organizational alignment reflects the strength of both our validated diagnostic assets and the broader potential of our platform,” added Dr. Chait. “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, a number of 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 highly accurate prostate cancer testing technology.

For more information and company news, visit ClevelandDx.com.

About Cleveland Diagnostics, Inc.
Cleveland Diagnostics is a precision oncology company focused on changing the shape of cancer detection. The company has unlocked the diagnostic power of protein structure with its revolutionary 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. Learn more at ClevelandDx.com and IsoPSA.com.