The new leader brings over 30 years of industry experience from Bayer, Siemens, and Ortho Clinical Diagnostics to lead commercial expansion.
Cleveland Diagnostics has appointed Michael Iskra as chief executive officer (CEO) to lead the company’s commercial expansion following US Food and Drug Administration (FDA) approval of its IsoPSA in vitro diagnostic kit.
Iskra brings more than 30 years of experience from multinational companies including Bayer, Siemens, and Ortho Clinical Diagnostics/QuidelOrtho. The precision oncology company received FDA approval in December 2025 for its IsoPSA IVD kit through the Premarket Approval process.
The IsoPSA test is a blood-based prostate cancer assay indicated as an aid in biopsy decisions for men 50 years and older with elevated PSA levels. With FDA approval, Cleveland Diagnostics can now supply the IsoPSA IVD assay as a kit to clinical labs nationwide.
“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,” says Iskra in a release. “The team has already proven success and laid groundwork for meaningful innovation that is changing the future of cancer care.”
Leadership Restructure Supports Commercial Goals
Under Iskra’s leadership, Cleveland Diagnostics will focus on scaling commercial adoption of the IsoPSA IVD assay kit and expanding clinical uptake. Dr Arnon Chait, the company’s former CEO, will serve as chief innovation officer to focus on the development of the IsoClear platform.
“This organizational alignment reflects the strength of both our validated diagnostic assets and the broader potential of our platform,” says Chait in a release. “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.”
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