Iskra brings decades of commercialization expertise with leading global healthcare organizations
Cleveland Diagnostics, Inc., a commercial-stage precision oncology company, has appointed Michael Iskra as its new Chief Executive Officer. Iskra brings over 30 years of experience with major multinational healthcare companies including Bayer, Siemens, and Ortho Clinical Diagnostics. He will use his expertise in global markets, strategic growth, and customer experience leadership to drive Cleveland Diagnostics’ next phase of innovation and commercial expansion. This leadership change follows the FDA approval of the company’s IsoPSA in vitro diagnostic kit in December 2025 through the Premarket Approval process. The blood-based IsoPSA test helps guide prostate biopsy decisions in men over 50 with elevated PSA levels, and FDA clearance now allows Cleveland Diagnostics to distribute the test kit to clinical laboratories nationwide, significantly increasing patient access.
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“I am thrilled to join Cleveland Diagnostics as we expand IVD access and build a platform that benefits business partners, caregivers, and patients,” said Michael Iskra, CEO. “The team has already laid the groundwork for meaningful innovation in cancer diagnostics, and I am proud to continue that mission alongside Arnon.” Under Iskra’s leadership, the company will focus on scaling commercial adoption of the IsoPSA IVD assay, expanding access to this novel prostate cancer test, and driving broader clinical uptake.
Dr. Arnon Chait will assume the role of Chief Innovation Officer to lead the development of the IsoClear platform, forming a complementary leadership team to execute the company’s strategy for 2026 and beyond. “This leadership alignment highlights the strength of our validated diagnostic tools and the broader potential of our platform,” said Dr. Chait. “With experienced commercial leadership in place, we are well positioned to accelerate the development of current and next-generation tests.”
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Since its founding in 2013, Cleveland Diagnostics has reached several important milestones including FDA breakthrough designation for the IsoPSA LDT in 2019, commercial launch of the LDT in 2020, multiple successful funding rounds, a national distribution partnership with Quest Diagnostics in 2023, and the recent FDA approval of the IsoPSA IVD Assay, each expanding patient access to accurate prostate cancer testing.
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