Cleveland Diagnostics Appoints Michael Iskra as CEO to Accelerate Growth Following FDA Approval of IsoPSA® Assay
Cleveland Diagnostics, a pioneering commercial-stage precision oncology company, has announced the appointment of Michael Iskra as its new Chief Executive Officer. With more than 30 years of experience leading global teams and driving strategic growth at major multinational healthcare and diagnostic companies, Iskra brings a strong track record in scaling operations, building high-performing commercial organizations, and enhancing customer experience across complex markets.
His appointment comes at a pivotal moment for Cleveland Diagnostics, which recently received FDA approval in December 2025 for its IsoPSA® in vitro diagnostic (IVD) kit through the rigorous Premarket Approval (PMA) process. The approval enables the company to expand access to its blood-based prostate cancer test nationwide by supplying the assay kit directly to clinical laboratories across the United States.
With this regulatory milestone achieved, Cleveland Diagnostics is now poised to accelerate commercialization and broaden clinical adoption of its IsoPSA test, making Iskra’s leadership particularly timely.
A New CEO for a Critical Growth Phase
Michael Iskra joins Cleveland Diagnostics following a distinguished career with several major multinational companies in the healthcare and diagnostics sector, including Bayer, Siemens, and Ortho Clinical Diagnostics/QuidelOrtho. His experience spans global market strategy, commercial operations, and transformative growth initiatives.
The company said that Iskra will apply his extensive market expertise and leadership capabilities to drive the next phase of innovation and commercial expansion. This includes building and strengthening customer experience teams, scaling operations, and ensuring that the company can effectively bring its diagnostic solutions to market at scale.
“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.”
Building on FDA Approval of IsoPSA
Cleveland Diagnostics’ IsoPSA test represents a significant advancement in prostate cancer diagnostics. The test is designed to support clinicians in the decision-making process regarding prostate biopsy for men aged 50 and older who have elevated PSA levels. By offering a blood-based alternative, IsoPSA aims to improve diagnostic accuracy, reduce unnecessary biopsies, and support earlier detection and more informed clinical decision-making.
The FDA approval of the IsoPSA IVD kit is a major milestone for the company and the broader precision oncology community. It marks a transition from a laboratory-developed test (LDT) model to a fully regulated IVD kit that can be supplied to clinical laboratories nationwide. This shift is expected to significantly expand access to the test, enabling more clinicians and patients to benefit from its advanced diagnostic capabilities.
With FDA approval secured, Cleveland Diagnostics is now positioned to scale distribution and commercialization, partnering with laboratories and healthcare systems to integrate the IsoPSA test into standard clinical workflows.
A Dual-Leadership Structure to Support Growth and Innovation
In conjunction with Iskra’s appointment, Cleveland Diagnostics announced a broader leadership alignment to support its strategic goals. Dr. Arnon Chait, a founding leader at the company, will assume the newly created role of Chief Innovation Officer, focusing on the development and expansion of the company’s broader IsoClear® platform.
This leadership structure is designed to balance commercial execution with continued innovation, ensuring that the company maintains momentum in both areas. While Iskra focuses on scaling commercial adoption and market penetration of IsoPSA, Dr. Chait will lead research and development efforts aimed at advancing the company’s next-generation diagnostic solutions.
“This organizational alignment reflects the strength of both our validated diagnostic assets and the broader potential of our platform,” said 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.”
A Track Record of Milestones
Since its founding in 2013, Cleveland Diagnostics has achieved a series of strategic milestones that have helped build its reputation as an emerging leader in prostate cancer diagnostics. Key achievements include:
- 2019 – Received FDA Breakthrough Device designation for its IsoPSA laboratory-developed test (LDT), recognizing its potential to offer significant advances in diagnostic capability.
- 2020 – Launched the IsoPSA LDT, making the test available to clinicians and patients.
- 2023 – Secured a national distribution agreement with Quest Diagnostics, significantly expanding access and reach across the United States.
- 2025 – Achieved FDA approval of the IsoPSA IVD Assay, enabling nationwide distribution of the kit to clinical laboratories.
Each milestone represents a key step in expanding patient access to the company’s diagnostic technology and building a foundation for long-term commercial success.
Scaling Commercial Adoption and Access
Under Michael Iskra’s leadership, Cleveland Diagnostics will focus on scaling the commercial adoption of the IsoPSA IVD kit and expanding access to the novel prostate cancer test. This will involve strengthening partnerships with clinical laboratories, healthcare systems, and medical professionals, as well as developing robust educational and support initiatives to facilitate integration into clinical practice.
By building out the commercial infrastructure needed to support nationwide distribution, Cleveland Diagnostics aims to make the IsoPSA test more widely available to clinicians and patients who could benefit from more accurate prostate cancer diagnostic tools.
The company’s goal is to reduce unnecessary biopsies, improve patient outcomes, and support more informed clinical decision-making through advanced diagnostic precision.
A Vision for the Future of Cancer Diagnostics
Cleveland Diagnostics is part of a broader shift in cancer care toward precision diagnostics that provide actionable insights and improve patient outcomes. With the IsoClear platform and the IsoPSA test, the company is developing tools that aim to refine cancer detection and risk stratification, supporting clinicians in delivering more personalized care.
The leadership transition is also a reflection of the company’s evolution from a development-stage innovator into a commercial-stage organization. As the company scales, it will need strong commercial leadership to ensure that its technology reaches patients and clinicians effectively, while maintaining its commitment to scientific rigor and clinical performance.
As Cleveland Diagnostics moves into 2026 and beyond, the company is positioned to build on its FDA-approved product and accelerate growth in the precision oncology market. With Michael Iskra at the helm and Dr. Arnon Chait leading innovation efforts, Cleveland Diagnostics is well positioned to execute on its strategy of expanding access, enhancing adoption, and advancing next-generation diagnostic technologies.
The combination of commercial leadership and scientific innovation reflects the company’s long-term vision of improving cancer care through advanced diagnostics and patient-centered solutions.
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