Cleveland Diagnostics Opens New Facility Amid Growing Demand for IsoPSA® Test

Continued clinical validation and Quest Diagnostics agreement fuel patient need; Expanded space supports platform development & prostate cancer test processing

Cleveland Diagnostics, Inc., a commercial-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, has opened a new, state-of-the-art facility. The space will help Cleveland Diagnostics meet the burgeoning demand for its innovative prostate cancer test, IsoPSA, while also supporting the development of additional product and platform enhancements. Designed with expansion in mind, the new Cleveland-based facility provides ample room to grow its workforce and manufacturing space to accommodate increased test demand as patient accessibility and interest continue to rise.

The facility features a new and larger clinical laboratory to meet growing demand for IsoPSA testing, labs for research and development, offices for collaboration and administration, and manufacturing space for future IVD kit production and distribution. The lab and office space will be critical as the company continues to scale up operations to develop additional early cancer-detection tests using its proprietary protein structure analysis platform.

The expansion news comes just a few months after Cleveland Diagnostics signed an agreement with Quest Diagnostics to broaden patient access to its novel IsoPSA test through Quest’s national service and logistics operation later this year.

“Transforming cancer diagnostics is no small feat, but we are well positioned to contribute to this important mission,” explained president and CEO, Arnon Chait, PhD. “This new facility represents our team’s commitment to advancing the science of early cancer detection through research, development, and distribution. As we continue to grow, this new space will be vital in making accurate and affordable diagnostic technology accessible to all patients, not only in prostate cancer but in other cancers as well.”

IsoPSA is a non-invasive, blood-based test that provides greater insight into patients’ elevated PSA levels, which is critical for early cancer detection in many patients while minimizing the overdiagnosis and overtreatment of others. The test has gone through extensive clinical validation studies that continue to prove its specificity and demonstrate clinical utility and value for broad patient populations. These studies include recently published articles highlighting both the test's ability to be unaffected by commonly used medications and IsoPSA’s clinical value in combination with MRI.

To learn more about Cleveland Diagnostics’ products and services, visit clevelanddx.com

About IsoPSA

IsoPSA is a non-invasive, blood-based test that demonstrated in large, multicenter studies superior diagnostic accuracy compared to prostate-specific antigen (PSA), the current standard of care in prostate cancer diagnosis. Cleveland Diagnostics currently offers IsoPSA as a laboratory-developed test (LDT) conducted at its high-complexity, CLIA-certified, CAP-accredited laboratory in Cleveland, Ohio.

About Cleveland Diagnostics, Inc.

Cleveland Diagnostics, Inc. is a commercial-stage diagnostics company developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. The Company’s Solvent Interaction Analysis™ (SIA) technology investigates protein biomarkers at the structural level in blood, providing better and more direct insights regarding the protein origin on the cellular level, thus improving test specificity to the underlying disease process. Its portfolio of non-invasive cancer diagnostics will be expanding from prostate cancer to additional cancers. Please visit us at ClevelandDx.com.

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