Cleveland Diagnostics
Overview
Cleveland Diagnostics, Inc. is a biotechnology company specializing in innovative cancer diagnostic blood tests based on protein structure analysis. Founded in 2013 and headquartered in Cleveland, Ohio, the company targets the early detection of cancer using its proprietary IsoClear™ platform. It was co-founded by Dr. Arnon Chait and others with a focus on improving the screening and diagnostic process in oncology.
Recent Developments
- August 2024: Cleveland Diagnostics launched a prostate cancer awareness campaign titled 'A PSA on PSA' to improve education on prostate cancer testing. This initiative originated in September 2023 and returns to raise funds for the cancer charity, ZERO Prostate Cancer. For every downloaded guide at PSAonPSA.com, the company donates to the charity.
- July 2024: The company appointed Dara Grantham Wright, a seasoned executive with extensive experience in clinical diagnostics, to its Board of Directors. This move is part of Cleveland Diagnostics' strategic expansion and commercialization of its IsoPSA® test.
- April 2024: Cleveland Diagnostics entered into a distribution agreement with Dow BioMedica to bring its IsoPSA prostate cancer test to Korea. This step marks the company's strategic efforts to broaden its international market presence.
- January 2024: The company secured over $75 million in growth capital financing, led by Novo Holdings. The funding aims to support the development and commercialization of its oncology diagnostics, including the IsoPSA test.
- 2024: Throughout 2024, Cleveland Diagnostics has been focused on broadening its diagnostic portfolio beyond prostate cancer, exploring tests for breast and lung cancers.
Company Information
| Attribute | Information |
|---|---|
| Founding Date | 2013 |
| Headquarters | Cleveland, Ohio, USA |
| Founders | Dr. Arnon Chait and others |
| Key Investors | Novo Holdings, Symbiotic Capital |
| Industry | Biotechnology, Cancer Diagnostics |
| Number of Employees | Approximately 73 (as of 2024) |
Early History
Cleveland Diagnostics was founded in 2013 by Dr. Arnon Chait, capitalizing on innovative diagnostic technologies developed in collaboration with Cleveland Clinic. The company emerged from AnalizaDx as a spin-off to commercialize novel cancer biomarkers. From its inception, Cleveland Diagnostics focused on non-invasive diagnostic solutions, particularly leveraging its proprietary Solvent Interaction Analysis (SIA) technology to identify structural changes in proteins as indicators for cancer.
Company Profile and Achievements
Cleveland Diagnostics has carved a niche in the diagnostic market with its emphasis on structural protein changes to distinguish cancerous from benign conditions. The IsoPSA test, their flagship product, represents a paradigm shift in prostate cancer diagnostics by reducing unnecessary biopsies by up to 55% over traditional PSA tests. Major milestones include receiving FDA breakthrough device designation, expanding licensing agreements (e.g., with Quest Diagnostics), and entering strategic international markets like South Korea.
- 2019: Received FDA breakthrough device designation for IsoPSA.
- 2021-2023: Garnered accreditation and coverage from Medicare, validating the clinical utility of IsoPSA.
- 2024: Secured significant investment to propel the product portfolio beyond prostate cancer.
Current Operations and Market Position
Cleveland Diagnostics currently focuses on the commercial expansion of IsoPSA and is positioned as a leader in non-invasive cancer diagnostics. Its innovative diagnostic solutions aim to minimize overtreatment and unnecessary medical procedures. The company capitalizes on strategic partnerships and advanced analytics to enhance diagnostic efficacy, standing out in the market by leveraging its proprietary technologies to provide clinically relevant insights.
Cleveland Diagnostics IsoClear Platform
Cleveland Diagnostics' IsoClear™ platform serves as the foundation for its diagnostic tests. This platform employs advanced protein interaction analysis to identify cancer presence at an earlier stage, giving healthcare providers more accurate diagnostic tools. The IsoClear™ platform's effectiveness is mainly demonstrated through IsoPSA, guiding further developments in cancer diagnostics.
Conclusion
Cleveland Diagnostics stands at the forefront of transformative changes in cancer diagnostics with its novel approach using protein structure analysis. As it expands its market reach and enhances its product line, the company is well-positioned to continue impacting cancer diagnostics significantly. With continued strategic investments and international partnerships, Cleveland Diagnostics aims to add invaluable tools to the oncological diagnostic toolkit, enhancing early detection and treatment outcomes.