Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company specializing in targeted radiotherapeutics for central nervous system (CNS) cancers, has announced significant progress in the launch of its subsidiary, CNSide Diagnostic LLC. The subsidiary focuses on the Cerebrospinal Fluid (CSF) Tumor Cell Enumeration laboratory-developed test (LDT), a cutting-edge diagnostic platform.
Recent milestones include expanding manufacturing capabilities, advancing commercial readiness, and appointing key leadership to drive the CNSide diagnostic business forward. Russ Havranek, MS, MBA, has been promoted to Executive Vice President, Commercial and Corporate Strategy, while Daniel Ortega, MBA, has been named Vice President, Development and Technical Operations.
“Russ and Daniel, along with our growing team, are instrumental in addressing the unmet medical needs in CNS cancer diagnosis and treatment,” said Marc H. Hedrick, M.D., President and CEO of Plus Therapeutics. “Their leadership will ensure we achieve our operational and commercial goals.”
Key Commercial Developments
CNSide launched commercially in Texas following successful CLIA accreditation and certification of its laboratory. The company is now expanding its reach with broader payor coverage and payment coding. Notably, CNSide recently secured a national policy agreement with UnitedHealthcare, providing access to over 51 million individuals across the U.S.
Key areas of commercial progress include:
- Expanding state licensing applications
- Securing proprietary lab analysis reimbursement codes and Medicare/Medicaid enrollment
- Growing commercial payor contracts
- Building out commercial operations, including customer service, marketing, market access, medical affairs, and sales
- Strengthening vendor partnerships for back-office support
“The past few months have been defined by focus and execution, driven by our mission to improve the lives of patients with CNS metastases,” said Russ Havranek. “We are encouraged by the strong interest in the CNSide CSF assay platform from NCI-Designated Cancer Centers and are assembling a world-class team to ensure its success.”
Mr. Havranek brings over 28 years of experience in developing and commercializing diagnostic and therapeutic products. His career spans leadership roles at companies such as Johnson & Johnson, Genentech (now Roche), and CareFusion (now Becton Dickinson). He holds an MBA from the Haas School of Business at UC Berkeley, an MS in Bioengineering from Clemson University, and a BS in Biomedical Engineering from Northwestern University.
Manufacturing and Diagnostics Operations
CNSide has expanded its clinical diagnostics footprint with a new state-of-the-art laboratory in Houston’s Texas Medical Center, the largest medical center in the world. This facility is designed to meet current and medium-term production needs while being scalable for future growth.
The new laboratory, located in Levit Green, is strategically positioned near MD Anderson Cancer Center and other leading institutions. The Texas Medical Center handles approximately 10 million patient interactions annually and contributes $25 billion to Houston’s GDP.
“This facility places us at the heart of medical innovation, enabling collaboration, scientific advancement, and clinical development,” said Daniel Ortega, Vice President, Development and Technical Operations.
Mr. Ortega oversees drug development, GMP manufacturing, clinical supply chain management, and CMC operations for Plus Therapeutics’ radiotherapeutic portfolio. With nearly 20 years of experience, he has held leadership roles at Azaya Therapeutics, Mission Pharmacal, and Viatris. He holds a Bachelor of Science from the University of Texas at San Antonio and an MBA from Texas A&M University–San Antonio.
About CNSide Diagnostic, LLC
CNSide Diagnostic, LLC, a subsidiary of Plus Therapeutics, develops and commercializes proprietary laboratory-developed tests like CNSide®, which identify tumor cells that have metastasized to the CNS in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform provides quantitative analysis of cerebrospinal fluid, improving the management of leptomeningeal metastases.
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for challenging CNS cancers. The company’s innovative pipeline includes treatments for leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). For more information, visit www.plustherapeutics.com.
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