UnitedHealthcare Grants National Coverage for Plus Therapeutics' CNS Cancer Test, Impacting Over 51 Million Members

What's Happening?

Plus Therapeutics has announced a significant agreement with UnitedHealthcare to provide national coverage for its CNSide® Cerebrospinal Fluid Tumor Cell Enumeration test, effective September 15, 2025. This test is designed for metastatic CNS cancer and is now potentially accessible to over 51 million members nationwide. The CNSide platform aids in rapid diagnosis and treatment monitoring for leptomeningeal metastases, a severe complication of advanced cancers. Since 2020, the test has been utilized over 11,000 times across more than 120 U.S. cancer centers, demonstrating high sensitivity and specificity. The announcement led to a substantial increase in Plus Therapeutics' stock value, with shares rising by approximately 60% in premarket trading.

Why It's Important?

The national coverage by UnitedHealthcare represents a major milestone for Plus Therapeutics, enhancing access to a critical diagnostic tool for advanced cancer patients. This development is expected to improve clinical outcomes by providing more precise guidance for treatment decisions. The coverage also signifies a validation of Plus Therapeutics' efforts to expand its market presence and underscores the importance of payer endorsements in the healthcare industry. For investors, the agreement is a positive signal, potentially driving revenue growth and increasing the company's market value. The broader impact includes potential shifts in how advanced cancer diagnostics are integrated into treatment protocols, emphasizing the role of innovative tests in improving patient care.

What's Next?

Following the UnitedHealthcare agreement, other national and regional payers may consider similar coverage decisions, potentially expanding access further. Plus Therapeutics is expected to continue its geographic expansion, starting with a Texas-first rollout and aiming for broader state licensure. The company will likely focus on increasing test adoption and monitoring reimbursement rates to translate coverage into tangible revenue growth. Additionally, the integration of CNSide with Plus Therapeutics' other programs, such as REYOBIQ™, could enhance its position in the oncology diagnostics market. Stakeholders will be watching for further policy developments regarding laboratory-developed tests, which could influence future regulatory and payer landscapes.

Beyond the Headlines

The agreement with UnitedHealthcare not only impacts Plus Therapeutics but also highlights the evolving landscape of cancer diagnostics. The focus on leptomeningeal metastases, a niche but critical area, underscores the need for specialized diagnostic tools in oncology. The success of CNSide could pave the way for similar innovations, encouraging investment in targeted diagnostics. Moreover, the regulatory environment for laboratory-developed tests remains fluid, with recent changes potentially easing federal uncertainties. This could lead to increased innovation and competition in the diagnostics sector, ultimately benefiting patients through improved access to cutting-edge technologies.