CNSide Diagnostics, a subsidiary of Plus Therapeutics, has secured laboratory licenses in California, Rhode Island, and Maryland, bringing its coverage to 48 of the 50 U.S. states. The expansion removes a key regulatory barrier and positions the company to offer its Cerebrospinal Fluid Tumor Cell Enumeration (TCE) test to a broader patient population across the country.
The CSF TCE assay has already been performed in more than 11,000 tests at 120 U.S. cancer institutions. It delivers 92 % sensitivity and 95 % specificity, and it has influenced treatment decisions in 90 % of cases, underscoring its clinical utility and the potential to drive adoption among oncologists and payors.
By extending state licensure, CNSide is poised to capture a larger share of the estimated $6 billion+ U.S. market for leptomeningeal metastasis diagnostics. The diagnostic platform is strategically linked to Plus Therapeutics’ lead radiotherapeutic, REYOBIQ, and the expanded reach is expected to accelerate commercialization and revenue generation in the coming years.
Russ Bradley, President and General Manager of CNSide Diagnostics, said the state licenses “are a key enabler of our plan to bring the benefits of CNSide CSF testing to the broadest possible set of patients with CNS cancers.” He added that the company remains focused on executing its U.S. market‑access and launch strategy and looks forward to continued expansion of coverage across payors and states.
While Plus Therapeutics continues to face significant cash burn and negative free cash flow, the licensing milestone is a critical step toward generating revenue from its diagnostic platform, which is projected to contribute materially to the company’s financials starting in fiscal year 2026.
The move also highlights the company’s broader strategy to build commercial infrastructure, secure insurance coverage, and obtain CLIA accreditation—prerequisites for market access and reimbursement for the CNSide assay.
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