Plus Therapeutics announces AMA approval of a billing code for CNSide® CSF Tumor Cell Enumeration test, enhancing reimbursement and adoption.
Quiver AI Summary
Plus Therapeutics, Inc. announced that the American Medical Association has approved a new Proprietary Laboratory Analyses CPT code (0640U) for its CNSide® Cerebrospinal Fluid Tumor Cell Enumeration (TCE) test, which will take effect on July 1, 2026. This dedicated billing code will facilitate payer claims processing and enhance clinical adoption as the company launches its CNS metastases diagnostic platform in the U.S. CEO Marc H. Hedrick emphasized that this milestone simplifies reimbursement for the test, making it easier for oncologists and neurologists to manage patients with leptomeningeal metastases. Additionally, the code will enable tracking of test utilization and support the ongoing commercial efforts of Plus Therapeutics. The company focuses on developing precision diagnostics and radiopharmaceuticals for central nervous system cancers.
Potential Positives
- The American Medical Association approved a dedicated PLA CPT code (0640U) for the CNSide CSF Tumor Cell Enumeration test, facilitating standardized claims submission and payer coverage determinations.
- This coding milestone may support broader clinical adoption of the CNSide test among oncologists and neurologists, enhancing diagnostic capabilities for patients with leptomeningeal metastases.
- The dedicated billing code strengthens the reimbursement infrastructure for Plus Therapeutics’ ongoing U.S. launch of CNSide, potentially contributing to revenue growth.
- Tracking of test utilization through the new PLA code allows for real-world evidence generation related to clinical outcomes, emphasizing the test's value in patient management and healthcare economics.
Potential Negatives
- Securing a dedicated billing code does not guarantee immediate clinical adoption or widespread utilization, which could hinder expected revenue growth from the CNSide test.
- There is a reliance on future market conditions and payer coverage, which are uncertain and could affect the Company's financial projections.
- The forward-looking statements highlight significant risks and uncertainties related to the Company's ability to raise capital and complete clinical studies, suggesting potential vulnerabilities in its operations and financial health.
FAQ
What is the new CPT code approved for Plus Therapeutics' CNSide test?
The new CPT code approved for the CNSide test is 0640U, effective July 1, 2026.
How does the PLA code impact CNSide CSF Tumor Cell Enumeration test?
The PLA code simplifies reimbursement processes and supports broader clinical adoption among oncologists and neurologists.
What is the significance of the coding milestone for Plus Therapeutics?
This coding milestone supports the commercial launch of CNSide Diagnostics and strengthens reimbursement infrastructure for the test.
What does CNSide Diagnostics, LLC specialize in?
CNSide Diagnostics specializes in developing laboratory tests to detect tumor cells in cerebrospinal fluid for metastatic CNS cancers.
Where is Plus Therapeutics headquartered?
Plus Therapeutics is headquartered in Houston, Texas, focusing on targeted radiotherapeutics for difficult-to-treat CNS cancers.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
HOUSTON, April 07, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, today announces that the American Medical Association (AMA) has approved a new, Proprietary Laboratory Analyses (PLA) Current Procedural Terminology (CPT) code for its CNSide ® Cerebrospinal Fluid (CSF) Tumor Cell Enumeration (TCE) test.
The dedicated billing code, 0640U, effective July 1, 2026, establishes a unique reimbursement identifier for the CNSide CSF TCE test, supporting payer claims processing and facilitating broader clinical adoptions as the Company continues the U.S. commercial launch of its CNS metastases diagnostic platform.
“Securing a dedicated PLA code for CNSide is an important milestone supporting the commercial launch of our CNSide Diagnostics business,” said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. “This coding milestone simplifies the reimbursement pathway for the CNSide CSF Tumor Cell Enumeration test and supports broader clinical adoption by oncologists and neurologists managing patients with leptomeningeal metastases. As awareness and payer coverage expand, we believe CNSide has the potential to become an important tool in the management of metastatic CNS cancers while contributing meaningfully to our revenue growth. Our diagnostics business continues to scale alongside our therapeutic pipeline, and we remain focused on building CNSide into a sustainable commercial franchise.”
Key implications of the newly assigned PLA code 0640U
- Supports payer reimbursement processes. Provides a dedicated billing code specific to the CNSide CSF Tumor Cell Enumeration test, enabling standardized claims submission and facilitating payer coverage determinations.
- Facilitates clinician adoption. Simplifies ordering and billing processes for clinicians and cancer centers evaluating patients with suspected leptomeningeal metastases.
- Enables national utilization tracking. PLA coding allows tracking of test utilization through claims data, supporting real-world evidence generation related to clinical outcomes and health economics.
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Supports ongoing U.S. commercial launch.
The coding milestone strengthens the reimbursement infrastructure supporting the Company’s ongoing U.S. launch of CNSide CSF test.
About PLA Codes
Proprietary Laboratory Analyses (PLA) codes are issued by the American Medical Association to uniquely identify specific laboratory tests performed by a single laboratory or manufacturer. A dedicated PLA code allows healthcare providers to bill insurers using a standardized code that reflects the specific diagnostic test performed, facilitating claims processing and enabling tracking of test utilization across the healthcare system.
About CNSide Diagnostics, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide
®
, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide
®
CSF Assay Platform enables quantitative detection and molecular characterization of tumor cells in cerebrospinal fluid, providing actionable diagnostic information to physicians managing patients with leptomeningeal metastases, a serious and often difficult-to-diagnose complication of advanced cancer. Leptomeningeal metastases occur when cancer spreads to the membranes surround the brain and spinal cord and are associated with significant morbidity and limited diagnostic tools, highlighting the need for more sensitive diagnostic approaches.
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products.
Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as "expect," "anticipate" "intend," "believe," "estimate," "will," and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: expectations regarding the completion of the proposed offering; the Company's ability to successfully raise sufficient capital on reasonable terms or at all; available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends; our ability to complete our pre-clinical or clinical studies; and changes in local or national economic conditions. This list of risks, uncertainties, and other factors is not complete. Any or all forward-looking statements the Company makes may turn out to be wrong and can be affected by inaccurate assumptions the Company might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2025, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
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