Plus Therapeutics Announces Successful Accreditation and Certification for Its CNSide® Diagnostics Clinical Laboratory
Plus Therapeutics (Nasdaq: PSTV) announced that its subsidiary, CNSide Diagnostics, has received CMS accreditation for its Houston-based laboratory. The certification confirms compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations for testing human specimens.
The accreditation is a crucial milestone for the broader market release of the CNSide cerebrospinal fluid (CSF) assay platform, designed for patients with or at risk for CNS cancers. This achievement enables state licensure in 48 states, broad commercial insurance coverage, access to government payor coverage, and expansion of payment coding opportunities.
Plus Therapeutics (Nasdaq: PSTV) ha annunciato che la sua controllata, CNSide Diagnostics, ha ottenuto l'accreditamento CMS per il laboratorio di Houston. La certificazione conferma la conformità alle normative Clinical Laboratory Improvement Amendments (CLIA) per i test su campioni umani.
Questo accreditamento rappresenta una tappa cruciale per il lancio commerciale su scala più ampia della piattaforma di test CSF CNSide, pensata per i pazienti affetti o a rischio di tumori del sistema nervoso centrale (SNC). L'obiettivo è consentire la licenza statale in 48 stati, una copertura assicurativa commerciale estesa, l'accesso alle coperture dei pagatori governativi e l'espansione delle opportunità di codifica dei pagamenti.
Plus Therapeutics (Nasdaq: PSTV) anunció que su filial, CNSide Diagnostics, ha recibido la acreditación de CMS para el laboratorio con sede en Houston. La certificación confirma el cumplimiento de las normas Clinical Laboratory Improvement Amendments (CLIA) para pruebas de muestras humanas.
La acreditación es un hito crucial para el lanzamiento comercial más amplio de la plataforma de ensayo CNSide para líquido cefalorraquídeo (CSF), diseñada para pacientes con tumores CNS o en riesgo de ellos. Este logro permite la licencia estatal en 48 estados, una cobertura amplia de seguros comerciales, acceso a la cobertura de pagadores gubernamentales y la expansión de las oportunidades de codificación de pagos.
Plus Therapeutics(Nasdaq: PSTV)는 자회사인 CNSide Diagnostics가 Houston에 위치한 연구소에 대한 CMS 인증을 받았다고 발표했습니다. 이 인증은 인간 표본 테스트를 위한 CLIA(임상검사개선법) 규정 준수를 확인합니다.
이 인증은 CNS 사이드 뇌척수액(CSF) 검사 플랫폼의 더 넓은 시장 출시를 위한 중요한 이정표로, CNS 암 환자 또는 위험이 있는 환자들을 대상으로 설계되었습니다. 이 성과로 48개 주에서 주 면허를 얻고, 광범위한 상업 보험 적용 범위, 정부 급여자 커버리지 접근성, 지불 코드화 기회의 확장이 가능해집니다.
Plus Therapeutics (Nasdaq: PSTV) a annoncé que sa filiale, CNSide Diagnostics, a reçu l'accréditation CMS pour le laboratoire basé à Houston. La certification confirme la conformité aux règles Clinical Laboratory Improvement Amendments (CLIA) pour les tests sur des échantillons humains.
Cet accréditement constitue une étape cruciale pour le lancement commercial plus large de la plateforme d’essai CSF CNSide, conçue pour les patients atteints ou à risque de cancers du système nerveux central. Cette réussite permet l’habilitation étatique dans 48 États, une couverture d’assurance commerciale étendue, l’accès à la couverture des payeurs gouvernementaux et l’expansion des possibilités de codage des paiements.
Plus Therapeutics (Nasdaq: PSTV) gab bekannt, dass seine Tochtergesellschaft CNSide Diagnostics die CMS-Akkreditierung für das Labor in Houston erhalten hat. Die Zertifizierung bestätigt die Einhaltung der Clinical Laboratory Improvement Amendments (CLIA) Vorschriften für Tests an menschlichen Proben.
Die Akkreditierung ist ein wichtiger Meilenstein für die breitere Markteinführung der CNSide CSF-Analyseplattform, die für Patienten mit CNS-Krebs oder einem Risiko dafür entwickelt wurde. Diese Leistung ermöglicht eine staatliche Genehmigung in 48 Bundesstaaten, eine breite kommerzielle Versicherung, den Zugang zur Deckung durch Regierungszahler und die Erweiterung von Abrechnungscodes.
Plus Therapeutics (ناسداك: PSTV) أعلنت أن شركتها التابعة، CNSide Diagnostics، قد حصلت على اعتماد CMS لمختبرها الواقع في هيوستن. تؤكد الشهادة الامتثال للوائح Clinical Laboratory Improvement Amendments (CLIA) لاختبار العينات البشرية.
هذا الاعتماد يمثل خطوة حاسمة لإطلاق المنصة الواسع لاختبار سوائل الدماغ الشوكي CSF CNSide المصممة لمرضى لديهم سرطان الجهاز العصبي المركزي أو معرضين للخطر. يتيح ذلك الترخيص الولائي في 48 ولاية وتغطية تأمينية تجارية واسعة والوصول إلى تغطية من قبل الجهات الحكومية وتوسع في فرص ترميز المدفوعات.
Plus Therapeutics (纳斯达克：PSTV) 宣布，其子公司 CNSide Diagnostics 已获得位于休斯顿的实验室的 CMS 认证。该认证确认符合针对人类样本测试的 CLIA（临床实验室改进法案） 要求。
这一认证是 CNSide 脑脊液（CSF）检测平台面向 CNS 癌症患者或有风险人群的更广泛市场发布的关键里程碑。此成就使在 48 个州获得州级许可、广泛的商业保险覆盖、可接入政府付款方的覆盖范围，以及支付编码机会的扩展成为可能。
- Achievement of CLIA accreditation enables access to broad commercial insurance coverage
- Certification allows state licensure in 48 of 50 states
- Accreditation enables access to Medicare and Medicaid payments
- Certification allows pursuit of unique reimbursement billing codes
- None.
Insights
Plus Therapeutics achieves critical CLIA lab certification, enabling nationwide commercialization and reimbursement potential for CNSide diagnostic platform.
Plus Therapeutics has secured a significant regulatory milestone with CLIA certification for its CNSide Diagnostics laboratory in Houston. This federal accreditation is fundamental to the commercialization strategy for their cerebrospinal fluid (CSF) assay platform targeting CNS cancer diagnostics.
The CLIA certification represents more than just regulatory compliance – it unlocks four critical commercial pathways: state licensure across 48 states, eligibility for private insurance reimbursement, access to Medicare/Medicaid payments, and the ability to pursue unique reimbursement billing codes. Without this certification, the company would face severe market restrictions regardless of the diagnostic's technical merits.
This achievement indicates Plus Therapeutics is executing its commercial roadmap methodically, transitioning from a purely clinical-stage company to one with potential near-term revenue generation capabilities. For a diagnostic targeting CNS cancers, securing the payment infrastructure is particularly crucial given the specialized nature of neurological testing and its typically higher reimbursement values.
The CLIA certification specifically validates the laboratory's proficiency testing, personnel qualifications, and quality control systems – essential elements for diagnostic reliability in the high-stakes arena of CNS cancer detection. While this doesn't guarantee commercial success, it removes a significant regulatory barrier that prevents many promising diagnostic technologies from reaching meaningful market penetration.
Certification critical to broad U.S. market release of the CNSide CSF Assay Platform
CNSide now meets key federal and state regulatory requirements, including those set by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Lab Improvement Amendments (CLIA)
HOUSTON, Texas, Sept. 18, 2025 (GLOBE NEWSWIRE) -- CNSide Diagnostics, LLC, a wholly-owned subsidiary of Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, announces that it has received a certificate of accreditation from CMS for its lab located in Houston, Texas. Following the recent planned laboratory audit, successful certificate of accreditation deems the lab compliant with Clinical Laboratory Improvement Amendments (CLIA) regulations enforced by the Centers for Medicare & Medicaid Services (CMS), which are federal standards for laboratories performing testing on human specimens.
“This is a key milestone on our trajectory to bring the CNSide cerebrospinal fluid (CSF) assay platform to the broadest possible set of patients with or at risk for CNS cancers and simultaneously underscores our commitment to the highest quality standards,” said Russ Bradley, CNSide Diagnostics, LLC President and General Manager. “Furthermore, accreditation is the latest tangible accomplishment in our U.S. market access and launch strategy.”
The certification ensures laboratories meet all requirements for proficiency testing, personnel qualifications, and quality control. Furthermore, achievement of this milestone is necessary to achieve a number of additional milestones such as:
- Obtaining state licensure in 48 of 50 states
- Ensuring broad-based commercial insurance coverage: Lab accreditation is necessary to secure reimbursement for patient testing from the broadest possible set of private payors
- Accessing government payor coverage: Lab accreditation is a mandatory requirement for labs to enroll in Medicare and Medicaid programs and receive payments for testing services
- Expanding payment coding: Lab accreditation is a necessary step for broad pursuit and registration of unique reimbursement billing codes
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 analysis and molecular characterization of tumor cells and circulating tumor DNA in the cerebrospinal fluid that inform and improve the management of patients with leptomeningeal metastases.
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. For more information, visit https://www.plustherapeutics.com.
Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. 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,” “potential,” “anticipating,” “planning” 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.
These statements include, without limitation, statements regarding the potential market for the CNSide CSF Assay, the timing in which the CNSide CSF Assay is commercially launched and commercialization is expanded, revenue and corporate profitability expectations including support reimbursements and payments for the CNSide CSF Assay, the development and utility of the CNSide CSF Assay and expectations as to the Company’s future performance, including the next steps in developing the Company’s product candidates.
Investor Contact
CORE IR
investor@plustherapeutics.com
FAQ
What certification did Plus Therapeutics' CNSide Diagnostics receive in September 2025?
How many states can CNSide Diagnostics operate in after receiving CLIA accreditation?
What is the CNSide CSF assay platform used for?
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