Angle PLC - Data Supporting FDA Approval Published in Journal
ANGLE plc (AIM:AGL)(OTCQX:ANPCY) has announced the publication of a clinical study supporting the FDA approval of its Parsortix PC1 system for isolating circulating tumor cells (CTCs) in metastatic breast cancer (MBC) patients. The study, published in the Journal of Experimental & Clinical Cancer Research, demonstrated the system's ability to capture and harvest CTCs from MBC patient blood samples for downstream analysis.
Key findings include:
- CTCs were identified in 45% of MBC patients
- CTC clusters were found in 56% of CTC-positive patients
- 70% of detected CTCs did not express the epithelial marker EpCAM
This data supported ANGLE's successful FDA De Novo request for the Parsortix PC1 system's classification as a Class II medical device in 2022.
ANGLE plc (AIM:AGL)(OTCQX:ANPCY) ha annunciato la pubblicazione di uno studio clinico a supporto dell'approvazione della FDA del suo Parsortix PC1 system per l'isolamento delle cellule tumorali circolanti (CTCs) nei pazienti con cancro al seno metastatico (MBC). Lo studio, pubblicato nel Journal of Experimental & Clinical Cancer Research, ha dimostrato la capacità del sistema di catturare e raccogliere le CTC dai campioni di sangue dei pazienti MBC per analisi successive.
I principali risultati includono:
- Le CTC sono state identificate nel 45% dei pazienti MBC
- Le formazioni di CTC sono state trovate nel 56% dei pazienti positivi per CTC
- Il 70% delle CTC rilevate non esprimeva il marcatore epiteliale EpCAM
Questi dati hanno supportato la richiesta De Novo della FDA da parte di ANGLE per la classificazione del sistema Parsortix PC1 come dispositivo medico di Classe II nel 2022.
ANGLE plc (AIM:AGL)(OTCQX:ANPCY) ha anunciado la publicación de un estudio clínico que apoya la aprobación de la FDA de su Parsortix PC1 system para el aislamiento de células tumorales circulantes (CTCs) en pacientes con cáncer de mama metastásico (MBC). El estudio, publicado en el Journal of Experimental & Clinical Cancer Research, demostró la capacidad del sistema para capturar y recolectar CTC de las muestras de sangre de pacientes con MBC para análisis posteriores.
Los hallazgos clave incluyen:
- Se identificaron CTC en el 45% de los pacientes con MBC
- Se encontraron agrupaciones de CTC en el 56% de los pacientes positivos a CTC
- El 70% de las CTC detectadas no expresaron el marcador epitelial EpCAM
Estos datos respaldaron la exitosa solicitud De Novo de ANGLE a la FDA para la clasificación del sistema Parsortix PC1 como dispositivo médico de Clase II en 2022.
ANGLE plc (AIM:AGL)(OTCQX:ANPCY)는 전이성 유방암(MBC) 환자에서 순환 종양 세포(CTC)를 분리하기 위해 Parsortix PC1 system의 FDA 승인을 지원하는 임상 연구를 발표했습니다. Journal of Experimental & Clinical Cancer Research에 발표된 이 연구는 MBC 환자의 혈액 샘플에서 CTC를 포착하고 수확하는 시스템의 능력을 입증했습니다.
주요 발견 사항은 다음과 같습니다:
- MBC 환자의 45%에서 CTC가 확인되었습니다
- CTC 양성 환자의 56%에서 CTC 클러스터가 발견되었습니다
- 검출된 CTC의 70%는 상피 마커 EpCAM을 발현하지 않았습니다
이 데이터는 2022년 Parsortix PC1 시스템을 2등급 의료기기로 분류하기 위한 ANGLE의 성공적인 FDA De Novo 요청을 지원했습니다.
ANGLE plc (AIM:AGL)(OTCQX:ANPCY) a annoncé la publication d'une étude clinique soutenant l'approbation par la FDA de son Parsortix PC1 system pour l'isolement des cellules tumorales circulantes (CTCs) chez les patients atteints de cancer du sein métastatique (MBC). L'étude, publiée dans le Journal of Experimental & Clinical Cancer Research, a démontré la capacité du système à capturer et récolter des CTC à partir d'échantillons de sang de patients MBC pour des analyses ultérieures.
Les principaux résultats comprennent :
- Les CTC ont été identifiées chez 45 % des patients MBC
- Des clusters de CTC ont été trouvés chez 56 % des patients positifs pour les CTC
- 70 % des CTC détectées n'exprimaient pas le marqueur épithélial EpCAM
Ces données ont soutenu la demande De Novo réussie d'ANGLE auprès de la FDA pour la classification du système Parsortix PC1 en tant que dispositif médical de Classe II en 2022.
ANGLE plc (AIM:AGL)(OTCQX:ANPCY) hat die Veröffentlichung einer klinischen Studie angekündigt, die die FDA-Genehmigung seines Parsortix PC1 system zur Isolierung von zirkulierenden Tumorzellen (CTCs) bei Patienten mit metastasiertem Brustkrebs (MBC) unterstützt. Die Studie, veröffentlicht im Journal of Experimental & Clinical Cancer Research, zeigte die Fähigkeit des Systems, CTCs aus Blutproben von MBC-Patienten zu erfassen und zu sammeln, um sie anschließend zu analysieren.
Wichtige Ergebnisse umfassen:
- CTCs wurden bei 45 % der MBC-Patienten identifiziert
- CTC-Cluster wurden bei 56 % der CTC-positiven Patienten gefunden
- 70 % der detektierten CTCs drückten den epithelialen Marker EpCAM nicht aus
Diese Daten unterstützten ANGLEs erfolgreiche FDA-De-Novo-Anfrage zur Klassifizierung des Parsortix PC1-Systems als Medizinprodukt der Klasse II im Jahr 2022.
- FDA approval of Parsortix PC1 system for CTC isolation in metastatic breast cancer patients
- Publication of supporting clinical study in a high-impact journal
- Demonstration of system's ability to capture CTCs not detectable by EpCAM-based technologies
- Successful identification of CTCs in 45% of metastatic breast cancer patients
- None.
DATA SUPPORTING FDA APPROVAL PUBLISHED IN HIGH-IMPACT JOURNAL
Publication of results from ANGLE's Parsortix PC1 system validates use of Parsortix System for CTC isolation and harvest in metastatic breast cancer
GUILDFORD, SURREY / ACCESSWIRE / August 22, 2024 / ANGLE plc (AIM:AGL)(OTCQX:ANPCY), a world-leading liquid biopsy company with innovative circulating tumour cell (CTC) solutions for use in research, drug development and clinical oncology, is pleased to announce the publication of one of the Company's clinical studies that was submitted to the FDA for De Novo regulatory clearance of the Parsortix® PC1 system.
This study, undertaken at ANGLE's UK laboratory, the University of Rochester, US, and the MD Anderson Cancer Center, US, reports that the Parsortix system successfully captured and harvested CTCs from metastatic breast cancer (MBC) patient blood samples for downstream analysis using immunofluorescence (IF) and cytological evaluation.
The study recruited 76 MBC patients whose blood samples were processed using the Parsortix PC1 system. CTCs were identified in
The data generated by this study supported ANGLE's FDA De Novo request for the classification of the Parsortix PC1 system as a Class II medical device, for use in MBC patients to capture and harvest CTCs for subsequent, user-validated, downstream analyses. This was granted by the FDA in 2022.
Chief Scientific Officer, Karen Miller, added:
"We are pleased to share the results of this clinical study, demonstrating the performance of the Parsortix PC1 system in successfully isolating CTCs from MBC patient blood samples. The data from this study contributed to the first-in class FDA De Novo regulatory clearance for the Parsortix PC1 system.
As announced in April 2024, we have further enhanced the sensitivity of our immunofluorescent labelling downstream research-use protocols and developed the proprietary CellKeep® slide to significantly increase the number of CTCs captured on the slides for this form of analysis."
The research has been published as a peer-reviewed publication in the Journal of Experimental & Clinical Cancer Research and is available online at https://angleplc.com/resources/publications/.
For further information:
ANGLE plc | +44 (0) 1483 343434 |
Andrew Newland, Chief Executive |
|
Berenberg (NOMAD and Broker) |
+44 (0) 20 3207 7800 |
FTI Consulting |
|
For Frequently Used Terms, please see the Company's website on https://angleplc.com/investor-relations/glossary/
Notes for editors
About ANGLE plc
ANGLE is a world-leading liquid biopsy company with innovative circulating tumour cell (CTC) solutions for use in research, drug development and clinical oncology using a simple blood sample. ANGLE's FDA cleared and patent protected circulating tumour cell (CTC) harvesting technology known as the Parsortix® PC1 System enables complete downstream analysis of the sample including whole cell imaging and proteomic analysis and full genomic and transcriptomic molecular analysis.
ANGLE's commercial businesses are focusing on diagnostic products and clinical services. Diagnostic products include the Parsortix® system, associated consumables and assays. The clinical services business is offered through ANGLE's GCLP-compliant laboratories. Services include custom made assay development and clinical trial testing for pharma.
Over 90 peer-reviewed publications have demonstrated the performance of the Parsortix system. For more information, visit www.angleplc.com
Any reference to regulatory authorisations such as FDA clearance, CE marking or UK MHRA registration shall be read in conjunction with the full intended use of the product:
The Parsortix® PC1 system is an in vitro diagnostic device intended to enrich circulating tumor cells (CTCs) from peripheral blood collected in K2EDTA tubes from patients diagnosed with metastatic breast cancer. The system employs a microfluidic chamber (a Parsortix cell separation cassette) to capture cells of a certain size and deformability from the population of cells present in blood. The cells retained in the cassette are harvested by the Parsortix PC1 system for use in subsequent downstream assays. The end user is responsible for the validation of any downstream assay. The standalone device, as indicated, does not identify, enumerate or characterize CTCs and cannot be used to make any diagnostic/prognostic claims for CTCs, including monitoring indications or as an aid in any disease management and/or treatment decisions.
All results reported in this announcement and any other products and services are for research use only and not for use in diagnostic procedures.
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SOURCE: ANGLE plc
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FAQ
What is the Parsortix PC1 system by ANGLE plc (OTCQX:ANPCY) approved for?
What percentage of metastatic breast cancer patients showed CTCs using ANGLE's Parsortix PC1 system (OTCQX:ANPCY)?
How does ANGLE's Parsortix PC1 system (OTCQX:ANPCY) differ from EpCAM-based CTC enrichment technologies?
When did ANGLE plc (OTCQX:ANPCY) receive FDA approval for the Parsortix PC1 system?
