Data supporting FDA approval published in Journal

Angle PLC

22 August 2024

 

For immediate release

22 August 2024

ANGLE plc ("the Company")

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

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 45% of MBC patients, with CTC clusters, known to have high metastatic potential, identified in 56% of the CTC positive patients. Among the MBC patient blood samples with detectable CTCs, 70% of the cells did not express the epithelial marker, EpCAM. This highlights the limitations of EpCAM-based CTC enrichment technologies and further underpins the rationale for the use of ANGLE's Parsortix system which harvests CTCs based on the size and deformability of the cells.

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	[phone]
Andrew Newland, Chief Executive Ian Griffiths, Finance Director
Berenberg (NOMAD and Broker) Toby Flaux, Ciaran Walsh, Milo Bonser	[phone]
FTI Consulting Simon Conway, Ciara Martin Matthew Ventimiglia (US)	[phone] [phone]

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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