ANGLE plc ("the Company")

NEW results supportING angle's her2 assay development programme

ANGLE and BioView present analytical validation data confirming high sensitivity and specificity of HER2 assay kit under development, alongside patient case study data

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 presentation of new data for ANGLE's HER2-CTC assay at the American Association for Cancer Research (AACR) Annual meeting being held in Chicago.

ANGLE is presenting a poster on Monday 28 April 2025 between 09:00 and 12:00 (Central Time) entitled "Analytical validation of ANGLE's combined IF and FISH assay for assessment of HER2 in circulating tumor cells" during the Liquid Biopsy: Circulating Tumor Cells 1 session, in Poster Section 29.

ANGLE and BioView are developing a HER2 assay kit to work alongside the Parsortix^® system to assess HER2 status of CTCs from a blood sample. The poster showcases this minimally invasive, real-time assessment for dynamic HER2 evaluation with target analytical sensitivity and specificity of over 98% that is linear, repeatable and reproducible.  

Metastatic breast cancer patient data presented in the poster exemplifies that despite HER2 negative primary tissue status, HER2 positive CTCs can be identified in some patients at a later timepoint, suggesting their cancer may have evolved and could benefit from HER2 targeted therapy.

HER2 is a protein that is associated with many cancers, particularly breast cancer, and HER2 tumour marker testing is used to determine if HER2 targeted therapy is likely to be effective. Current standard of care evaluates HER2 status using tissue biopsy. It is well established that HER2 status can change over time, resulting in the original tissue biopsy assessment being out of date. As a result, patients who could benefit from HER2 targeted treatment may be missed.

Overall, these results showcase that ANGLE's HER2-CTC assay can provide reliable and critical up to date information about the changing HER2 status of patients which is not available through tissue biopsy alone, potentially identifying new patients for HER2 targeted treatment.

ANGLE's Chief Scientific Officer, Karen Miller, commented:

"We are pleased to announce this new data to support HER2 CTC assessment using the Parsortix system. Liquid biopsy assessment of CTCs enables dynamic changes in HER2 status to be monitored in a minimally invasive way and has the potential to help guide more effective patient treatment options."

This poster is available for review at: https://angleplc.com/resources/posters/.

For further information:

For Research Use Only. Not for use in diagnostic procedures.

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 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 clinical services and diagnostic products. The clinical services business is offered through ANGLE's GCLP-compliant laboratories. Services include custom made assay development and clinical trial testing for pharma. Products include the Parsortix system, associated consumables and assays.

Over 100 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.