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.”