Angle plc announced 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 systems. 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 PC 1 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.