ANGLE PLC (AIM:AGL, OTCQX:ANPCY) announced the publication of data that it said supported the FDA approval of its Parsortix PC1 system for harvesting circulating tumour cell (CTC).
The data was published in the Journal of Experimental & Clinical Cancer Research and was also previously submitted to the FDA.
Angle, in Thursday’s statement, said the study validates Parsotix’s use for isolating and harvesting CTCs in metastatic breast cancer patients.
"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,” chief scientific officer Karen Miller said in Thursday’s statement.
“The data from this study contributed to the first-in-class FDA De Novo regulatory clearance for the Parsortix PC1 system.”
The study was conducted at ANGLE's UK laboratory, the University of Rochester, and the MD Cancer Center in the US. It demonstrated that the Parsortix system successfully captured and harvested CTCs from the blood samples of 76 patients.
CTCs were identified in 45% of patients, with clusters detected in 56% of CTC-positive cases.
Notably, 70% of the CTCs did not express the epithelial marker EpCAM – a result that highlighted the limitations of EpCAM-based technologies that are currently in use.
ANGLE believes this data played a crucial role in ANGLE's FDA De Novo request, which led to the classification of the Parsortix PC1 system as a Class II medical device in 2022.
Karen Miller added: “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."