Angle PLC - Guildford, England-based liquid biopsy company - Celebrates research data on its Parsortix PC1 system that it says supports approval by the US Food & Drug Administration. Data was published as a peer-reviewed publication in the Journal of Experimental & Clinical Research. The study had been submitted to the FDA for De Novo clearance of the Parsortix PC1 system. The De Novo process provides a pathway to classify some novel medical devices. The study reports that the Parsortix system successfully captured and harvested circulating tumour cells (CTC) from metastatic breast cancer patient blood samples for downstream analysis using immunofluorescence and cytological evaluation. Angle says the publication validates the use of the Parsortix system for CTC isolation and harvest in metastatic breast cancer.
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