ANGLE’s Parsortix® instrument is an in vitro diagnostic device intended to enrich circulating tumour cells (CTCs) from peripheral blood collected in K2EDTA tubes from patients diagnosed with metastatic breast cancer. The system employs a single use 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 can then be harvested for use in subsequent downstream assays. Please note, 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. The Parsortix® instrument is available as an RUO version, Parsortix® PR1 system, and as an FDA approved device, Parsortix® PC1 Clinical System. Please note, that the Parsortix® PC1 Clinical System is cleared by the FDA only when used with the MBC-01 Metastatic Breast Cancer Kit and ICT-01 Instrument Control Test kit in compliance with the approved instructions for use.