A hit for Angle could mean clearance next year

Angle’s unusual spin on the notion of a liquid biopsy crept closer to the US today with a positive pivotal readout in metastatic breast cancer. The ANG-002 trial enrolled 200 breast cancer patients – who were either newly diagnosed or had progressive or recurrent disease and were about to start a new line of therapy – and 200 healthy women. The Parsortix device was reliably able to detect entire cancer cells that had split off from tumours and were circulating in cancer patients’, but not healthy volunteers’, blood, compared with cytological evaluation of stained slides by a pathologist. Actual figures for sensitivity, specificity and positive and negative predictive values were not released; the company says full bioinformatic analysis is due in June. The ANG-002 trial was designed to support Angle’s application for de novo clearance of Parsortix for breast cancer, but the FDA has recently let the company know that these results will not be sufficient on their own. Angle says additional analytical studies, which will carry “minimal cost”, will also be needed. The submission will be made in the fourth quarter, meaning that clearance could come in early 2020.

The Parsortix procedure

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