Angle files De Novo FDA submission for CTC collection device in breast cancer

Liquid biopsy developer Angle said on Monday that it has submitted a full de novo submission to the US Food and Drug Administration for its Parsortix system for use with metastatic breast cancer (MBC) patients.

The UK-based firm said the submission provides a data package that highlights Parsortix’s ability to harvest circulating tumor cells (CTCs) from MBC patient blood samples for downstream analysis.

Parsortix uses a microfluidic technology in a disposable cassette to capture and harvest CTCs from blood based on their less-deformable nature and larger size compared to other blood components.

Angle believes that the ability to harvest MBC cells offers the potential for a wide range of downstream analyses, providing patients with personalized cancer care through a non-invasive liquid biopsy assay.

The firm said it is following a de novo FDA process for the Parsortix system because there is no identified predicate device.

We believe there is a tremendous opportunity for Angle to secure the first ever FDA clearance for a platform that captures and harvests intact circulating tumor cells from patient blood for subsequent analysis, in the first instance for metastatic breast cancer,” Andrew Newland, founder and CEO of Angle, said in a statement. “We believe that FDA regulatory clearance … would further competitively differentiate our Parsortix liquid biopsy system and guide to an acceleration in commercial adoption of the system in both research and clinical settings.”

If Angle receives FDA clearance for the assay, the firm plans to then register for a CE mark to allow clinical sales in both the US and Europe.

Source: https://www.genomeweb.com/

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