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Liquid biopsy company ANGLE recently announced that the U.S. Food and Drug Administration (FDA) has conducted a substantive review of the application of the liquid biopsy technology Parsortix for patients with metastasis breast cancer (MBC).
September 28, ANGLE said it had submitted a complete Class II FDA submission for its Parsortix system to seek FDA approval for MPC patients.
, the FDA has completed its administrative review to determine whether the submission contains all the necessary information for a substantive review.
ANGLE's Parsortix system uses cell separation technology, which captures all types of circulating tumor cells (CTCs) and CTC clusters in a viable form.
CTC allows analysis of DNA, RNA, and proteins to provide a comprehensive understanding of cancer, providing analysis similar to tissue biopsies.
addition, CTC analysis is a non-invasive process that can be repeated as needed, which is an important factor because cancer changes over time. "We believe angle has a huge opportunity to ensure FDA approval to capture and collect complete circulating tumor cells from patients' blood for subsequent analysis, especially for metastasis breast cancer," said Andrew Newland, founder and CEO of
ANGLE."
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