Liquid biopsy company ANGLE has announced that the US Food and Drug Administration has accepted its submission for substantive review of its Parsortix system for use with metastatic breast cancer (MBC) patients.
On 28 September, ANGLE said that it had submitted a full Class II De Novo FDA submission for its Parsortix PC1 system seeking FDA approval for use with MBC patients.
Following that submission, the FDA has completed its administrative review – a formal process undertaken by the FDA to determine that the submission contains all the necessary elements and information needed for the FDA to proceed with a substantive review.
ANGLE’s Parsortix system uses cell separation technology and enables a liquid biopsy to be used to provide the cells of interest to the user in a format suitable for multiple types of downstream analyses.
The system can capture all types of circulating tumour cells (CTC) as well as CTC clusters in a viable form. CTCs allow a comprehensive picture of a cancer to be seen as they allow DNA, RNA and protein analysis and thus provide comparable analysis to a tissue biopsy.
In addition, CTC analysis is a non-invasive process so it can be repeated as often as needed – an important factor since cancer develops and changes over time.
“We are pleased that our FDA submission has successfully completed FDA administrative review and is now in substantive review,” said Andrew Newland, founder and chief executive of ANGLE.
“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 tumour cells from patient blood for subsequent analysis, in the first instance for metastatic breast cancer.”