RNS FDA Submission28 Sep 2020 08:05
Angle PLC ANGLE announces completion of FDA submission
Source: UK Regulatory (RNS & others)
TIDMAGL
RNS Number : 2189A
Angle PLC
28 September 2020
For immediate release 28 September 2020
ANGLE plc ("the Company")
ANGLE ANNOUNCES COMPLETION OF FDA SUBMISSION
Full Class II De Novo FDA Submission seeking clearance of the Parsortix system for metastatic breast cancer
Potential to be the first ever FDA clearance for a system to harvest intact cancer cells from a simple blood draw for subsequent analysis
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce that it has submitted a full De Novo FDA Submission for its Parsortix(R) PC1 system seeking FDA clearance for use with metastatic breast cancer (MBC) patients ("the Submission").
The Submission provides a data package demonstrating the performance of the Parsortix system in harvesting cancer cells from MBC patient blood for subsequent analysis. The directors believe that the capability to harvest these cells provides the potential for a wide range of downstream analyses, which may transform the treatment of cancer, providing patients with personalised cancer care through a non-invasive, repeat biopsy based on a simple blood test (a "liquid biopsy").
Submission details
The Submission is the output of five years' work including extensive dialogue with FDA, and the development of over 400 technical reports and documents, which have now been submitted to FDA. The characterisation of the system included the assessment, inter alia, of performance with clinical samples, recovery, linearity, limit of detection, reproducibility, repeatability, blood volume, blood stability and interfering substances both exogenous and endogenous, requiring over 15,000 samples to be run on the Parsortix system in the UK and at clinical sites in the United States. This process, combined with the manufacture of the Parsortix system and associated consumables, has been completed and fully documented under ANGLE's ISO 13485 quality system and in compliance with numerous other technical and quality standards active in the United States and Europe. The Submission has also been designed to meet the requirements for European CE Mark and, if granted clearance by FDA in the United States, ANGLE intends to register for European CE Mark clearance allowing clinical sales in both the United States and Europe for the intended use.
We are most grateful to over three hundred MBC patients at four leading US cancer centres and several thousand healthy volunteer donors, who have donated blood to allow us to undertake the extensive studies necessary for the Submission.
Market potential
ANGLE intends that the Parsortix system will eventually be adopted worldwide. Cowen Equity Research estimate the market opportunity for liquid biopsy in the United States alone to be up to US$ 130 billion per annum.
The current National Cancer Guidelines in the
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