ANGLE plc Achieves World First with FDA Clearance for its Parsortix System
News | 08-06-2022
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is absolutely delighted to announce that the US Food and Drug Administration (FDA) has cleared the Parsortix® system for its intended use with metastatic breast cancer (MBC) patients.
This ground-breaking FDA clearance is the first-ever FDA product clearance to harvest cancer cells from a patient blood sample for subsequent analysis and offers the prospect of a new era of personalised cancer care.
The Parsortix system’s capability to harvest circulating cancer cells for analysis from a patient blood sample has the potential to transform treatment decisions for cancer patients as it opens up the opportunity for repeat non-invasive biopsies to assess cancer status. The Company believes intact circulating cancer cells are the “best sample” for analysis, adding vital additional information to the current industry approach of analysing fragments of dead cancer cells (known as ctDNA).
FDA product clearance, which is the global gold standard for medical devices, gives ANGLE first mover advantage for intact cell analysis in the global liquid biopsy market, which it is estimated will grow to over US$100 billion per annum in the United States alone. Securing this clearance is the culmination of a sustained effort by the Company for over six years. The credibility associated with medical device FDA product clearance cannot be under-estimated and we anticipate that this will turbocharge all aspects of commercialisation of the Parsortix system and be a key factor in its adoption by large-scale medtech and pharma companies.
The Parsortix system approach utilises a unique technology developed, owned and patent protected by ANGLE. We believe that first mover advantage in the market is likely to be sustained for a number of years and ANGLE is not aware of any competitors even having started a similar FDA product clearance process.
ANGLE Founder and Chief Executive, Andrew Newland, commented:
“We are absolutely delighted that FDA has cleared the Parsortix system and believe this heralds a new era for personalised cancer care.
This ground-breaking first ever FDA product clearance in metastatic breast cancer provides the platform for ANGLE to work with our collaborators and customers to support further FDA submissions and the establishment of numerous specific clinical uses across different cancer types. By making the Parsortix system widely available, we intend to support the entire industry in its adoption of liquid biopsy solutions for repeat non-invasive diagnostics for personalised cancer care. Large-scale medtech and pharma companies now have an FDA cleared platform on which to develop new medical solutions.
We are most grateful to over three hundred metastatic breast cancer patients and several thousand healthy volunteer donors, who donated blood to allow us to achieve this major breakthrough in the adoption of liquid biopsy as a potential new standard in the care of cancer patients. We also thank investors for providing the considerable financial support, and patience, that has allowed us to undertake such a substantial exercise.”
About ANGLE plc www.angleplc.com
ANGLE is a world leading liquid biopsy company with sample-to-answer solutions. ANGLE’s proven patent protected platforms include a circulating tumor cell (CTC) harvesting technology known as the Parsortix® system and a downstream analysis system for cost effective, highly multiplexed analysis of nucleic acids and proteins.
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