NEW YORK — Angle said on Wednesday that its Parsortix cell sorting system has received US Food and Drug Administration clearance for use in the isolation of circulating metastatic breast cancer cells for liquid biopsy testing.
The FDA clearance "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," Angle Founder and CEO Andrew Newland said in a statement. "By making the Parsortix system widely available, we intend to support the entire industry in its adoption of liquid biopsy solutions for repeat noninvasive diagnostics for personalized cancer care. Large-scale medtech and pharma companies now have an FDA-cleared platform on which to develop new medical solutions."
Newland has previously said that Angle is also exploring the use of Parsortix in ovarian cancer and prostate cancer.
Angle said that the system received a De Novo Class II classification from the FDA, based on over 400 technical reports and documents and the processing of more than 16,000 samples to demonstrate its performance.
The UK-based company said it is also seeking CE-IVD marking for Parsortix.