ANGLE PLC (LON:AGL, OTCQX:ANPCY) said it has submitted for regulatory approval in the US its Parsortix PC1 liquid biopsy for use in women with metastatic breast cancer (MBC).
The UK group is making what is called a De Novo submission to the US Food & Drug Administration, demonstrating the device’s performance harvesting cancer cells for analysis.
The system has been developed to provide 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”.
ANGLE said five years' work, including over 400 technical reports and documents and the results from 15,000 samples, have now been submitted to the FDA.
It stressed that the schedule for the process was “uncertain”, adding that the “earliest likely timing for clearance is six months after submission”.
“We believe that FDA regulatory clearance, considered the gold standard for approval of medical diagnostic systems globally, would further competitively differentiate our Parsortix liquid biopsy system and should lead to an acceleration in commercial adoption of the system in both research and clinical settings,” said Andrew Newland, ANGLE’s founder and chief executive.
According to a report by Cowen Equity Research, the market opportunity for a liquid biopsy in the US alone is estimated to be up to US$130bn.
It offers a quick, simple and safe alternative to an invasive tumour biopsy, which brings with it significant risks.
The FDA submission is a significant landmark for the group, which has spent years developing Parsortix as well as collaborating with key opinion leaders in the medical and academic fields to create a bedrock of data for the device.