ANGLE PLC said the American regulator is now moving to a “substantive review” of the company’s liquid biopsy after an initial hurdle was quickly negotiated.
The US Food & Drug Administration’s (FDA) administrative review is designed to ensure the research group has submitted all the necessary “elements and information” and paves the way for the detailed assessment of ANGLE’s Parsortix system.
The company is seeking Class II De Novo FDA clearance for the cancer detection system and is hoping to receive sign-off for its use in metastatic breast cancer.
In achieving this regulatory landmark Parsortix would be the first device approved by the American drugs watchdog for the harvesting of circulating tumour cells, which can then be assessed to design the best possible treatment regimen.
Included in the submission is five years’ work and over 400 technical reports.
The FDA’s goal is to make a decision on a De Novo request in 150 review days. As such ANGLE said the earliest prospect for regulatory clearance is the second quarter of next year.
In a statement, ANGLE’s founder and chairman, Andrew Newland said: “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.”