ANGLE PLC (LON:AGL) confirmed it completed and submitted a response to questions raised by the US Food and Drugs Administration (FDA) in its Additional Information Request as part of the clearance process for its Parsortix system.
The liquid biopsy company said in line with industry best practice it does not intend to provide any further updates on communication with FDA regarding the submission while the regulatory process is as expected.
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ANGLE continues to anticipate a regulatory decision from the US authorities during the second half of 2021.
The firm is developing a cell separation technology called the Parsortix system, which enables a liquid biopsy (a simple blood test) to be used to provide the cells of interest to the user in a format suitable for multiple types of downstream analyses.
It is following a De Novo FDA process for the Parsortix system, and as there is no predicate device there is uncertainty over the timing of the process and its ultimate success.
The system is based on a microfluidic device that captures cells based on a combination of their size and compressibility.
It is the subject of 26 granted patents in Europe, the US, China, Australia, Canada, India, Japan and Mexico with three extensive families of patents are being progressed worldwide.
It has CE Mark in Europe for the indicated use and, in the US, ANGLE is seeking approval for use with metastatic breast cancer patients.
"We are pleased to have submitted a comprehensive response to FDA's request for additional information and look forward to FDA completing its substantive review," said founder and chief executive Andrew Newland in a release.