The med-tech firm is seeking Food & Drug Administration Class II regulatory clearance for its Parsortix technology that harvests circulating tumour cells, which provide the tell-tale signs of cancer. FDA sign-off is seen as the gold standard for a medical device.
The assessment itself revealed Parsortix was able to harvest cancer cells from the blood of a significant proportion of metastatic breast cancer patients.
It also achieved exploratory goals such as being able to “interrogate” patient blood using certain analysis techniques.
In discussions with the FDA, the regulator has identified certain additional experiments that should be carried out. ANGLE said they are of “minimal cost” and will allow its researchers to submit Parsortix data early in the fourth quarter, meaning it could potentially receive its certification in early 2020.
“We are working to complete the remaining analytical study work and the full data analysis and interpretation so that an FDA submission can be made as soon as possible,” said chief executive Andrew Newland.
"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.
“This clearance, considered the gold standard for approval of medical diagnostic systems globally, would further competitively differentiate the Parsortix system and should lead to an acceleration in commercial adoption of the system in both research and clinical settings.”