The medical tech firm said headline data from these studies, as well as a successful FDA clinical pivotal clinical study, originally announced in May, had been submitted to the FDA with the aim of getting market clearance for Parsortix to be used in metastatic breast cancer patients.
ANGLE has opted to pWATCH: ANGLE PLC submits its flagship Parsortix liquid biopsy diagnostic to the FDAursue clearance for Parsortix using the De Novo process, an FDA pathway that involves dialogue with the regulator to assess the risk of a product that does not have an equivalent currently on the market. This process is expected to conclude in the first quarter of 2020, with clearance predicted to follow after in Q3.
“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”, said ANGLE’s chief executive, Andrew Newland.
“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", he added.
ANGLE’s house broker, finnCap, said that while the Q3 clearance date was later than they had previously anticipated, it had an “inconsequential impact” on their forecasts and the target price for the company was maintained at 135p.
Analysts added that the De Novo process is a “sensible de-risking strategy” which will “minimise the overall timescales for clearance by addressing FDA questions early”.
In early trading on Wednesday, ANGLE’s shares were 1.1% higher at 76.8p.