ANGLE PLC (LON:AGL) has predicted that it will receive regulatory clearance for its Parsortix cancer test by the third quarter of this year following a successful face-to-face meeting with the US Food and Drug Administration (FDA).
The AIM-listed firm said it is now preparing for a full De Novo submission to the FDA, a process that allows the regulator to approve medical devices that have no comparative already on the market.
Parsortix is a blood test designed to help doctors detect signs of cancer at an early stage, offering a less invasive alternative to tissue biopsies currently used in hospitals.
ANGLE said it is aiming to file its De Novo submission in the first quarter of 2020, with the prospect of regulatory clearance by the third quarter.
While the FDA had requested additional analytical study work, the company said this will be undertaken in parallel with its drafting for the De Novo submission and will not impact the overall timescale of the process.
“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 ANGLE chief executive Andrew Newland.
In a note, analysts at house broker finnCap, which peg the company with a 115p target price, said the successful meeting had “significantly de-risked the regulatory path” for ANGLE, predicting that FDA clearance will be “a watershed moment” that will catalyse more commercialisation and partnership deals.
The shares surged 9.2% to 69p in early trading on Wednesday.