StockMarketWire.com - Liquid biopsy company Angle said it had submitted positive results from analytical studies for its liquid biopsy system to the US health regulator and hoped to obtain clearance in the third quarter of next year.

The clinical and analytical studies were designed to support a De Novo submission pathway to the FDA where Angle was seeking classification and marketing authorisation (clearance) for its parsortix system for the intended use with metastatic breast cancer patients.

A formal review meeting ahd been requested with the FDA to review the submission and confirm that the headline data and proposed solutions meet requirements, the company said.

Headline data from the analytical studies and the successful FDA pivotal clinical study, announced on 31 May 2019, were submitted to the FDA on 29 October ahead of a full De Novo submission seeking FDA clearance of the company's parsortix system, Angle said.

'Angle now believes that a strong data package has been assembled to support both the clinical and analytical performance of the Parsortix system with the prospect of FDA clearance in Q3 CY20,' it added.

At 9:52am: [LON:AGL] Angle PLC share price was -2.5p at 73.5p



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