StockMarketWire.com - Liquid biopsy company Angle reported 'positive' results from its clinical study for metastatic breast cancer.

The study achieved its primary objective, demonstrating that the Parsortix system's ability to capture and harvest cancer cells from the blood of a significant proportion of metastatic breast cancer patients, the company said.

The 400 subject ANG-002 clinical study (the Study) was designed to support a De Novo submission to the United States Food and Drug Administration (FDA) seeking Class II regulatory clearance for ANGLE's Parsortix system for the intended use with metastatic breast cancer patients.

The study also achieved its exploratory goals by 'demonstrating that the cells harvested from patient blood using the Parsortix system could be interrogated using different subsequent analysis techniques,' Angle said.

The harvested cells were also able to be used for the generation of cDNA libraries of sufficient quality for use in RNA-seq evaluation, with full bioinformatic analysis due in June.

The company said its ongoing discussions with FDA as part of the De Novo process had recently identified additional analytical study experiments that would be needed to support FDA clearance.

'The additional studies have minimal cost and are expected to be completed to allow FDA submission in early Q4 CY19 offering the prospect of FDA clearance in early CY20. The timing of FDA regulatory clearance is dependent on the FDA's review and response to our submission,' Angle added.


At 9:01am: [LON:AGL] Angle PLC share price was +3p at 73.5p



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