31st Oct 2019 15:38
(Alliance News) - Angle PLC said late Wednesday it had submitted positive results from its Parsortix analytic studies to the US Food & Drug Administration on Tuesday.
Angle is seeking Class II classification and marketing authorisation for its Parsortix system for use with metastatic breast cancer patients.
The liquid biopsy company said it is following the De Novo regulatory submission pathway for its Parsortix system as there is no similar product already on the market. It is hoping for FDA clearance in the third quarter of 2020.
"We are delighted with the positive results from the FDA analytical studies to accompany the positive results from the pivotal FDA clinical study that have previously been announced," said Founder & 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."
Angle shares were down 2.9% at 69.94 pence late Thursday in London.
By Tom Waite; [email protected]
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