17th Mar 2014 10:34
LONDON (Alliance News) - ANGLE PLC said Monday it has made a submission to the United States Food and Drug Administration for the authorisation of the sale of its Parsortix cell separation system as an in vitro diagnostic device in the United States.
The specialist meditech firm has applied to the FDA under the 501(k) programme, one of the regulatory pathways for medical devices in the United States.
ANGLE said it expects to receive FDA clearance by the end of he third quarter this year, although no guarantees can be made around the exact timing of authorisation.
FDA regulatory clearance would allow sale of the Parsortix system to hospital pathology laboratories and other clinical customers in the United States for the harvesting and molecular analysis of large cells such as circulating tumour cells from patient blood.
Looking ahead, the firm remains focused on its ultimate objective of the widespread adoption of the Parsortix system in the diagnosis and treatment of cancer patients. "According to statistics from the World Health Organisation, there were 14 million new cancer cases worldwide in 2012, a marked rise on the 12.7 million cases in 2008. ANGLE estimates that this represents a potential market for the Parsortix system worth in excess of GBP8 billion per annum worldwide," said the company.
ANGLE's Founder and Chief Executive, Andrew Newlan, said, "We are pleased to have submitted our FDA application and are excited about the potential of having an FDA authorised system that can harvest cancer cells from blood for mutational analysis. We believe the simplicity of our approach provides strong competitive advantages in the major emerging market of personalised cancer care."
ANGLE shares were trading 4.27% higher Monday morning at 92.8 pence per share.
By Alice Attwood; [email protected]; @AliceAtAlliance
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