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First patient enrolled in FDA study
First patient enrolled in FDA study.
About this update from Cellbxhealth Plc
[{"type":"text","content":"\n \nRNS Number : 8764J Angle PLC 05 April 2018 \n\n\n\n\n\nFor immediate release\n\n\n 5 April 2018\n\n\n\n\n \nANGLE plc (\"the Company\")\n \nFIRST PATIENT ENROLLED IN CLINICAL STUDY TO SUPPORT FDA CLEARANCE OF THE PARSORTIX SYSTEM \n \nFDA clearance would provide worldwide differentiation for the Parsortix system in the multi-billion dollar liquid biopsy market\n \n \nANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce that the first patient has been enrolled into its ANG-002 FDA clinical study for metastatic breast cancer. ANGLE is seeking to become the first ever company to receive FDA Class II clearance for a product for harvesting intact circulating tumor cells (CTCs) from patient blood for subsequent analysis1. \n \nThe successful start of this study is the culmination of an enormous amount of work to develop, test and finalise the protocols involved and secure all of the necessary approvals for the clinical study. There were significant technical issues that had to be addressed in relation to the downstream analysis techniques. Optimisation of the techniques used to analyse cells harvested by the ParsortixTM system has required the development of know-how which, now successfully completed, adds to the overall capability and differentiation of the Parsortix system in the market. \n \nFDA clearance is the de facto global gold standard for in vitro diagnostic tests as well as a legal requirement for sale of the product for the intended clinical use in the United States. Securing FDA clearance has the potential to differentiate ANGLE in the liquid biopsy market, validating the clinical and analytical performance of the system and thereby positively influencing Parsortix system adoption worldwide. \n \nThe clinical study involves recruitment of 200 metastatic breast cancer patients and 200 healthy volunteers enrolled at leading US cancer centres and is designed to support potential clearance by the FDA for the following intended use:\n \n\"The ParsortixTM PC1 instrument is an in vitro diagnostic device intended to harvest circulating tumor cells (CTCs) from the peripheral blood of patients diagnosed with metastatic breast cancer. Harvested CTCs can be used in subsequent analyse...