LONDON: ANGLE plc has completed the fitout and staffing of its clinical services laboratories in Guildford UK, and Plymouth Meeting PA, United States.
This launch comes ahead of schedule with the US laboratory being completed sooner than anticipated and the UK laboratory opening in line with anticipated timescales.
Together, these laboratories will allow ANGLE to accelerate the commercial deployment of the Parsortix system by offering services to pharmaceutical and biotech customers for use in cancer drug clinical trials and, once the laboratories are accredited and tests validated, through the provision of Laboratory Developed Tests (LDTs) for patient care.
ANGLE’s sample to answer liquid biopsy solution via a simple blood test enables longitudinal monitoring of patients during drug trials (before, during and after drug intervention) which is not possible with tissue biopsy.
This represents a significant market opportunity for ANGLE. In a single subset of this market, there are over 2,000 PD-L1/PD-1 interventional trials registered on clinicaltrials.gov, enrolling over 300,000 patients, which would be potential targets for ANGLE’s pharma services business.
ANGLE is targeting future clinical studies for adoption of the Parsortix system and has developed service capabilities in the United Kingdom and the United States to process samples on a commercial scale as part of global pharma trials. ANGLE has already established dialogue with prospective customers and collaborators for the deployment of CTC liquid biopsy analysis in cancer drug trials, with a number of these conversations at an advanced stage.
Both the UK and US laboratories will seek ISO15189 accreditation and the US laboratory will also seek Clinical Laboratory Improvement Amendments (CLIA) accreditation, which will allow them to market LDTs for clinical use. Given the extensive clinical work already completed with the Ovarian Cancer Pelvic Mass Triage assay, it is anticipated that this will be ANGLE’s first LDT to market.
ANGLE Founder and Chief Executive, Andrew Newland, commented: “The new clinical services laboratories are an important element in the Company’s commercial strategy and we are pleased to launch the global offering ahead of schedule. This will accelerate commercialisation of the Parsortix system and act as a demonstrator to support product deployment.
As well as working with pharmaceutical company customers directly, we are keen to work with contract research organisations both as a white label service and, when they wish to deploy the tests internally, by supplying Parsortix systems so that they can directly offer their own CTC services for cancer drug trials.
This will enable us to scale the commercial use of the Parsortix system in this large market. We are in advanced discussions with potential customers and we look forward to updating the market on the first contracts in due course.”
ANGLE is a world leading liquid biopsy company with sample-to-answer solutions. ANGLE’s proven patent protected platforms include a circulating tumor cell (CTC) harvesting technology and a downstream analysis system for cost effective, highly multiplexed analysis of nucleic acids and proteins. www.angleplc.com