UPDATE ON SUBMISSION FOR FDA CLEARANCE OF THE PARSORTIX SYSTEM
Additional Information Request received from FDA as expected and ANGLE response being prepared in line with expected timescales
FDA has indicated its review processes for non COVID-19 devices are currently slower than usual due to COVID-19 pandemic priorities
GUILDFORD, SURREY / ACCESSWIRE / March 4, 2021 / ANGLE plc (AIM:AGL)(OTCQX:ANPCY), a world-leading liquid biopsy company, announces that, following substantive review of ANGLE's FDA submission requesting De Novo clearance of the Parsortix® PC1 system, FDA has provided a written response in the form of an Additional Information Request (AIR). Receipt of an AIR was expected and is in line with typical De Novo clearance processes. ANGLE is confident of being able to provide a full response to all the information requests raised.
Some of the technical information requested necessitates some targeted additional analytical studies. However, these additional analytical studies do not require patient samples and ANGLE anticipates that the necessary studies, which are already at an advanced planning stage, can be completed and the response submitted by early May.
In its communication with FDA, ANGLE has been advised that, due to unprecedented allocation of resources to COVID-19 priorities, it is currently unclear how quickly FDA will be able to review ANGLE's response to the AIR once it has been submitted. Whilst there has not been a delay to date, taking into account the possibility that FDA processes are delayed, it is now more likely that FDA clearance, if granted, would occur in the second half of 2021 rather than the previous guidance of the "earliest prospect of FDA clearance being Q2 CY21". ANGLE notes that FDA processes are outside the Company's control and ANGLE is continuing to expedite all aspects of the process which are under its control in line with previously advised timescales.
ANGLE Founder and Chief Executive, Andrew Newland, commented:
"The Additional Information Request is largely as expected consisting of questions and clarifications. We are encouraged that, whilst there is an element of new work needed, this does not require the acquisition of further time-consuming patient samples. ANGLE has mapped out a comprehensive and positive response to FDA's request and is confident that this can be submitted as planned. We appreciate the current pressure on FDA resources, given COVID-19 priorities and thank the Agency for the progress already made with the substantive review.
Separate from FDA product clearance, ANGLE is continuing to make encouraging progress towards the establishment of clinical laboratories and the development of a new pharma services business and looks forward to announcements in relation to these in due course."
* ANGLE is following a De Novo FDA process for Parsortix, as there is no predicate device. Consequently, there is inherent uncertainty over the timing of the process and its ultimate success.
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The information communicated in this announcement is inside information for the purposes of Article 7 of Regulation 596/2015.
For Frequently Used Terms, please see the Company's website on https://angleplc.com/investor-relations/glossary/
Notes for editors
About ANGLE plc www.angleplc.com
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.
ANGLE's cell separation technology is called the Parsortix® system, and it enables a liquid biopsy (a simple blood test) to be used to provide the cells of interest to the user in a format suitable for multiple types of downstream analyses. The system is based on a microfluidic device that captures cells based on a combination of their size and compressibility. The system is epitope independent and can capture all types of CTCs as well as CTC clusters in a viable form (alive). CTCs enable the complete picture of a cancer to be seen as being an intact cell they allow DNA, RNA and protein analysis and thus provide comparable analysis to a tissue biopsy. Because CTC analysis is a non-invasive process, unlike tissue biopsy, it can be repeated as often as needed. This is important because cancer develops and changes over time and there is a clear medical need for up-to-date information on the status. In addition, the live CTCs harvested can be cultured, which offers the potential for testing response to drugs outside the patient.
The Parsortix technology is the subject of 26 granted patents in Europe, the United States, China, Australia, Canada, India, Japan and Mexico with three extensive families of patents are being progressed worldwide.
The Parsortix system has a CE Mark in Europe for the indicated use and, in the United States, a De Novo Submission has been made to FDA for the Parsortix® PC1 system seeking FDA clearance with Class II Classification for use with metastatic breast cancer patients. FDA clearance is seen as the global standard. ANGLE is seeking to be the first ever FDA cleared system for harvesting CTCs for subsequent analysis.
ANGLE has also completed two separate 200 subject clinical studies under a program designed to develop an ovarian cancer pelvic mass triage test, with the results showing best in class accuracy (AUC-ROC) of 95.1%. The pelvic mass triage assay has undergone further refinement and optimisation and is currently in the process of a 200 patient clinical verification study.
ANGLE's technology for the multiplex evaluation of proteins and nucleic acids of all types is called the HyCEADTM Ziplex® platform and is based on a patented flow through array technology. It provides for low cost, highly multiplexed, rapid and sensitive capture of targets from a wide variety of sample types. A proprietary chemistry approach (the HyCEAD method) allows for the capture and amplification of over 100 biomarkers simultaneously in a single reaction. The HyCEAD Ziplex system is extremely sensitive and is ideal for measuring gene expression and other markers directly from Parsortix harvests and was used in the ovarian cancer pelvic mass triage test to achieve best in class accuracy (AUC-ROC) of 95.1%.
ANGLE's proprietary technologies can be combined to provide automated, sample-to-answer results in both centralised laboratory and point-of-use cartridge formats.
ANGLE has established formal collaborations with world-class cancer centres and major corporates such as Abbott, Philips and QIAGEN, and works closely with leading CTC translational research customers. These Key Opinion Leaders (KOLs) are working to identify applications with medical utility (clear benefit to patients), and to secure clinical data that demonstrates that utility in patient studies. The body of evidence as to the benefits of the Parsortix system is growing rapidly from our own clinical studies in metastatic breast cancer and ovarian cancer and also from KOLs with 41 peer-reviewed publications and numerous publicly available posters, available on our website.
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SOURCE: ANGLE plc