TIDMAGL
RNS Number : 1033R
Angle PLC
04 March 2021
For immediate release 4 March 2021
ANGLE plc ("the Company")
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
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(R) 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.
For further information:
ANGLE plc +44 (0) 1483 343434
Andrew Newland, Chief Executive
Ian Griffiths, Finance Director
Andrew Holder, Head of investor Relations
finnCap Ltd (NOMAD and Joint Broker)
Corporate Finance - Carl Holmes, Simon
Hicks
ECM - Alice Lane, Sunila de Silva +44 (0)20 7220 0500
WG Partners (Joint Broker)
Nigel Barnes, Nigel Birks, Andrew Craig,
Chris Lee +44 (0) 203 705 9330
FTI Consulting
Simon Conway, Ciara Martin, Stephanie
Cuthbert +44 (0) 203 727 1000
Matthew Ventimiglia (US) +1 (212) 850 5624
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(R)
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(R) 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 HyCEAD(TM) Ziplex(R)
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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