TIDMAGL
Angle PLC
15 March 2022
For immediate release 15 March 2022
ANGLE plc ("the Company")
UPDATE ON LABORATORY ACCREDITATION
ANGLE's US clinical laboratory issued Certificate of
Registration, a key step to achieving CLIA accreditation
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, provides an update on the accreditation of its clinical
laboratory in the United States to allow Parsortix(R) tests to be
offered for patient management.
The Centers for Medicare and Medicaid Services (CMS) has issued
a Certificate of Registration, under the Clinical Laboratory
Improvement Amendments (CLIA), to the Company's United States
clinical laboratory. This is a key step towards achieving CLIA
accreditation of the laboratory. Following CMS audit, including an
inspection of the facilities and documentation on the validation of
assays to be performed together with associated quality control
procedures, a Certificate of Compliance will be issued. This will
complete the accreditation process that permits the laboratory to
process samples for patient management from the majority of the
United States, with a small number of States requiring additional
procedures which will be progressed separately.
As previously communicated, ANGLE has established clinical
laboratories in the United States and the UK that have the
capability of offering validated clinical tests for patient
management. Accreditation of the UK laboratory is also being
progressed under parallel processes in the UK. The laboratories are
intended as accelerators and demonstrators in support of the
Company's established plan for product sales of Parsortix
instruments and cassettes for widespread medical use and are
already actively providing research use services to pharmaceutical
and biotech customers running cancer drug trials.
ANGLE Chief Medical Officer, Dr Todd Druley, commented:
"The issuance of a Certificate of Registration under CLIA is an
important step towards accreditation of our United States clinical
laboratory and the roll out of our commercial offerings in the
United States with the intended launch of laboratory developed
tests for patients. Accreditation will also provide recognition of
the qualifications of our laboratory and critical assurances to
support the growth in our pharma services business."
For further information:
ANGLE plc +44 (0) 1483 343434
Andrew Newland, Chief Executive
Ian Griffiths, Finance Director
Andrew Holder, Head of Investor Relations
Todd Druley, Chief Medical Officer (US) +1 (314) 807 4936
Berenberg (NOMAD and Joint Broker)
Toby Flaux, Jen Clarke, Milo Bonser, Shiv Dave +44 (0) 20 3207 7800
Jefferies (Joint Broker)
Max Jones, Thomas Bective +44 (0) 20 7029 8000
FTI Consulting
Simon Conway, Ciara Martin +44 (0) 203 727 1000
Matthew Ventimiglia (US) +1 (212) 850 5624
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 may 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 of a patient's tumor. In addition, the live CTCs harvested
by the Parsortix system can be cultured, which offers the potential
for testing tumor 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 a 200 patient
clinical verification study has now completed enrolment.
ANGLE's technology for the multiplex evaluation of proteins and
nucleic acids of all types is called the HyCEAD(TM) 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 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
55 peer-reviewed publications and numerous publicly available
posters, available on our website.
ANGLE has established clinical services laboratories in the UK
and USA to accelerate commercialisation of the Parsortix system and
act as demonstrators to support product development. The
laboratories offer services to pharmaceutical and biotech customers
for use of Parsortix in cancer drug trials and, once the
laboratories are accredited and tests validated, will provide
Laboratory Developed Tests (LDTs) for patient management.
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