RCS - Angle PLC - Update on laboratory accreditation

AngleAnnouncement

15/03/2022 07:00

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RNS Number : 7485E  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(®) 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)               +44 (0) 20 3207 7800

 Toby Flaux, Jen Clarke, Milo Bonser, Shiv Dave

 Jefferies (Joint Broker)                         +44 (0) 20 7029 8000

 Max Jones, Thomas Bective

 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/
(https://angleplc.com/investor-relations/glossary/)

 

Notes for editors

 

About ANGLE plc www.angleplc.com (http://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 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(®)
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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