Update on laboratory accreditation

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	[phone]
Andrew Newland, Chief Executive Ian Griffiths, Finance Director Andrew Holder, Head of Investor Relations Todd Druley, Chief Medical Officer (US)	[phone]
Berenberg (NOMAD and Joint Broker) Toby Flaux, Jen Clarke, Milo Bonser, Shiv Dave	[phone]
Jefferies (Joint Broker) Max Jones, Thomas Bective	[phone]
FTI Consulting Simon Conway, Ciara Martin Matthew Ventimiglia (US)	[phone] [phone]

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 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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