RCS - Angle PLC - Data supporting FDA approval published in Journal

AngleAnnouncement

22/08/2024 07:00

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RNS Number : 3188B  Angle PLC  22 August 2024

 For immediate release  22 August 2024

 

ANGLE plc ("the Company")

 

DATA SUPPORTING FDA APPROVAL PUBLISHED IN HIGH-IMPACT JOURNAL

 

Publication of results from ANGLE's Parsortix PC1 system validates use of
Parsortix System for CTC isolation and harvest in metastatic breast cancer

 

 

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company with
innovative circulating tumour cell (CTC) solutions for use in research, drug
development and clinical oncology, is pleased to announce the publication of
one of the Company's clinical studies that was submitted to the FDA for De
Novo regulatory clearance of the Parsortix(®) PC1 system.

 

This study, undertaken at ANGLE's UK laboratory, the University of Rochester,
US, and the MD Anderson Cancer Center, US, reports that the Parsortix system
successfully captured and harvested CTCs from metastatic breast cancer (MBC)
patient blood samples for downstream analysis using immunofluorescence (IF)
and cytological evaluation.

 

The study recruited 76 MBC patients whose blood samples were processed using
the Parsortix PC1 system. CTCs were identified in 45% of MBC patients, with
CTC clusters, known to have high metastatic potential, identified in 56% of
the CTC positive patients. Among the MBC patient blood samples with detectable
CTCs, 70% of the cells did not express the epithelial marker, EpCAM. This
highlights the limitations of EpCAM-based CTC enrichment technologies and
further underpins the rationale for the use of ANGLE's Parsortix system which
harvests CTCs based on the size and deformability of the cells.

 

The data generated by this study supported ANGLE's FDA De Novo request for the
classification of the Parsortix PC1 system as a Class II medical device, for
use in MBC patients to capture and harvest CTCs for subsequent,
user-validated, downstream analyses. This was granted by the FDA in 2022.

 

Chief Scientific Officer, Karen Miller, added:

"We are pleased to share the results of this clinical study, demonstrating the
performance of the Parsortix PC1 system in successfully isolating CTCs from
MBC patient blood samples. The data from this study contributed to the
first-in class FDA De Novo regulatory clearance for the Parsortix PC1 system.

 

As announced in April 2024, we have further enhanced the sensitivity of our
immunofluorescent labelling downstream research-use protocols and developed
the proprietary CellKeep(®) slide to significantly increase the number of
CTCs captured on the slides for this form of analysis."

 

The research has been published as a peer-reviewed publication in the Journal
of Experimental & Clinical Cancer Research and is available online at
https://angleplc.com/resources/publications/.

 

 

For further information:

 

 ANGLE plc                               +44 (0) 1483 343434
 Andrew Newland, Chief Executive

 Ian Griffiths, Finance Director

 Berenberg (NOMAD and Broker)            +44 (0) 20 3207 7800

 Toby Flaux, Ciaran Walsh, Milo Bonser

 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

 

ANGLE is a world-leading liquid biopsy company with innovative circulating
tumour cell (CTC) solutions for use in research, drug development and clinical
oncology using a simple blood sample. ANGLE's FDA cleared and patent protected
circulating tumour cell (CTC) harvesting technology known as the Parsortix(®)
PC1 System enables complete downstream analysis of the sample including whole
cell imaging and proteomic analysis and full genomic and transcriptomic
molecular analysis.

 

ANGLE's commercial businesses are focusing on diagnostic products and clinical
services. Diagnostic products include the Parsortix(®) system, associated
consumables and assays. The clinical services business is offered through
ANGLE's GCLP-compliant laboratories.  Services include custom made assay
development and clinical trial testing for pharma.

 

Over 90 peer-reviewed publications have demonstrated the performance of the
Parsortix system. For more information, visit www.angleplc.com
(http://www.angleplc.com)

 

 

Any reference to regulatory authorisations such as FDA clearance, CE marking
or UK MHRA registration shall be read in conjunction with the full intended
use of the product:

The Parsortix(®) PC1 system is an in vitro diagnostic device intended to
enrich circulating tumor cells (CTCs) from peripheral blood collected in
K(2)EDTA tubes from patients diagnosed with metastatic breast cancer.  The
system employs a microfluidic chamber (a Parsortix cell separation cassette)
to capture cells of a certain size and deformability from the population of
cells present in blood.  The cells retained in the cassette are harvested by
the Parsortix PC1 system for use in subsequent downstream assays.  The end
user is responsible for the validation of any downstream assay.  The
standalone device, as indicated, does not identify, enumerate or characterize
CTCs and cannot be used to make any diagnostic/prognostic claims for CTCs,
including monitoring indications or as an aid in any disease management and/or
treatment decisions.

All results reported in this announcement and any other products and services
are for research use only and not for use in diagnostic procedures.

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