ANGLE PRESENTS NEW POSTER AT AMERICAN SOCIETY FOR CLINICAL PATHOLOGY MEETING
Poster describes novel use of Pap stain procedure to analyse morphology of CTCs harvested using the Parsortix system
Approach could be easily implemented in standard pathology laboratory workflows
GUILDFORD, SURREY / ACCESSWIRE / September 13, 2022 / ANGLE plc (AIM:AGL)(OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce that its United States clinical laboratory team presented a new poster at the 100th American Society for Clinical Pathology (ASCP) meeting in Chicago, Illinois, USA between 7-9 September 2022. The poster, which describes the novel use of Papanicolaou (Pap) staining procedures with cells harvested from blood samples using the Parsortix® system, was selected as a finalist for a prestigious Blue Ribbon award for laboratory practice by ASCP judges.
Pap staining is a polychromatic cytopathological staining technique used to differentiate cells in a sample and is most commonly used as a screening method for cervical cancer. In the experiments described in the poster, the ANGLE team used the technique to look at the morphology of metastatic malignant cells harvested by the Parsortix system, as a way of identifying CTCs. The team concluded that patient sample CTC analysis can be performed by combining the use of the Parsortix system with standard cytology staining and optimised analysis by qualified cytologists.
Pap staining is a reliable and inexpensive technique used in pathology laboratories world-wide and ANGLE believes that when used with a Parsortix harvest, it could enable cytologists to quickly, and reliably, identify cells of interest. For example, circulating tumour cells (CTCs) identified in blood samples from cancer patients in remission could alert clinicians to the need for further investigation and testing.
ANGLE Founder and Chief Executive, Andrew Newland, commented:
"As we look to build adoption of the Parsortix system in clinical laboratories for its intended use, the ability to place the system in standardised, low-cost laboratory workflows is a significant advantage. I am delighted that the clinical laboratory team has achieved this recognition and look forward to seeing a positive impact on the commercial roll-out of the Parsortix system".
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 known as the Parsortix® system and a downstream analysis system for cost effective, highly multiplexed analysis of nucleic acids and proteins.
ANGLE's Parsortix® system is FDA cleared for its intended use in metastatic breast cancer and is currently the first and only FDA cleared medical device to harvest intact circulating cancer cells from blood.
Intended use
The Parsortix® PC1 system is an in vitro diagnostic device intended to enrich circulating tumor cells (CTCs) from peripheral blood collected in K2EDTA 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.
The Parsortix system enables a liquid biopsy (a simple blood test) to be used to provide the circulating metastatic breast cancer cells 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 phenotypes of CTCs (epithelial, mesenchymal and EMTing CTCs) as well as CTC clusters in a viable form (alive). CTCs harvested from the system enable a complete picture of a cancer to be seen; as being an intact cell they allow DNA, RNA and protein analysis as well as cytological and morphological examination and may provide comparable analysis to a tissue biopsy in metastatic breast cancer. 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.
In the United States, the Parsortix® PC1 system has received a Class II Classification from FDA for use with metastatic breast cancer patients. FDA clearance is seen as the global gold standard. ANGLE's Parsortix system is the first ever FDA cleared system for harvesting CTCs for subsequent analysis. ANGLE has applied the IVD CE Mark to the same system for the same intended use in Europe.
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 HyCEADTM 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 68 peer-reviewed publications and numerous publicly available posters from 31 independent cancer centres, available on our website.
ANGLE has established clinical services laboratories in the UK and the United States to accelerate commercialisation of the Parsortix system and act as demonstrators to support product development. The laboratories offer services globally 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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