Revolutionizing Cancer Diagnosis: Unveiling the Potential of ANGLE Parsortix at the AACR 2023 Conference

ANGLE plc (AIM:AGL)(OTCQX:ANPCY), a world-leading liquid biopsy company, is excited to present a poster at the American Association for Cancer Research (AACR) annual meeting in Orlando, Florida.

This poster showcases the groundbreaking work the company has done since FDA clearance to develop protocols for combining immunofluorescent (IF) staining for epithelial, mesenchymal and epithelial-to-mesenchymal (EMT) phenotype characterisation of circulating tumour cells (CTCs) with HER2 fluorescence in-situ hybridization (FISH) staining for gene amplification assessment on samples from blood processed using the Parsortix® system. This incredible breakthrough has the potential to revolutionize cancer diagnosis and treatment.

The Parsortix system was able to successfully isolate CTCs from the blood of metastatic breast cancer (MBC) patients, paving the way for the subsequent detection of HER2 protein expression and characterization of the epithelial, mesenchymal and EMT phenotypes using the ANGLE developed Portrait Flex IF assay. This study showcases the promising potential of this technology in the field of cancer research.

ANGLE’s Portrait Flex assay for HER2 protein expression detection demonstrated remarkably high levels of both analytical sensitivity and specificity, with values surpassing 90%. Furthermore, combining IF and FISH staining for cancer cell recovery yielded results comparable to those achieved with the HER2 FISH assay alone, suggesting that the two downstream analysis methods can be effectively used together to optimise HER2 expression analysis.

In a study involving 16 patients with metastatic breast cancer (MBC), the Parsortix system was used to process blood samples, followed by analysis using the Portrait Flex assay, which included the HER2 antibody to detect protein. The results showed that 81% (13/16) of the patients tested positive for circulating tumor cells (CTCs), and 38.5% (5/13) of those CTC-positive patients had CTCs with high levels of HER2 protein expression.

Furthermore, 10 out of the 13 CTC-positive patients had at least one CTC cluster, ranging from 2 to 110 CTCs per cluster and 1 to 29 clusters per patient. This is significant as CTC clusters have been linked to increased metastatic potential. The presence or absence and the level of HER2 expression for a patient at a given timepoint is a crucial factor in determining the best treatment course.

At the AACR annual meeting, the Parsortix system, combined with ANGLE’s Portrait Flex IF assay and a commercially available HER2 FISH assay, was presented as a successful way to detect HER2 protein expression and characterize epithelial, mesenchymal, and EMT cells in CTCs harvested from the blood of MBC patients. This research not only demonstrates the efficacy of the Parsortix system but also shows the potential of this technology in the field of cancer research.

Recent studies have revealed that even patients with HER2-low breast cancer (defined as IHC score 1+ and 2+ and HER2-negative by FISH) can benefit from new HER2 targeted antibody-drug conjugates, a discovery that provides hope to those with a previously untreatable form of the disease. This is a breakthrough in the treatment of breast cancer, which has long been known to be a highly heterogeneous disease with HER2 status changing over time.

The development of a CTC-based HER2 assay presents a unique commercial opportunity, allowing for the assessment of HER2 gene expression and protein levels through the analysis of fluorescence intensities. Such a test could revolutionize the way HER2 status is monitored throughout disease progression, providing a much-needed solution and significantly expanding the size of the HER2 diagnostic market.

ANGLE Founder and Chief Executive, Andrew Newland, commented:

At this year’s AACR Annual Meeting, ANGLE presented a poster showcasing the potential of the Parsortix system for harvesting and analyzing CTCs using a combined IF and FISH approach.

We also successfully demonstrated the ability to detect HER2 protein overexpression in CTCs isolated from patients with metastatic breast cancer (MBC), a finding which has significant commercial value due to the introduction of new drugs targeting low HER2 expression.

As part of ANGLE’s program to develop ‘content’ for Parsortix, we are proud to have achieved proof of concept for our Portrait Flex IF assay which has the potential to improve patient stratification and cancer diagnosis.

About ANGLE plc

ANGLE is revolutionizing the world of liquid biopsy with its sample-to-answer solutions. Utilizing its patented Parsortix® system for harvesting circulating tumor cells (CTCs), ANGLE is leading the way in providing a reliable and accurate method for cancer diagnosis.

ANGLE’s Parsortix® system has been granted FDA clearance for its intended use in metastatic breast cancer – a milestone that makes it the world’s first and only FDA approved medical device capable of harvesting intact circulating cancer cells from blood. This breakthrough technology opens up an array of possibilities for more effective diagnosis, treatment and monitoring of breast cancer.

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