Tuesday, October 4, 2022


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Novel Assay Developed Using the Parsortix System Accurately Predicts Malignancy in Pelvic Mass

Publication of results from ANGLE’s pelvic mass pilot study in collaboration with Wilmot Cancer Institute in a high-impact journal. The study informed the development of ANGLE’s pelvic mass triage test for detection of ovarian cancer requiring surgical intervention

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ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce the publication of results from a clinical study undertaken in partnership with the Wilmot Cancer Institute, University of Rochester, NY, US. The Parsortix® system was utilised for cancer detection in 183 women with a pelvic mass who had a range of benign and malignant conditions. The results have been published in the respected, high impact, journal Obstetrics & Gynecology (“The Green Journal”).

The population of cells captured from peripheral blood by the Parsortix system were subjected to multiplexed gene expression analysis, and these results were combined with serum protein biomarkers to form a predictive algorithm, referred to as the Malignancy Assessment using Gene Identification in Captured Cells (“MAGIC”) algorithm. The MAGIC algorithm successfully and accurately detected malignancy in women with a pelvic mass more effectively than serum biomarkers alone. The MAGIC algorithm’s unique grouping of 8 genes and 4 serum biomarkers (ROC-AUC 95.1%, 95% CI = 92.0 – 98.2%) significantly outperformed all individual genes (ROC-AUCs = 50.2 to 65.2%; all p<0.001), the serum biomarker only algorithm (ROC-AUC = 89.6%, 95% CI = 84.3 – 95.0%), and the gene only algorithm (ROC-AUC = 88.0, 95% CI = 82.9 – 93.0%, p=0.005) for the discrimination of benign tumours from all cancers. Importantly, MAGIC was able to accurately identify malignancy for both early stage (ROC-AUC: 89.5%, 95% CI = 81.3 – 97.8%) and late-stage (ROC-AUC: 98.9%, 95% CI = 96.7 – 100%) epithelial ovarian cancer. Furthermore, the algorithm not only detected epithelial ovarian cancer, but also detected non-ovarian primary cancers and metastatic cancers.

This research highlights the potential of combining the multiplexed gene analysis of captured cells with serum biomarkers from a simple blood test for rapid and accurate pelvic mass triage. This may help to identify the presence of gynaecological cancers at an earlier stage whilst accurately identifying benign conditions that could be managed locally rather than by a specialist.

This successful study was used to inform a clinical verification study which is currently ongoing and from which headline results are expected shortly. Assuming similar results, ANGLE intends to establish this test (referred to as the Landscape+TM Ovarian assay) as a laboratory developed test in its own clinical laboratories. The test has the potential to significantly improve patient outcomes whilst at the same time reduce overall healthcare costs.

Approximately 5-10% of women will present with a pelvic mass during their lifetime. For these women, accurate and early diagnosis of malignancy is critical. Around 20,000 women are diagnosed with ovarian cancer in the US each year. Sadly, almost 60% of cases are diagnosed when the cancer has metastasised, resulting in a 5-year survival rate of just 31%. Current diagnosis relies on imaging and elevated levels of serum biomarker CA-125, which has poor specificity. Where malignancy is suspected, patients usually undergo surgical resection. However, there is a need for more accurate and timelier triage of patients with a pelvic mass to enable early detection of malignancy so that these patients can be referred to high-volume physicians and institutions. It has been shown that surgical staging and debulking by gynaecological oncologists at these high-volume institutions improves survival for ovarian cancer patients.

Dr. Richard Moore, Director of the division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Wilmot Cancer Institute, University of Rochester commented:

“As a leading translational research team with a focus on gynecologic oncology biomarkers, we are excited to present the results of this important study. Ovarian cancer is difficult to detect in women with an ovarian cyst or a pelvic mass and identifying patients at high risk is critical. Our team, in association with ANGLE plc, created the MAGIC algorithm employing the Parsortix system as a key tool in assisting in the detection of ovarian cancer in patients with a pelvic mass, an area of significant unmet need. I also see this technology as an important tool for prognostic indicators and even diagnosis as further research is developed.”

Professor Kyu Kwang Kim, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Wilmot Cancer Institute, University of Rochester added:

“This hybrid technology explores the versatility of CTC evaluation in combination with serum biomarkers to improve the detection of cancer. The MAGIC algorithm is an exciting advance towards more effective pelvic mass triage.”

ANGLE Founder and Chief Executive, Andrew Newland, added:

“Currently gene expression in CTCs is an emerging field not yet incorporated into existing clinical risk-stratification models for ovarian cancer. This prospective clinical trial employing novel technology introduces the combination of CTC and serum biomarker analysis and is therefore an important milestone towards improving pelvic mass triage. We now look forward to receiving the headline results from an ongoing clinical verification study in this setting, and we anticipate that the Landscape+ Ovarian assay will be ANGLE’s first laboratory developed test to be offered from our own clinical laboratories.”

The research has been published as a peer-reviewed publication in the Journal Obstetrics & Gynecology and will be available online here.

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