Angle PLC - Completion of Ovarian Cancer Pre-Study
SUCCESSFUL COMPLETION OF OVARIAN CANCER PRE-STUDY
Pre-study demonstrates ANGLE's optimised sample-to-answer molecular solution with patient samples
The pre-study, undertaken by Dr.
The pre-study comprised the evaluation of blood samples from 26 Stage III/IV ovarian cancer patients and 28 healthy volunteers using ANGLE's sample-to-answer molecular solution: Parsortix harvested circulating tumour cells and HyCEAD-Ziplex performed multiplex RNA expression analysis of those cells. The observed discrimination between cancer patients and healthy volunteers suggests the potential for both high sensitivity (correctly detecting cancer) and high specificity (correctly detecting no cancer i.e. low false positives).
The pre-study results demonstrate that the optimisation of the sample-to-answer molecular solution has been successful, paving the way to initiate the 200 subject ovarian cancer clinical verification study of patients who are presenting with a pelvic mass and scheduled for surgery. A positive outcome from the clinical verification study would support ANGLE's plans to launch a clinical assay for the detection of ovarian cancer in women with an abnormal pelvic mass.
This study is expected to start in early Q3 CY19 and is projected to complete in Q1 CY20. Project timelines assume a similar enrolment rate to the previous 200 patient pelvic mass study conducted by the same clinical centre but patient enrolment is outside of the Company's control.
ANGLE Founder and Chief Executive,
"The performance of ANGLE's optimised sample-to-answer molecular solution for ovarian cancer in the pre-study is encouraging. We are excited about progressing the full clinical verification study which will help support the launch of a clinical assay at a clinical laboratory and/or via a commercial partnership."
Approximately 5% to 10% of women will be diagnosed with a pelvic mass during their lifetime, with 13% to 21% of these women being subsequently diagnosed with ovarian cancer. A test to detect circulating tumor cells in the blood and hence ovarian cancer prior to surgery would enable women to be triaged to appropriate surgical procedures improving patient outcomes whilst at the same time reducing overall healthcare costs. ANGLE estimates that the global market size for this clinical application is worth
Results for ANGLE's previous 200-subject ovarian cancer study with
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For Frequently Used Terms, please see the Company's website on http://www.angleplc.com/the-parsortix-system/glossary/
Notes for editors
1. The area under the curve (AUC) for a receiver operating characteristic (ROC) plot, a plot of 1-specificity on the x-axis vs. the sensitivity on the y-axis at each possible threshold for a test's results, is a measure of a diagnostic test's accuracy. The accuracy of the test depends on how well the test separates the two groups being compared into those with the outcome (sensitivity) and those without the outcome (specificity) in question. An AUC of 1 (100%) represents a perfect test while an AUC of 0.5 (50%) represents a worthless test. The traditional academic classification system for ROC-AUCs is 90% to 100% = excellent; 80% to 90% = good; 70% to 80% = fair; 60% to 70% = poor; 50% to 60% = fail. Source:
In addition to his clinical interest in ovarian and endometrial cancers,
ANGLE is a world leading liquid biopsy company with sample-to-answer solutions. ANGLE's proven patent protected platforms include an epitope-independent 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 ParsortixTM 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 downstream subsequent analyses. CTCs enable the complete picture of a cancer to be seen as they allow DNA, RNA and protein analysis and the live cells harvested can be cultured. The Parsortix technology is the subject of 21 granted patents in
ANGLE's technology for the multiplex evaluation of proteins and nucleic acids of all types is called the HyCEADTM Ziplex® 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 Ziplex system 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 (ROC-AUC) 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 QIAGEN, Abbott and Philips, 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 20 peer-reviewed publications and numerous publicly available posters, available on our website.
This information is provided by RNS, the news service of the
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