ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce that ethics approval has been obtained from the University of Rochester Medical Center Wilmot Cancer Institute for its ovarian cancer clinical verification study.
The first subjects have already been enrolled into the Study, which comprises a 70-subject pre-study followed by a 200-subject clinical study, evaluating the use of ANGLE’s modified and further optimised ParsortixTM and HyCEADTM Ziplex® platforms as a simple blood test to detect the presence of ovarian cancer in women with a pelvic mass. The Study is expected to complete in Q1 CY2020.
Since its acquisition of the HyCEAD Ziplex downstream analysis platform in November 2017, ANGLE has undertaken extensive optimisation of both the HyCEAD Ziplex platform and its combination with the Parsortix system to provide an assay predictive of ovarian cancer risk. A detailed market review has been completed to identify key user requirements for adoption of the test and work has been completed to address these identified user requirements with key improvements including:
- improved analytical sensitivity of the HyCEAD Ziplex platform enabling the detection of a single cancer cell harvested by the Parsortix system from a 10ml blood sample
- incorporation of assay controls and use of fractional sampling to demonstrate reproducibility and reliability of performance
- development of methods to allow for patient blood sample processing for up to 96 hours after collection without significantly compromising the assay sensitivity, thus opening up the possibility for the test to be offered by large central laboratories with sufficient time for sample transportation.
The entire sample-to-answer process has been analytically validated using contrived samples and is now being tested in the clinical setting. Testing of the modified and further optimised Parsortix and HyCEAD Ziplex platforms has begun in the pre-study using known ovarian cancer patients and healthy volunteers to confirm the performance of various improvements to the process. Upon successful completion of the initial testing phase, the blinded, independently controlled 200-subject verification study of the targeted population of pelvic mass patients prior to surgery will begin. The Study has been designed to evaluate performance of the predictive assay in a new patient cohort and, assuming the initial testing is successful, is expected to complete within 12 months.
Once the new performance data is available and, assuming comparable results to the previous study, ANGLE intends to use this data in discussions with large clinical laboratories and/or women’s health companies to secure a partner for clinical deployment utilising the sales and distribution channels of the partner to scale deployment. The test has the potential to significantly improve patient outcomes whilst at the same time reducing overall healthcare costs.
Dr Richard Moore, Director of the Gynecologic Oncology Division, University of Rochester Medical Center Wilmot Cancer Institute, commented:
“The planned 200-subject study is designed to verify the clinical performance of the novel ANGLE ovarian cancer assay in discriminating malignant from benign pelvic masses prior to surgery. The test’s high sensitivity and specificity, demonstrated in a previous study presented at the 2018 SGO annual meeting, will help to ensure that women with ovarian cancer get the best possible specialist treatment whilst women with a benign condition will be able to have their treatment locally with the physicians they know.”
ANGLE Founder and Chief Executive, Andrew Newland, commented:
“The performance of the HyCEAD Ziplex system in conjunction with Parsortix endorses the Company’s decision to acquire the platform and opens a wide range of commercial opportunities. The first clinical application in ovarian cancer is an exemplar with a large opportunity for ANGLE and we are excited about progressing the clinical verification study.”
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 US$1 billion per annum.
Results for ANGLE’s previous 200-subject ovarian cancer study with University of Rochester Medical Center Wilmot Cancer Institute were presented at The Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer in New Orleans in March 2018. The assay (combining Parsortix and HyCEAD Ziplex) achieved a high degree of accuracy for the prediction of the presence of ovarian cancer, with a ROC-AUC1 of 95.1%. The novel test achieved higher sensitivity and specificity than any other test available for the same clinical application. In particular, existing tests suffer from low specificity with a high false positive rate.
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