ANGLE (AGL ) has completed its 200 ovarian cancer clinical verification study ("the Study") patient enrolment.
The Study, which will be undertaken by the University of Rochester Medical Center Wilmot Cancer Institute, New York, USA, will now evaluate the use of ANGLE's Parsortix® system for circulating tumour cell (CTC) harvest and subsequent downstream analysis with ANGLE's HyCEAD™ multiplex RNA platform as a simple blood test to detect the presence of ovarian cancer in women with a pelvic mass prior to surgery.
Dr Richard Moore, Director of the Gynecologic Oncology Division, University of Rochester Medical Center, Wilmot Cancer Institute commented: "This 200-patient 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 through a simple blood test. The test's high sensitivity and specificity, if verified, will help to ensure that women with ovarian cancer get the best possible treatment whilst women with a benign condition will be able to have their treatment locally with the physicians they know."
The test has the potential to significantly improve patient outcomes, whilst also reducing overall healthcare costs. Approximately 5% to 10% of women will be diagnosed with an ovarian cyst or pelvic mass during their lifetime and, in the United States alone, more than 200,000 women undergo surgery for pelvic mass each year.
Although commonly benign, up to 12% of patients who undergo surgery will subsequently be diagnosed, post surgery, with ovarian cancer. Current diagnosis of ovarian cancer ahead of surgery is unreliable with both high false positive results and high false negative results, as it utilises ultrasound imaging and the measurement of CA-125 protein in blood. Imaging is imprecise and CA-125 protein is a non-specific analyte (it can be upregulated for reasons other than cancer).
The performance of ANGLE's predictive ovarian cancer detection assay, which achieved an AUC-ROC1 >95% in a previous 200 patient study performed by ANGLE, is being evaluated in a new patient cohort. It is anticipated that the remaining patients' surgical procedures, clinical status determinations and clinical database inputs will be finalised and 'locked' (kept secure and inaccessible until sample evaluation is completed) by the end of Q2 2021. The clinical status of the new patient cohort will be kept blinded until after the molecular analysis of the Study samples is performed. The HyCEAD molecular analysis of the Parsortix processed samples is expected to take place in Q3 2021 with the Study reporting headline results in Q4 2021.
With validation, there is also the potential for use of the ovarian cancer test to extend beyond the initial intended use of pelvic mass surgery triage to include conservative management (watchful waiting) to avoid a surgery for pelvic mass where malignancy is not suspected, monitoring of ovarian cancer patients after treatment, and molecular evaluation of the tumour to aid in drug selection. ANGLE estimates that the total addressable market for this test is up to US $1.8 billion per annum in the United States alone.
ANGLE Founder and Chief Executive, Andrew Newland, commented: "Completion of patient enrolment is a key step in this pivotal study towards demonstrating the capability of a Parsortix-based blood test to accurately detect the presence of ovarian cancer. Subject to the test performing as expected and securing the necessary accreditations of the Company's clinical laboratories to run molecular assays, the timing of which is outside our direct control, we are targeting launch of this test around the end of the calendar year."
View from Vox
Investors will be pleased that Angle has hit its timeline for the successful enrolment of 200 patients first articulated back in October 2020. With headline results and initial launch planned for 4Q20, the next 12 months could be pivotal for the Company.
Shares in Angle reacted positively to the announcement rising 1.33% in morning trading. This adds to a spectacular month for ANGLE investors with the shares rising from 77p in March to 114.5p as of today.
Clearly, If the results from this test reflect the results from ANGLE’s own 200 patient study, Angle’s technology will represent ‘best in class’ assay and we would expect the shares to react accordingly surpassing the current consensus price target of 150p.