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ANGLE plc Patient Enrollment Completed

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ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that its 200 patient ovarian cancer clinical verification study (“the Study”) has completed patient enrolment.

The Study, undertaken by the University of Rochester Medical Center Wilmot Cancer Institute, New York, USA (URMC), is designed to 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.

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.

Once the new performance data is available, and assuming positive results, ANGLE intends to establish this test as a laboratory developed test (LDT) for discriminating malignant from benign pelvic masses prior to surgery.  ANGLE expects this to be the first molecular LDT to become available in its recently established clinical laboratories, once necessary accreditations have been achieved, around the end of this year.

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).

As such, in patients indicated for surgery for an ovarian cyst or pelvic mass, there is a key unmet medical need to accurately determine, ahead of surgery, whether cancer is present. An accurate diagnosis would enable patients to be triaged to specialist cancer surgeons, where malignancy is probable.  Cancer patient outcomes are significantly worse when surgery is not undertaken by a specialist cancer surgeon and the pelvic mass is malignant rather than benign.

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.

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