Ovarian cancer is the 10th most common cancer in women with 324,000 new cases diagnosed globally each year and 930,000 women living with this cancer.
Even in developed nations, such as the United States, ovarian cancer is often diagnosed at a late stage when the cancer has metastasised. For the 55% patients presenting with late-stage disease the average five-year survival rate is just 31%.
Earlier diagnosis of ovarian cancer is needed to improve patient prognosis and survival. ANGLE has developed an assay for the triage of women presenting with a pelvic mass. In combination with the current standard of care this will help clinicians better establish which women are at the highest risk of malignancy.
Key statistics
10th
most common cancer in women
324,000
new cases diagnosed globally each year
930,000
women living with ovarian cancer
31%
five-year survival rate for late-stage diagnosis*
55%
patients present with late-stage disease*
To date ANGLE has completed three ovarian clinical studies in 600 participants with uniformly positive results.
In September 2022, ANGLE announced positive results from the third study, an ovarian cancer clinical study demonstrating that the Parsortix® system, coupled with gene expression analysis of circulating tumour cells (CTCs), can be used to determine if a woman is at risk of a malignant pelvic mass.
This 200-patient study was performed in collaboration with the University of Rochester Medical Centre Wilmot Cancer Institute with samples analysed in ANGLE’s clinical laboratory in the United States.
CTCs were evaluated using ANGLE’s ovarian assay to determine the expression levels of 164 different gene transcripts. Analysis of the data produced an algorithm to predict the risk of malignancy by combining the physician’s initial cancer risk assessment (benign vs. malignant), the patient’s age, and the RNA expression levels of 23 critical genes.
The performance of the Parsortix ovarian assay in this study had an area under the curve (AUC) 95.4%. This is in line with the high level of accuracy demonstrated in ANGLE’s previous 200 patient multicenter study reported in 2018 (AUC 95.1%) and achieved ANGLE’s objective of best-in-class results with both sensitivity and specificity exceeding 90%.
EMBER2, pelvic mass study:
Following the successful completion of the pelvic mass study for the detection of ovarian cancer reported in 2022, ANGLE has continued the enrolment of women with a pelvic mass into the EMBER2 clinical study. Study recruitment was completed in September 2023 after reaching 400 patients with 1,400 blood tubes processed on the Parsortix system. The cell harvest has been stored for future molecular analysis.
This is in line with the high level of accuracy demonstrated in ANGLE’s previous 200 patient multicenter study reported in 2018 (AUC 95.1%) and achieved ANGLE’s objective of best-in-class results with both sensitivity and specificity exceeding 90%.
The next generation ANGLE pelvic mass triage test has the ability to out-perform current clinical practice in accurately discriminating malignant from benign pelvic masses prior to biopsy or surgery. The improved accuracy of the test results in a high level of sensitivity as well as a substantial reduction in false positives.”
Dr Richard Moore
Director of the Gynecologic Oncology Division, University of Rochester Medical Center Wilmot Cancer Institute, United States
The clinical results demonstrate ANGLE’s capability to undertake complex molecular analysis of CTCs harvested using Parsortix technology.
The data also confirms the suitability of Parsortix technology for use in both hospital and centralised laboratories.
In addition to ANGLE sponsored studies Trinity College, Dublin have published a study where the Parsortix technology was utilised to isolate CTCs from the blood of high-grade serous ovarian cancer patients to investigate the role of Plasminogen activator inhibitor 1 (PAI-1) in CTC survival and proliferation.
See: https://pubmed.ncbi.nlm.nih.gov/38143926/
Research from the Edith Cowen University in Western Australia also demonstrated that the Parsortix system was able to enrich both single CTCs and CTC clusters from high grade serous ovarian cancer patient blood samples. Furthermore, the team demonstrated that CTCs from ovarian cancer patients express PD-L1 and that CTCs undergoing EMT were significantly associated with PD-L1 expression.
*Based on US data alone. For Research Use Only. Not For Use in Diagnostic Procedures.