A blood test successfully identified ovarian cancer from circulating cells, and may enable this cancer to be detected early and prior to surgery, results of the first phase of a clinical verification study show.
This first stage or pre-study was conducted at the University of Rochester Medical Center Wilmot Cancer Institute, and assessed Angle‘s Parsortix and HyCEAD Ziplex systems as a simple blood test to discriminate between benign and malignant pelvic masses.
A method to identify circulating tumor cells so to screen ovarian cancer before surgery would help in determining the most appropriate surgical procedures to use, improving patient outcomes and easing overall healthcare costs, the company said in a press release.
Blood samples of 26 Stage III/IV ovarian cancer patients and 28 healthy volunteers were analyzed in this pre-study. Parsortix harvested circulating tumor cells, and HyCEAD-Ziplex analyzed their RNA – the intermediate molecules between DNA and proteins.
The systems’ ability to differentiate women with ovarian cancer from healthy volunteers suggests both high sensitivity and high specificity, which refer to correct detection of cancer and low number of false positives.
These findings also support the start of a full clinical test planned in 200 women with a pelvic mass and scheduled for surgery. This verification study is expected to start in late 2019 and finish in early 2020. Enrollment is expected to be similar to the ANG-003 trial (NCT02781272), conducted at the same University of Rochester center. If successful, this study would support Angle’s plans to market its ovarian cancer test.
“The performance of Angle’s optimised sample-to-answer molecular solution for ovarian cancer in the pre-study is encouraging,” Andrew Newland, Angle’s founder and chief executive, said in the release. “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.”
Results presented in March 2018 at The Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer showed that the combination of the Parsortix and HyCEAD Ziplex systems in ANG-003 — also with 200 ovarian cancer patients — were highly accurate in predicting the presence of ovarian cancer. The test had higher sensitivity and specificity than any other available method for the same use.
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