VolitionRX has entered an agreement with the University of Oxford to start a clinical trial that will evaluate its Nucleosomics platform technology for the diagnosis of endometriosis through a simple blood test.
The trial will focus on the development of a simple blood test to help clinicians diagnose endometriosis at an earlier stage.
As part of the deal, the university will provide VolitionRx with serum and plasma samples from 350 patients with endometriosis and 150 control patients over a period of two years.
Samples are donated by participating women through the biospecimen repository of the Oxford Endometriosis CaRe Centre.
Endometriosis is a common and painful condition, where endometrial tissue that normally lines the cavity of the uterus, grows in other parts of the body.
It is a benign condition with a strong inflammatory component, which makes the disease a good candidate for Volition’s NuQ assays.
This condition mostly affects women during their reproductive life span, and currently there are no clinically useful biomarkers available.
For endometriosis, diagnosis is only possible by performing minimally invasive surgery, also known as laparoscopy.
The 350-patient sample collection, supplemented with 150 retrospectively-collected samples, will include healthy and endometriosis-positive individuals confirmed by laparoscopy.
The company said differences in circulating nucleosomes will be evaluated across the menstrual cycle using its Nucleosomics technology platform.
Collection of samples will be led by professors Christian Becker and Krina Zondervan, from the Nuffield Department of Obstetrics & Gynaecology, University of Oxford, who are also co-directors of the Endometriosis CaRe Centre.
The trial will evaluate the samples collected from patients undergoing laparoscopic surgery for endometriosis-related symptoms or patients undergoing laparoscopic tubal sterilisation.
Collection is expected to be completed at the end of 2016, as part of an ongoing biospecimen collection and biobanking programme.
Mr Becker said: “We are looking forward to the results of this study.
“It compliments our ongoing efforts in the Endometriosis CaRe Centre of identifying non-invasive biomarkers for endometriosis which will be an essential step towards improved patient care.”