New research published in the journal BMC Cancer has shown that Arquer Diagnostics’ ADXGYNAE urine test could help to improve the diagnostic pathway for women suspected to have endometrial cancer.
ADXGYNAE uses a patented technology to detect the cancer biomarker Minichromosome Maintenance Complex Component 5 (MCM5).
The study, which enrolled 125 patients, showed that ADXGYNAE can accurately detect the presence of an endometrial tumour with a sensitivity of 87.8%. Of these patients, 41 had endometrial cancer, 26 had ovarian cancer and 58 were benign controls.
Endometrial cancer is the fourth most common cancer in the UK and the sixth most common globally, but diagnostic options are still poor.
Most women being screened for endometrial cancer end up undergoing an invasive womb-lining biopsy. Just 3% to 5% of these procedures result in a cancer diagnosis according to Arquet.
University of Manchester professor of gynaecological oncology Richard Edmondson, the study’s lead investigator, said: “ADXGYNAE is a non-invasive test which has the potential to rule out cancer with high accuracy. We hope that further clinical trials, including a pre-regulatory trial in the US, will show that ADXGYNAE, which can be carried out quickly and easily in NHS hospitals, will reduce the number of women needing these further procedures to confirm a diagnosis and provide faster reassurance for those who do not have cancer.”
Arquer Diagnostics has another, similar product on the market called ADXBLADDER. ADXBLADDER can rule out the presence of bladder cancer with a negative predictive value of 99% in newly diagnosed patients and those undergoing routine monitoring.