New urine test could detect womb cancer in three hours

pharmafile | February 3, 2021 | News story | Research and Development Cancer, urine test 

A simple test using patented technology to detect the cancer biomarker MCM5 (Minichromosome Maintenance Complex Component 5) in urine could help gynaecologists rule out endometrial cancer in as little as three hours, according to a recent study.

New research recently published in the journal BMC Cancer shows that the non-invasive urine test, ADXGYNAE, could have an important role in the diagnostic pathway for women suspected of having the disease, reducing the need for painful, invasive procedures.

The new data for ADXGYNAE is the latest to highlight the effectiveness of the non-invasive ADX portfolio of diagnostic tests developed by UK-based Arquer Diagnostics. The study, which enrolled a total of 125 patients from Saint Mary’s Hospital in Manchester, showed that ADXGYNAE can accurately detect the presence of an endometrial tumour with a sensitivity of 87.8%.

While this study enrolled patients already known to have endometrial cancer, in a prospective population the sensitivity would generate a 99.3-99.5% Negative Predictive Value (NPV), reinforcing that ADXGYNAE could be a valuable rule-out test for the disease.

Around 9,400 women are diagnosed with endometrial cancer, also known as uterine or womb cancer, in the UK each year. This makes it the fourth most common cancer in women in the UK – and the sixth most common globally – and the incidence and prevalence continue to rise each year.

Richard Edmondson, Professor of Gynaecological Oncology at The University of Manchester, Consultant at Saint Mary’s Hospital, and lead investigator of the new research, said: “Endometrial cancer, which affects the lining of the womb, is the most common gynaecological cancer in the UK. Although many women are diagnosed at an early stage when treatment is successful, unfortunately, due to a variety of reasons, such as issues with diagnostic procedures or women presenting too late, some are still diagnosed at a late stage.

“Diagnosis usually involves taking a biopsy from the lining of the womb which can be uncomfortable and even painful on some occasions. Many thousands of these tests are carried out in the UK each year. But most women who undergo a biopsy will be found not to have a cancer.

“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.”

Darcy Jimenez

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