Future watch

Innovative urine test rules out endometrial cancer in up to 99% of cases

February 11, 2021

For the first time, a simple, innovative test which uses 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. New research recently published in the journal BMC Cancer shows that ADXGYNAE could have an important role in the diagnostic pathway for women suspected of having the disease, reducing the need for painful, invasive procedures.

This 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 – part of the Manchester University NHS Foundation Trust (MFT) – 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 this 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. Over the past decade in the UK, uterine cancer incidence rates increased by 13%, in part fuelled by factors including increased rates of obesity, poor lifestyles and increased glycaemic load. Unfortunately, because of a lack of diagnostic options, over 11 million invasive and painful tests are conducted globally each year, with just 3-5% resulting in a cancer diagnosis.

Professor 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.”

Nadia Whittley, Chief Executive Officer of Arquer Diagnostics, said:

“We know that there is a significant need to develop non-invasive and accurate diagnostic tests for endometrial cancer. At Arquer, we are proud to be able to build on the work we have been doing in bladder cancer to bring a new diagnostic option to women suspected of endometrial cancer. In initial studies, our ADXGYNAE test is quick, painless and could rule out cancer with 99% accuracy and this should be validated by our ongoing studies currently being conducted. We are excited to continue with further clinical trials of ADXGYNAE in both the USA and Europe to bring this new diagnostic option to the Endometrial Cancer Pathway as quickly as possible.”

Arquer Diagnostics’ first product currently marketed and available in clinical practice is ADXBLADDER. In rigorous clinical trials, ADXBLADDER has shown that it can rule out the presence of bladder cancer with an NPV of 99% in newly diagnosed patients and those undergoing routine monitoring, without the need for invasive and unnecessary procedures.

Arquer Diagnostics has conducted a large number of clinical trials of MCM5 at over 20 centres in countries including the UK, Italy, Spain, France and the Netherlands, which demonstrate the science behind its technology.

To access the full research paper, please click here.

News & Analysis

by Editor