NHS Forth Valley joins study into test which could rule out womb cancer in three hours

Most womb cancer, also known as endometrial cancer, usually starts in the lining of the womb.

Detecting the cancer marker MCM5 (Minichromosome Maintenance Complex Component 5) in the urine could reduce the need for painful invasive procedures and biopsies in women suspected of having the disease.

The study, which the local health board is the only site in Scotland to be part of, will concentrate on women with post-menopausal bleeding, one of the most common symptoms of womb cancer.

Diagnosis usually involved taking a biopsy from the lining of the womb, which can be uncomfortable and even painful on some occasions.

Thousands of these tests are carried out in the UK each year however most women who undergo a biopsy will be found not to have endometrial cancer.

The non-invasive diagnostic test known as ADXGYNAE has been developed by Arquer Diagnostics.

It has already been the subject of a study in Manchester, which showed ADXGYNAE can accurately detect the presence of an endometrial tumour with a sensitivity of 87.8 per cent.

While this study enrolled patients already known to have endometrial cancer, in a prospective population this sensitivity would generate a 99.3 to 99. per cent negative predictive value (NPV), reinforcing that it could be a valuable test for ruling out the disease.

With around 9400 women diagnosed with endometrial cancer in the UK each year, it makes it the fourth most common cancer in women in the UK, and the sixth most common globally.

There are currently a lack of diagnostic options and each year over 11 million invasive and painful tests are conducted around the world each year, with between three and five per cent resulting in a cancer diagnosis.

Dr Sarah Barr, consultant gynaecologist, said: “I’m very excited that NHS Forth Valley is participating in this important study.

"Womb cancer is becoming increasingly common, but it usually presents early with unscheduled vaginal bleeding after menopause and is often very treatable when identified early.

"We really want to encourage anyone with these symptoms to come and have a check up as soon as possible but we know gynaecological internal examinations are not always very easy and can sometimes mean that people are too scared to come and be seen.

"A reliable non-invasive test using a simple urine specimen could be a game changer for early diagnosis, both for improving outcomes for women with cancer and for being able to reassure women experiencing potential symptoms when they don’t have cancer.”

Nadia Whittley, chief executive officer of Arquer Diagnostics, added: “We know that there is a significant need to develop non-invasive and accurate diagnostic tests for endometrial cancer.

"In initial studies our ADXGYNAE test is quick, painless and could rule out cancer with 99 per cent accuracy and this should be validated by our ongoing studies currently being conducted.

"We are enthusiastic to be continuing with further clinical trials in both the USA and Europe to bring this new diagnostic option to the endometrial cancer pathways as quickly as possible.”