New Test Enables Non-Invasive Detection of Endometrial Cancer

Arquer Diagnostics is developing non-invasive tests for diagnosing and monitoring cancer, using patented technology to detect the cancer biomarker MCM5. In a study recently published in BMC Cancer, its urine-based test – ADXGYNAE – was shown to accurately rule out the presence of an endometrial tumor. 

Technology Networks had the pleasure of speaking with Nadia Whittley, Chief Executive Officer of UK-based Arquer Diagnostics, to learn more about the study and its significance. In this interview, Nadia also discusses the science behind the test and how it could be employed to detect other types of cancer.

Laura Elizabeth Lansdowne (LL): How common is endometrial cancer?

Nadia Whittley (NW): This is a devastating disease – the fourth most common cancer in women in the UK – and the sixth most common globally. In the UK alone, around 9,400 women are diagnosed with endometrial cancer which is also known as uterine or womb cancer. And unfortunately the numbers are continuing to rise each year. In fact, over the past decade, the number of women being diagnosed with this disease has increased by 13%, in part-fueled by factors including increased rates of obesity, poor lifestyles and increased glycemic load.

Anna MacDonald (AM): How is endometrial cancer currently diagnosed?

NW: We know that 10% of women over the age of 55 suffer from post-menopausal bleeding which is the most common symptom of endometrial cancer and it accounts for 5% of secondary care referrals. There is a lack of diagnostic options which means diagnosis usually involves an internal ultrasound and a biopsy, where a tissue sample is taken from the lining of the womb by hysteroscopy. This can be uncomfortable and even painful. More than 11 million of these invasive tests are conducted globally each year yet the majority of women are found not to have cancer, with just 3–5% resulting in a positive diagnosis.

AM: The potential for urine-based detection was recently described in a paper published in BMC Cancer. Can you give us an overview of the study, its findings, and their significance?

NW: This new research has shown that ADXGYNAE could have an important role in the diagnostic pathway for women suspected of having endometrial cancer which would reduce the need for many of the painful, invasive procedures currently used. This new data for ADXGYNAE is the latest to highlight the effectiveness of our non-invasive ADX portfolio of diagnostic tests. It found that ADXGYNAE can accurately detect the presence of an endometrial tumor with a sensitivity of 87.8%. The study enrolled 125 patients already known to have endometrial cancer, but in a prospective population, this sensitivity would generate a 99.3–99.5% Negative Predictive Value (NPV). This reinforces our belief that ADXGYNAE could be a valuable rule-out test for the disease and we are hopeful this will be validated by our ongoing studies. We are incredibly 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 to help spare women from unnecessary tests.

LL: What is MCM5? Can you explain why this is a suitable biomarker for cancer detection? How does it work?

NW: MCM5 – or minichromosome maintenance complex component 5 – is a protein in urine produced by the expression of the MCM5 gene. All cancer cells – in every cancer type – are continually dividing, or replicating, so contain MCM5. Healthy cells which will normally line the uterus and are shed into secretions, which are then found in urine, do not contain MCM5. However, when a tumor is present in the uterus, cancer cells are now shed into the secretions and found in urine, which means the MCM5 biomarker will be present and can be detected by our patented technology in ADXGYNAE. This is also used in our ADXBLADDER diagnosis test which detects MCM5 shed from the bladder lining into the urine if bladder cancer is present. ADXBLADDER has already proven in numerous studies to be highly accurate at ruling out the disease and is already available for urologists to use across Europe and the UK.

AM: Are there any other cancers that could be detected with MCM5? Do you have any other tests in development?

NW: Absolutely. We aren’t stopping at bladder and endometrial cancers. We know there are other cancers which our technology should be able to rule out and we are dedicated to our mission of pushing the boundaries of innovative oncology diagnostics. Our next major focus is on prostate cancer which is the most common cancer in men in the UK and second most common globally. We know that there is a strong clinical need for an accurate prostate cancer test and our initial trial data is very exciting and already strong enough for us to move on to a larger study. We are hopeful this will produce even more reliable data which will drive our prostate cancer diagnostic test to the next stage.

Nadia Whittley was speaking to Laura Elizabeth Lansdowne, Managing Editor, and Anna MacDonald, Science Writer for Technology Networks.