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A New Wave in Diagnosis in Women’s Health

A New Wave in Diagnosis in Women’s Health

World Ovarian Cancer Day will be recognised on May 8th, hot on the heels of Adenomyosis Awareness Month in April and Endometriosis Awareness in March. Three distinct conditions which impact women across their lifetime with one common problem – delayed diagnosis and treatment.

Thought Leadership, Women
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The World Ovarian Cancer Coalition report that in 2020, 313,959 women worldwide were diagnosed with ovarian cancer. By 2040 this will have risen to 445,721, an increase of 42%. As the number of women diagnosed with ovarian cancer increases, so does the number of women dying from the disease. Ovarian cancer deaths are due to rise from 207,252 in 2020 to 313,617 by 2040, an increase of 51%. In Africa, the number of deaths will almost double. Given the rapid increase in the number of women projected to be diagnosed each year, the Coalition anticipate that this figure will be markedly higher – unless there are significant improvements in prevention, diagnosis, and care. Ovarian cancer in its early stages may be more challenging to diagnose because symptoms may be subtle or nonspecific. Diagnosis may occur several months after the onset of symptoms or when symptoms become severe enough to prompt a visit to the healthcare provider. Prognosis for advanced-stage ovarian cancer is generally poorer compared to early-stage disease. The 5-year survival rate for stage III ovarian cancer typically ranges from 30% to 50%, while the 5-year survival rate for stage IV ovarian cancer is lower still, around 20%. In contrast, the 5-year survival rate for stage I ovarian cancer is relatively high, almost reaching 90%.

Endometriosis is a condition which affects 1 in 10 women of reproductive age, that’s 190 million women globally and symptoms may persist into post-menopausal years. It occurs when tissue similar to that which lines the uterus, grows outside the uterus as lesions in the pelvic cavity. This tissue responds to hormones and still behaves as it would if it lined the uterus, so it thickens and bleeds with a woman’s monthly hormone cycle. This causes inflammation which results in patients living in constant chronic pain and up to 50% will have fertility issues. In adenomyosis, some of this tissue grows into the myometrium, which is the muscular inner wall of the uterus. The exact prevalence of adenomyosis is unknown but it is known to be more common in people who are older than 40 or have had a procedure on their uterus. 

Today, women will suffer for 10 years with endometriosis before receiving a diagnosis. Multiple healthcare provider visits, misdiagnosis 74% of the time and long waiting lists to see a specialist all contribute to the delay in diagnosis. The gold standard for diagnosis of endometriosis is laparoscopy, which requires an operative procedure under general anaesthesia to visualise the lesions which is expensive, not without risks and has an error rate of 15%. In an absence of a diagnosis, patients with chronic pain use prescription medications that offer short term pain relief – 89% take opioids. Diagnosis of adenomyosis is further confounded by the fact that the gold standard is histological examination of a hysterectomy specimen which is not an option for younger people wishing to conceive. The lack of availability of an accurate non-invasive diagnostic impedes a healthcare provider’s ability to make a differential diagnosis or detect early adenomyosis or endometriosis.

 

How did we get here?

 

Although endometriosis and adenomyosis often affect women during their reproductive years and ovarian cancer is more common in older women (over 50), they share many common symptoms – pelvic pain, menstrual irregularities and painful intercourse. An acute problem is the need to break down taboos and increase the range of accessible information so that women (whether 15 or 60) and healthcare providers are better able to discuss these issues.

These complex journeys to diagnosis and through care for these conditions are in part attributable to historical underfunding of research into health in women, under-representation of women in trials, and concerns about disparities of experience of care including feeling heard or listened to – a majority of those diagnosed with endometriosis recall symptom onset in adolescence, and many remember not being offered timely treatment. 

Most pronounced are racial disparities; Black women have 20% higher odds of diagnosis at late-stage ovarian cancer compared with white women and although black women are equally as likely to suffer from endometriosis as white women, they are still twice as likely to experience infertility, and half as likely to seek treatment. While lack of knowledge about different patterns or presentations of symptoms may explain delayed diagnosis it is also likely that biases and discrimination in health research, guidance, and health care also play a role. 

 

Where to start? 

As discussed earlier, there are numerous factors that contribute to this diagnostic delay, including inconsistent symptom recognition by both the patient and the healthcare provider, and the lack of a non‐invasive diagnostic test. At OnaWave Medical, we are developing such a test, focusing first on earlier and easier diagnosis of endometriosis in younger women. Young women experience substantial disruption to careers and education from symptoms of severe pain (described as ‘crippling’ and ‘horrific’), tiredness, and side effects of analgesia such as nausea. For these women, the consideration of endometriosis as a diagnosis may be overlooked for painful periods, for example, resulting in a protracted patient journey (up to 12 years from onset to diagnosis), affecting quality of life12 and the development of co-morbid conditions. In fact, the risk of developing adenomyosis and ovarian cancer is twice as high in patients with endometriosis. A stitch in time…

 

OnaWave Medical’s technology involves the development and integration of a smartphone app, device with wearable sensors, and machine learning algorithms to characterise/predict endometriosis. The patient will wear the device at home for 30 minutes per day for at least one menstrual cycle and enter their symptoms in the app. The sensors measure the electrical activity of the slow waves in the uterus which are altered in the disease state. Using our algorithm, the biomarker can give a likelihood of this patient having endometriosis. Together, the healthcare provider and patient can discuss the next steps in care, preventing the progression of the disease and protecting future fertility.

Development of an at-home digital diagnostic test alone will not solve all issues related to timely access to care. At OnaWave Medical, we use technology to advance knowledge in relation to these conditions and work around barriers (limitations in access to care due to race/geography/age/socio-economic status) where possible, while also advocating for their removal – we aspire to a care model in which every person with painful periods or difficulty getting pregnant receives a diagnosis. Furthermore, the economic and healthcare burden of this condition underscores the importance of early detection, effective management strategies, and supportive care services to mitigate the impact on not only individuals but also healthcare systems and society at large (more on that again). 

This article recognizes that people have diverse gender identities and strives to use gender-inclusive language. In some instances, the words “woman” and “women” are used to describe individuals whose sex assigned at birth was female, whether they identify as female, male, or non-binary. When describing or referencing study populations used in research, the article uses the gender terminology reported by the study investigators.

 

Discover more about OnaWave Medical:

 

OnaWave Medical are developing a digital biomarker-based risk-stratification platform and associated wearable solutions that can identify pelvic conditions, such as endometriosis, to support clinical decision-making and enhance the delivery of personalized care for the individual. This work is funded by the European Union under the European Innovation Council Transition program (Project EndoSolve).

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