Lorna Rothery spoke to Marina Rigau, CEO and Co-Founder of EIT Health-supported start-up MiMARK, about the challenges associated with the diagnosis of gynaecological conditions.
By 2040, the number of endometrial cancer (EC) cases is due to increase by 46%.1 Yet, current diagnostic approaches fall short in detecting endometrial cancer in a timely and accurate way.
To discuss the necessary changes to the current gynaecological cancer treatment paradigm and the need to support innovative diagnostics solutions, Lorna Rothery spoke to Marina Rigau, the CEO and Co-Founder of gynaecological cancer diagnostics start-up, MiMARK.
What are the current diagnosis and treatment options for diagnosing gynaecological cancers, and what are their shortcomings?
Women’s health has been neglected for centuries, meaning that specific challenges or diseases that affect women and girls often remain under-acknowledged or unaddressed. A prime example of this is the flawed approach to diagnosing gynaecological cancer, such as EC.
As it stands, the current diagnosis procedure of EC is founded on the appearance of unspecific signs or symptoms, with post-menopausal bleeding (PMB) being the most common one. While an estimated seven million people in the EU are afflicted by PMB, only 5-10% will be diagnosed with EC.2
Despite this, women being assessed for PMB will undergo a multi-step diagnostic process to detect for the presence of EC. This approach is time-consuming, resource-intensive, and oftentimes, invasive, and uncomfortable for women.
Patients assessed for EC undergo a pathological examination of an endometrial biopsy (pipelle biopsy), whereby tissue from the lining of the womb is taken and assessed for cancerous or abnormal cells in the womb lining.
This initial approach has several shortcomings. First, it fails to diagnose EC in 31% of patients,3 and has a proven record of providing faulty diagnoses in over 55% of cases.4 These failures are associated with the scarce cellularity of a sample. In these cases, patients must undergo a hysteroscopy – an invasive, riskier, and uncomfortable procedure used to examine the uterus to detect EC.
The clinical needs of patients are left unmet by the current gynaecological diagnostics and treatment paradigm. There is an obvious need to devise and implement a strategy to detect the presence of EC quickly, accurately and as pain-free as possible in order to drastically improve patient experiences and outcomes. That is precisely what our mission is at MiMARK.
What is MiMARK and how is it addressing the shortfalls in gynaecological cancer care?
MiMARK is a women’s health, women-led start-up that is revolutionising approaches to gynaecological cancer diagnostics.
Formed in 2021 and cemented during the EIT Health 2020 WildCard Programme’s women’s health challenge and latterly, the EIT Health 2022 Catapult Competition semi-finals in 2022-23, our committed team is united by the conviction that we can improve the diagnosis of gynaecological cancer.
Supported by EIT Health funding and an array of partners and opinion leaders, MiMARK is developing innovative in vitro solutions to improve the management of life-threatening gynaecological malignancies, such as EC.
Our first in vitro diagnostic test (IVD) – WomEC – uses a panel of protein biomarkers present in uterine fluids to detect EC, thereby avoiding invasive procedures and offering a model of healthcare that is model rooted in efficient and accurate diagnosis. WomEC is our first product in development, an IVD test based on the detection of protein biomarkers in the uterine fluid.
By using uterine fluid rather than cellular material for EC diagnosis, WomEC can provide a highly accurate diagnosis – with 99% sensitivity, 79% specificity, 97% negative predictive value and 87 % positive predictive value – on all patients undergoing the diagnostic procedure for EC.5
The test will be run in semi-automated platforms or as a manual assay, and our goal is that WomEC will support gynaecologists in making timely, objective, and quantitative diagnoses of EC, whilst limiting the need for additional invasive procedures (hysteroscopies). By boosting rapid, early detection of the cancer, WomEC will also facilitate early intervention, thereby improving patient outcomes by reducing morbidity and increasing life expectancy.
Our success has been accelerated by EIT Health’s support. We represent just one of the many examples of EIT Health-backed solutions that shift the dial from a traditional, treatment-based healthcare model to a preventative model.
Through their expertise in technology, business development and management, MiMARK has been able to grow and thus offer a solution that has the potential to transform how we deliver care for women.
How will new diagnostic solutions boost efficiencies in our healthcare system?
First and foremost, our approach to gynaecological cancer diagnostics will benefit patients. By minimising the prevalence of invasive (and sometimes unnecessary) procedures like hysteroscopies, MiMARK is enhancing women’s experiences with care.
The likelihood of receiving a hysteroscopy as a part of the diagnosis procedure can deter women from seeking gynaecological care, meaning that gynaecological cancer may go undiagnosed. For those that undergo hysteroscopies, the experience can be highly traumatic due to the invasive nature of the procedure. We are therefore determined to offer women a less invasive, lower-risk experience by bringing WomEC to the fore of gynaecologic cancer diagnostics.
Healthcare professionals will also benefit from the use of WomEC for gynaecological cancer diagnostics. Namely, this approach will improve diagnosis time, inform better treatment plans and alleviate the burden of providing unnecessary hysteroscopies to benign patients. Solutions like WomEC will provide practitioners with an accurate, objective, and rapid diagnosis – slashing the typical diagnosis time frame from one month to two days. Healthcare professionals will also be able to confidently identify benign patients and, conversely, determine high-risk EC patients, urgently establishing the optimal care path.
Overall, the benefits of a shift towards a more efficient approach to gynaecological diagnostics will be felt at all levels, by various stakeholders. By avoiding unnecessary hysteroscopies, approximately 1.3 billion euros will be saved annually6 – a lump sum that can be redirected towards better addressing other women’s health issues.
The clinical needs of patients are left unmet by the current gynaecological diagnostics and treatment paradigm
What are MiMARK’s plans for developing and implementing its solution and beyond?
We aim to be a key player in transforming gynaecological cancer diagnostics. This entails developing our WomEC solution and making it accessible to patients and healthcare practitioners around Europe, while also looking to expand our IVD approach to better the diagnosis of other gynaecological issues, such as ovarian cancer.
The WomEC assay is currently undergoing the prototype stage of development for the manual immunoassay (ELISA) and will enter the clinical validation stage this year. We are aware of market fragmentation globally and plan to partner with industry leaders to reach and penetrate markets, initially with a focus on the EU and the United States.
Looking ahead, we will strive to apply our insights and findings around the utility of gynaecological fluid for diagnostics to improve the diagnostics and treatment of other women’s health issues, such as ovarian cancer.
Our grand plan is crystal clear: we want to transform the current guidelines in gynaecological cancer prevention, screening and diagnostics while contributing to a cultural shift whereby women have access to the necessary tools and knowledge to empower them with options for optimal care.
In doing so, we will help to close the gender gap by providing women with better care and boosting investment in women’s health solutions.
What role do stakeholders play in ensuring the prompt and widespread adoption of new models of healthcare?
In order to unlock the full impact of solutions such as ours, there must be buy-in from stakeholders across industries. Without full confidence in the transformative potential of innovative approaches to delivering care, the implementation of life-changing solutions such as WomEC will be stunted.
Organisations such as EIT Health are on the frontlines of preparing stakeholders – from healthcare to policymakers – to embrace world-class ideas and build an atmosphere conducive to their adoption and implementation.
Platforms for dialogue such as the EIT Health Think Tank are invaluable in readying the industry for much-needed changes and encouraging healthcare leaders to discuss challenges facing the industry. EIT Health also provides budding entrepreneurs and start-ups with a platform for visibility, mentorship, training, and funding through its programmes.
EIT Health’s WildCard Programme and Catapult Competition were formative learning opportunities that accelerated our development by providing us with expert guidance, business insight, access to funding and exposure to EIT Health’s vast network of industry-leading innovators. These programmes were a necessary launchpad for us to refine our mission and business model, and the continued support of EIT Health will be vital as we look to introduce our WomEC solution to the European market.
By bridging the worlds of research, education and innovation, and connecting aspiring entrepreneurs with expert support, EIT Health is sowing the seeds for the widespread uptake of new models of delivering healthcare, such as WomEC.
For more information on how EIT Health supports new models of healthcare delivery such as MiMARK, visit: https://eit.europa.eu/news-events/news/eit-health-backed-mimark-reimagines-endometrial-cancer-care
References
- https://gco.iarc.fr/tomorrow/
- Clarke MA et al., 2018. http ://doi: 10.1001/jamainternmed.2018.2820.
- van Hanegem N, Prins MMC, Bongers MY, Opmeer BC, Sahota DS, Mol BWJ, et al. The accuracy of endometrial sampling in women with postmenopausal bleeding: A systematic review and meta-analysis. Vol. 197, European Journal of Obstetrics and Gynecology and Reproductive Biology. Elsevier Ireland Ltd; 2016. p. 147–55.
- Crosbie EJ, Kitson SJ, McAlpine JN, Mukhopadhyay A, Powell ME, Singh N. Endometrial cancer. The Lancet [Internet]. 2022 Apr 9 [cited 2022 Nov 29];399(10333):1412–28. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0140673622003233
- https://www.mimark.es/#whoweare
- https://www.mimark.es/#whoweare
This article is from issue 25 of Health Europa Quarterly. Click here to get your free subscription today.
