3 min read
The BBC covered an encouraging development this week in the diagnosis of endometriosis, a condition that is still all too often characterised by delay, uncertainty, and a reliance on invasive procedures for confirmation. You can read the article here.
What stands out is not only that new diagnostic tools are emerging, but that they approach the biology of endometriosis from entirely different angles.
One of these, Endotest from Ziwig, focuses on molecular biology. It uses a saliva sample to detect a specific microRNA signature associated with the disease, combining next generation sequencing with artificial intelligence. The clinical validation data are particularly striking, with a large multicentre study reporting sensitivity of around 97% and specificity of approximately 94%, leading to an overall accuracy of about 96.6%. This kind of performance, in a non‑invasive test, would have seemed ambitious not so long ago.
The other, EndoSure, takes a completely different approach, rooted in physiology rather than molecular markers. It measures gastrointestinal myoelectrical activity through an electroviscerogram, looking for a distinctive pattern in smooth muscle electrical signalling. The underlying concept is that endometriotic lesions secrete signalling molecules that disrupt normal neuromuscular control in the gut, resulting in a characteristic shift in frequency patterns. This produces what is effectively a measurable “electrical fingerprint” of the disease.
What unites these technologies is their potential to address one of the most persistent problems in endometriosis care: the time it takes to reach a diagnosis. In the UK, that delay now averages over nine years, and can be even longer in some patient populations. During that time, many patients undergo repeated consultations, inconclusive imaging, and often a gradual normalisation of symptoms that can be anything but normal.
Replacing, or at least supplementing, diagnostic laparoscopy with non‑invasive, scalable tools has the potential to change that experience significantly. Earlier diagnosis should mean earlier intervention, a clearer understanding of disease prevalence, and the ability to generate more robust clinical datasets.
However, it also brings into sharper focus a question that is perhaps less comfortable: what happens once a diagnosis is made?
At present, treatment options remain comparatively limited. Patients are often offered pain management, hormonal therapies, or surgery, sometimes in combination and often with variable success. While there is a growing pipeline of therapeutic approaches, progress through the regulatory pathway has been slow, and there is not yet a well-established template for bringing new endometriosis treatments to market.
This has implications beyond the clinic. For companies working in this space, it translates into longer development timelines, significant evidentiary requirements, and a comparatively short effective window of exclusivity once a product is approved (because patent term is finite). In a field that has historically been underfunded relative to its prevalence and impact, those factors can make investment more challenging to secure and sustain. It also means that intellectual property strategies need to be particularly robust, supporting value over extended development periods and helping to mitigate some of that inherent uncertainty.
There is, though, a more optimistic way of looking at this shift. Improved diagnostics do not just change how quickly patients are identified; they also change the data landscape. Better defined patient populations, earlier stage identification, and more accessible testing all make it easier to design and execute clinical trials. They can facilitate recruitment, enable more granular stratification, and ultimately generate the kind of evidence that regulators require.
In that sense, these diagnostic advances may do more than shorten the path to diagnosis. They may help to lay the groundwork for the next generation of therapies, simply by making the disease easier to study at scale.
So, while the introduction of tools like Endotest and EndoSure might appear, at first glance, to be a step forward in diagnostics alone, they have the potential to influence the entire ecosystem of endometriosis care. If they succeed in reducing diagnostic delays and improving data quality, they could become an important catalyst for therapeutic innovation as well.
Fran is a Partner and Patent Attorney at Mewburn Ellis. She works in all patent cycle stages within the life sciences sector – from invention capture, drafting and patent strategy to prosecution and global portfolio management. Fran is a member of our plant variety rights team, having completed the official WIPO course on plant variety protection under the UPOV convention. As such, she has extensive experience dealing with plant-related inventions, including obtaining plant variety rights and entry onto the national list and common catalogue.
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