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HIKE: Development of a commercial urine test for the earlier detection of endometriosis

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Project Description

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Endometriosis is a chronic incurable condition that is associated with debilitating pain and subfertility. It affects 190 million women worldwide, takes 8 years to diagnose and costs the UK economy £8.2 billion each year in loss of work (predominantly) and healthcare costs.

There is currently no way of diagnosing endometriosis except through invasive laparoscopy procedures which offer little benefit to patients with stage I/II superficial endometriosis. For patients with stage III/IV deep endometriosis, laparoscopy performed by skilled specialist surgeons can provide an opportunity to remove some lesions but this treatment is associated with significant rates of recurrence (approx 40%) while hormonal treatments are incompatable with fertility and have a side-effect profile that is intolerable to many. This points to the urgent need to rapid, robust and, ideally, non-invasive tests to identify endometriosis early and direct patients to the most appropriate clinical care. Although there is no cure for endometriosis, best practise and timely treatment(s) can reduce the severity of symptoms and significantly improve the quality of life for women living with the condition. We have developed a urine test for endometriosis, EndUriT, that offers an opportunity to prioritise patients onto the correct tertiary care pathway, saving patients and the NHS, time and money.

EndUriT can differentiate women with deep from those with superficial endometriosis or pelvic pain (no endometriosis). We now want to refine the test and determine its absolute sensitivity and specificity. We received an amended ethical approval to collect blood and urine samples from 500 healthy donors and patients and now want to assess (1) fresh versus frozen samples (2) samples stored in preservative (3) impact of phase in the menstrual cycle (4) time of day of urine collection (5) first void versus mid-stream urine in anticipation of commercialising EndUriT with Preventx and using Novosanis's preservative.

EndUriT has the opportunity to address one of the most common illnesses in society today. At least as frequent as diabetes, endometriosis is a prime example of an unmet health need. Endometriosis patients suffer particularly from gender inequality, caused by chronic underfunding in women's health. We are seeking funding to address this.

Status Project Live
Funder(s) Medical Research Council
Value £54,915.00
Project Dates Jul 1, 2023 - Mar 31, 2025
Partner Organisations Novosanis
Preventx Limited

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