Today, MDNA Life Sciences announces that it is to launch the world’s first blood test for endometriosis, able to detect the disease in up to 9 out of 10 cases. Results will be available in a matter of days after the test is carried out, enabling doctors to make earlier decisions on diagnosis and treatment.
Endometriosis, a debilitating condition affecting 1 in 10 women of reproductive age (1.5 million in the UK), causes years of pain and distress. A surgical procedure is required to definitively diagnose the condition, resulting in an average time to diagnosis of 7.5 years.
Using its proprietary technology, MDNA has developed techniques to exploit the unique characteristics of mutations in mitochondrial DNA, which can act as biomarkers for the presence of a range of diseases. After successfully identifying biomarkers for different types of cancer, researchers at MDNA’s Newcastle upon Tyne laboratory have now identified biomarkers associated with endometriosis. Results of a clinical study recently published in the peer-reviewed journal Biomarkers in Medicine, show that the newly identified biomarkers can accurately detect endometriosis in blood samples in up to 9 out of 10 cases, even in its early stages.
MDNA has now embarked on a programme to create a CE-marked test kit to enable clinical laboratories in the UK and worldwide to carry out the test on a commercial basis. The CE process will be completed in 9-10 months when the test will be made available through MDNA’s distribution partners.
Dr Andrew Harbottle, MDNA Life Sciences’ Chief Science Officer explains:
Mutations in mitochondrial DNA act as ideal biomarkers, providing us with a unique and detailed diary of damage to the DNA and accurately detecting many difficult to diagnose diseases and conditions, such as endometriosis.
MDNA’s Mitomic™ Technology platform identifies and optimises the best biomarkers to detect a specific disease. The company has already demonstrated the accuracy of its technology in a blood test for prostate cancer, which is the best performing in the market. As well as the new test for endometriosis, MDNA is planning to release tests for ovarian cancer and pancreatic cancer next year. Tests for lung, liver, and stomach cancers will follow in 2021 and more tests are in the pipeline.
Harry Smart, MDNA Life Sciences’ Chairman says
We are the only company to use mitochondrial DNA to detect diseases and have developed a library of 16,000 biomarkers to date. Our ground-breaking test for endometriosis will fundamentally change the way this debilitating disease is detected and diagnosed. We look forward to helping UK women get treatment sooner, reducing their pain and distress and providing cost savings to health services.
An official statement from the World Endometriosis Research Foundation and the World Endometriosis Society states that the development of “low-invasive tests/biomarkers” for endometriosis remains high on the list of priorities of what is needed to improve the diagnosis, management, and prognosis (progression/regression) of treated endometriosis.
Dr Christian Becker, Endometriosis Care Centre in Nuffield Department of Women’s and Reproductive Health at the University of Oxford says,
Endometriosis not only causes enormous suffering to the affected women, but also brings a tremendous medical and economic burden to bear on society. There is a long lag phase between the onset and diagnosis of the disease, mainly due to its non-specific symptoms and because it can only be diagnosed invasively by laparoscopy. A specific, non-invasive test to aid diagnosis of endometriosis is certainly an unmet clinical need.