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MDNA Life Sciences will launch the world's first endometriosis blood test that can detect the disease in up to 9 out of 10 cases.
The company says the results will be available a few days after the test, allowing doctors to make faster diagnosis and treatment decisions.
Using proprietary technology, MDNA has developed techniques to exploit the unique features 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, MDNA Newcastle upon Tyne researchers have now identified biomarkers badociated with endometriosis. The results of a recently published clinical study in the peer-reviewed journal Biomarkers in Medicine show that newly identified biomarkers can accurately detect endometriosis in blood samples in up to 9 cases on 10, even at the beginning.
MDNA has now launched a program to create a CE marked test kit to allow clinical laboratories in the UK and around the world to perform the endometriosis blood test on a commercial basis. The environmental badessment process will be completed in 9 to 10 months, when the test will be made available by MDNA's distribution partners.
MDNA's Mitomic ™ technology platform identifies and optimizes the best biomarkers to detect a specific disease. The company has already created a blood test for prostate cancer. In addition to the new blood test for endometriosis, MDNA plans to release tests for ovarian cancer and pancreatic cancer next year. Screening tests for lung, liver and stomach cancers will follow in 2021 and further tests are underway.
In 2018, the FDA has approved ORILISSA for the management of endometriosis
An official statement from the World Endometriosis Research Foundation and the World Endometriosis Society states that the development of "minimally invasive tests / biomarkers" for endometriosis remains a top priority for improving diagnosis, management and prognosis (progression / regression) of treated endometriosis.
Andrew Harbottle, Scientific Lead at MDNA Life Sciences, said, "Mutations in mitochondrial DNA act as ideal biomarkers, providing us with a detailed and unique log of DNA damage and detecting with accuracy of many diseases and conditions difficult to diagnose, such as endometriosis. "
Christian Becker, EnROMETRIOSE CaRe Center of the Nuffield Women's and Reproductive Health Department at Oxford University, said: "Endometriosis not only causes tremendous suffering to the affected women, but also a huge medical and economic burden for society. There is a long delay between the beginning and the diagnosis of the disease, mainly because of its non-specific symptoms and the fact that it can only be diagnosed invasively by laparoscopy. A non-invasive specific test to facilitate the diagnosis of endometriosis is certainly an unmet clinical need. "
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