The company, a pioneer in the science of mitochondrial DNA, said the tool can detect the disease in up to nine out of 10 cases, and that because results are known within days, physicians and patients can make relatively earlier treatment decisions.
The United Kingdom-based company is in the process of creating a CE-certified kit for commercial testing by clinical laboratories. That will take up to 10 months, a news release said. The test would initially be available to women in the United Kingdom, although the exact timeline is not clear.
Through its proprietary Mitomic Technology platform, the company has created ways to use the unique features of mutations in mitochondrial DNA, which can serve as biomarkers for several disorders. MDNA said that results of a recent study, published in Biomarkers in Medicine, demonstrates that the newly identified biomarkers can accurately detect endometriosis, even in early stages.
”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,” said Andrew Harbottle, MDNA life sciences chief science officer.
Using the platform, MDNA has already developed a blood test for prostate cancer, and is planning to produce tests for ovarian and pancreatic cancers next year. Tests for lung, liver, and stomach cancers are on tap for 2021.
”We are the only company to use mitochondrial DNA to detect diseases, and have developed a library of 16,000 biomarkers to date,” said Harry Smart, MDNA’s chairman. “Our groundbreaking test for endometriosis will fundamentally change the way this debilitating disease is detected and diagnosed. We look forward to helping U.K. women get treatment sooner, reducing their pain and distress, and providing cost savings to health services.”
Endometriosis affects one in 10 women of childbearing age, 200 million globally, and 1.5 million in the UK. The often-debilitating and painful condition historically requires a laparoscopy for definitive diagnosis. Because physicians often attribute symptoms to urinary tract infection, pelvic inflammatory disease, irritable bowel syndrome, and even menstruation, the disease can go undiagnosed for an average of 7.5 years.
According to a joint statement by the World Endometriosis Research Foundation and the World Endometriosis Society, low-invasive tests and biomarkers for endometriosis are urgently needed to improve diagnosis, management, and prognosis.
Christian Becker, MD, of Nuffield Health, said: “Endometriosis not only causes enormous suffering to the affected women, but also brings a tremendous medical and economic burden to bear on society. A specific, non-invasive test to aid diagnosis of endometriosis is certainly an unmet need.”
Endometriosis occurs when womb cells develop elsewhere in the body, often causing inflammation, bleeding, severe cramping, and sometimes scar tissue. It also can cause infertility.
According to its website, the development of MDNA Life Sciences began in 2001, when researchers discovered that mitochondrial DNA could be used to identify biomarkers for the recognition of human disease. That led to a growing MDNA portfolio of tests for the diagnosis of hard-to-detect disorders such as endometriosis.