First-of-Its-Kind Blood Test Aids in Diagnosis of Endometriosis

Patients living with endometriosis may endure significant pain (especially at the time of menstruation), reduced fertility, increased hospitalizations, and a poorer quality of life. Earlier disease identification and management can prevent long-term complications that reduce quality of life. However, diagnostic delay is a significant hurdle to timely management of the disease. It can often take up to a decade and referrals to numerous specialists before receiving a definitive diagnosis and treatment plan. The lack of a non-invasive diagnostic tool is a meaningful contributor to this problem. Now, a breakthrough, non-invasive, blood test that aids in the diagnosis of active endometriosis is filling a diagnostic gap which is over a century old.

Dot Laboratories, Inc.’s (DotLab, Branford, CT, USA) DotEndo is the first-of-its-kind blood test for endometriosis. The breakthrough blood test analyzes the expression of microRNA biomarkers associated with the endometriosis to provide a clear positive or negative result, not a risk profile. The unique, non-invasive test that only requires a blood draw can provide answers earlier to help speed up the diagnostic journey - preventing disease progression by beginning treatment sooner. DotEndo may help identify endometriosis as a cause for those 25-50% of patients who experience unexplained infertility.

DotEndo was developed based on over a decade of peer-reviewed scientific research and development, demonstrating the association of microRNAs to endometriosis and infertility. DotLab’s EMPOWER is the first of its kind clinical study and one of the largest efforts ever to develop a non-invasive diagnostic test for endometriosis. The EMPOWER Study is a prospective, observational, multi-center cohort study enrolling approximately 750 females of reproductive potential aged 18-49 who have been referred to undergo laparotomy or laparoscopy or other procedures for suspected endometriosis and other benign gynecological indications. DotLab has also been granted three key patents by the United States Patent and Trademark Office for its technology focused on the diagnosis, assessment, and characterization of endometriosis.

"DotLab tackled a holy grail in women's health - endometriosis - which is notorious for its complex biology and the sheer scale of the unmet medical need," said DotLab's CEO Heather Bowerman. "We're proud to share the news of these inventions and intellectual property achievements, which are ultimately a much-needed win for millions of patients."

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