The study will evaluate the test’s ability to monitor how the disease progresses and how endometriosis patients respond to treatment.
“We are pleased about the new longitudinal study at Yale and are committed to helping patients suffering from this disease,” Heather Bowerman, CEO of DotLab, said in a press release.
Laparoscopic surgery is now the only way to accurately diagnose endometriosis. With no technology available to monitor disease progression or therapy response, there is a significant unmet medical need among this population for reliable and accurate tests.
In a previous proof-of-concept study, which assessed the potential of DotLab’s biomarkers to monitor disease progression and treatment response, this class of biomarkers was shown to have the potential to be used both to diagnose endometriosis and to monitor its progression and response to therapy.
More specifically, the study showed that the levels of micro ribonucleic acid (microRNA) biomarkers in this test reverted to normal levels after treatment and matched the severity of disease.
These results were published in the study, “Serum MicroRNA Biomarkers Regulated by Simvastatin in a Primate Model of Endometriosis,” in the journal Reproductive Sciences.
In this new study, led by Hugh Taylor, MD, chair of the department of obstetrics, gynecology, and reproductive sciences at Yale, a team will collect samples of blood serum and saliva from patients who are currently receiving treatment for endometriosis for 48 weeks, after diagnosis with laparoscopic surgery.
If patients have to change treatments, researchers will repeat sample collection before the start of the new medication. Biomarker levels will be measured in each sample and monitored for change over time to evaluate patient response to therapy.
Applications of this technology could be useful in both clinical practice and clinical research, such as the collection of real-world evidence on the effectiveness of a new class of Gonadotropin-releasing hormone (GnRH) antagonists for endometriosis.
Endometriosis is an estrogen-dependent disease that could be treatable by estrogen withdrawal, a therapy that uses GnRH antagonists. The problem is that complete estrogen withdrawal results in unacceptable side effects. To overcome this problem, a combination of low-dose estrogen and progestin together with a GnRH agonist is used, with the goal of limiting these side effects. DotLab’s technology could be used to monitor the effectiveness of this treatment over time.