DotLab’s microRNA-based Test May Help Monitor Endometriosis, Study Shows

DotLab’s microRNA-based Test May Help Monitor Endometriosis, Study Shows

The levels of nine small RNA molecules in blood circulation may help monitor endometriosis progression and response to treatment, according to researchers.

This finding was reported in the study “Serum MicroRNA Biomarkers Regulated by Simvastatin in a Primate Model of EMS,” published in the journal Reproductive Sciences.

The small molecules, called microRNAs or miRNAs, are important regulators of genes levels. They are also sensitive to changes that happen in cells. This means that miRNAs have the potential to work as sensors of the status of cells, and ultimately of the body’s equilibrium.

Previous studies have shown that specific microRNAs are altered in endometriosis. These could also be reliable tools to identify endometriosis patients without the burden of surgery.

This study was led by led by Hugh Taylor, MD, chair of obstetrics, gynecology, and reproductive sciences at the Yale School of Medicine, and founder and chief medical officer of DotLab.

DotLab is currently developing an endometriosis test based on these microRNAs and their diagnostic and prognostic potential.

The test has been designed to detect and quantify microRNAs in saliva through a device that has been approved by the U.S. Food and Drug Administration. The company is scheduled to launch its diagnostic test later this year.

Researchers evaluated the levels of nine microRNAs previously linked to endometriosis in blood samples collected from 16 baboons with surgically induced endometriosis.

The animals were randomly treated with either a placebo or 20 mg of simvastatin daily for 90 days. Endometriosis progression was evaluated through the end of the study by laparoscopic surgery.

Simvastatin, marketed by Merck under the brand name Zocor, is a statin commonly prescribed to lower cholesterol levels. Growing evidence has suggested statins can ease endometriosis symptoms and potentially prevent disease progression.

The researchers found that the animals treated with simvastatin had smaller endometriosis lesions, with a 65% reduced volume compared to placebo-treated animals.

The team also found that simvastatin induced changes in the levels of some specific microRNAs. The levels of miR-150-5p and miR-451a were reduced by 90-93%, whereas miR-3613-5p levels increased by 7.5-fold in the simvastatin-treated group.

“The changes in circulating miRNA level patterns parallel our previous results in human patients, and show that specific miRNAs correlate with endometriosis severity and reverted toward control levels after simvastatin treatment,” the researchers wrote.

Because simvastatin is not a current standard treatment for endometriosis, the team is planning additional studies to evaluate changes in microRNA biomarkers in response to hormone-based endometriosis treatments, such as oral contraceptives or gonadotropin-releasing hormone (GnRH) therapies.

“Future studies in primates and humans will help clarify which miRNA biomarkers best correlate with therapeutic response, to optimize their clinical utility for managing the disease,” the team wrote.

 

“This study is the first to show that the levels of DotLab’s biomarkers change with endometriosis treatment,” Heather Bowerman, CEO of DotLab, said in a press release. “We are excited for the potential of the test to not only aid in diagnosing endometriosis, but also monitor disease progression.”