Feinstein Institutes’ ROSE Study Advances Endometriosis Diagnostic Test

Endometriosis is a chronic and often debilitating condition that affects roughly 10% of women and adolescents of reproductive age. Characterized by endometrial-like tissue growing outside the uterus, it frequently causes severe pain, infertility, and a significant reduction in quality of life—including job loss, financial burdens, and trouble forming and maintaining relationships. Despite its prevalence, however, patients frequently face years, or sometimes decades, before they are diagnosed.

Such a delay begs the question: What must be done to improve endometriosis diagnostic tools?

To answer this query, investigators at Northwell Health’s Feinstein Institutes for Medical Research have, for more than a decade, worked to address this diagnostic gap. Christine N. Metz, Ph.D., and Peter K. Gregersen, M.D., lead the Research OutSmarts Endometriosis (ROSE) study and have been working to develop a fast, easy, and noninvasive test using a person’s menstrual blood to identify the disorder.

The ROSE study—initiated in 2013—compares the menstrual discharge, or effluent, of women with and without endometriosis in search of distinct biological markers that could be used to diagnose the disease without the need for invasive surgery. Menstrual flow contains tissue from the endometrium (uterine lining), and it is well-documented that women with endometriosis have altered cells in their uterine lining. The study has already enrolled more than 3,700 participants and is one of the first attempts to translate these cellular differences into a diagnostic test.

“Many women tell us they’ve been dismissed by doctors, friends, coworkers, and even parents,” said Dr. Metz, professor in the Institute of Molecular Medicine at the Feinstein Institutes. “Our goal with the ROSE study is to provide a reliable, early diagnostic tool that validates their experiences and enables timely treatment.”

Endometriosis lesions commonly adhere to various organs in the pelvic cavity—such as the uterus, ovaries, bladder, and rectum—often causing severe pain during hormonal fluctuations. The symptoms are complex and can be easily missed or misinterpreted by healthcare providers. On average, women visit six different health care providers over several years before receiving a diagnosis.

Building on laboratory discoveries and clinical research data, Drs. Metz and Gregersen launched the ROSE II clinical trial in 2022. This study is actively recruiting U.S. women between 18 and 40 years old who suspect they may have endometriosis and are scheduled for diagnostic endometriosis surgery. Researchers analyze the trial participants’ menstrual blood (collected by participants at home) to compare the results with their laparoscopic surgery findings to validate the accuracy of the menstrual blood diagnostic test.

Both the ROSE and ROSE II studies are working towards the same goal: U.S. Food and Drug Administration approval for this one-of-a-kind endometriosis test with the hope that one day analyzing menstrual effluent will become a routine aspect of a gynecological visit.

To further their research, the ROSE team received a $500,000 prize earlier this year from the National Institutes of Health’s Rapid Acceleration of Diagnostics Technology (RADx Tech) program; this adds to the $350,000 the team won over the past year from RADx, (the entire prize is $850,000). The RADx Tech initiative, originally established to speed the development of innovative diagnostic tests, expands its focus to critical health challenges, including conditions like endometriosis, by supporting advanced technology platforms and rapid development pathways.

“Receiving this RADx Tech prize is a tremendous endorsement of the critical work we’ve been doing since 2013,” stated Dr. Gregersen, professor in the Institute of Molecular Medicine at the Feinstein Institutes. “This federal support acknowledges the need and promise of our research in transforming endometriosis diagnosis from a long, arduous process into a simple, effective screening. This funding is crucial for moving our innovations from the lab to patients’ lives.”

The ROSE study team was also the recipient of a $1 million award at the 2018 Northwell Innovation Challenge, a Northwell “Shark Tank”-style competition, for its research. Northwell Innovations continues to support the team’s development of this important diagnostic.

The Feinstein Institutes for Medical Research houses the research institutes of Northwell Health, the largest healthcare provider and private employer in New York State. Encompassing 50-plus research labs, 3,000 clinical research studies, and 5,000 researchers and staff, the Feinstein Institutes raises the standard of medical innovation through its six institutes of behavioral science, bioelectronic medicine, cancer, health system science, molecular medicine, and translational research. The Institutes claim to be the global scientific leader in bioelectronic medicine—an innovative field of science that can potentially revolutionize medicine. The Feinstein Institutes publishes two open-access, international peer-reviewed journals, Molecular Medicine and Bioelectronic Medicine. Through the Elmezzi Graduate School of Molecular Medicine, the Institutes offer an accelerated Ph.D. program.