NEWS RELEASE

Department of Defense
United States Army Medical Research and Development Command
Congressionally Directed Medical Research Programs

Released: May 13, 2022

CDMRP-Funded Research Leads to FDA Breakthrough Device Designation for MS Blood Biomarker Test

---- New Hope for Early Diagnosis, Effective Treatment

The Congressionally Directed Medical Research Programs (CDMRP) funded a research study in 2017 to develop a blood biomarker test with the potential to positively impact how Multiple Sclerosis (MS) is diagnosed and treated.

Dr. Tanuja Chitnis
Brigham and Women's Hospital
Harvard Medical School

In April, 2022, the U.S. Food and Drug Administration (FDA) granted a Breakthrough Device designation to the company, Quanterix, for developing a blood test to predict the risk of disease activity in people with Relapsing-Remitting Multiple Sclerosis (RRMS). The test incorporates results from the CDMRP Multiple Sclerosis Research Program (MSRP) Investigator-Initiated Research Award recipient, Dr. Tanuja Chitnis, Professor of Neurology, Brigham and Women's Hospital, Harvard Medical School.

�At CDMRP, all of our research programs share the goal of transforming healthcare for Service Members, their Families, and the American public,� COL Sarah Goldman, director of CDMRP, said. �The Breakthrough Device designation for the MS blood biomarker test is a fantastic achievement, and CDMRP is honored to have supported the early research that will improve the ability to diagnose patients with MS as early as possible. I am looking forward to seeing the scientific community continue to build upon this research and to improve care for patients and their families.�

According to Dr. Chitnis, the new test has several advantages for patients and doctors, such as convenience. The test can be done in an office setting and would not require the use of an MRI.

�It could lead to closer monitoring of the risk of relapse, better treatment outcomes, and ultimately prevent longer-term disability,� she said.

In addition, Dr. Chitnis said the test provides hope for MS patients and their caregivers, while the research is unique and provides for productive collaboration between researchers and institutions. The ongoing work and translational research are supported by CDMRP.

�I have been working in this field for 20 years, and I believe that we are advancing in our understanding of MS to the point where we will see major breakthroughs towards treatments and a cure in the next decade,� Dr. Chitnis said.

Dr. Chitnis and her team evaluated biomarkers that identified MS patients at high risk for relapse or worsening disability outcomes. They used biosamples from a large cohort of more than 2,100 MS patients, including RRMS patients, followed over 10 years. They zeroed in on serum neurofilament light chain (sNfL), a protein that indicates neural-axonal damage, by comparing serum from patients in remission and from those who had a newly detected lesion using gadolinium-enhancing (Gd) MRI. From studying the correlation between sNfL and the ages of patients in remission immediately after a clinical relapse and immediately after a lesion, they found sNfL as a marker of clinical relapses and Gd MRI lesions. They also observed a different correlation of sNfL levels with age depending on the Gd lesion status in MS patients.

MS is a degenerative, chronic, immune-mediated disease of the central nervous system that leads to cumulative neurologic disability over several years. It affects nearly one million people in the United States.

*The FDA's Breakthrough Devices program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. For more information go to https://www.fda.gov.

For the new FY22 MSRP funding opportunities, please refer to the program announcements at https://cdmrp.health.mil/funding/msrp.

For more information about the CDMRP, our research programs, as well as research highlights please visit the website at https://cdmrp.health.mil.

Point of Contact:

CDMRP Public Affairs
usarmy.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@mail.mil
301-619-7783

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