Quanterix’s blood test for multiple sclerosis relapse risk nabs FDA breakthrough nod

Though relapsing-remitting multiple sclerosis, or RRMS, can be managed with many of the approved treatments for MS symptoms, there is still not scientifically proven, FDA-cleared way to predict when or if another relapse period will occur.

There may be one on the horizon, however, since Quanterix recently received the regulator’s breakthrough device designation for a blood test designed to do exactly that.

In RRMS, the most common form of multiple sclerosis, periods of stable remission are interrupted by relapses of new or worsening symptoms—like visual loss or double vision, numbness, weakness and balance issues—that last at least 48 hours. Quanterix’s test is designed to look for signs that a patient will relapse within the next four years.

Click here to read the full article at Fierce Biotech

Disclaimer: BioPharma Global is not responsible for, and expressly disclaims all liability for, damages of any kind arising out of use, reference to, or reliance on any information contained within the article. Content available through the site may contain links and information to other websites. Links from BioPharma Global to third-party sites do not constitute an endorsement by BioPharma Global of the mentioned parties.

BioPharma Global is a mission-driven corporation dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with unmet medical needs. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

Add a Comment

Your email address will not be published. Required fields are marked *