Quanterix Blood Test for MS Earns Breakthrough Devices Designation

Currently, there is no way to determine when a relapse will occur in relapsing and remitting multiple sclerosis (MS), one of the two main forms of MS. However, this may soon be changing. According to Andrea Park in FierceBiotech, Quanterix, a precision health company, developed a blood test that would help patients and healthcare providers predict potential relapses. Additionally, the FDA recently granted this blood test Breakthrough Devices Designation. 

What is Breakthrough Devices Designation?

Solvd Health explains that Breakthrough Devices designation is:

granted to novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This includes devices subject to premarket approval applications (PMAs), premarket notification (510(k)), or requests for De Novo designation.

To receive Breakthrough Devices designation, the device must provide a more effective path to treat or diagnose these conditions. It must also represent a breakthrough technology, add to the best interest of patients, offer significant advantages over alternatives, or fill an unmet need (i.e. no other alternatives exist). 

Blood Tests to Determine MS Relapses

Altogether, Quanterix developed the blood test to help patients determine whether they could relapse over the next four years. It works by analyzing serum and plasma within blood samples to search for neurofilament light chain (NfL). As explained in an unrelated article published in Frontiers in Neuroscience, NfL is considered a biomarker for many neurodegenerative diseases. Finding higher NfL levels could predict a heightened chance at relapsing in the future. 

More so, the blood test could also help determine what therapies are most effective by observing NfL modulation. For example, the researchers found that monoclonal antibodies helped to significantly reduce NfL levels, suggesting a lower chance of relapse in the future. 

About Multiple Sclerosis (MS)

Multiple sclerosis (MS) is a chronic neurological disease, often considered an autoimmune disease, which affects the brain and spinal cord. In MS, the immune system mistakenly attacks myelin, or the protective coating of nerve cells. As nerve fibers become exposed, they can also become damaged, causing inhibited communication between the brain and the body. Above, I explained that relapsing-remitting MS is one of the main forms; the other is called progressive MS, in which the condition progresses without any periods of remission. This condition is most common in young adults through middle-aged adults, and is 2x more common in females than males. Symptoms can include:

  • Muscle weakness
  • Back or eye pain
  • Tremors
  • Difficulty speaking or slurred speech
  • Loss of balance and coordination
  • Numbness or “pins and needles” sensations
  • Visual disturbances
  • Incontinence
Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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