Mynd Tests MAP, Blood Biomarker for MS Diagnosis
Mynd Diagnostics is launching a clinical study to test the ability of a blood biomarker, which the company coined Mynd anti-inflammatory peptide (MAP), to help in the diagnosis and monitoring of multiple sclerosis (MS).
Starting in the first quarter of 2022, the company will collect blood samples from diagnosed patients to compare their biomarker levels against control samples.
Pending positive results, the company plans to apply to the U.S. Food and Drug Administration (FDA) as early as the second half of 2022 for an approval to be able to produce and market a MAP biomarker-based test that would be made available to patients through their doctors.
“It is our goal through Mynd Diagnostics’ clinical validation study targeting MS to provide health care practitioners with an objective diagnostic aid to help discover MS earlier and monitor treatment progress or regression,” Lyle Oberg, MD, said in a press release. Oberg is co-founder and CEO of Mynd Life Sciences, the company holding Mynd Diagnostics.
A first step in the diagnosis is a comprehensive physical and neurologic examination, including imaging tests to look for damage in the brain and spinal cord. Additional testing, such as a spinal tap to collect a sample of cerebrospinal fluid (the liquid surrounding the brain and spinal cord) to look for signs of inflammation, may be needed.
“According to the National Multiple Sclerosis Society, at this time no symptoms, physical findings or laboratory tests can, by themselves, determine if you have MS,” Oberg said. “This makes MS such a challenging disease to diagnose; the wide variance of symptoms can make early detection difficult.”
Biomarkers are useful indicators for diagnosing diseases, monitoring healthy people to detect early signs of disease, and determining whether a treatment is working.
By developing a biomarker-based test, Mynd Diagnostics hopes to provide healthcare professionals an objective tool to help identify and monitor not only MS, but perhaps other neurodegenerative diseases.