MYND Diagnostics has commenced clinical research on a testing procedure as an aid for diagnosing and monitoring multiple sclerosis utilizing the company’s proprietary anti-inflammatory peptide biomarker.
“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,” says Lyle Oberg, MD, CEO of MYND. “This makes MS such a challenging disease to diagnose; the wide variance of symptoms can make early detection difficult. 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.”
MYND Diagnostics will be initiating a clinical validation of the MAP biomarker in MS by collecting known blood samples of MS patients and quantifying the presence of MAP against control samples. This validation is planned to start in first quarter 2022. The company anticipates that, pending those results, a submission for FDA approval could take place as early as second half 2022 to prepare for commercialization and making the MAP Biomarker test available to the public through healthcare practitioners.
The company’s goal is to develop and refine a diagnostic protocol to monitor and potentially identify inflammatory diseases of the central nervous system such as multiple sclerosis. The company’s aid to diagnosis test is intended to give health care providers an objective monitoring tool to improve patient outcomes by providing more tailored and efficacious treatments.
MS currently affects approximately 2,800,000 people around the world, females far more often than males, and it is estimated that every 5 minutes, someone in the world is diagnosed with MS. Nearly 1,000,000 of those people are living in the United States. Canada continues to have one of the highest rates of MS in the world, with over 90,000 people living with MS or 1 in every 400 people.