MYND Diagnostics has commenced clinical research on a testing procedure using an Alzheimer’s biomarker for diagnosing and monitoring the disease utilizing the company’s proprietary anti-inflammatory peptide (MAP) biomarker.
MYND Diagnostics will be initiating a clinical validation of the MAP biomarker in Alzheimer’s disease (AD) by collecting known blood samples of AD and quantifying the presence of MAP against control samples. The validation of this Alzheimer’s biomarker is planned to start in first quarter 2022. Pending those results, the company anticipates that a submission for FDA approval could take place as early as second half 2022 to prepare for commercialization and making the MAP Biomarker available to the public through healthcare practitioners.
“Our research team has begun to research and explore the potential application of our proprietary MAP biomarker for use in the identification of Alzheimers disease,” says Lyle Oberg, MD, CEO of MYND. “The ability to make an early, accurate, dependable diagnosis in Alzheimer’s Disease patients thereby allowing for earlier intervention is a huge step forward in the fight against this terrible disease. We are extremely excited that the MAP biomarker has the potential to bridge that gap. The company’s ultimate goal specific to diagnostics is to provide a cost-effective, easy to use diagnostic test kit that can be administered from anywhere with a dried blood spot. Helping families and healthcare practitioners with an effective tool for early diagnosis, monitoring and treatment for the millions impacted by this disease will be a significant innovation in central nervous system medicine.”
The company’s goal is to develop a diagnostic test using its Alzheimer’s biomarker to monitor and potentially diagnose inflammatory diseases of the central nervous system such as Alzheimer’s Disease. The company’s diagnostic test is intended to give healthcare providers an objective monitoring tool to improve patient outcomes by providing more tailored and efficacious treatments.
Approximately 44 million people worldwide live with AD or a related form of dementia. It is the sixth-leading cause of death in the U.S., killing more people than breast cancer and prostate cancer combined. Only approximately one in four people with the disease get diagnosed. Further, the Alzheimer’s Disease diagnostics and therapeutics market was valued at $6.6 billion in 2020, and it is expected to reach approximately $9 billion in 2026, registering a CAGR of nearly 5.36% during the forecast period, 2021-2026.