MYND Diagnostics Commences Clinical Research on Multiple Sclerosis Biomarker Test

Rhea-AI Summary

MYND Diagnostics, a subsidiary of MYND Life Sciences, has launched a clinical validation study for its proprietary MAP biomarker test aimed at aiding the diagnosis and monitoring of Multiple Sclerosis (MS). The study, expected to start in Q1 2022, will quantify MAP levels in MS patients' blood samples compared to controls. Successful results could lead to an FDA approval submission in H2 2022, making the test available through healthcare providers. The global MS therapeutic market was valued at $22.99 billion in 2018 and is projected to reach $28 billion by 2026.

Positive

• Initiation of clinical validation study for MAP biomarker test in MS diagnostics.
• Potential for FDA submission in H2 2022, setting the stage for commercialization.
• Opportunity to revolutionize MS diagnostics and treatment monitoring.
• Addressable market is substantial; MS therapies market projected to grow.

Negative

• None.

MYND Diagnostics will be initiating a clinical validation study on the use of its proprietary biomarker testing in Multiple Sclerosis diagnostics

VANCOUVER, BC, Nov. 18, 2021 /PRNewswire/ - MYND LIFE SCIENCES INC. ("MYND" or the "Company") (CSE: MYND) (OTC: MYNDF) is pleased to announce its wholly-owned subsidiary MYND DIAGNOSTICS INC. ("MYND Diagnostics") has commenced clinical research on a testing procedure as an aid for diagnosing and monitoring Multiple Sclerosis ("MS") utilizing the Company's proprietary anti-inflammatory peptide ("MAP") 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 MS¹", stated Dr. 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.

The global multiple sclerosis therapies market was valued at $22.99 billion in 2018, and is projected to reach $28.00 billion by 2026, registering a CAGR of 2.5% from 2019 to 2026.² Management's view is that the total addressable market is substantial and existing diagnostic methods are outdated and ready for disruption.  Management believes this affordable tool coupled with MYND Diagnostics' proprietary intellectual property has the potential to revolutionize how central nervous system diseases are diagnosed and monitored around the globe.

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 States³. 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 people⁴.

ABOUT MYND LIFE SCIENCES INC.

MYND Life Sciences Inc., the parent company of MYND Diagnostics Inc., is a medical biotech drug research and development company focused on neuro-pharmaceutical and novel psilocybin drug development, diagnostics and vaccines. The Company is advancing pharmaceuticals through rigorous science and clinical trials, while diligently patenting and safeguarding its intellectual property. For more information and to subscribe to the Company's mailing list, please visit https://myndsciences.com/contact/.

CONTACT INFORMATION

MYND Life Sciences Inc.
Dr. Lyle Oberg, MD, CEO
Email: ir@myndsciences.com 
Web: www.myndsciences.com

Forward-Looking Statements

This news release contains forward-looking statements and information within the meaning of applicable securities legislation. Often, but not always, forward-looking statements and information can be identified by the use of words such as "plans", "expects" or "does not expect", "is expected", "estimates", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Forward looking statements or information involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of MYND to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this release.  

Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information. The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

None of the securities issued in connection with the Offering will be registered under the United States Securities Act of 1933, as amended (the "1933 Act"), and none of them may be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the 1933 Act. This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of the securities in any state where such offer, solicitation, or sale would be unlawful.

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1	National (US) Multiple Sclerosis society
2	https://www.alliedmarketresearch.com/multiple-sclerosis-market
3	https://www.nationalmssociety.org/About-the-Society/News/Updated-Atlas-of-MS-Shows-Over-2-8-million-People
4	https://mssociety.ca/research-news/article/prevalence-and-incidence-of-ms-in-canada-and-around-the-world

 

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SOURCE Mynd Life Sciences Inc.

FAQ

What is MYND Diagnostics' new study about?

MYND Diagnostics is conducting a clinical validation study on its MAP biomarker test to aid in diagnosing and monitoring Multiple Sclerosis (MS).

When will the clinical validation study for the MAP biomarker test start?

The clinical validation study is expected to begin in the first quarter of 2022.

What are the potential implications of the MAP biomarker test?

If successful, the MAP biomarker test could lead to earlier MS diagnosis and improved treatment monitoring, pending FDA approval.

What is the size of the market for MS therapies?

The global market for MS therapies was valued at $22.99 billion in 2018 and is projected to reach $28 billion by 2026.