FDA approval could spark huge interest in Mainz Biomed (NASDAQ:MYNZ)

Colorectal cancer (CRC) is the second most lethal cancer in the U.S. and Europe, but also the most preventable with early detection providing survival rates above 90%. Annual testing costs per patient are minimal, especially when compared to late-stage treatments of CRC which cost patients an average of $38,469 per year. The American Cancer Society estimates that in 2021 there will be approximately 149,500 new cases of colon and rectal cancer in the U.S. with 52,980 resulting in death. Recent FDA decisions suggest that screening with stool DNA tests such as ColoAlert in the US should be conducted once every three years starting at age 45. Currently, there are 112 million Americans aged 50+, a total that is expected to increase to 157 million within 10 years. Appropriately testing these US-based 50+ populations every three years as prescribed equates to a US market opportunity of approximately $3.7 Billion per year.

Mainz Biomed (NASDAQ:MYNZ) develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert, an accurate, non-invasive, and easy-to-use early detection diagnostic test for colorectal cancer. ColoAlert is currently marketed across Europe with FDA clinical study and submission process intended to be launched in the first half of 2022 for U.S. regulatory approval. Mainz Biomed’s product candidate portfolio includes PancAlert, an early-stage pancreatic cancer screening test based on Real-Time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples, and the GenoStick technology, a platform being developed to detect pathogens on a molecular genetic basis.

Mainz Biomed recently announced it has successfully completed the pre-submission process with the U.S FDA for its ColoAlert Pivotal Clinical Trial. (13)

The global cancer diagnostics market size was estimated at $124.96 billion in 2021 and is expected to reach over $258 billion by 2030. (14)

The company’s flagship product (ColoAlert) could become an inexpensive alternative in a $3.7 billion market. (1)

With colorectal cancer (CRC) being the second most lethal cancer in the U.S. and Europe, it is also the most preventable with early detection which is where Mainz Biomed has its focus with its cutting-edge diagnostic tests. (12)

Company insiders are still sitting on over 23% of available shares as of June 10, 2022. Not to mention, Mainz Biomed only has 11.9 million shares available in its float. (13)(15)

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Some of other biotech stocks to keep on radar are Amgen (AMGN), Biogen (BIIB, Harmony Biosciences Holdings (HRMY), Regeneron Pharmaceuticals (REGN), Corcept Therapeutics (CORT), Incyte (INCY), Axsome Therapeutics (NASDAQ:AXSM), Exelixis (NASDAQ:EXEL), Vertex Pharmaceuticals (NASDAQ:VRTX)


12.) https://www.globenewswire.com/en/news-release/2022/03/31/2413485/0/en/Mainz-Biomed-Completes-Successful-Pre-Submission-Process-with-the-U-S-FDA-for-ColoAlert-s-Pivotal-Clinical-Trial.html

13.) https://finviz.com/quote.ashx?t=MYNZ

https://www.globenewswire.com/en/news-release/2022/03/31/2413485/0/en/Mainz-Biomed-Completes-Successful-Pre-Submission-14.) Process-with-the-U-S-FDA-for-ColoAlert-s-Pivotal-Clinical-Trial.html

14.) https://www.precedenceresearch.com/cancer-diagnostics-market

15.) https://www.benzinga.com/quote/MYNZ