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Cancer is never fun to talk about…
The chances of it impacting either yourself, your family, or your friends appears to be growing on a yearly basis.
Though types like breast, lung, and prostate cancer are typically the most talked about, they’re not the only forms out there.
What do you know about colorectal cancer? Did you know it is the second most lethal form of cancer in the United States?
Good news is, it is highly preventable with early detection providing 5- year survival rates above 90%.
Colorectal cancer often develops from polyps.
These are initially benign cell clusters that occur in many people. However, the cells of the polyps can undergo genetic changes, causing the cells to mutate and become precursors of colorectal cancer called adenomas.
The classification of colorectal cancer stages is often based on the so-called Dukes Stages:
Through the analysis of tumor DNA, ColoAlert detects significantly more cases of colorectal cancer than other stool tests and allows for an earlier diagnosis in those affected – all in a simple at-home stool test!
Recent FDA decisions suggest that screening should be conducted once every three years starting at age 45.
~38.8% Age 50 to 75 have never been screened (in USA
The company aims to become the leading global brand for CRC detection through extensive US and European market partnerships.
THE COMPETITION’S APPROACH…
The largest U.S. provider independently markets and distributes its product directly. All nationwide samples must come from, and be returned to, a single corporate laboratory – a time-consuming process.
MAINZ BIOMED’s APPROACH…
RELATIONSHIPS: Established regional and national labs offer existing client relationships (i.e.: physicians, clinics, hospitals, universities, government institutions, health organizations, etc).
PROFITABILITY: ColoAlert is designed for profitability, rapid commercial uptake, and broad consumer acceptance.
PROTECTION: Mainz BioMed protects its intellectual property through trade secrets to control all critical reagents, processes and formulations.
At this moment, Exact Sciences, the makers of ColoGuard, offers the only other competitive product using similar technology.
Other sector companies promote testing for CRC but are using standard tests like FIT or occult blood testing.
Currently, Exact Sciences (Nasdaq: EXAS) has a market cap of ~$14.4 billion (as of 2/10/22).
With such little competition in the market, can you see why Mainz Biomed (Nasdaq: MYNZ) could be extremely undervalued at this moment?
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Potential for ColoAlert to Emerge as the Most Robust and Accurate At-home Screening Test for Colorectal Cancer
Biomarkers Demonstrated Unique Ability to Identify Curable Precancerous Colonic Polyps as well as Curable Early-Stage Colorectal Cancer
BERKELEY, Calif. and MAINZ, Germany, Jan. 05, 2022 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today it has entered into a Technology Rights Agreement with Socpra Sciences Santé Et Humaines S.E.C. (“TTS”) to access a portfolio of novel mRNA biomarkers for potential future integration into ColoAlert, the Company’s highly efficacious, and easy-to-use detection test for colorectal cancer (“CRC”).
Mainz is currently marketing ColoAlert in Europe through its unique business model of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility. The Company is also preparing to initiate ColoAlert’s regulatory pathway for approval in the United States.
Under the terms of the Technology Rights Agreement, the Company has the unilateral option to license the exclusive global rights to five gene expression biomarkers which have demonstrated a high degree of effectiveness in detecting CRC lesions including advanced adenomas (“AA”), a type of pre-cancerous polyp often attributed to this deadly disease.
In a study evaluating these biomarkers published in the online peer review journal platform MDPI (March 11, 2021), study results achieved overall sensitivities of 75% for AA and 95% for CRC, respectively, for a 96% specificity outcome.
If these statistical results are duplicated when the biomarkers are integrated into ColoAlert, we believe that it will ultimately position the Company’s CRC test to be the most robust and accurate at-home diagnostic screening test on the market. It will not only detect cancerous polyps with a high degree of accuracy but has the potential to prevent CRC through early detection of precancerous adenomas.
The Company will now commence a clinical study in Europe to evaluate the effectiveness of these biomarkers to enhance ColoAlert’s utility in terms of extending its capability to include the identification of advanced adenomas, while increasing rates of diagnostic sensitivity and specificity.
Given ColoAlert in its present form has already been CE-IVD marked (complying with EU safety, health and environmental requirements), the timeline and process to initiate this “add-on” study is expedited, and the company is targeting the first half of 2022 to launch the clinical study. Furthermore, data generated by the study may potentially be incorporated into the Company’s design of ColoAlert’s U.S. clinical trial for consideration by the FDA.
And Here’s Why That Last Sentence Is So Important…
If the FDA grants premarket approval for ColoAlert, it could become a significantly cheaper alternative to ColoGuard, the product from Exact Science (~$14 Billion market cap).
As GenX individuals age into their 40’s and 50’s they become part of the age group recommended to begin testing for CRC and more.
Source 1: https://mainzbiomed.com/wp-content/uploads/2021/07/Mainz-BioMed-Corporate-Update-January-2022-v1.13.21-1.pdf
Source 2: https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html
Source 3: https://www.coloalert.com/pages/about-crc
Source 4: https://www.prb.org/resources/u-s-population-is-growing-older/
Source 5: https://idataresearch.com/an-astounding-19-million-colonoscopies-are-performed-annually-in-the-united-states/
Source 6: https://idataresearch.com/an-astounding-19-million-colonoscopies-are-performed-annually-in-the-united-states/
Source 7: https://finance.yahoo.com/quote/EXAS?p=EXAS&.tsrc=fin-srch
Source 8: https://finance.yahoo.com/news/mainz-biomed-acquires-exclusive-rights-080100033.html
Source 9: https://www.pancan.org/press-releases/pancreatic-cancer-still-on-path-to-become-second-leading-cause-of-cancer-related-death-in-u-s-by-2020/
Source 10: https://www.mayoclinic.org/diseases-conditions/colon-cancer/in-depth/colon-cancer-screening/art-20046825
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