A novel blood test for detecting colon cancer, the third most lethal type of cancer in the US, has been created. The Colorectal Cancer Screening Blood Test can identify cancer at early stages. This discovery comes at a time when over one-third of eligible individuals refuse to undergo a colonoscopy, the recommended screening test for colon cancer. According to a release from Any Lab Test Now, the test searches for three protein markers in the blood that are strongly linked to colon cancer. However, Mainz Biomed (NASDAQ:MYNZ) is proposing an even better solution to detect colon cancer, ColoAlert, that is more accurate at the detection of early stage cancers than a blood test. This early detection diagnostic test for colorectal cancer that is reliable, does not need any invasive procedures, and is simple to use. Exact Sciences (NASDAQ:EXAS), Guardant Health (NASDAQ:GH), Veracyte (NASDAQ:VCYT), and Hologic, Inc. (NASDAQ:HOLX) are other companies that either have or are developing tools to detect colorectal cancer.
Mainz Biomed (NASDAQ:MYNZ) develops economically viable molecular genetic diagnostic solutions for fatal diseases. ColoAlert is the company’s flagship product, a reliable, non-invasive, and simple-to-use early detection diagnostic test for colorectal cancer based on real-time Polymerase Chain Reaction (PCR) multiplex detection of molecular-genetic indicators in stool samples. ColoAlert’s core market is now Europe but the company is currently undertaking a critical FDA clinical trial to obtain US approval.
On May 10, Mainz Biomed announced a research collaboration with Microba Life Sciences, a precision microbiome company that uses a world-leading technology platform to measure the human gut microbiome to discover and develop novel therapeutics for major diseases. Microba and Mainz Biomed will conduct a pilot research project using Microba’s proprietary metagenomic sequencing technology and bioinformatic techniques to potentially find novel microbiome biomarkers for pancreatic cancer detection as part of the collaboration.
“We are excited by the opportunity to collaborate with Microba as PancAlert is being developed for early-stage disease detection with the goal of being a first-in-class screening test for this deadly form of cancer,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Given the growing understanding of the microbiome’s role in pancreatic cancer, we believe it’s of paramount importance to explore integrating diagnostic microbiome biomarkers into the test as it advances to the clinical stage of development and as such, are delighted to align with a global leader in sourcing and analyzing microbiome generated species and datasets.”
The project is planned to last until late 2023 and will use Microba’s Community Profiler (MCP), the company’s proprietary metagenomic platform technology. MCP has proven to be a best-in-class research technique, capable of producing comprehensive and accurate species profiles of human gastrointestinal samples.
On May 3, Mainz Biomed also announced the addition of Eurofins GeLaMed to its network of lab partners delivering PCR test kit processing of ColoAlert. Eurofins GeLaMed has four facilities in Germany and is part of Eurofins Scientific, a multinational laboratory business with over 61,000 personnel in 61 countries and more than 450 million tests performed yearly.
Eurofins GeLaMed offers a diverse range of high-quality services throughout eleven medical disciplines, including advanced and current diagnostic choices in human genetics, medical microbiology, laboratory medicine, and molecular diagnostics. GeLaMed’s nearly 500 personnel process more than 15,000 orders each working day and provide more than 2,000 different analytical methods from their laboratory medicine and microbiology portfolios under the supervision of medical doctors.
According to the terms of the agreement, Eurofins GeLaMed will provide ColoAlert at its testing locations, and Mainz Biomed will assist with physician and patient education programs during March Colorectal Cancer Awareness Month, highlighting the importance of early screening for the detection and prevention of CRC.
Mainz Biomed announced on April 4 that three German companies had integrated ColoAlert into their separate corporate health programs.
The company has an online portal where employees can register to receive the ColoAlert test. Once the sample is received and processed, the employee receives confidential test results via the portal, along with an explanation of the results. If an employee has given permission for their physician to be notified of test results, the doctor may contact the patient directly. Mainz Biomed‘s commitment to the BGM program includes CRC education for employees and physicians, as well as recommendations for next steps.
Biotech Companies Are Progressing on Colorectal Cancer Diagnostic Solutions
Exact Sciences (NASDAQ:EXAS) presented fresh data illustrating the company’s breakthrough technology and methods to early cancer diagnosis at the American Association for Cancer Research® (AACR) Annual Meeting 2023, which took place from April 14 to 19 in Orlando, Florida. Exact Sciences’ data presentations support its blood-based multi-cancer early detection (MCED) test, preliminary data for the company’s molecular residual disease (MRD) technologies, colorectal cancer screening strategies, and a study involving the OncoExTraTM test, which uses next-generation sequencing (NGS) to look at a tumor’s RNA and DNA to help decide how to treat it.
Guardant Health (NASDAQ:GH) will show how well its blood-based screening technology finds early-stage colorectal cancer (CRC) at Digestive Disease Week (DDW), which will be held May 6–9, 2023 in Chicago, Illinois. The ECLIPSE study has been accepted as a late-breaking abstract. The late-breaking abstract for the ECLIPSE Study and another abstract that talks about the possibilities of Guardant Health‘s blood-based screening technology are now available online through the DDW meeting planner. The talk on May 9 will have more data and analysis of how the trial was set up than what is in the online abstract.
Data published online in The Lancet Oncology suggest that Veracyte (NASDAQ:VCYT)‘s Immunoscore Immune Checkpoint (IC) assay may identify patients with metastatic colorectal cancer (mCRC) who are likely to benefit from immune checkpoint inhibitor (ICI) therapy in addition to standard first-line treatment. The data comes from the phase II AtezoTRIBE trial, an Italian clinical study that took place in several locations and was funded by the GONO Foundation. The great majority (about 95%) of mCRC cancers contain a competent DNA mismatch repair (pMMR) system and are microsatellite stable. These cancers are immunogenic and do not respond to immune checkpoint drugs. Previous research showed that the combination of FOLFOXIRI and bevacizumab improves immunogenicity in pMMR mCRC. Researchers discovered a minor benefit of the experimental treatment regimen in this subgroup in the current trial.
Hologic, Inc. (NASDAQ:HOLX)‘s Back to Screening campaign encourages women to schedule their annual mammograms now that healthcare institutions across are reopening after the COVID-19 outbreak. During the epidemic, numerous health officials, professional societies, and patient advocacy groups advised women to delay screening mammograms. Thus, March breast, cervical, and colorectal screening appointments dropped 86% to 94% from previous years.Due to COVID-19 epidemic delays in screening and treatment, the National Cancer Institute predicts 10,000 more Americans will die from breast or colorectal cancer in the next decade.ii Breast imaging facilities now accept patients for routine mammograms, however Hologic found that 27% of complying women plan to skip or delay their 2020 mammogram.
Meanwhile, ColoAlert sales for Mainz Biomed grew by 130% from fiscal year 2021 to fiscal 2022. At the end of the year, the company had $17.1 million in cash on hand.
Featured Image Depositphotos @ alpha spirit Depositphotos_14998143_S
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6) This document contains forward-looking information and forward-looking statements, within the meaning of applicable Canadian securities legislation, (collectively, “forward-looking statements”), which reflect management’s expectations regarding Mainz Biomed NV’s future growth, future business plans and opportunities, expected activities, and other statements about future events, results or performance. Wherever possible, words such as “predicts”, “projects”, “targets”, “plans”, “expects”, “does not expect”, “budget”, “scheduled”, “estimates”, “forecasts”, “anticipate” or “does not anticipate”, “believe”, “intend” and similar expressions or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved, or the negative or grammatical variation thereof or other variations thereof, or comparable terminology have been used to identify forward-looking statements. These forward-looking statements include, among other things, statements relating to: (a) revenue generating potential with respect to Mainz Biomed NV’s industry; (b) market opportunity; (c) Mainz Biomed NV’s business plans and strategies; (d) services that Mainz Biomed NV intends to offer; (e) Mainz Biomed NV’s milestone projections and targets; (f) Mainz Biomed NV’s expectations regarding receipt of approval for regulatory applications; (g) Mainz Biomed NV’s intentions to expand into other jurisdictions including the timeline expectations relating to those expansion plans; and (h) Mainz Biomed NV’s expectations with regarding its ability to deliver shareholder value. Forward-looking statements are not a guarantee of future performance and are based upon a number of estimates and assumptions of management in light of management’s experience and perception of trends, current conditions and expected developments, as well as other factors that management believes to be relevant and reasonable in the circumstances, as of the date of this document including, without limitation, assumptions about: (a) the ability to raise any necessary additional capital on reasonable terms to execute Mainz Biomed NV’s business plan; (b) that general business and economic conditions will not change in a material adverse manner; (c) Mainz Biomed NV’s ability to procure equipment and operating supplies in sufficient quantities and on a timely basis; (d) Mainz Biomed NV’s ability to enter into contractual arrangements with additional Pharmacies; (e) the accuracy of budgeted costs and expenditures; (f) Mainz Biomed NV’s ability to attract and retain skilled personnel; (g) political and regulatory stability; (h) the receipt of governmental, regulatory and third-party approvals, licenses and permits on favorable terms; (i) changes in applicable legislation; (j) stability in financial and capital markets; and (k) expectations regarding the level of disruption to as a result of CV-19. Such forward-looking information involves a variety of known and unknown risks, uncertainties and other factors which may cause the actual plans, intentions, activities, results, performance or achievements of Mainz Biomed NV to be materially different from any future plans, intentions, activities, results, performance or achievements expressed or implied by such forward-looking statements. Such risks include, without limitation: (a) Mainz Biomed NV’s operations could be adversely affected by possible future government legislation, policies and controls or by changes in applicable laws and regulations; (b) public health crises such as CV-19 may adversely impact Mainz Biomed NV’s business; (c) the volatility of global capital markets; (d) political instability and changes to the regulations governing Mainz Biomed NV’s business operations (e) Mainz Biomed NV may be unable to implement its growth strategy; and (f) increased competition.
Except as required by law, Mainz Biomed NV undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future event or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. Neither does Mainz Biomed NV nor any of its representatives make any representation or warranty, express or implied, as to the accuracy, sufficiency or completeness of the information in this document. Neither Mainz Biomed NV nor any of its representatives shall have any liability whatsoever, under contract, tort, trust or otherwise, to you or any person resulting from the use of the information in this document by you or any of your representatives or for omissions from the information in this document.
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