DGAP-News: Mainz BioMed N.V. / Key phrase(s): Miscellaneous
30.11.2021 / 09:01
The issuer is solely accountable for the content material of this announcement.

Mainz Biomed Establishes Partnership with Precision for Medicine to Support ColoAlert’s U.S. Regulatory and Commercial Strategy

BERKELEY, CA – MAINZ, Germany – NOVEMBER 30, 2021 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostics firm specializing within the early detection of most cancers, introduced immediately the Company has engaged Precision for Medicine, a number one international Clinical Research Organization to supply U.S. regulatory and reimbursement advisory help for ColoAlert, Mainz’s extremely efficacious and easy-to-use diagnostic take a look at for colorectal most cancers.

“As an rising industrial stage firm with a portfolio of non-invasive, extremely efficacious diagnostics for detection of early-stage most cancers indications in improvement, we’re aware of the necessity to function a streamlined company and medical group,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “I’m extraordinarily happy to associate with Precision for Medicine as they supply premier and complete options that may assist guarantee ColoAlert is properly positioned to realize FDA regulatory approval, and acceptance by the Centers for Medicare and Medicaid (CMS) for reimbursement which is in fact, important for gaining industrial traction.”

Precision for Medicine will work with Mainz’s administration crew to develop and implement a U.S. centered regulatory and market entry technique for ColoAlert, the Company’s distinctive, life-saving early detection take a look at for colorectal most cancers (CRC). This will embody help in drafting ColoAlert’s medical improvement plan to make sure the trial design is cost-effective, strong, and environment friendly. Inherent to this train would be the integration of CMS tips, using at present marketed CRC screening assessments as benchmarks to supply ColoAlert with an optimum product profile for regulatory approval and success within the market. Along the best way, Precision for Medicine will advise Mainz all through its interplay with the FDA’s pre-submission protocol.

About ColoAlert
ColoAlert detects colorectal most cancers (CRC) through a simple-to-administer take a look at with a sensitivity and specificity practically as excessive because the invasive colonoscopy*. The take a look at makes use of proprietary strategies to investigate cell DNA for particular tumor markers mixed with the fecal immunochemistry take a look at (FIT) and is designed to detect tumor DNA and CRC circumstances of their earliest levels. The product is CE-IVD marked (complying with EU security, well being and environmental necessities) and is transitioning to compliance with IVDR. The product is commercially accessible in a collection of nations within the European Union. Mainz Biomed at present distributes ColoAlert by way of a lot of medical associates. Once accredited within the U.S., the Company’s industrial technique is to ascertain scalable distribution by way of a collaborative associate program with regional and nationwide laboratory service suppliers throughout the nation.
*Dollinger MM et al. (2018)

About Colorectal Cancer
Colorectal most cancers (CRC) is the second most deadly most cancers within the U.S. and Europe, but in addition essentially the most preventable with early detection offering survival charges above 90%. Annual testing prices per affected person are minimal, particularly when in comparison with late-stage therapies of CRC which value sufferers a median of $38,469 per 12 months. The American Cancer Society estimates that in 2021 there can be roughly 149,500 new circumstances of colon and rectal most cancers within the U.S. with 52,980 leading to demise. Recent FDA choices counsel that screening with stool DNA assessments similar to ColoAlert within the US needs to be carried out as soon as each three years beginning at age 45. Currently there are 112 million Americans aged 50+, a complete that’s anticipated to extend to 157 million inside 10 years. Appropriately testing these US-based 50+ populations each three years as prescribed equates to a US market alternative of roughly $3.7 Billion per 12 months.

About Mainz Biomed N.V.

Mainz Biomed develops market-ready molecular genetic diagnostic options for life-threatening situations. The Company’s flagship product is ColoAlert, an correct, non-invasive, and easy-to-use early detection diagnostic take a look at for colorectal most cancers. ColoAlert is at present marketed throughout Europe with FDA medical examine and submission course of meant to be launched within the first half of 2022 for U.S. regulatory approval. Mainz Biomed’s product candidate portfolio contains PancAlert, an early-stage pancreatic most cancers screening take a look at based mostly on Real-Time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples, and the GenoStick expertise, a platform being developed to detect pathogens on a molecular genetic foundation.

For extra data please go to www.mainzbiomed.com

For media enquiries, please contact press@mainzbiomed.com

For investor enquiries, please contact ir@mainzbiomed.com

About Precision for Medicine

Precision for Medicine is the primary biomarker-driven medical analysis companies group supporting life sciences firms in the usage of biomarkers important to concentrating on affected person therapies extra exactly and successfully. Precision applies novel biomarker approaches to medical analysis that combine medical trial execution with deep scientific information, laboratory experience and superior knowledge sciences. This convergence of trials, labs and knowledge sciences is driving sooner medical improvement and approval. Precision for Medicine is a part of Precision Medicine group with over 2,500 folks in 40 areas within the U.S., Canada, and Europe. For extra data, go to https://www.precisionformedicine.com.

Forward-Looking Statements

Certain statements made on this press launch are “forward-looking statements” throughout the that means of the “protected harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements could also be recognized by way of phrases similar to “anticipate”, “imagine”, “anticipate”, “estimate”, “plan”, “outlook”, and “venture” and different comparable expressions that predict or point out future occasions or developments or that aren’t statements of historic issues. These forward-looking statements mirror the present evaluation of current data and are topic to varied dangers and uncertainties. As a consequence, warning have to be exercised in counting on forward-looking statements. Due to identified and unknown dangers, precise outcomes could differ materially from the Company’s expectations or projections. The following elements, amongst others, might trigger precise outcomes to vary materially from these described in these forward-looking statements: (i) the failure to fulfill projected improvement and associated targets; (ii) adjustments in relevant legal guidelines or laws; (iii) the impact of the COVID-19 pandemic on the Company and its present or meant markets; and (iv) different dangers and uncertainties described herein, in addition to these dangers and uncertainties mentioned every now and then in different stories and different public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional data regarding these and different elements which will impression the Company’s expectations and projections could be present in its preliminary filings with the SEC, together with its Prospectus filed on October 12, 2021 and amended on October 25, 2021 and November 1, 2021. The Company’s SEC filings can be found publicly on the SEC’s web site at www.sec.gov. Any forward-looking assertion made by us on this press launch relies solely on data at present accessible to Mainz Biomed and speaks solely as of the date on which it’s made. Mainz Biomed undertakes no obligation to publicly replace any forward-looking assertion, whether or not written or oral, which may be made every now and then, whether or not because of new data, future developments or in any other case, besides as required by legislation.



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By Seth A. Dunbar

Seth Dunbar leads clinical research study operations and quality & compliance. He is experienced working with teams to help drug sponsors better leverage eSource data. With 10+ years of experience Seth brings expertise developing eClinical services that integrate data and technology to help companies optimise study execution.

One thought on “Mainz Biomed Establishes Partnership with Precision for Medicine to Support ColoAlert’s U.S. Regulatory and Commercial Strategy”
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