Mainz Biomed Forms Agreement With Quest Diagnostics To Provide Clinical Trials Laboratory Services For Colorectal Cancer Screening Test

Issuer: Mainz BioMed N.V. / Key word(s): Alliance
19.12.2024 / 14:00 CET/CEST
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Mainz Biomed Forms Agreement with Quest Diagnostics to Provide Clinical Trials Laboratory Services for Colorectal Cancer Screening Test

Quest to Support Mainz Biomed's ReconAAsense FDA Study and Has Option to Commercialize Test Kit Assuming FDA Approval

BERKELEY, US and MAINZ, Germany – December 19, 2024 -- 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 an agreement with Quest Diagnostics (NYSE:DGX), a leading provider of diagnostic information services, to support commercialization of Mainz Biomed's NextGen screening test for colorectal cancer.

Mainz Biomed's stool-based ColoAlert test is designed to detect colorectal cancer tumor DNA to aid in identifying colorectal cancer in early stages. Through polymerase chain reaction (PCR) technology, a small sample of DNA can be examined through a patient's stool sample to identify genetic mutations that may lead to a cancer diagnosis. Mainz Biomed's ColoAlert test has shown promising sensitivity and specificity in identifying colorectal cancer, including advanced adenomas, in preliminary data.

Quest will provide clinical trial laboratory services for Mainz Biomed's ReconAAsense study, a prospective clinical study that will include approximately 15,000 subjects from 150 sites across the United States to develop data supporting FDA validation of the NextGen test. In addition, Mainz Biomed will provide Quest with the option to exercise semi-exclusive rights to provide testing services based on the test kit for an eighteen-month period, assuming its approval by the FDA.

Colorectal cancer (CRC) is the third most common cancer globally, with more than 1.9 million new cases reported in 2020, according to World Cancer Research Fund. The US Preventive Services Task Force recommends that screening with stool DNA-FIT (sDNA-FIT) tests should be conducted once every one to three years starting at age 45. Roughly one-third of US residents aged 50-75 have never been screened for colon cancer. This gap in screening represents a $4.0B+ total market opportunity in the US. Offering alternative screening modalities, such as sDNA-FIT, may help bridge this gap.

“We are excited by the opportunity to work with Quest Diagnostics,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed.“Quest is a leader in cancer diagnostics and knows how to scale these innovations to make them broadly accessible to patients in need. With their support, we are positioned to advance commercial development of our ColoAlert test in order to help more patients gain access to quality screening.”

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About Mainz Biomed NV

Mainz Biomed 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 marketed across Europe and the United Arab Emirates. The Company is currently running a pivotal FDA clinical study for US regulatory approval. Mainz Biomed's product candidate portfolio also 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. To learn more, visit mainzbiomed or follow us on LinkedIn , Twitter and Facebook .

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Forward-Looking Statements

Certain statements made in this press release are“forward-looking statements” within the meaning of the“safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as“anticipate”,“believe”,“expect”,“estimate”,“plan”,“outlook”, and“project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company's expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the“SEC”) by the Company. Additional information concerning these and other factors that may impact the Company's expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on April 9, 2024. The Company's SEC filings are available publicly on the SEC's website at Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.

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