Mainz Biomed Establishes Physician-Led Laboratory Expanding Service Offering for Privately Insured Patients in Germany

Rhea-AI Summary

Mainz Biomed N.V. (NASDAQ:MYNZ) announces the opening of the 'European Oncology Lab' (EOL), a physician-led facility in Saarland, Germany, offering ColoAlert® as a laboratory medical service directly to physicians and patients. This expansion aims to make early colorectal cancer (CRC) detection more accessible for the approximately 8.7 million individuals covered by private health insurance in Germany. The new revenue growth opportunity is expected to complement the company's established commercial sales channels, coinciding with Colorectal Cancer Awareness Month in March.

Market Research Analyst

The establishment of the European Oncology Lab (EOL) by Mainz Biomed represents a strategic move to streamline the delivery of ColoAlert, its diagnostic service for early colorectal cancer detection. By offering ColoAlert directly to physicians and patients, Mainz Biomed is not only expanding its distribution channels but also enhancing its billing capabilities with private health insurers. This is particularly significant considering the 10.5% of the German population covered by private health insurance, a segment that is often more profitable due to higher reimbursement rates compared to public health insurance.

The direct-to-consumer and direct-to-physician model could lead to increased market penetration and customer loyalty. The convenience of this service is likely to be a competitive advantage in the molecular diagnostics market. However, the success of this initiative will depend on the effectiveness of the company's outreach and marketing strategies to both physicians and patients, as well as the operational efficiency of the EOL in handling the increased volume of tests.

Financial Analyst

Opening the European Oncology Lab (EOL) is a capital-intensive venture that has the potential to impact Mainz Biomed's financials positively. By internalizing the service, the company could realize better margins on ColoAlert due to reduced reliance on third-party labs. The ability to invoice private health insurers directly may also result in improved cash flows and quicker reimbursement times. However, investors should monitor the company's quarterly reports for increased operational costs associated with running the EOL and the impact on net income.

It's also worth noting the timing of the announcement, aligning with Colorectal Cancer Awareness Month, which may provide a temporary boost in sales and marketing effectiveness. However, the long-term financial impact will hinge on sustained demand and the company's ability to maintain service quality while scaling operations.

Medical Research Analyst

The opening of Mainz Biomed's European Oncology Lab (EOL) is a noteworthy development in the field of molecular genetics diagnostics. ColoAlert's direct availability through the EOL could potentially increase the rate of early colorectal cancer (CRC) detection by improving access to testing. Early detection is critical in improving CRC outcomes and the convenience of the EOL may encourage higher testing rates among the privately insured population.

However, it will be essential to evaluate the accuracy and reliability of ColoAlert tests administered through the EOL compared to other established diagnostic methods. The company must ensure that the quality of testing remains high as the service scales up, as any compromise in test accuracy could damage the company's reputation and lead to a loss of trust among healthcare providers and patients.

Company opens own physician-led laboratory, ‘European Oncology Lab’ (EOL), thereby offering ColoAlert® as a laboratory medical service directly to physicians and patients

BERKELEY, Calif. and MAINZ, Germany, Feb. 06, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a leader in molecular genetics diagnostic solutions for early cancer detection, announces the opening of the ‘European Oncology Lab’ (EOL). The physician-led facility represents an expansion of the Company’s collaboration with Laboratory Dr. Buhlmann with a shared location in Saarland, Germany.

Via the EOL, medical professionals or patients can now order ColoAlert^® directly with Mainz Biomed as a laboratory medical service, meeting a crucial requirement to invoice private health insurance companies. This advancement makes it more convenient for approximately 8.7 million individuals, or 10.5% of Germany’s population are covered by private health insurance (PHI) as estimated by the Association of Substitute Health Insurance Funds in 2022.

Darin Leigh, Chief Commercial Officer of Mainz Biomed, commented: “This expansion marks a significant milestone in our mission to make early CRC detection more accessible for patients in Germany. The ability to invoice ColoAlert as a laboratory medical service opens a new revenue growth opportunity in addition to our established commercial sales channels. Given that March is Colorectal Cancer Awareness Month, we are very excited about this new opportunity to create visibility around the importance of earlier CRC detection.

In addition to this new offering, Mainz Biomed has a unique business model of partnering with third-party laboratories and experienced distribution partners as opposed to the traditional methodology of operating a single facility for test processing. Additionally, the Company sells the CRC screening solution via its own online shop and provides CRC screening services to corporations with established corporate health programs (“betriebliches Gesundheitsmanagement”).

ColoAlert^® offers a non-invasive, highly sensitive, and specific screening for colorectal cancer, utilizing advanced PCR technology to detect molecular-genetic biomarkers (DNA) in stool samples. This innovative approach provides a significant advantage over traditional fecal occult blood tests (FIT), enabling earlier and more accurate detection of CRC.

Physicians and privately insured patients interested in ColoAlert^® are encouraged to contact Mainz Biomed or visit www.coloalert.de for more information on how to access the test.

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information.

Please follow us to stay up to date:
LinkedIn
X (Previously Twitter)
Facebook

About ColoAlert^®
ColoAlert^®, Mainz Biomed’s flagship product, delivers high sensitivity and specificity in a user-friendly, at-home colorectal cancer (CRC) screening kit. This non-invasive test can be indicative of tumors as determined by analyzing tumor DNA, offering better early detection than fecal occult blood tests (FOBT). Based on PCR-technology, ColoAlert^® detects more cases of colorectal cancer than other stool tests and allows for an earlier diagnosis (Dollinger et al., 2018). The product is commercially available in select EU countries through a network of leading independent laboratories, corporate health programs and via direct sales. To receive marketing approval in the US, ColoAlert^® will be evaluated in the FDA-registration trial ‘ReconAAsense.’ Once approved in the US, the Company’s commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country.

About Colorectal Cancer
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 International. The US Preventive Services Task Force recommends that screening with stool DNA tests such as ColoAlert^® should be conducted once every three years starting at age 45. Each year in the US, 16.6 million colonoscopies are performed. However, 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.

About Mainz Biomed N.V.  
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 based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. ColoAlert^® is currently marketed across Europe. The Company is 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. To learn more, visit mainzbiomed.com.   

For media inquiries

In Europe:
MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
mainzbiomed@mc-services.eu

In the U.S.:
Blueprint Life Science Group
Hershel Berry
+1 415 505 3749
hberry@bplifescience.com

For investor inquiries, please contact info@mainzbiomed.com

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 7, 2023. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. 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.

What is the ticker symbol for Mainz Biomed N.V.?

The ticker symbol for Mainz Biomed N.V. is MYNZ.

Where is the 'European Oncology Lab' (EOL) located?

The 'European Oncology Lab' (EOL) is located in Saarland, Germany.

What medical service is being offered directly to physicians and patients at the EOL?

ColoAlert® is being offered as a laboratory medical service directly to physicians and patients at the EOL.

How many individuals in Germany are estimated to be covered by private health insurance (PHI)?

Approximately 8.7 million individuals, or 10.5% of Germany's population, are estimated to be covered by private health insurance (PHI) as of 2022.

What revenue growth opportunity does the EOL expansion offer?

The ability to invoice ColoAlert as a laboratory medical service at the EOL opens a new revenue growth opportunity for Mainz Biomed N.V.