By Meg Flippin, Benzinga

Mainz Biomed N.V. (NASDAQ: MYNZ), the molecular genetics diagnostic company specializing in the early detection of cancer, is moving closer to commercializing its early colorectal cancer detection screening ColoAlert® in the U.S. by inking deals with Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services.

As part of the agreements, Mainz Biomed said Quest Diagnostics will provide clinical trial and laboratory services to support its ReconAAsense Food and Drug Administration pivotal study of ColoAlert. The clinical trial is slated to kick off next year with up to 15,000 patients. If ColoAlert gets the nod from the U.S. FDA, it will be able to target the millions of Americans at risk of colorectal cancer. Mainz has said its commercial strategy is to establish scalable distribution in the U.S. through a collaborative partner program with regional and national laboratory service providers.

The recent strategic alliance with Thermo Fisher Scientific (NYSE: TMO), a global leader in life sciences with annual revenue exceeding $40 billion, represents a monumental step forward in transforming cancer prevention in the United States, says Mainz. This partnership harnesses Thermo Fisher's extensive expertise and state-of-the-art infrastructure to drive innovation in healthcare solutions.

Adding further depth to this initiative is the collaboration with Quest Diagnostics, a leader in advanced testing and sampling technologies. Quest Diagnostics offers a broad range of services, including routine blood work, genetic and molecular testing and specialized diagnostic services for various diseases, such as cancer, cardiovascular conditions and infectious diseases.

Mainz reports that Quest Diagnostics is widely recognized for its national network of laboratories, extensive patient service centers and cutting-edge technology that ensures accurate and timely test results. As a significant player in the healthcare industry, particularly in diagnostic testing and sampling, Quest Diagnostics serves millions of patients and healthcare providers annually, making it a critical component in advancing precision and scalability in early cancer detection and prevention.

With $8 million in funding dedicated to expediting FDA approval, this initiative aims to rapidly advance critical milestones, laying the groundwork for massive expansion. Together, Mainz believes these partnerships are poised to catalyze a sweeping transformation in public health outcomes, creating a tidal wave of innovation and economic growth that will ripple across the healthcare landscape.

In addition to supporting the clinical trial, Mainz said Quest Diagnostics has a semi-exclusive right to market ColoAlert in the U.S. for an eighteen-month period. If exercised, this option will allow Quest Diagnostics the opportunity to offer the product to multiple channels, including physicians, health systems, hospitals, health plans, employers and consumers, reports Mainz Biomed.

“We are excited by the opportunity to collaborate with Quest Diagnostics,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Teaming with Quest Diagnostics during our critical FDA Study will be key to our long-term success.”

ColoAlert is an early detection screening that spots bleeding and non-bleeding tumors through tumor DNA analysis. ColoAlert analyzes samples for the four tumor markers associated with cancer: KRAS-mutation, BRAF-mutation, total amount of human DNA and occult blood. By analyzing tumor DNA, Mainz says ColoAlert detects 85% of colorectal cancer cases, often in the very early stages of the disease.

Based on recent trials, Mainz Biomed says ColoAlert’s sensitivities exceeded 90% for detecting colorectal cancer and over 80% for advanced adenomas. Detecting advanced adenomas is crucial in preventing colorectal cancer, as identifying patients with these lesions allows for timely intervention through colonoscopy and adenoma removal, thereby averting cancer development, reports Mainz.

It's a big market for Mainz Biomed to address, given colorectal cancer 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 U.S. Preventive Services Task Force recommends that screening with stool DNA tests be conducted once every three years, starting at age 45. As it stands, 71% of the diagnoses made are in the later stages of the disease. But if it's caught early, the survival rate after five years is 90%. Despite those favorable odds, only about four in ten colorectal cancers are spotted at the early stage.

Each year in the U.S., 16.6 million colonoscopies are performed, yet about one-third of US residents aged 50-75 have never been screened for colon cancer. This gap in screening represents a $4 billion total market opportunity in the U.S., according to estimates compiled by Mainz Biomed.

ColoAlert, if approved in the U.S., may help rectify that lack of timely screening. After all, Mainz Biomed says its detection system is less invasive than ColoGuard, the leading at-home test in the U.S., because it requires very small samples to test. It’s one of the reasons the company boasts 98% patient satisfaction in Germany. ColoAlert is also easy to use, which should be a big driver of adoption. Within five minutes your sample is collected and packaged and on the way to the lab. Patients receive a kit in the mail that includes instructions, a stool collector and a shipping label to return the kit to their local lab for testing. Patients receive the results in a few days.

Mainz Biomed wants to bring its ColoAlert early cancer screening test to the U.S., and it is inking deals and readying clinical trials to achieve that. Its agreements with Quest Diagnostics put it one step closer. Stay tuned in 2025 – there may be lots more to come from Mainz Biomed on its path to commercializing ColoAlert in the U.S. and beyond.

Featured photo by National Cancer Institute on Unsplash.

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