Mainz Biomed Partners with Quest Diagnostics for Colorectal Cancer Screening
BERKELEY, Calif. and MAINZ, Germany – Mainz Biomed N.V. (NASDAQ:MYNZ), a prominent player in molecular genetics diagnostics, has entered into a significant agreement with Quest Diagnostics, a leader in diagnostic information services. This collaboration aims to accelerate the commercialization of Mainz Biomed’s innovative NextGen screening test for colorectal cancer.
Understanding ColoAlert: Early Detection of Colorectal Cancer
At the heart of this partnership is Mainz Biomed's stool-based ColoAlert test. This advanced diagnostic tool is designed to facilitate the early detection of colorectal cancer by identifying tumor DNA in stool samples. This is accomplished through polymerase chain reaction (PCR) technology, which allows for a detailed examination of small DNA samples, pinpointing genetic mutations that could indicate the presence of cancer. Preliminary data suggests that the ColoAlert test offers impressive sensitivity and specificity for detecting colorectal cancer and advanced adenomas.
Collaboration on Clinical Trials for Enhanced Validation
Under this agreement, Quest Diagnostics will provide essential clinical trial laboratory services for Mainz Biomed's ReconAAsense study. This is a prospective clinical trial encompassing approximately 15,000 subjects across 150 locations within the United States, aimed at gathering data to support FDA validation for the NextGen test. Additionally, Mainz Biomed will grant Quest the option to acquire semi-exclusive rights to testing services based on the test kit for an eighteen-month period, contingent on FDA approval.
Addressing a Significant Screening Gap
Colorectal cancer ranks as the third most prevalent cancer worldwide, with over 1.9 million new cases reported in the recent past. The US Preventive Services Task Force recommends that adults aged 45 and older undergo screening with stool DNA-FIT (sDNA-FIT) tests every one to three years. Alarmingly, about one-third of Americans aged 50 to 75 have never undergone screening for colon cancer, representing a substantial market opportunity exceeding $4.0 billion. This partnership aims to provide alternatives, such as sDNA-FIT tests, to improve access and encourage screening.
Leadership Insights on Advancing Patient Care
Guido Baechler, CEO of Mainz Biomed, expressed enthusiasm about this collaboration, stating, “We are excited by the opportunity to work with Quest Diagnostics. Their expertise in cancer diagnostics and ability to scale innovations will help us make our ColoAlert test widely accessible to patients in need. With their support, we are well-positioned to advance the commercial development of our ColoAlert test, ultimately aiding in delivering quality screening to more individuals.”
About Mainz Biomed and Its Innovations
Mainz Biomed N.V. is committed to creating market-ready molecular genetic diagnostic solutions for life-threatening conditions. Their flagship product, ColoAlert, is renowned for being an accurate, non-invasive diagnostic test for early detection of colorectal cancer. Currently marketed in Europe and the UAE, the company is pursuing FDA approval through a pivotal clinical study in the United States. Furthermore, Mainz Biomed’s pipeline includes PancAlert, an emerging pancreatic cancer screening test that utilizes real-time PCR technology to detect molecular-genetic biomarkers from stool samples.
Frequently Asked Questions
What is the main focus of the agreement between Mainz Biomed and Quest Diagnostics?
The agreement focuses on commercializing Mainz Biomed's NextGen screening test for colorectal cancer through clinical trials.
What does the ColoAlert test detect?
The ColoAlert test detects colorectal cancer tumor DNA present in stool samples to identify cancer at early stages.
How does the partnership help the colorectal cancer screening landscape?
This collaboration aims to improve access to early screening and address the large number of individuals who have not been screened.
What is the significance of the ReconAAsense study?
The study is crucial for gathering data supporting FDA validation for the NextGen test, involving thousands of participants.
What future products is Mainz Biomed developing?
Mainz Biomed is also working on PancAlert, an early-stage pancreatic cancer screening test using advanced molecular techniques.
