Mainz Biomed partners with Quest Diagnostics to commercialize a colorectal cancer screening test, enhancing early detection efforts.
Quiver AI Summary
Mainz Biomed N.V. has announced a partnership with Quest Diagnostics to commercialize its stool-based colorectal cancer screening test, ColoAlert, which detects tumor DNA to identify early-stage cancer. The test utilizes PCR technology to analyze DNA from stool samples for genetic mutations associated with colorectal cancer. Preliminary data indicates good sensitivity and specificity for the test, and Quest will assist with clinical trial services for a large study aimed at FDA validation involving 15,000 subjects. This collaboration provides Quest with potential semi-exclusive rights to testing services based on the ColoAlert test, pending FDA approval. Colorectal cancer is a leading global health issue, and this partnership aims to enhance patient access to cancer screening solutions, addressing a significant market gap in the U.S.
Potential Positives
- Mainz Biomed has announced a collaboration with Quest Diagnostics, a leader in cancer diagnostics, which can enhance the commercial development and accessibility of their ColoAlert test for colorectal cancer.
- The ColoAlert test, designed for early detection of colorectal cancer, has shown promising sensitivity and specificity in preliminary data, positioning it as a viable alternative in the growing market for cancer screening.
- The prospective clinical study, ReconAAsense, involving approximately 15,000 subjects, will support FDA validation of the NextGen test, potentially leading to wider adoption and increased sales opportunities for Mainz Biomed.
- The partnership addresses a significant market opportunity in the U.S., where many residents are not screened for colon cancer, highlighting the potential impact of the ColoAlert test in improving public health outcomes.
Potential Negatives
- The press release includes a significant disclaimer regarding forward-looking statements, highlighting uncertainty and risks associated with the company’s projected development and regulatory approval timelines, which may undermine investor confidence.
- Mainz Biomed operates in a competitive market for colorectal cancer diagnostics, and the mention of reliance on Quest Diagnostics for commercialization raises questions about their independence and control over the product's market introduction.
- The announcement does not provide concrete timelines or specifics on regulatory approval, which may leave stakeholders unclear about when the ColoAlert test will be available in the market.
FAQ
What is the collaboration between Mainz Biomed and Quest Diagnostics?
Mainz Biomed and Quest Diagnostics have agreed to commercialize the ColoAlert test for colorectal cancer, enhancing cancer screening accessibility.
What is the ColoAlert test?
The ColoAlert test is a stool-based screening designed to detect colorectal cancer tumor DNA for early diagnosis.
How does the ColoAlert test work?
The test examines a small DNA sample from stool using PCR technology to identify genetic mutations linked to colorectal cancer.
What clinical study is Mainz Biomed conducting?
Mainz Biomed's ReconAAsense study will involve approximately 15,000 subjects to support FDA validation of the NextGen test.
Why is colorectal cancer screening important?
Colorectal cancer is the third most common cancer globally, and early screening can significantly improve treatment outcomes.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$MYNZ Hedge Fund Activity
We have seen 6 institutional investors add shares of $MYNZ stock to their portfolio, and 6 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- STEWARD PARTNERS INVESTMENT ADVISORY, LLC added 29,000 shares (+inf%) to their portfolio in Q3 2024
- TWO SIGMA SECURITIES, LLC added 23,515 shares (+inf%) to their portfolio in Q3 2024
- VONTOBEL HOLDING LTD. added 20,000 shares (+80.0%) to their portfolio in Q3 2024
- CITADEL ADVISORS LLC removed 18,157 shares (-100.0%) from their portfolio in Q2 2024
- JANE STREET GROUP, LLC added 14,559 shares (+inf%) to their portfolio in Q3 2024
- UBS GROUP AG removed 3,207 shares (-100.0%) from their portfolio in Q2 2024
- NORTHWESTERN MUTUAL WEALTH MANAGEMENT CO removed 2,500 shares (-100.0%) from their portfolio in Q2 2024
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
BERKELEY, Calif. and MAINZ, Germany, Dec. 19, 2024 (GLOBE NEWSWIRE) -- 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 Biomeds’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.”
Please follow us to stay up to date:
LinkedIn
X (Previously Twitter)
Facebook
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.com
or follow us on
LinkedIn
,
Twitter
and
Facebook
.
For media inquiries
MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
mainzbiomed@mc-services.eu
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 9, 2024. 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.
This article was originally published on Quiver News, read the full story.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
