Mainz Biomed Partners with Trusted Health Advisors to Support U.S. Go-To-Market Strategy for Next Generation Early Colorectal Cancer Diagnostic
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Insights
The collaboration between Mainz Biomed and Trusted Health Advisors (THA) represents a significant step in the commercialization of advanced diagnostic tools for colorectal cancer (CRC). The medical research community is keenly interested in the development of Mainz Biomed's ReconAAsense trial, which is a nucleic acid-based detection test for CRC screening. The trial's focus on Advanced Adenoma (AA) detection is particularly noteworthy as AA is a precursor to CRC and its early detection is crucial for effective intervention and improved patient survival rates.
From a medical research perspective, the potential market impact of a successful PMA outcome for ReconAAsense could be substantial. Given the high incidence and mortality rates associated with CRC, the introduction of a more accessible and accurate screening test could lead to earlier detection and treatment, ultimately saving lives and reducing healthcare costs associated with late-stage cancer care. Moreover, the partnership with THA, led by industry veterans Dr. Wohlgemuth and Dr. Tabibiazar, adds credibility to the endeavor and could enhance the speed and efficiency of the product's market entry.
The strategic partnership between Mainz Biomed and THA underscores a shift in the healthcare industry towards more collaborative and partnership-driven commercial strategies. Mainz Biomed's approach of partnering with third-party laboratories for the distribution of its CRC screening test is a departure from the traditional model of operating a single facility. This could disrupt the current market by potentially increasing patient access and reducing time-to-market for innovative diagnostic solutions.
Analyzing the potential financial implications, if the ReconAAsense test receives FDA approval, Mainz Biomed could see a significant increase in revenue streams and market share within the diagnostic sector. The test's ease of use and non-invasive nature may lead to higher adoption rates among patients and healthcare providers, thereby creating a competitive advantage. The anticipation of product approval and market entry by 2026 could also influence Mainz Biomed's stock performance as investors gauge the company's growth potential based on these developments.
From a market analysis standpoint, the partnership between Mainz Biomed and THA could have a ripple effect on the diagnostics market, particularly in the U.S. The involvement of THA, with its established track record in supporting diagnostic product launches, suggests a well-orchestrated go-to-market strategy that could facilitate rapid market penetration upon FDA approval. The ReconAAsense test's self-administration feature aligns with current consumer health trends favoring convenience and privacy, which may drive consumer preference and adoption.
Additionally, the cost-effectiveness of early AA detection over cancer treatment could lead to favorable insurance coverage policies, further incentivizing the use of Mainz Biomed's test. Stakeholders, including healthcare providers, insurers and patients, stand to benefit from the potential positive outcomes of the ReconAAsense trial. It's also important to monitor how competitors in the CRC screening space may respond to this partnership and the impending trial results, as this could influence market dynamics and strategic positioning.
- Dr. Jay Wohlgemuth, former Chief Medical & Scientific Officer of Quest Diagnostics and Dr. Ray Tabibiazar, a seasoned industry executive, to lead collaboration
- Mainz Biomed’s Pivotal FDA PMA clinical trial (ReconAAsense) evaluating gold standard self-administered colorectal cancer screening test on track to commence patient enrollment in 2024
BERKELEY, Calif. and MAINZ, Germany, March 05, 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, announced today a partnership with Trusted Health Advisors (THA), a market leader in supporting the U.S. launches and management of commercial programs for diagnostic products.
Mainz Biomed is in late-stage clinical development of a highly accurate and easy-to-use nucleic acid-based detection test for colorectal cancer (CRC) screening diagnostics that it intends to distribute, if approved, via the Company’s unique business model of marketing products via partnerships with third-party laboratories. In the U.S., Mainz Biomed is in final regulatory planning stages of ReconAAsense clinical trial to seek Premarket Approval (PMA) for its next generation diagnostic test. The Company currently commercializes its first-generation test in Europe and in select international territories through its flagship product ColoAlert® via partnerships with third-party laboratories.
“As we make the final preparations to commence patient enrollment in the ReconAAsense trial and given the potentially transformative role the test will have on the market if approved, we are excited by the opportunity to be in a position to advance our U.S. go-to-market strategy for our innovative approach in CRC screening,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Through our partnership with THA, we plan to expedite and enhance the deployment of our differentiated commercial strategy to enable an efficient and impactful transition to the marketplace for the product which if approved, we anticipate will occur in 2026. We look forward to working with Drs. Wohlgemuth, Tabibiazar and the entire THA team.”
“Mainz Biomed’s early data in accurate detection of Advanced Adenoma has the potential to transform colon cancer screening” said Dr. Jay Wohlgemuth, Managing Partner at THA. “Detecting AA lesions allows for early intervention and significantly increases the chance of successful treatment and survival. Furthermore, early detection and treatment of AA is more cost-effective than treating cancer.”
“Mainz Biomed’s easy-to-use kit as well as their differentiated business model to commercialize their diagnostic test via partnerships with third-party laboratories versus the traditional methodology of operating a single facility, could dramatically increase patient access to the test and help improve patient outcomes,” said Dr. Ray Tabibiazar, Managing Partner at THA, “the THA team is excited to support Mainz Biomed in its efforts to advance this promising pre-cancer test for patients in need.”
The partnership with THA will be led by Drs. Jay Wohlgemuth and Ray Tabibiazar, Managing Partners of the firm. Dr. Wohlgemuth brings to the project a prolific development and commercial background in healthcare innovation having most recently served in multiple senior executive roles at Quest Diagnostics including, Chief Medical Officer, Chief Scientific Officer and Senior Vice President. In addition, Dr. Wohlgemuth was a co-founder, Chief Medical Officer and Vice President of R&D for CareDx, a leader in testing for transplant patients for which he was awarded Technology Pioneer 2005 at the World Economic Forum in Davos. Dr. Tabibiazar is a veteran CEO, entrepreneur and investor in the biotechnology and diagnostics space. The THA team brings extensive experience and capabilities, from R&D through commercialization, across the diagnostics industry, including lab diagnostics, in vitro diagnostics, medical devices, and population health management. To learn more about THA, please visit https://www.trustedhealthadvisors.us
ReconAAsense (ClinicalTrials.gov Identifier: NCT05636085) is Mainz Biomed’s pivotal FDA PMA clinical trial evaluating a next generation CRC screening test which will integrate the Company’s portfolio of novel gene expression (mRNA) biomarkers. Recently (Q4 2023), Mainz Biomed announced groundbreaking results from ColoFuture (international) and eAArly DETECT (U.S.) clinical studies evaluating these biomarkers whereby ColoFuture reported sensitivity for CRC of
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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
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.
FAQ
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