Mainz Biomed Announces Interim Read Out For Its eAArly DETECT 2 Clinical Study

Mainz Biomed Announces Interim Read Out For Its eAArly DETECT 2 Clinical Study

Dil Bar Irshad | May 16, 2025 | 10:06 PM IST | Breaking News | Follow on Google News

Mainz Biomed Announces Interim Read Out For Its eAArly DETECT 2 Clinical Study

BERKELEY, US – MAINZ, Germany – May 16, 2025 — 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 that it intends to provide an interim read out of its eAArly DETECT 2 feasibility study by the end of summer 2025. The study is evaluating the Company’s next-generation colorectal cancer (CRC) screening test that integrates Mainz Biomed´s proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test over a population of approximately 2,000 average-risk patients to validate the industry-leading results of previous feasibility studies and support the transition of CRC screening to CRC prevention.

The eAArly DETECT 2 study is expected to complete enrollment in the second half of 2025, and the Company targets reporting top-line results by the fourth quarter of 2025. Based on the study’s outcome, Mainz Biomed intends to finalize its protocols for ReconAAsense, the Company’s U.S. pivotal study, which is on track to initiate in 2026. This next-generation CRC and APL (Adenomatous Polyps) test will not only detect cancerous polyps with a high degree of accuracy but can potentially prevent the disease through early detection of precancerous adenomas.

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“We are excited about the progress the team has been making on eAArly DETECT 2 and look forward to providing partners and shareholders an interim update, targeted for the end of this summer,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “This clinical trial is particularly exciting for the Company, the patient community, and the medical professionals alike. By precisely detecting advanced precancerous lesions and early-stage CRC, we aim to advance our mission of eliminating colorectal cancer and ultimately reducing global cancer mortality rates.”

The five novel gene expression (mRNA) biomarkers, which the Company acquired from Sherbrooke University in 2022, have demonstrated a unique ability to identify advanced adenomas – curable precancerous colonic polyps – as well as treatable early-stage CRC. The eAArly DETECT 2 study will further evaluate and confirm the effectiveness of these biomarkers combined with Mainz Biomed’s proprietary algorithm to enhance product specifications, extending its capability to include the identification of advanced adenomas while increasing rates of diagnostic sensitivity and specificity for early-stage CRC.

Dil Bar Irshad

Dil Bar Irshad is a seasoned journalist, hails from Jammu Kashmir's Doda, covers political, social, business stories, index stories.