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Mainz Biomed Reports Positive Topline Results from Pooled Study Evaluating Novel mRNA Biomarkers and Proprietary AI Algorithm for Integration into Pivotal FDA PMA Clinical Trial for Next Generation Colorectal Cancer Diagnostic
Mainz Biomed reports positive topline results from a pooled study evaluating novel mRNA biomarkers and a proprietary AI algorithm for integration into a pivotal FDA PMA clinical trial for next-generation colorectal cancer diagnostic. The groundbreaking results show a sensitivity for colorectal cancer of 92% with specificity of 90% and best-in-class sensitivity for advanced adenoma of 82%. The study included 690 subjects from Mainz Biomed's clinical trials, aiming to optimize sensitivity and specificity in CRC screening. The results represent a critical milestone towards launching the FDA PMA pivotal study ReconAAsense, planned to recruit up to 15,000 patients. Mainz Biomed's innovative next-generation test has the potential to disrupt the at-home CRC diagnostic screening market by providing a robust and accurate test.
Mainz Biomed comunica risultati positivi dai dati preliminari di uno studio combinato che valuta nuovi biomarcatori di mRNA e un algoritmo di intelligenza artificiale proprietario per l'integrazione in uno studio clinico PMA della FDA di riferimento per la diagnosi del cancro colorettale di nuova generazione. I risultati rivoluzionari mostrano una sensibilità per il cancro colorettale del 92% con una specificità del 90% e una sensibilità di classe migliore per l'adenoma avanzato dell'82%. Lo studio ha coinvolto 690 soggetti provenienti dagli studi clinici di Mainz Biomed, con l'obiettivo di ottimizzare la sensibilità e la specificità nello screening del CRC. I risultati rappresentano un traguardo fondamentale verso l'avvio dello studio pivotale PMA della FDA ReconAAsense, che prevede di reclutare fino a 15.000 pazienti. Il test innovativo di nuova generazione di Mainz Biomed ha il potenziale per rivoluzionare il mercato degli screening diagnostici del CRC da casa, offrendo un test robusto e accurato.
Mainz Biomed informa sobre resultados positivos en los resultados principales de un estudio combinado que evalúa nuevos biomarcadores de ARNm y un algoritmo de IA propio para su integración en un ensayo clínico PMA de la FDA pivotal para el diagnóstico del cáncer colorrectal de próxima generación. Los resultados pioneros muestran una sensibilidad del 92% para el cáncer colorrectal con una especificidad del 90% y la mejor sensibilidad de su clase para adenoma avanzado del 82%. El estudio incluyó a 690 sujetos de los ensayos clínicos de Mainz Biomed, con el objetivo de optimizar la sensibilidad y la especificidad en la detección de CRC. Los resultados representan un hito crucial hacia el lanzamiento del estudio pivotal PMA de la FDA ReconAAsense, planeado para reclutar hasta 15.000 pacientes. La prueba innovadora de próxima generación de Mainz Biomed tiene el potencial de transformar el mercado de pruebas diagnósticas de CRC en casa, proporcionando una prueba robusta y precisa.
마인츠 바이오메드는 새로운 mRNA 바이오마커와 독자적인 AI 알고리즘을 평가하기 위해 진행된 통합 연구에서 긍정적인 최종 결과를 보고하였습니다. 이는 차세대 대장암 진단을 위한 FDA PMA 임상 시험에 통합될 예정입니다. 혁신적인 결과는 대장암에 대해 92%의 민감도와 90%의 특이성을 보여주었으며, 고도의 선종에 대해서는 업계 최고 수준의 82% 민감도를 나타냈습니다. 연구에는 마인츠 바이오메드의 임상 시험에서 모집된 690명의 대상자가 포함되었으며, CRC 스크리닝에서의 민감도와 특이성을 최적화하는 것을 목표로 하였습니다. 이 결과는 FDA PMA의 중요한 연구인 ReconAAsense를 시작하는 결정적인 이정표를 나타냅니다. 이 연구는 최대 15,000명의 환자를 모집할 계획입니다. 마인츠 바이오메드의 혁신적인 차세대 검사는 가정용 CRC 진단 스크리닝 시장을 혁신할 잠재력을 가지고 있으며, 강력하고 정확한 검사를 제공합니다.
Mainz Biomed annonce des résultats positifs des premiers résultats d'une étude groupée évaluant de nouveaux biomarqueurs d'ARNm et un algorithme d'IA propriétaire pour intégration dans un essai clinique pivotal PMA de la FDA pour le diagnostic du cancer colorectal de nouvelle génération. Les résultats révolutionnaires montrent une sensibilité pour le cancer colorectal de 92% avec une spécificité de 90% et une sensibilité de premier ordre pour l'adénome avancé de 82%. L'étude a inclus 690 sujets issus des essais cliniques de Mainz Biomed, visant à optimiser la sensibilité et la spécificité dans le dépistage du CRC. Les résultats représentent une étape cruciale vers le lancement de l'étude pivot PMA de la FDA ReconAAsense, prévue pour recruter jusqu'à 15 000 patients. Le test innovant de nouvelle génération de Mainz Biomed a le potentiel de bouleverser le marché du dépistage diagnostique du CRC à domicile en fournissant un test robuste et précis.
Mainz Biomed berichtet über positive Topline-Ergebnisse aus einer gepoolten Studie, die neuartige mRNA-Biomarker und einen proprietären KI-Algorithmus bewertet, um sie in eine entscheidende FDA PMA klinische Studie für die Diagnostik von Darmkrebs der nächsten Generation zu integrieren. Die bahnbrechenden Ergebnisse zeigen eine Sensitivität für Darmkrebs von 92% bei einer Spezifität von 90% und eine branchenführende Sensitivität bei fortgeschrittenem Adenom von 82%. Die Studie umfasste 690 Teilnehmer aus den klinischen Studien von Mainz Biomed, mit dem Ziel, die Sensitivität und Spezifität beim CRC-Screening zu optimieren. Die Ergebnisse stellen einen entscheidenden Meilenstein auf dem Weg zur Durchführung der zentralen FDA PMA-Studie ReconAAsense dar, die geplant ist, bis zu 15.000 Patienten zu rekrutieren. Der innovative Test der nächsten Generation von Mainz Biomed hat das Potenzial, den Markt für häusliche CRC-Diagnosetests zu revolutionieren, indem er einen robusten und genauen Test bietet.
Positive
Groundbreaking topline results demonstrate sensitivity for colorectal cancer of 92% with specificity of 90% and best-in-class sensitivity for advanced adenoma of 82%.
The study included 690 subjects from Mainz Biomed's clinical trials to optimize sensitivity and specificity in CRC screening.
Results represent a critical milestone towards launching the FDA PMA pivotal study ReconAAsense, planned to recruit up to 15,000 patients.
Mainz Biomed's innovative next-generation test has the potential to disrupt the at-home CRC diagnostic screening market by providing a robust and accurate test.
Negative
None.
Insights
The recently announced topline results by Mainz Biomed present a significant leap in colorectal cancer diagnostics. A sensitivity of 92% in detecting colorectal cancer is notable when compared to the current alternatives, potentially positioning Mainz Biomed's next generation diagnostic tool at the forefront of the market. Moreover, the advanced adenoma detection rate of 82% suggests a reliable ability to spot pre-cancerous lesions, which could have a profound impact on patient outcomes by permitting earlier intervention. The use of mRNA biomarkers in conjunction with a FIT test and an AI algorithm represents a sophisticated and modern approach to screening, which may lead to a paradigm shift in non-invasive testing practices. Should the FDA PMA clinical trial validate these findings, we could see an increased adoption rate for Mainz Biomed's screening tool, potentially increasing the company's market share and influencing its stock valuation positively.
In terms of market dynamics, the impressive specificity and sensitivity rates reported by Mainz Biomed could disrupt the colorectal cancer screening market. Early detection of CRC is a critical factor in patient survival rates and has been an ongoing focus within the medical community. Mainz Biomed's test, if approved, might not only capture a significant share of the CRC screening market but also could expand the total market by increasing the number of people who get screened. This potential market expansion and the shift towards non-invasive, at-home testing could attract considerable investor interest. The stock may see increased volatility leading up to the publication of the full study results and the FDA PMA study outcome. Investors will be paying close attention to peer-reviewed publications and regulatory milestones, which are key indicators of future revenue potential and can drive capital flows in the biotech sector.
From a strategic standpoint, the methodology of pooling data from different continents is a robust approach that may address the diversity of the patient population, which is a critical element in validating the efficacy of a diagnostic tool across varied ethnic and genetic backgrounds. The integration of AI to enhance diagnostic accuracy is becoming increasingly prevalent in precision medicine; it gives Mainz Biomed's product a competitive edge in the industry. If the FDA PMA study is successful, Mainz Biomed will have to navigate the challenges of scaling production, distribution and marketing to meet the anticipated demand. Furthermore, they'll need to establish solid reimbursement pathways with insurers, which can be a significant factor impacting the adoption rate of new diagnostic tests in clinical practice. This upstream preparation can determine the long-term success and market penetration of their CRC screening tool.
Groundbreaking topline results demonstrated sensitivity for colorectal cancer of 92% with specificity of 90% and best-in-class sensitivity for advanced adenoma of 82%
690 subjects analyzed including previously unexamined and reported patients from Company’s ColoFuture and eAArly DETECT studies utilizing the mRNA biomarkers, FIT test, and a proprietary AI Algorithm
The power to determine advanced adenoma, lesions in a pre-cancerous stage, can change the entire CRC diagnostic field, by treating the patient before the polyps can progress to cancer
BERKELEY, Calif. and MAINZ, Germany, April 25, 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 groundbreaking topline results from a pooled clinical study which included new patients and subjects from Mainz Biomed’s ColoFuture (Europe) and eAArly DETECT (U.S.) clinical trials evaluating the potential to integrate its portfolio of proprietary novel gene expression (mRNA) biomarkers into a next generation version of the Company’s colorectal cancer (CRC) screening tool. The topline results confirm the positive efficacy results previously reported with a sensitivity for colorectal cancer of 92% with a specificity of 90% and a sensitivity for advanced adenoma of 82%, which is best-in-class and compare favorably to existing commercial products.
“We conducted this pooled study to fine-tune the minimal biomarker set to be used to optimize sensitivity and specificity of the results in Mainz Biomed’s next generation CRC screening tool. The new data read-out demonstrates that our next generation product candidate for early-stage CRC detection utilizing mRNA biomarkers, a FIT test and a proprietary AI algorithm has consistently delivered high sensitivity and specificity for both advanced adenomas and colorectal cancer,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “This strong performance is particularly noteworthy as the pooling a significantly higher number of patients, namely two entirely separate patient cohorts from two continents as well as previously unexamined patient samples. Hence these results represent a critical milestone on our path to launching our FDA PMA pivotal study ReconAAsense, which is planned to recruit up to 15,000 patients.”
The pooled results include 690 evaluable subjects across 21 sites in the U.S. and 9 sites in Europe. The two cohorts included patients (US cohort aged 45 and older and European cohort aged 40 and older) that provided a stool sample before undergoing a colonoscopy to either screen for CRC (average risk), to follow up on a positive non-invasive test, imaging or symptoms, or if a subject was already identified as having colorectal cancer but before any treatment had been administered. Following colonoscopy and any applicable histopathology, subjects were classified into groups: CRC, advanced adenoma, non-advanced adenoma, no findings, or non-colorectal cancer. Each subject outcome was compared to the results from the next generation test incorporating the novel mRNA biomarkers and FIT.
The Company plans to publish results of this study at a major medical conference during the second quarter of 2024.
According to the Centers for Disease Control and Prevention (CDC), colorectal cancer is the second most lethal cancer in the U.S. and Europe, but also the most preventable, with early detection providing survival rates above 90%. Mainz Biomed’s proprietary portfolio of mRNA biomarkers has previously demonstrated the ability to detect CRC lesions, including advanced adenomas, a type of pre-cancerous polyp often attributed to this deadly disease. The power to determine lesions in a pre-cancerous stage can change the entire CRC diagnostic field, by treating the patient before the polyps can progress to a cancerous stage. This is especially remarkable as recent studies reveal that blood tests, despite their perceived convenience, lack the sensitivity to detect pre-cancerous conditions effectively. In the landscape of early colon cancer diagnostics with non-invasive tests, stool-based screening methods proved to be the most precise. Subject to a positive outcome of the FDA PMA study, Mainz Biomed’s innovative next generation test has the potential to disrupt the at-home CRC diagnostic screening market by providing the most robust and accurate test and become new gold standard.
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, Franck et al. 2024). 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 $4.0B+ total market opportunity in the US.
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 planning to run 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.
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.
FAQ
What are the topline results reported by Mainz Biomed from the pooled study involving novel mRNA biomarkers and a proprietary AI algorithm for colorectal cancer diagnosis?
The topline results show a sensitivity for colorectal cancer of 92% with specificity of 90% and best-in-class sensitivity for advanced adenoma of 82%.
How many subjects were included in the study evaluating the mRNA biomarkers and AI algorithm for CRC screening?
The study included 690 subjects from Mainz Biomed's clinical trials.
What is the purpose of the pooled clinical study conducted by Mainz Biomed?
The study aimed to fine-tune the minimal biomarker set for Mainz Biomed's next-generation CRC screening tool to optimize sensitivity and specificity.
What is the significance of the study results for Mainz Biomed?
The results represent a critical milestone towards launching the FDA PMA pivotal study ReconAAsense, planned to recruit up to 15,000 patients.
How can Mainz Biomed's next-generation test impact the CRC diagnostic screening market?
The innovative test has the potential to disrupt the at-home CRC diagnostic screening market by providing a robust and accurate test.
