Mainz Biomed Forms Agreement with Quest Diagnostics to Provide Clinical Trials Laboratory Services for Colorectal Cancer Screening Test
Mainz Biomed (NASDAQ:MYNZ) has partnered with Quest Diagnostics to advance its colorectal cancer screening test. Quest will provide laboratory services for Mainz's ReconAAsense FDA study, which will involve approximately 15,000 subjects across 150 US sites. The agreement includes an option for Quest to obtain semi-exclusive rights for testing services pending FDA approval.
The company's ColoAlert test, utilizing PCR technology to analyze stool samples for cancer DNA, has demonstrated promising sensitivity in detecting colorectal cancer and advanced adenomas. This development targets a significant market opportunity, as about one-third of US residents aged 50-75 have never undergone colorectal cancer screening, representing a potential $4.0B+ market in the US.
Mainz Biomed (NASDAQ:MYNZ) ha instaurato una partnership con Quest Diagnostics per avanzare il suo test di screening per il cancro del colon-retto. Quest fornirà servizi di laboratorio per lo studio ReconAAsense della FDA di Mainz, che coinvolgerà circa 15.000 soggetti in 150 siti negli Stati Uniti. L'accordo include un'opzione per Quest di ottenere diritti semi-esclusivi per i servizi di test, in attesa di approvazione da parte della FDA.
Il test ColoAlert dell'azienda, che utilizza tecnologie PCR per analizzare i campioni di feci alla ricerca di DNA cancerogeno, ha mostrato una sensibilità promettente nel rilevamento del cancro del colon-retto e degli adenomi avanzati. Questo sviluppo si rivolge a un'opportunità di mercato significativa, poiché circa un terzo dei residenti statunitensi di età compresa tra 50 e 75 anni non ha mai effettuato uno screening per il cancro del colon-retto, rappresentando un potenziale mercato di oltre 4,0 miliardi di dollari negli Stati Uniti.
Mainz Biomed (NASDAQ:MYNZ) se ha asociado con Quest Diagnostics para avanzar en su prueba de detección de cáncer colorrectal. Quest proporcionará servicios de laboratorio para el estudio ReconAAsense de la FDA de Mainz, que involucrará aproximadamente a 15,000 sujetos en 150 sitios en Estados Unidos. El acuerdo incluye una opción para que Quest obtenga derechos semiexclusivos para los servicios de prueba, a la espera de la aprobación de la FDA.
La prueba ColoAlert de la compañía, que utiliza tecnología PCR para analizar muestras de heces en busca de ADN canceroso, ha demostrado una sensibilidad prometedora en la detección de cáncer colorrectal y adenomas avanzados. Este desarrollo se dirige a una oportunidad de mercado significativa, ya que aproximadamente un tercio de los residentes de EE.UU. de entre 50 y 75 años nunca se ha sometido a un examen de cáncer colorrectal, lo que representa un mercado potencial de más de 4,0 mil millones de dólares en EE.UU.
Mainz Biomed (NASDAQ:MYNZ)는 Quest Diagnostics와 협력하여 대장암 선별 검사를 발전시킬 예정입니다. Quest는 Mainz의 ReconAAsense FDA 연구를 위해 실험실 서비스를 제공하며, 이 연구에는 약 15,000명의 피험자가 150개의 미국 사이트에서 참여하게 됩니다. 이 계약에는 FDA 승인을 기다리는 기간 동안 Quest가 시험 서비스에 대한 반독점적 권리를 얻을 수 있는 옵션이 포함되어 있습니다.
회사의 ColoAlert 검사는 PCR 기술을 이용해 대변 샘플에서 암 DNA를 분석하며, 대장암 및 고급 선종을 감지하는 데 있어 유망한 민감도를 보여주었습니다. 이 개발은 미국에서 50세에서 75세 사이의 주민 중 약 3분의 1이 대장암 선별 검사를 받은 적이 없어 40억 달러 이상의 잠재적 시장 기회를 목표로 합니다.
Mainz Biomed (NASDAQ:MYNZ) s'est associé à Quest Diagnostics pour faire avancer son test de dépistage du cancer colorectal. Quest fournira des services de laboratoire pour l'étude ReconAAsense de la FDA de Mainz, qui impliquera environ 15 000 sujets sur 150 sites aux États-Unis. L'accord comprend une option pour Quest d'obtenir des droits semi-exclusifs pour les services de test, sous réserve de l'approbation de la FDA.
Le test ColoAlert de l'entreprise, utilisant la technologie PCR pour analyser des échantillons de selles à la recherche de l'ADN cancéreux, a montré une sensibilité prometteuse dans la détection du cancer colorectal et des adénomes avancés. Ce développement vise une opportunité de marché significative, car environ un tiers des résidents américains âgés de 50 à 75 ans n'ont jamais effectué de dépistage du cancer colorectal, représentant un marché potentiel de plus de 4,0 milliards de dollars aux États-Unis.
Mainz Biomed (NASDAQ:MYNZ) hat sich mit Quest Diagnostics zusammengeschlossen, um seinen Screening-Test auf Darmkrebs voranzutreiben. Quest wird Laborleistungen für die FDA-Studie ReconAAsense von Mainz bereitstellen, die etwa 15.000 Teilnehmer an 150 Standorten in den USA umfassen wird. Die Vereinbarung umfasst eine Option für Quest, semi-exklusive Rechte für Testdienstleistungen unter dem Vorbehalt der FDA-Zulassung zu erwerben.
Der ColoAlert-Test des Unternehmens nutzt PCR-Technologie zur Analyse von Stuhlproben auf Krebs-DNA und hat vielversprechende Sensitivität bei der Erkennung von Darmkrebs und fortgeschrittenen Adenomen gezeigt. Diese Entwicklung zielt auf eine bedeutende Marktchance ab, da etwa ein Drittel der US-Bürger im Alter von 50 bis 75 Jahren noch nie einen Darmkrebsscreening-Test durchgeführt hat, was einen potenziellen Markt von über 4,0 Milliarden Dollar in den USA darstellt.
- Partnership with major diagnostic provider Quest Diagnostics
- Large-scale FDA study involving 15,000 subjects across 150 sites
- Quest has option for semi-exclusive commercialization rights
- Addresses $4.0B+ market opportunity in the US
- Preliminary data shows promising sensitivity in cancer detection
- FDA approval still pending
- Quest's commercialization rights are time- to 18 months
- Faces competition in established screening market
Insights
The collaboration between MYNZ and Quest Diagnostics represents a pivotal development in colorectal cancer (CRC) screening. The ReconAAsense study's scope of 15,000 subjects across 150 sites is substantial and well-designed for FDA validation. ColoAlert's PCR-based approach for detecting tumor DNA in stool samples aligns with current screening recommendations and could potentially improve early detection rates.
The market opportunity is compelling - with one-third of US residents aged 50-75 having never been screened, representing a
For a micro-cap company with
The global context is important - CRC being the third most common cancer globally with 1.9 million new cases in 2020 indicates substantial market potential. The partnership with Quest adds credibility to MYNZ's commercial strategy and could potentially lead to increased institutional interest in the stock, despite its current micro-cap status.
Quest to Support Mainz Biomed’s ReconAAsense FDA Study and Has Option to Commercialize Test Kit Assuming FDA Approval
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
“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.”
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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
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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.
FAQ
What is the size of ReconAAsense FDA study for MYNZ's colorectal cancer test?
What is the market opportunity for MYNZ's colorectal cancer screening test in the US?
What technology does MYNZ's ColoAlert test use for cancer detection?
What are Quest Diagnostics' commercialization rights for MYNZ's test kit?
How often should MYNZ's stool DNA-FIT test be conducted according to guidelines?
