- Distinguished Professor Emeritus of Medicine at Indiana University School of Medicine, Chancellor’s Professor at Indiana University Purdue University Indianapolis, and Director of Endoscopy at Indiana University Hospital in Indianapolis
BERKELEY, Calif. and MAINZ, Germany, Sept. 20, 2022 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic firm specializing within the early detection of most cancers, introduced at this time the appointment of Dr. Douglas Okay. Rex to its Medical Advisory Board (MAB). Dr. Rex is the most recent trade skilled to be part of the MAB which was established to assist Mainz’s forthcoming U.S. pivotal trial for ColoAlert, the Company’s extremely efficacious, and easy-to-use detection take a look at for colorectal most cancers (CRC).
“As one of the world’s leading experts in the field of colorectal cancer screening, we’re proud to welcome Dr. Rex to our MAB and will certainly benefit greatly from his participation,” stated Guido Baechler, Chief Executive Officer of Mainz Biomed. “We are fortunate to have a remarkable group of experts join our MAB. Their unparalleled expertise is already paying dividends and will continue to be invaluable as we take the necessary steps to prepare for our pivotal US clinical trial which is on track to commence in 2022.”
Dr. Rex is Distinguished Professor Emeritus of Medicine at Indiana University School of Medicine, Chancellor’s Professor at Indiana University Purdue University Indianapolis, and Director of Endoscopy at Indiana University Hospital in Indianapolis. He graduated from Harvard College, Summa Cum Laude in 1976 and with highest distinction from Indiana University School of Medicine in 1980. He served as Chief Medical Resident at Indiana University Hospital and joined the school at Indiana University in 1985. He is a full-time medical gastroenterologist at Indiana University Hospital.
His main analysis pursuits have been in colorectal illness and, specifically, colorectal most cancers screening and the technical efficiency of colonoscopy. He co-authored the colorectal most cancers screening suggestions of the American College of Gastroenterology and the U.S. Multi-Society Task Force on Colorectal Cancer. He additionally authored the suggestions on high quality in colonoscopy of the U.S. Multi-Society Task Force on Colorectal Cancer and the American College of Gastroenterology/American Society of Gastrointestinal Endoscopy. He has authored greater than 300 authentic analysis papers, 70 e book chapters, 230 invited papers, 75 editorials, and 40 guideline papers. He has twice chaired the U.S. Multi-Society (ACG, ASGE, AGA) Task Force on Colorectal Cancer. He is a previous president of the American College of Gastroenterology and The American Society for Gastrointestinal Endoscopy.
“As someone who has devoted much of their career to the fight against colorectal cancer, I believe that advanced, accurate and simple-to-administer screening solutions like ColoAlert have the potential to significantly impact the scale and devastating nature of this terrible disease,” stated Dr. Rex. “I’m very pleased to be working with the highly-talented Mainz Biomed team and distinguished fellow Medical Advisory Board members and trust that we can provide meaningful benefit from our combined expertise to ably support the Company’s forthcoming U.S. pivotal trial for ColoAlert.”
Mainz is at the moment advertising and marketing ColoAlert by way of its distinctive business mannequin of partnering with third-party laboratories for take a look at equipment processing versus the standard methodology of working a single facility. The Company can also be operating ColoFuture, a global medical examine evaluating the potential to combine a portfolio of in-licensed novel mRNA biomarkers into the product which have beforehand demonstrated the distinctive skill to determine curable precancerous colonic polyps, in addition to treatable early-stage CRC (Herring et al 2021). ColoFuture is evaluating the effectiveness of those biomarkers to improve ColoAlert’s technical profile to lengthen its functionality to embody the identification of superior adenomas (AA), a kind of pre-cancerous polyp typically attributed to CRC, whereas rising ColoAlert’s charges of diagnostic sensitivity and specificity. The outcomes of the examine will in the end affect the configuration of ColoAlert prior to commencing the U.S. pivotal examine which is on observe to start in 2022.
About ColoAlert
ColoAlert detects colorectal most cancers (CRC) by way of a simple-to-administer take a look at with a sensitivity and specificity almost as excessive because the invasive colonoscopy*. The take a look at makes use of proprietary strategies to analyze cell DNA for particular tumor markers mixed with the fecal immunochemical take a look at (FIT) and is designed to detect tumor DNA and CRC circumstances of their earliest levels. The product is CE-IVDR marked (complying with EU security, well being and environmental necessities). The product is commercially out there in a collection of nations within the European Union and within the United Arab Emirates. Mainz Biomed at the moment distributes ColoAlert by way of quite a few medical associates. Once authorized within the U.S., the Company’s business technique is to set up scalable distribution by way of a collaborative associate program with regional and nationwide laboratory service suppliers throughout the nation.
*Dollinger MM et al. (2018)
About Colorectal Cancer
Colorectal most cancers (CRC) is the second most deadly most cancers within the U.S. and Europe, but in addition probably the most preventable with early detection offering survival charges above 90%. Annual testing prices per affected person are minimal, particularly compared to late-stage therapies of CRC which value sufferers a mean of $38,469 per 12 months. The American Cancer Society estimated that in 2021 there have been roughly 149,500 new circumstances of colon and rectal most cancers within the U.S. with 52,980 leading to demise. Recent FDA selections counsel that screening with stool DNA checks similar to ColoAlert within the US must be carried out as soon as each three years beginning at age 45. Currently there are 112 million Americans aged 50+, a complete that’s anticipated to enhance to 157 million inside 10 years. Appropriately testing these US-based 50+ populations each three years as prescribed equates to a US market alternative of roughly $3.7 Billion per 12 months.
About Mainz Biomed N.V.
Mainz Biomed develops market-ready molecular genetic diagnostic options for life-threatening situations. The Company’s flagship product is ColoAlert, an correct, non-invasive, and easy-to-use early detection diagnostic take a look at for colorectal most cancers. ColoAlert is at the moment marketed throughout Europe and within the United Arab Emirates with the intention of starting its pivotal FDA medical examine in 2022 for U.S. regulatory approval. Mainz Biomed’s product candidate portfolio additionally contains PancAlert, an early-stage pancreatic most cancers screening take a look at based mostly on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples.
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Forward-Looking Statements
Certain statements made on this press launch are “forward-looking statements” inside the which means of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements could also be recognized by means of phrases similar to “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and different comparable expressions that predict or point out future occasions or traits or that aren’t statements of historic issues. These forward-looking statements replicate the present evaluation of present data and are topic to numerous dangers and uncertainties. As a outcome, warning should be exercised in counting on forward-looking statements. Due to recognized and unknown dangers, precise outcomes could differ materially from the Company’s expectations or projections. The following components, amongst others, might trigger precise outcomes to differ materially from these described in these forward-looking statements: (i) the failure to meet projected growth and associated targets; (ii) adjustments in relevant legal guidelines or rules; (iii) the impact of the COVID-19 pandemic on the Company and its present or supposed markets; and (iv) different dangers and uncertainties described herein, in addition to these dangers and uncertainties mentioned from time to time in different studies and different public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional data regarding these and different components that will affect the Company’s expectations and projections could be present in its preliminary filings with the SEC, together with its registration assertion on Form F-1 filed on January 21, 2022. The Company’s SEC filings can be found publicly on the SEC’s web site at www.sec.gov. Any forward-looking assertion made by us on this press launch relies solely on data at the moment out there to Mainz Biomed and speaks solely as of the date on which it’s made. Mainz Biomed undertakes no obligation to publicly replace any forward-looking assertion, whether or not written or oral, that could be produced from time to time, whether or not because of new data, future developments or in any other case, besides as required by regulation.
