Despite significant progress, cancer continues to be the second-largest cause of death in the U.S. Unfortunately, more than 1.9 million new cases of cancer are likely to be diagnosed in the U.S. alone this year and more than 600,000 deaths are expected from the disease.
This is a good time to take a look at the cancer-fighting space on Wall Street, especially as healthcare is often considered an inflation hedge.
“Our goal is to reduce these statistics and save lives by raising awareness about the simplicity and efficacy of using at-home CRC detection kits, like ColoAlert. Our non-invasive DNA stool test allows people to screen themselves in the comfort of their own home and then receive a follow-up notification from their physician to discuss results and next steps.”
Guido Baechler, Chief Executive Officer of Mainz Biomed
Overall, the lifetime risk of developing colorectal cancer is about 1 in 23 for men and 1 in 26 for women says the American Cancer Society.
The American Cancer Society’s estimates for the number of colorectal cancers in the United States for 2023 are:
And colorectal cancer cases are rising in young adults.
Why is there an uptick? Nobody knows for sure but a sedentary lifestyle, overweight and obesity, smoking, heavy alcohol use, low-fiber, high-fat diets or diets high in processed meats, and other environmental factors have all been associated with the disease.
Screening is important because when found early, colorectal cancer is highly treatable. Early stages of colorectal cancer usually present no symptoms so screening is crucial.
According to the Centers for Disease Control and Prevention (“CDC”), Colorectal cancer (CRC) is the second most lethal cancer in the United States and Europe, but also the most preventable, with early detection providing survival rates above 90%!
A colonoscopy is one of several screening tests for colorectal cancer, but they can be awfully invasive.
MYNZ’s flagship product is ColoAlert, an accurate, non-invasive, and easy-to-use early detection diagnostic test for colorectal cancer. It is simple, fast, accurate, and non-invasive.
ColoAlert detects colorectal cancer (CRC) via a simple-to-administer test with a sensitivity and specificity nearly as high as the invasive colonoscopy (Dollinger MM et al., 2018). The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemical test (FIT). It is designed to detect tumor DNA and CRC cases in their earliest stages.
Patients receive a simple kit that includes instructions, a stool collector and shipping instructions to return the kit through regular mail to their local lab for testing and results. IT’S THAT EASY.
While the product is not approved yet for the U.S., it may be in the future, and this could be a game changer considering that it needs smaller samples than rival Cologuard!
10 Comparing ColoAlert sensitivity with FITs (Gies et al. Gastroenterology 154/2018)
11 98% overall satisfaction with ColoAlert in our internal customer survey.
*Dollinger MM et al. (2018), ClinLab 64 (10), 1719-1730 and Gies et al. (2018). Gastroenterology 154 (1), 93-104.and Cooper GS et al. (2018). Dig Dis Sci. 63 (6), 1449-1453. * 18 study centres, 566 patients, 10/2018 and Amani et al. (2019). Clin. Lab. 65:1751-1754.
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions and is transforming at-home cancer detection.
Clinical laboratory tests save costs and lives by enabling early detection and prevention of disease. Patients with cancers and other conditions are living longer and enjoying better health because of medical revolutions in diagnostic technology.
At its center are genetic and genomic tests that identify the unique genetic profile of individual patients or their disease and allow physicians to tailor treatment to those unique characteristics.
Mainz Biomed is commercializing ColoAlert across Europe and in select international markets through a differentiated business model of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility.
Under the standard terms of all partnerships, Mainz Biomed is providing ColoAlert to the respective labs, including co-branding with key accounts, whereby each facility purchases Mainz Biomed’s customized polymerase chain reaction (“PCR”) assay kits on an on-demand basis and provides their respective network of physicians and patients with a comprehensive solution for advanced CRC detection.
DNA extraction for the company’s flagship product ColoAlert is now automated on the Thermo Scientific™ KingFisher™ Apex.
This essential partnership enables laboratories around the world to increase their testing capacity and to optimize their resource allocation.
* Extraction time, does not include sample pre-treatment. For Laboratory Use.
MYNZ is evaluating the mRNA biomarkers acquired from SOCPRA in ColoFuture and eAArly DETECT, an international multi-center clinical study (U.S. and Europe) assessing the potential for integrating the mRNA biomarkers into ColoAlert.
This particular portfolio of mRNA biomarkers selected by the company was based on work in the field by the University of Sherbrooke, where researchers tested multiple novel transcriptional biomarkers using colorectal cancer and pre-cancerous lesion samples.
Results from these studies demonstrated that the mRNA targets chosen by the company provided a dynamic combination of sensitivity and specificity of detection.
The ColoFuture study (extended into the U.S. as eAArly DETECT) is evaluating the effectiveness of these biomarkers to enhance ColoAlert's technical profile to expand its capability to identify A.A. while increasing ColoAlert's rates of diagnostic sensitivity and specificity. As noted, ColoFuture's eAArly DETECT study is on track to complete enrollment in the first quarter of 2023, with results also expected in the first half of 2023. That milestone, once reached, could become a catalyst for growth!
Even studying mRNA biomarkers is a hot sector. Both Pfizer (NYSE: P.F.E.) and Moderna (NASDAQ: MRNA) are investing considerable resources in appraising their value in a new generation of medicine!
MYNZ has highlighted that the outcome of its eAArly DETECT study will inform its decision of whether to integrate the biomarkers into the ReconAAsense study, which is on track to enroll patients in the summer of 2023!
The results from that study are planned to be reported in 2025, forming the basis of the data package to be reviewed by the F.D.A. to achieve marketing authorization.
MYNZ has also announced additional commercial partnerships for ColoAlert with Marylebone Laboratory and Instituto de Microecologia, two leading independent laboratories covering England and Spain.
That deal will expand MYNZ's revenue-generating reach and target an addressable market in Spain estimated at 26 million patients and a London-region patient treatment opportunity of roughly 9 million individuals.
Revenues from that deal could accrue quickly. MYNZ says they are working on completing the necessary technical and co-marketing activities to ensure a successful commercial launch in these markets.
Mainz BioMed is currently developing proprietary genetic testing methods for pancreatic cancer.
With every problem comes an opportunity -- in this case, a massive opportunity because cancer is a big problem. Both large and small companies are developing new ways of diagnosing and treating cancer and MYNZ may have one of the best ways to fight off colon cancer early on.
The company's closest peer, Exact Sciences (NASDAQ: EXAS) - ColoGuard product is only sold in the US - and has a market cap of about $11 billion. TO REITERATE.... COLOALERT IS EASIER TO ADMINISTER AND MORE ACCURATE!
AND… MYNZ currently carries an $18 price target! With leading analysts CANTOR FITZGERALD and H C WAINWRIGHT recommending the stock!
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