(MYNZ) Is Blasting Vertically Early, Up Approximately 11% On Huge Breaking News
MYNZ needs immediate attention.
Up approximately 11% early, MYNZ is riding high on breaking news today. Check it out:
Mainz Biomed Announces IRB Approval and Initiation of US Pivotal FDA Clinical Study
- ReconAAsense study examining the clinical performance of mRNA and DNA test combined with a fecal immunochemical test for early detection of advanced adenoma and colorectal cancer to enroll 15,000 subjects across the United States, results expected in 2025
- Aims to enhance technical profile of the Mainz Biomed test to identify advanced adenomas (AA), a type of pre-cancerous polyp that can lead to colorectal cancer (CRC)
- Study will form the basis of the data package for review by the U.S. Food and Drug Administration (FDA) to achieve marketing authorization
BERKELEY, Calif. and MAINZ, Germany, Dec. 06, 2022 (GLOBE NEWSWIRE) -- Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that it has received approval from an independent Institutional Review Board (IRB) for the protocol ReconAAsense, the Company’s U.S. pivotal study to evaluate the clinical performance of its highly efficacious and easy-to-use detection test for colorectal cancer (CRC). Mainz Biomed will now initiate the study, which will form the basis of the data package to be submitted for review by the U.S. Food and Drug Administration (FDA) to achieve marketing authorization.
ReconAAsense is a prospective clinical study that will include approximately 15,000 subjects from 150 sites across the United States. The study objectives include calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) in average-risk subjects for CRC and advanced adenomas (AA).
“Given that colorectal cancer continues to be one of the deadliest forms of cancer, early detection plays a critical role in disease prevention and treatment,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “We look forward to commencing the U.S. regulatory approval process for our next-generation product and are passionate about bringing this easy-to-administer test to the U.S. In addition, we eagerly await results from the ColoFuture feasibility study, as the potential to include novel biomarkers to detect advanced adenomas will be a game changer for at-home CRC screenings.”
Read the full article here.
Could this news provide MYNZ with the breakout spark for it to run down previous highs?
Right now it trades above several lines of potential support including its:
- 5-Day Simple Moving Average (SMA)
- 20-Day SMA
- 50-Day SMA
- 5-Day Exponential Moving Average (EMA)
- 13-Day EMA
If potential support keeps growing at these levels, it could act as the building blocks for a continued vertical run near term.
Get MYNZ on your radar quickly.
Tuesday's opening bell is nearly here. Here's what you need to know.
I've been tracking a specific Nasdaq past champ that requires full attention ASAP.
In fact, this isn't just a 1X past champ, it's a 2X past champ.
When I delivered this idea to your inboxes originally, it went absolutely bonkers.
Running an insane 200+% (approx.) in the short term, it turned into a stunning multi-dollar mover.
With its breakout potential starting to grow again, I brought it back to attention only to watch it pop another 30+% in a very little period of time.
Now, with several key potential catalysts including a low float, huge revenue news, a recent corporate update, and a November press release regarding the U.S. extension of a prefeasibility study, it needs to own the top spot on your watch-list immediately.
Right now, there is only one profile to be watching closely at Tuesday, December 6th's opening bell:
*Mainz Biomed B.V. (MYNZ)*
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.
And right now, 5 potential catalysts could provide this profile with a breakout spark near term. Here's what to know:
No. 1 - Low Float Volatility Could Be On Display Daily
No. 2 - Two Different Analysts Provide An Average Price Target Of $20
No. 3 - Company Announces eAArly DETECT, U.S. Extension Of Key Prefeasibility Study
No. 4 - Q3 Update Paints The Picture Of A Company Moving In The Right Direction
No. 5 - Key Company Highlights (Including Revenue Growth) Provide A Bullish Future Outlook
But more on those in a second...
About MYNZ: Early Identification Of Cancer Saves Lives
Mainz BioMed – founded in Mainz, Germany and aiming to become a leading provider of easy-to-use diagnostic solutions for patients everywhere.
Developing market-ready molecular in-vitro diagnostics tests since 2010.
Their goal is to place effective solutions where they need to be… In your hands.
A Blockbuster Early Detection Test for Colorectal Cancer
Significant Impact: Colorectal cancer is the 2nd most lethal cancer in the US, but also highly preventable; with early detection providing 5-year survival rates above 90%.
Revenue Generating: ColoAlert is CE-IVD marked and is approved for sale in Europe. European sales will provide near-term revenue potential, while we prepare our entry into the US market. Process launched in 1Q2022.
U.S. Markets: We have begun the FDA process. Recent FDA guidance recommends colorectal cancer screening for everyone over the age of 45, which translates to market potential of over 52Mn tests per year.
Ease of Use: Non-invasive test, which can be taken at home, with rapid response of 92% specificity and 85% sensitivity (which is expected to be increased for the FDA product). Designed to be easier to administer than Exact Science’s ColoGuard, more accurate than FIT, and much less invasive than a colonoscopy.
Experienced Management: Seasoned and experienced management, board & advisors with particular skill sets in commercializing and monetizing medical diagnostics at some of the largest medical companies in the world.
Attractive Valuation: They believe their current valuation holds tremendous upside.