Curated News
By: NewsRamp Editorial Staff
July 19, 2024
Mainz BioMed Seeks FDA Breakthrough Device Designation for Advanced Colorectal Cancer Test
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- Seeking FDA Breakthrough Device Designation could give Mainz BioMed a competitive advantage in the cancer screening market.
- Mainz BioMed has submitted an application to the FDA for Breakthrough Device Designation for its non-invasive colorectal cancer screening product.
- Mainz BioMed's innovative cancer screening product could lead to earlier detection, potentially saving lives and improving patient outcomes.
- Mainz BioMed has developed an advanced non-invasive colorectal cancer screening product incorporating a novel portfolio of mRNA biomarkers.
Impact - Why it Matters
This news matters as the Breakthrough Device Designation could accelerate the approval process for an innovative non-invasive colorectal cancer screening product, potentially benefiting early cancer detection efforts.
Summary
Mainz BioMed CEO Guido Baechler has submitted an application to the U.S. FDA for Breakthrough Device Designation for their non-invasive Next Generation colorectal cancer screening product. The product includes mRNA biomarkers and could expedite the approval process, benefiting early cancer detection efforts. The regulatory submission is supported by strong clinical study results, and the Next Generation Test integrates Fecal Immunochemical Test with proprietary mRNA biomarkers and AI.
Source Statement
This curated news summary relied on this press release disributed by News Direct. Read the source press release here, Mainz BioMed Seeks FDA Breakthrough Device Designation for Advanced Colorectal Cancer Test
