Mainz Eyes Breakthrough Device Designation for Next Gen CRC Screening Test

 

• On the basis of its positive clinical studies Mainz Biomed has now defined the final configuration including its novel mRNA biomarkers of the Next Generation Test to be used in pivotal registration study ReconAAsense
• A recent clinical analysis of this new configuration demonstrates sensitivity for colorectal cancer of 97% and 88% for advanced adenomas, with specificity of 93%

https://www.biospace.com/article/releases/mainz-biomed-announces-submission-for-fda-breakthrough-device-designation-for-its-next-generation-crc-screening-test/