
June 23 ,11 Medical Devices Breakthrough! The Most Recent FDA Guidance on opening public discussions what makes a solid Acceptance Criteria of this highly potential tool of Ultra High Throughput Sequencing for Clinical Diagnostic Applications that has been successfully used in research. This is how a scientific community is building a forum of different expertise to deliver long waited cutting-edge tools in clinical diagnostics.
What does it mean to you? Remember Craig Veneer, and his monumental work on human genome sequencing took about 10 years! However, with the advance of technology and Bioinformatics software that can make intelligent conclusions out of billions Sequencing Combinations thus assisting the cancer patients to come closer to the root cause of the illness or a break in the biological mechanism. It's just a first phase and it's open to public with an early registration. The first task will be to assess the public health applications that can benefit from a such technology. You are invited and better be there to find out where the major resources will go first! As a result of such FDA sponsored discussions and experience sharing I would not be surprised to learn about the kick-off of some clinical trials on limited basis for strictly controlled groups that offer an accuracy of results and the acceptance criteria but only for those critical patients who can't wait too long.
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