Posted On: 10/16/2016 4:35:36 PM
Post# of 9144
Re: rayludwiczak #2534
Rayz,
From the provisional PDF information, the numbers are excellent and should be attractive enough to enable the technology to be used anywhere. With that stated, to interest anyone in use of the assay, a peer reviewed paper must be published, which I expect will happen after the presentation at CAOG. There are many business sectors that use systems of bacteria detection for food safety, environmental testing, manufacturing QA/QC processes, pharmaceutical manufacturing and testing without the need of FDA approval. NNLX has already stated they're working with a very large medtech company for customized use of the N-Assay.
The FDA has to at least sign off on clinical use for humans but first the would want to see the published paper.
That is the process. No need to be a nervous nelly about it.
Scott
From the provisional PDF information, the numbers are excellent and should be attractive enough to enable the technology to be used anywhere. With that stated, to interest anyone in use of the assay, a peer reviewed paper must be published, which I expect will happen after the presentation at CAOG. There are many business sectors that use systems of bacteria detection for food safety, environmental testing, manufacturing QA/QC processes, pharmaceutical manufacturing and testing without the need of FDA approval. NNLX has already stated they're working with a very large medtech company for customized use of the N-Assay.
The FDA has to at least sign off on clinical use for humans but first the would want to see the published paper.
That is the process. No need to be a nervous nelly about it.
Scott
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