this brings up another point - what exactly is
Post# of 30028
- what exactly is the IP and patent protections around LymPro blood based assay bio-marker technology
- and do IP and patent protections actually exist to protect both the Dx itself, as well as shareholders who have invested in LymPro, as NonosomiX appears to be compelling competition
- thus far, it only appears that LymPro has been cited as proprietary
Quote:
"Mr. Commissiong discusses the announced completion of the 'Fit-for-Purpose' validation of the Company's 'proprietary' Alzheimer's blood diagnostic LymPro Test(R) and what it means for Amarantus."
http://finance.yahoo.com/news/amarantus-biosc...00087.html
- what we do know is LymPro has now recieved "Fit-for-Purpose" designation
- but what exactly is the 'Fit-for-Purpose" designation mean
- and who assigns it?
Quote:
"The ‘Fit for Purpose Flow Cytometry Assay Validation’ is the ‘Analytical Performance Package’ (APP) that the Company has been alluding to as the critical set of experiments required to demonstrate that we have the commercial-grade reproducibility required to support a successful diagnostic test. The reason the term ‘Fit for Purpose’ is used instead of ‘Analytical Performance Package,’ is because under CLIA there is no single standard required to demonstrate reproducibility, and therefore the analytical package being established is fit for the purpose of launching LymPro under CLIA. The ‘Fit for Purpose’ package requirements were developed by our diagnostic product development unit in close consultation with our corporate advisors and the team at Icon, who collectively have several decades of experience in launching CLIA-certified Laboratory Developed Tests (LDTs)."
http://www.thechairmansblog.com/amarantus-bio...8cJD5.dpuf