Chairmans Blog : Initiating Studies for CLIA Launch at Icon Central Laboratories
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Master Services Agreement with ICON for Global Diagnostic Central Laboratory Services and Therapeutic Clinical Development
This morning we announced the initiation of CLIA-enabling studies at Icon Central Laboratories, a CLIA-certified laboratory that will serve as the facility that carries out the LymPro assay for CLIA launch. I wanted to touch on several aspects of this new relationship in today’s blog.
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).
In Icon, we have found a tremendous group to work with as they are very experienced in flow cytometry and have a global distribution network. Icon has developed a tremendous niche in providing central laboratory and clinical trial supporting services to small and large biopharmaceutical companies, including several of the largest Alzheimer’s-focused therapeutic developers.
This arrangement is not a classic partnership, as Amarantus is maintaining all intellectual property rights to current and future versions of LymPro at the current time. This is a services agreement that gets the ball rolling on the CLIA process as we make progress on our ongoing LP-002 clinical study and puts Icon in a sub-contractor relationship with respect to LymPro. Icon will be providing central laboratory services to Amarantus in a fee-for-service arrangement, which is their primary business model. This services agreement extends over four years and covers LymPro’s central laboratory requirements under CLIA (under CLIA, only 1 laboratory facility can run a Laboratory Developed Test), in addition to consulting support for Eltoprazine’s further clinical development and our MANF program as we move it towards human trials. With this agreement, we also gain access to a global distribution network for LymPro, including central laboratories in Europe, Singapore, India and China that will allow LymPro to enter these new markets seamlessly through an already established distribution framework.
We are continuing to evaluate shareholder value creating arrangements for our diagnostics division, including a potential ‘spin-out’ or other business arrangements that would make strategic sense for the various LymPro and Amarantus stakeholders. We will not be giving additional details related to those possible arrangements in today’s business update call, as we are contractually prohibited from doing so.
We thank you for taking the time to read this blog, and look forward to interacting with our shareholders this afternoon during our business update call where we will describe in detail what we believe is the initial target market opportunity for LymPro, biopharmaceutical therapeutic trials.
With Warm Regards,
Gerald E. Commissiong
