Sunday, January 12, 2014 8:12:43 AM
• Licensed LymPro from Provista Life Sciences in December 2012
• Becton Dickinson (BD) Biosciences in serving as the GLP Reference Lab for
the assay development and clinical trials
• DEVELOPMENT PLAN TO FDA APPROVAL
– Q4/2013 – Feasibility Studies to establish reproducibility pathway
– Q1/2014 – Conduct 50-60 person pilot study in AD vs. Control to re-
establish clinical performance and measure effect size
– 1H/2014 – Conduct ~250 person Clinical Performance Study to verify
literature & establish LymPro as Laboratory-Developed Test under CLIA
– 2H/2014 Ini7ate Commercial Sales as a “Home Brew” under CLIA
– Seek CE Mark ~ mid 2015
– Submit FDA package ~ mid 2016
• Concurrently work with pharma companies to establish LymPro poten7ally as a companion diagnos7c for therapeu7c products
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