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Monday, April 08, 2013 11:50:09 AM
After establishing the analytical performance of the assay in an outsourced GLP laboratory, Amarantus plans to conduct a small clinical performance study at an independent laboratory in the second quarter of 2013 to verify the previously published findings. During the third quarter of 2013, the Company expects to initiate a pivotal diagnostic accuracy study (Phase 2) at the same independent laboratory to generate sufficient data to validate the clinical performance (sensitivity / specificity) that would support a CLIA launch, with data available in the first half of 2014.
The only diagnostics that require Phase III are ones for diseases such as cancer, in which the diagnostics results would have implications in a doctors approach (i.e., chemo vs. surgery).
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