"LymPro will have great utility to the pharmaceuti
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Based on the strength of these results, the company has expanded the inclusion criteria to also enroll patients diagnosed with mild Alzheimer's disease. 68 additional subjects will be recruited, including 34 mild-to-severe Alzheimer's patients, and 34 healthy controls. Amarantus anticipates completing enrollment of the 68 patient LP-002 extension in the fourth quarter and will announce data from an in-depth analysis from the full cohort of 140 subjects (72 patients + 68 patient extension) shortly thereafter.
"Amarantus is aiming to be first to market with an accurate, reliable and commercially- viable diagnostic blood test for Alzheimer's disease," said Gerald E. Commissiong. "Today's data gives us all the information we need to move full steam ahead with this strategy. We can now tailor our initial marketing efforts towards the $150M RUO market, primarily targeting pharmaceutical companies engaged in Alzheimer's disease therapeutic trials. We have nearly completed assembling the resources needed to launch LymPro to the RUO community in the fourth quarter. Thereafter, we intend to market LymPro to the broader medical community, initially under CLIA. We estimate the worldwide market for an Alzheimer's diagnostic is $3B"
The company will make a final decision on which version of LymPro (Version 1 or Version 2) to launch under the CLIA designation, which will be marketed to the general population, following an in-depth analysis from the full cohort of 140 subjects. The company anticipates launching LymPro under CLIA shortly after product launch in the RUO marketplace.