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blackhawks

08/06/13 11:54 AM

#80113 RE: dubbya #80112

If the test is validated, whats left to "develop"?



The test has NOT been validated yet by BD. It is BEING assayed by BD.

LymPro hasn't been validated yet by BD. Validation is underway at BD, otherwise we would have read about confirmation of the accuracy and specificity of the LymPro AD test as quoted below from earlier studies:


Quote:
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showing 98% sensitivity and 96% specificity for Alzheimer's disease diagnosis.
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We did NOT read about a validation of those numbers in today's letter from Gerald.

Here is the schedule for LymPro evaluation as released in April:

April 08, 2013 07:30 AM Eastern Daylight Time
Amarantus Outlines LymPro Alzheimer’s Diagnostic Development Strategy

"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."

zoomboom

08/06/13 12:01 PM

#80114 RE: dubbya #80112

Results obtained in phase 1 trials needed to be verified. AMBS hired BD to verify these results.

And now BD has Agreed to be the Development Lab partner.

Speculate