Replies to post #541998 on Momentum Players

[cyclone101]

AMBS moving on dece nt news out this am -- up 6.4% and 07c hit -- looking to break in to the 08c ranges again today ---

[langlui]

What's Next For Amarantus Diagnostics (AMBS).. hgue stuff!!!!!!!!

After establishing the analytical performance of the assay in an outsourced GLP laboratory (Sun Health Research Institute), 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 II) at Sun Health Research Institute to generate sufficient data to validate the clinical performance (sensitivity / specificity) that would support a Clinical Laboratory Improvement Amendment (CLIA) launch.

CLIA was passed by congress in 1988 to establish a quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. CLIA is user fee funded and operates under the Centers for Medicare & Medicaid Services (CMS) financial management operation. However, the categorization of commercially marketed in vitro diagnostic tests under CLIA is the responsibility of the FDA.

Amarantus Diagnostics is seeking to develop LymPro under the CLIA pathway. The product would be intended for the in vitro qualitative determination of a stimulation index in human blood derived lymphocytes in patients with evidence of cognitive impairment to aid in the diagnosis of dementia of the Alzheimer's type. We suspect the test will not be used as a standalone diagnostic, but as an adjunct to clinical assessments and other diagnostic evaluations, potentially including MRI or Amyvid-PET, and that a positive test offers clinical utility as an aid to help identify those patients with cognitive impairment who have dementia associated with Alzheimer's disease. In the simplest analogy, LymPro is a highly specific and sensitive smoke detector, and where there is smoke, there is usually a fire.

Data from the phase II CLIA study noted above with Sun Health Research Institute is expected during the first half of 2014. This data will include analytical performance characteristics and reproducibility of the assay. Assuming positive data, we believe Amarantus could be in position to file for CLIA clearance and hear back by the end of 2014.