Amarantus Bioscience Holdings Inc (AMBS)

[JPetroInc]

3 + Years of LymPro CLIA – and Still no CLIA

Improving Healthcare for Patients & Families: Believing in our Vision through Ups & Downs
November 6, 2015

http://www.thechairmansblog.com/amarantus-bioscience/gerald-commissiong/improving-healthcare-for-patients-and-their-families-believing-in-our-vision-through-ups-and-downs/

With data coming up on the use of LymPro in Chronic Traumatic Encephalopathy that we recently completely enrollment for in Boston University’s DETECT study, we believe we have sufficient critical mass to make a very successful business from our current diagnostics portfolio and are now focused on the CLIA launch plans for these products.

Amarantus Fundamentals Are Improving
November 19, 2013

http://seekingalpha.com/article/1848901-amarantus-fundamentals-are-improving

Amarantus expects to be in a position to submit the necessary data package to CLIA to support the intended use statement "Aid in the diagnosis of Alzheimer's disease" and commercial launch of LymPro in the second half of 2014 as a Laboratory-Developed Test (LDT) through CLIA. Following clearance under CLIA, Amarantus will focus on gaining U.S. FDA approval for multi-lab use. This could occur in 2015.

Amarantus Outlines LymPro Alzheimer's Diagnostic Development Strategy
April 8, 2013

http://www.dailyfinance.com/2013/04/08/amarantus-outlines-lympro-alzheimers-diagnostic-de/

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. As part of that pivotal study, LymPro will be evaluated as an "aid to the diagnosis of Alzheimer's disease." The Company intends to initiate commercial worldwide sales following assessment of the validation study data.

Amarantus Bio-Science Licenses LymPro Alzheimer's Disease Diagnostic Blood Test
December 14, 2012

http://www.amarantus.com/news/press-releases/detail/453/amarantus-bioscience-licenses-lympro-alzheimers-disease

LymPro is ready to move into a Phase 2 validation study. If successful, LymPro can begin generating revenue as a laboratory developed test ("LDT") within 18 months of study initiation through commercial sales and through sales to companies performing Alzheimer's disease clinical research. Under the terms of the agreement, Amarantus has agreed to issue two million shares of restricted common stock to MDx, pay a development milestone upon successful completion of the Phase 2 validation study, as well as pay a nine percent royalty on sales. In addition, Amarantus has agreed to retain MDx to perform the necessary validation study to gain Clinical Laboratory Improvement Amendments (CLIA) certification for LymPro. Together, Amarantus and MDx will expand their relationships with large pharmaceutical companies, and will also seek additional grant funding for the further development of LymPro.