Posted On: 06/19/2014 12:38:23 AM
Post# of 30038
5. The LymPro Test ® History (as recounted by others)
The LymPro assay was original conceived by Thomas Arendt and Jens Stieler. Their host institution,
University of Leipzig, filed patent applications to protect the intellectual property. GW Medical licensed the
associated intellectual property from Leipzig University in 2004 and went on to begin commercial
development, primarily through NIH funding. In 2007, GW Medical was acquired by Provista Life
Sciences as part of a strategic alignment of capabilities and assets. Provista Life Sciences was a
privately-held diagnostics company focused on developing diagnostic tests and commercializing them in
its CLIA-certified laboratory as Laboratory-developed Tests (“LDT”).
In 2008, Provista was working to complete a pivotal Clinical Performance Study under an NIH SBIR
Phase 2 grant, when the instrumentation they were using became defective, ultimately making the results
from that study unreliable and causing them to miss their milestone with the NIH. At the same time
Provista Life Sciences had another promising diagnostic test in its pipeline, the dtectDx Breast, a breast
cancer diagnostic targeting pre-symptomatic breast cancer.
At that time in 2008, the Provista investors decided they wanted to focus their resources on the breast
cancer asset and monetize the Alzheimer’s asset. Coupled with the inability to achieve the milestones set
out in the Phase 2 NIH grant due to the instrumentation failure and a general lack of funding from private
investors in neuroscience research from 2008-2011, the LymPro Test ® seemed to be a much less
attractive asset than the dtectDx Breast test. As such, the LymPro Test ® was spun out into MemoryDx to
allow the founders of GW Medical to continue their pursuit of bringing the LymPro test to market. The
team at GW Medical/Provista/Memory Dx established the methods, got quality results and published their
follow-up 2012 Neurobiology of Aging study. Memory Dx entered into an exclusive licensing agreement
with Amarantus in December 2012, giving Amarantus rights to develop LymPro commercially for AD.
It is important to understand that it was a strategic business decision that Provista was faced with
between advancing their breast cancer asset or their AD asset. Recalling that their breast cancer assay
was already validated as an assay under CLIA, was beginning to generate revenue, and in a market with
many drugs approved and being approved, it was probably a wise business decision. However, in today’s
climate where the FDA is pressing for earlier drug development, AD appears to be a ripe opportunity for
the LymPro test.
The LymPro assay was original conceived by Thomas Arendt and Jens Stieler. Their host institution,
University of Leipzig, filed patent applications to protect the intellectual property. GW Medical licensed the
associated intellectual property from Leipzig University in 2004 and went on to begin commercial
development, primarily through NIH funding. In 2007, GW Medical was acquired by Provista Life
Sciences as part of a strategic alignment of capabilities and assets. Provista Life Sciences was a
privately-held diagnostics company focused on developing diagnostic tests and commercializing them in
its CLIA-certified laboratory as Laboratory-developed Tests (“LDT”).
In 2008, Provista was working to complete a pivotal Clinical Performance Study under an NIH SBIR
Phase 2 grant, when the instrumentation they were using became defective, ultimately making the results
from that study unreliable and causing them to miss their milestone with the NIH. At the same time
Provista Life Sciences had another promising diagnostic test in its pipeline, the dtectDx Breast, a breast
cancer diagnostic targeting pre-symptomatic breast cancer.
At that time in 2008, the Provista investors decided they wanted to focus their resources on the breast
cancer asset and monetize the Alzheimer’s asset. Coupled with the inability to achieve the milestones set
out in the Phase 2 NIH grant due to the instrumentation failure and a general lack of funding from private
investors in neuroscience research from 2008-2011, the LymPro Test ® seemed to be a much less
attractive asset than the dtectDx Breast test. As such, the LymPro Test ® was spun out into MemoryDx to
allow the founders of GW Medical to continue their pursuit of bringing the LymPro test to market. The
team at GW Medical/Provista/Memory Dx established the methods, got quality results and published their
follow-up 2012 Neurobiology of Aging study. Memory Dx entered into an exclusive licensing agreement
with Amarantus in December 2012, giving Amarantus rights to develop LymPro commercially for AD.
It is important to understand that it was a strategic business decision that Provista was faced with
between advancing their breast cancer asset or their AD asset. Recalling that their breast cancer assay
was already validated as an assay under CLIA, was beginning to generate revenue, and in a market with
many drugs approved and being approved, it was probably a wise business decision. However, in today’s
climate where the FDA is pressing for earlier drug development, AD appears to be a ripe opportunity for
the LymPro test.
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