The
core of the gmsbiotech technology platform is a very low cost and high
throughput method to fabricate microarrays and other similar solid
state devices for the analysis of many gene sites in parallel. This
technology was invented by the founders of gmsbiotech, while still at
Baylor College of Medicine and has been exclusively licensed to GenUSA.
For all other microarray technologies as currently practiced in the
marketplace by Affymetrix, Illumina and others, microarrays are
fabricated by covalent attachment of DNA fragments to specific sites on
a surface to form an array of sites ("the microarray") that can
independently engage in DNA hybridization analysis with a complex
solution state DNA mixture of interest: each DNA site on the micro
array performing a unique DNA hybridization test. The spontaneous
assembly of an orderly DNA monolayer on the microarray surface and the
resulting novel duplex form that results upon binding to it, is the
basis for the gms IP position. However, the invention has direct
practical ramifications that will allow gms success in the clinical and
population-scale microarray market. To understand the technical basis
for that market distinction, it is necessary to recognize the cost
savings and manufacturing simplicity that arise from the GenUSA "self
assembly" technology.
The existing microarray technologies require that the DNA fragments
used to make a microarray are chemically linked to the microarray
surface. This requires that they be prepared as an expensive,
chemically-altered DNA derivative, at a cost that is about 3 times
greater than that if the same fragment were unmodified and that they
are printed onto surfaces with (expensive) reactive chemical films.
Thus, the gms technology, which does not require any modification of
the DNA and minimal (inexpensive) modification of the surface,
automatically yields a 10-fold fold reduction in cost of goods.
Independent of nucleic acid cost, the gms technology enables even
larger cost savings, due to the intrinsic efficiency of the gms
manufacturing process. The chemical linkage process that is the basis
for all alternative microarray technologies is intrinsically
inefficient: whether the DNA is assembled on the microarray surface (as
for Affymetrix) or linked to the surface after fabrication (as for most
other companies). Thus, the current technologies typically require
dispensing of a 10-fold excess of DNA, over that required to actually
cover the microarray surface. In the GenUSA technology, the adsorptive
self assembly is nearly quantitative, requiring no more that a one-fold
excess of applied material. When the very low intrinsic cost of goods
is paired with the increase in manufacturing efficiency, the net result
is that GenUSA can fabricate extremely high quality microarrays to
service a growing public health screening, medical genomics, forensic
and Homeland Defense market, at a cost of manufacture that is 1/10 of
the other microarray technologies.
Finally, gms has found a way to completely bypass DNA purification in
its HLA-typing products: enabling routine HLA typing from a microliter
(about 1/50th of a drop) of raw blood; or enabling HLA typing from
about 1/10th of the dried blood in a single 2mm punch-out from a
neonatal filter paper card; or enabling HLA typing from 1/50th of the
rehydrated sample derived from an ordinary cheek swab. The ability to
use such very simple collection approaches, and the ability to bypass
DNA purification from them has great practical significance: In terms
of logistics, it makes sample collection for HLA typing as simple and
inexpensive as can be possible, in a way that fits naturally into
existing, large-scale public health sample collection schemes. In terms
of work-flow, it cuts in half, the time and the number of steps
required to perform such HLA typing. And finally in terms of cost, it
completely eliminates the cost of DNA purification from HLA-typing,
thus reducing the cost per HLA test by about 50%.
In the aggregate, this suite of HLA-typing technologies is designed to
allow, for the first time, routine high-resolution HLA-typing at the
population-scale, on raw samples, at an aggregate cost that has dropped
to about 1/10th that of HLA-typing, as currently employed in solid
organ transplantation.
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