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 gmsbiotech. 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 gmsbiotech "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 gmsbiotech 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 gmsbiotech 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, gmsbiotech 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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