gmsbiotech (gms) has developed a plan to penetrate the new and
rapidly growing personalized medicine marketplace, based on the
development of its unique microarray technology. The beach-head
product in this market is "The HLA Chip" which is based on Human
Leukocyte Antigen (HLA) typing: with proven market applications for
tissue transplantation and stem cell therapeutics; and early stage but
high-growth-potential markets, also based on HLA analysis, for vaccine
development, personalized vaccine delivery, personalized treatment for
autoimmune diseases (MS, Arthritis), and personalized treatment of
microbial infection. Follow-on gmsbiotech products in the personalized
medicine market will service chemical therapeutics: especially those
applications where personal genetic variation at a number of gene sites
can cooperate to alter treatment responsiveness: as in obesity,
depression and cardiovascular risk. The underlying feature of all these
gene-based medical applications is a focus on sets of 100-300 single
nucleotide polymorphisms (SNPs) in parallel. Because of the gmsbiotech
unique
microarray technology, the company can develop highly accurate
SNP-based test panels as high quality, low cost, simple-to-use micro
array products, with specialized content based on an advanced,
proprietary gmsbiotech bio-informatics platform.
The accuracy,
simplicity and cost effectiveness of the "HLA Chip" is expected to
expand the current proven market for HLA genotyping by at least a
factor of three within five years and a factor of ten within 7 years,
as HLA typing is enabled as a routine component of vaccine development,
vaccine delivery, an expanded tissue typing market (including stem cell
therapy) and as a method of patient stratification for autoimmune
diseases (MS, Arthritis).
Additional simplification of the
HLA-typing process has been enabled by a new approach to sample
preparation, developed at gmsbiotech, which completely bypasses the DNA
purification steps that are common to nearly all other complex
genotyping tests. This new approach will be sold by gmsbiotech as kits
for
“enhanced” PCR amplification products, each tuned to a
specific gmsbiotech
HLA-typing test, and tuned to a specific sample type such as raw blood,
dried blood spots and cheek swabs.
Using
the graphical user interface (GUI) for the Ricimer Data Analysis
Software package, there are several methods for viewing the
slide: Slide View: Information pertaining to the entire slide
can
be seen at a glance on the left side of the GUI. Well View:
Information specific to the well currently under examination can be
seen on the right. Spots are color-coded as noted in the
key. The HLA type of a processed sample can be determined at
the
touch of a button with minimal software training needed.
“Well
Quality Factor” is a measure of confidence in the accuracy of the HLA
call. A well quality factor of 1 represents the highest
confidence. Well quality factors >1 are of lower
confidence. When available, NMDP codes for the allele strings
are
automatically included. Reports are automatically generated
by
Ricimer. Other report formats (ex. Excel-compatible for ease
in
importing to databases) are also available. The probabilities
are
calculated based solely on the frequency that any given allele pair is
known to occur in the worldwide human population according to the dbMHC
database: http://www.ncbi.nlm.nih.gov/gv/mhc/ihwg.cgi?ID=9&cmd=PRJOV
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