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PROOF for FFPE samples
January 2013
EDIT CONNECT
SHARING OPTIONS:
TUCSON, Ariz.—HTG
Molecular
Diagnostics and the Centre of Excellence for the
Prevention of Organ
Failure (PROOF Centre) have finalized a license agreement that
provides HTG exclusive rights to commercialize PROOF Centre-
developed
gene expression blood tests to evaluate the prognosis of chronic
obstructive pulmonary disease (COPD) patients who are likely to
experience frequent exacerbations known as lung attacks.
HTG will develop the assay on its
proprietary qNPA platform.
Vancouver-based PROOF Centre—a
not-for-profit organization focused on developing blood tests for
chronic organ disease—will be involved in the clinical
validation
in Canada and provide key opinion leader support for regulatory
approval in North America.
Lung
attacks are the leading cause of
emergency room visits and hospitalizations among chronic COPD
sufferers, accounting for more than $5.7 billion direct
and $6.7
billion indirect healthcare costs every year in Canada alone.
According to the World Health Organization (WHO), an estimated 210
million people worldwide have COPD, and 3 million deaths are
attributed to
the disease annually. WHO predicts COPD will become the
third-leading cause of death by 2030. A large portion of COPD-related
mortality is due to lung
attacks. Like lung cancer, COPD is seen most
frequently among tobacco smokers.
"We started working with PROOF
several years ago on an organ rejection assay as they were looking
for a multiplexed gene expression solution," says TJ Johnson, CEO
of HTG. "This
agreement is the first of many that HTG and PROOF
Centre hope will bring medically valuable biomarker tests to the
clinic. Basically, our platform is
an extraction-free chemistry for
multiplexed analysis of RNA. We are preparing to launch a new
platform we call EDGE that provides walkaway automation
and less than
24-hour turnaround. First steps are to fully develop the COPD assay,
integrate it onto our EDGE automation system, install the system
and
bring the assay up in the PROOF CLIA lab, complete the validation and
then prepare for full commercialization."
HTG's core technology is its
quantitative nuclease-protection assay, or qNPA platform, which
enables researchers to observe gene-expression
levels in hundreds or
thousands of samples simultaneously without requiring RNA extraction,
cDNA synthesis, RNA amplification or RNA-labeling steps.
These steps
are often performed on other gene-expression platforms, Johnson
notes.
HTG currently sells qNPA
ArrayPlates
that can analyze gene-expression levels in as many as 47 multiplexed
genes in a 96-well format. The company has also made its assay
platform-agnostic by striking deals with other tool manufacturers.
For instance, it penned an alliance with Luminex last year and one
with Roche NimbleGen in 2009.
While HTG has traditionally sold its
products to researchers, in
recent years, it has set its sights on
the clinical molecular diagnostics market. As a result of this shift
in emphasis, the company changed its name
from High Throughput
Genomics to HTG Molecular Diagnostics in March 2012.
According to Johnson, scientists can
use
the qNPA assay to profile gene expression in formalin-fixed
paraffin embedded samples as part of an extraction-free protocol—an
ability that he is
convinced gives HTG an edge in the diagnostics
space.
"Although we effectively handle most
sample types, we
offer the greatest advantages with FFPE," he says.
"Our extraction-free protocol is effective assessing the soluble
and nonsoluble RNA in FFPE."
He also cites a "significant market
need" to work with smaller sample sizes, and says HTG's assays
"work
effectively with less than a single 5-micron section of
tissue."
"The development of these blood tests
has been driven by a huge unmet
clinical and social need," says Dr.
Bruce McManus, director of the PROOF Centre. "This agreement with
HTG Molecular Diagnostics will facilitate
bringing these tests to
market faster, providing physicians with tools to improve patient
care and management and help alleviate suffering of patients
with
COPD."
Code: E011315 Back |
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