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Gene Express' Colette Saccomanno
Gene Express Strides into Translational Medicine
Laurie Sullivan
Dr. Colette Saccomanno,
Director of Business Development for Gene Express, talked to Pharma
DD about the company’s quantitative PCR technology, its fresh new
business model, and a promising role in translational medicine.
Note:
The term translational medicine has a variety of interpretations and
meanings among different people. In the context of the area that Gene
Express is focused on, Dr. Saccomanno defines translational medicine as that
part of clinical research that allows a clinical discovery to go from the
bench to the patient.
“StaRT-PCR
technology is competitive template PCR with an elegant twist,” says
Saccomanno, describing her company’s proprietary platform. Founded in
1992, Gene Express underwent a decade of maturation spent on developing
methods to automate processes and validating the internal standards that are
the key to its StaRT-PCR
technology. The fruits of its labor have ripened, culminating in a banner
year for the company.
At the beginning of 2006,
Gene Express underwent a strategic shift and modified its business model.
While the proprietary StaRT-PCR
technology has been available since 2003 on a fee-for-service basis, the
company moved to begin out-licensing the technology, signing its first
licensing agreement with Gene Logic on October 31. Gene Logic will now be
able to offer StaRT-PCR services commercially to all its clients in the same way
it has been offering microarrays and related services for several years.
In
March, Gene Express announced that StaRT-PCR
would be included in the MicroArray Quality Control (MAQC) study. The MAQC
Consortium was assembled by the US FDA to evaluate microarray platforms and
to establish quality-control parameters for future regulatory submissions.
StaRT-PCR
“Primer”
StaRT-PCR
is a unique quantitative and standardized multi-gene expression measurement
platform. In 2003, Gene Express began offering StaRT-PCR
services from its SEM (Standardized Expression Measurement) Center, which
uses robotic systems to conduct high-throughput StaRT-PCR
gene expression (or transcript abundance) measurement. The critical
differentiator between StaRT-PCR
and other quantitative RT-PCR methods is
use of a standardized mixture of internal standards
(SMIS) in each gene expression measurement, providing integrated quality
control. Each SMIS contains standards for normalizer genes (e.g. GAPD and
ACTB) and up to 93 target genes. Each
target is measured relative to its respective internal standard within the
SMIS.
For the most part, Gene
Express’ clients have used StaRT
to examine their samples in a way that allows them to define biomarker
panels with more confidence. For example, using StaRT
it is possible to whittle a set of 50–100 genes that are putatively linked
to a disease state or therapeutic response down to a mere handful. The
mathematical relationship of how certain of those genes interact and are
expressed relative to one another (dubbed the “Interactive Transcript
Abundance Index”) provides a snapshot of how a patient is responding (or
not responding) to a drug, or can accurately stage a disease such as bladder
or lung cancer.
Pfizer Presents StaRT-PCR
Results at DIA Meeting
Pfizer conducted a study to
validate the StaRT-PCR method, presenting its results at the Drug
Information Association meeting in June 2005. Gene Express worked closely
with Pfizer, looking at whole blood samples to define a reference range for
gene expression in healthy individuals. In the same way that labs today
profile blood for levels of glucose, electrolytes, etc., Saccomanno predicts
that at some point in the future it will be possible to profile blood to
obtain baseline levels of gene expression, enabling baseline monitoring of
health or detection and measurement of biomarkers in diseased states. In its
presentation, Pfizer concluded that it is possible to use StaRT-PCR
methods to define normal ranges of transcript abundance measurements values
in whole blood.
A Rosy Future
Having cemented the
licensing agreement with Gene Logic, Gene Express now seeks to sign
additional CROs. The company is in discussions with several pharma and
biotech companies regarding
SEM
Center
licensing to support their internal programs. An overarching goal is that
ultimately, a sufficient number of CROs will license StaRT-PCR that big pharma will be able to access the technology
through their preferred provider CRO networks when it comes time for them to
outsource their larger clinical trials.
A Cut Above
Last but not least, StaRT-PCR
is currently the only quantitative PCR technology that meets all of the
analytical chemistry performance requirements defined by the US FDA as
necessary for genomic data regulatory submissions in support of clinical
trials. StaRT-PCR also meets the
criteria defined by the Clinical Laboratory Improvement Amendment of 1988 (CLIA)
to support the use of genomic biomarkers for diagnostic testing.
StaRT-PCR
has been used in many published studies for transcript abundance
measurement, demonstrating its overall performance characteristics and
providing extensive validation of the method in independent laboratories.
Copyright
2006, Cambridge Healthtech Institute. All Rights Reserved.
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