|
DNA
and RNA Genomic Extractions
As a full service central laboratory
ICON Central Laboratories offers DNA extraction capabilities as
well as specimen storage services.
 |
For sponsors requiring support for
DNA extractions, we have developed procedures that produce
high quality and high yield DNA. ICON Central Laboratories
offers two methods for DNA extractions. Our primary method
of extraction is a modified salt precipitation method. This
method produces an average yield of 229 µ of DNA and
a concentration of 489 µ/ml of DNA. The quality of material
rendered from this extraction process is acceptable for PCR,
Southern blotting and sequencing downstream testing. For frozen,
archived or older samples, in which DNA extraction can prove
more challenging, we utilize GeneCatcher™ technology.
This method facilitates rapid and efficient extraction of
genomic DNA from blood without the use of centrifugation.
Purified DNA extracted using this method is appropriate for
the most sensitive downstream applications, including PCR
and restriction enzyme digestion.
Upon request, ICON Central Laboratories
will send our extracted material to the client’s selected
pharmacogenomic laboratory to ensure that the extraction material
meets study specific clinical requirements.
Our laboratories also extract
high quality RNA with an average yield of 6-10 µ of
total RNA, depending upon the source of extracted material.
This material is well suited for downstream applications such
as Northern analysis, RT-PCR and Gene Chip Sequencing. We
utilize the BioRobot Universal System for RNA extractions.
This fully automated method utilizes a 96-well format and
facilitates extraction of highly pure RNA. The material is
then quantified on the SpectraMax® Plus. We use the Agilent
Bioanalyzer® to determine the quality of the extracted
material.
Specimen
Storage Services
Sample storage and management
is a critical need for many pharmaceutical sponsors. At ICON
Central Laboratories we take our responsibility for archiving,
management and shipment of these specimens very seriously.
Our North American and European facilities have controlled
and alarmed freezers, supported by backup generators that
provide frozen storage at – 20, -80 or – 180o
C, as necessary to support long term frozen storage needs.
Our bar code technology facilitates efficient specimen archival
and retrieval. In addition to these standards services, our
specimen storage and management services include:
- Custom manifest, generated
in a Microsoft Excel® format that provides ready access
to accurate specimen demographics at the front end and facilitates
merging into the clinical database from 3rd party labs,
once concentration results are completed;
- Sample tracking that provides
a full accounting of samples from the investigator sites;
- One kit and one shipping
address for all study specimens, making specimen preparation
and shipping easier for investigator sites. The ICON Lab
Manual provides instructions on how to collect, prepare
and ship specimens for testing and storage. Supplies can
be included in the ICON collection kit box or supplied separately
to the sites, at the sponsor’s option;
- On-time batch shipping of
samples to the sponsor’s designated analytical labs
with the accompanying manifest, thereby eliminating the
need to enter demographics and reducing queries between
the labs, sites and sponsors;
- The capability to provide
more comprehensive tracking of a sample’s status.
For example, a sample can be "transferred" in
and out when the specimen is expected to return to our storage
facilities or "shipped" in or out when permanently
removed from our storage facilities and sent to another
lab. This distinction supports chain of custody documentation.
All stored specimens are tracked, based on the client’s
specifications and they can be changed mid-study.
GeneCatcher™ is a trademark
of Invitrogen Corporation. BioRobot Universal System is manufactured
by Qiagen, Inc. SpectraMax® is a registered trademark of Molecular
Devices Corporation. Agilent Bionalyzer® is a registered trademark
of Agilent Technology Inc. Specimen Storage and Management Services
|
The Challenge: A large,
Massachusetts-based biotechnology company often had to wait months
to years to lock the PK portion of a study database.
The Solution: By working
with ICON Laboratories, they were able to design a PK process flow
that would benefit their clinical and data departments, as well
as the investigator sites and the CRAs working with those sites.
The result of this collaborative effort? The sponsor has been able
to perform up to 70 studies a year, many of which are highly PK
intensive, and bring every one of them to database lock on time
- locking both the clinical and the PK database simultaneously.
|
