PRESS RELEASE - Integrated DNA Technologies

PRESS RELEASE
Date 16 May 2008 Ref 08IDT04
Product Integrated DNA Technologies
enquiries Lynette Brown – Advertising and Product Manager
t: +1 319-665-7208 e: lbrown@idtdna.com
Media
enquiries
Alto Marketing Limited
Neil Ravenhill – Scientific Communications Specialist
t: +44 (0)1489 557672 e:neilr@alto-marketing.com
Integrated DNA Technologies, Inc., Opens New
Business Unit, Launches New Products for the
Manufacture of Diagnostic Oligonucleotides.
Dedicated production facility registered with the FDA, ISO 13485:2003 certified for
supply of in-vitro diagnostics components and Analyte Specific Reagents (ASRs).
Fluorescent Dyes and Quenchers now available for royalty free use in Diagnostic and
Commercial Applications.
CORALVILLE, Iowa – Integrated DNA Technologies (IDT), a world leader in
oligonucleotide production, has today announced that it has opened a new business
unit dedicated to the manufacture of oligonucleotides for use in diagnostic products.
The company has been awarded ISO 13485:2003 certification at its Coralville facility,
for its new business unit called “Clinical and Commercial Manufacturing” (CCM). This
globally recognized certificate confirms that IDT meets the rigorous standards required
for the supply of custom manufacturing/processing services, customer support and
sales distribution of molecular biology products for molecular in vitro diagnostic devices
and licensed nucleic acid tests. This covers its synthetic oligonucleotides as well as the
associated reagents and consumables.
Bill Jones, Director of Quality Assurance for IDT, said, “This dedicated manufacturing
suite, with its additional ISO 13485 certification and compliance with FDA 21 CFR Part
820 QSR/cGMP, positions IDT to better serve both our current and future
clinical/medical device customers. It will also be important for other commercial
customers with applications that need a higher level of process control and
compliance.”
Trey Martin, COO of IDT commented, "This new business unit has evolved through
years of partnership and interaction with our family of customers researching and
performing in-vitro diagnostics. This arrangement allows IDT to further improve our
service to these customers by offering dedicated processing, purification, analysis,
formulation, functional testing and final fill services in purpose-built clean room suites
with assigned senior production staff. IDT’s enormous investment in quality
manufacturing; from our pioneering efforts in 100% mass spec QC, to our purity
guarantees for purified oligos, to our industry-leading Raw Material QC, processing and
reagent production infrastructure were the original reasons these customers chose IDT
for their oligonucleotide needs. Now we are able to assure these customers that
through all regulatory channels IDT can scale with them to address the specific needs
of oligos in the clinic.”
The ISO 13485:2003 certification and subsequent registration of the facility with the
FDA, follows a series of audits - carried out by BSI Management Systems, a prominent

PRESS RELEASE
quality management systems registrar - requiring on-site assessments, examinations
of IDT's documented procedures, and an audit of overall operations. System quality is
then monitored through periodic surveillance audits of IDT's processes, by BSI
Management Systems. As a result the ISO 13485:2003 certification provides a clear,
recognized, and highly respected standard for quality management in the highly
regulated clinical/medical market.
Freedom Dyes
In addition, the company announced the availability of an entire suite of fluorescent
dyes and quenchers that can be used in diagnostic products, which require no
additional licensing from IDT or third parties. The so-called Freedom Dye program
currently provides ten fluorescent dyes and companion dye-quenchers that can be
used by CCM clients as ready replacements for royalty-bearing dyes and quenchers inlicensed
from third parties.
Roman Terrill, General Counsel and Sr. VP of Regulatory Affairs for IDT, commented,
“IDT decided that if it was to open a business unit which promised a complete OEM
solution to the IVD and ASR community, it had to deliver both regulatory compliance
and cost savings to the customer. We’ve done that with the CCM service offering in
part by creating our Freedom Dye program. With these dyes, IDT can both
manufacture dye-labeled oligos for use in NAT products and can potentially rescue
those products from any expensive royalty obligations associated with the diagnostic
use of proprietary dyes or quenchers.” For a complete listing of the Freedom Dyes go
to http://www.idtdna.com/catalog/Modifications/Dyes.aspx.
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About IDT
Integrated DNA Technologies (IDT) is the largest supplier of custom nucleic acids in the United
States, serving academic, government and commercial researchers in biotechnology, clinical
diagnostics, and pharmaceutical development. IDT’s primary business is the manufacturing of
custom, synthetic DNA and RNA oligonucleotides. Founded in 1987 by Joseph Walder, M.D.,
Ph.D. (Northwestern University), IDT has achieved annual double-digit growth over the past 10
years. Today, IDT synthesizes and ships an average of 36,000 custom oligos per day to its more
than 77,000 customers worldwide. IDT manufacturing locations include facilities in Coralville,
Iowa; San Diego, Calif.; and Leuven, Belgium.
Integrated DNA Technologies
800-328-2661 (US & Canada)
+1 319-626-8400 (outside US)
productinfo@idtdna.com
www.idtdna.com
For more information on IDT’s CCM facility, please contact ccminfo@idtdna.com.