New Business Unit Dedicated to Manufacture of Molecular IVD Components

Integrated DNA Technologies 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 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 in-licensed 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.'