Integrated DNA Technologies Opens Unit for Diagnostic Oligonucleotides

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 10 fluorescent dyes and companion dye-quenchers that can be used by clients as ready replacements for royalty-bearing dyes and quenchers in-licensed from third parties.

Oligonucleotides are short segments of DNA or RNA, frequently used as probes for detecting nucleic acids because they bind to their complements. Procedures that use oligonucleotides include DNA microarrays, southern blots, fluorescent in situ hybridization (FISH), and polymerase chain reaction (PCR).

The company was awarded International Organization for Standardization (ISO) 13485:2003 certification at the new facility, which 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 [U.S.] American Food and Drug Administration (FDA; Rockville, MD, USA) regulations, position 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.”


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Integrated DNA Technologies
American Food and Drug Administration