The molecular diagnostics market is growing at approximately 12% annually and is accompanied by the increasing need for oligonucleotides that can be used in diagnostic tests . This rapidly growing demand has made it critical to understand the requirements for oligos used in such testing, and to discriminate between what is required by law in the US, and what is not required, but prudent, when purchasing oligos for use in medical diagnostics. At the heart of this question is the difference between Good Manufacturing Practices (GMP) and ISO 13485 certification (Table 1), and what these credentials mean for oligonucleotides manufactured for human diagnostics.
Table 1. Comparison of GMP vs. ISO 13485.
A consumer often must trust his life to a medical device or rely on a diagnostic test for critical health information. To ensure such devices and tests are safe and effective, the Food and Drug Administration (FDA) established quality system regulations under the Code of Federal Regulations (CFR), Title 21, Part 820. These regulations outline the legal requirements for how medical devices and diagnostic tests are manufactured. One of the requirements in the CFR requires the manufacturer to have a system in place for documenting the validation and control of all their processes. They must also acknowledge any change in their processes, and record, track, and correct the production of products as necessary. This set of actions is referred to as GMP and requires extensive validation and record keeping. For GMP facilities producing finished devices, GMP regulations are not optional but are required by law. With a registered GMP facility, IDT ensures that our GMP oligonucleotides are manufactured in compliance with these regulations, as appropriate.
The International Organization for Standardization (ISO) is a voluntary, non-governmental organization that provides unified standards for many different areas of industrial activity. The ISO 13485 designation is the standard for manufacturers of medical diagnostics. While this designation is similar to GMP in many respects, holding an ISO 13485 certification is not a legal requirement, but is accepted as an international standard. Manufacturers are continually audited and must be recertified on a regular basis. The regular ISO audits ensure that the reported standards of manufacturing are maintained and encourage continuous improvements. The manufacturing processes of the IDT GMP division has been ISO 13485:2003 certified since 2008 (ref. BSI certificate FM 513219).
IDT oligonucleotides for diagnostics applications
In addition, the IDT GMP business unit is registered with the United States FDA as a contract manufacturer of oligonucleotide components for in vitro diagnostic devices (IVDs) and analyte-specific reagents (ASRs) for laboratory developed tests (LDTs). What does this mean for customers purchasing oligos for use in human diagnostics? GMP manufacturing compliance and ISO 13485 certification provide proof that the manufacturer has a system in place to validate and provide traceability for oligonucleotide manufacturing history during the production process. This in turn helps to ensure that the oligonucleotide quality and specifications are consistent and reproducible. These certifications indicate that IDT quality system requirements and product realization plans align with the needs of our customers requiring oligos for regulated or diagnostic end-use applications.
The IDT GMP division provides convenient, online ordering of probes and primers for gene expression and genotyping, including a range of modifications and deliverable yield capabilities from a few nmol up to multiple grams. The GMP division also boasts supplemental services such as dedicated purification columns, aliquoting, and other custom packaging and formulation services.