Have a molecular assay to commercialize? Let’s build it together.

Guidance and support from assay development through commercialization

Your team is busy developing fast, sensitive, and accurate molecular tools, for improved disease research and clinical diagnostics for better healthcare outcomes. This requires:

You know IDT as a source of high quality, trusted control and custom oligonucleotides, reagents, and assays. But did you also know we can provide dedicated people and resources to help with the process of assay development through commercialization? We are the trusted B2B supplier to more than 500 diagnostic and biotechnology organizations (read about some of these here), and have helped commercialize thousands of GMP and OEM assays for molecular diagnostics.

Here's what we can help with at each stage of the process:

Discovery research

• A broad portfolio—over 500 modification and modified bases
• Tools to guide experimental design—easy-to-use PCR, qPCR, NGS, and CRISPR design tools
• Expert technical support—21 regionalized, scientific application specialists and 93 customer support staff available via phone, chat, and email

Development and scale-up

• Manufacturing expertise—we synthesize and QC more than 90,000 GMP oligonucleotides per year
• Extensive scalability—single lots from pictogram to multigram scale per oligo
• Multiple production options—plate vs. tube, custom formulations, your packaging

Verification and validation

• Assigned QA and QC specialists—expertise to ensure your product meets all specifications and requirements
• ISO certification—IDT maintains ISO 13485; ISO 14644 certifications
• US FDA registration—contract manufacturer for in vitro diagnostic devices (IVD / ASR) & nucleic acid tests (NAT), and FDA Registration #3004513294

Commercialization

• Flexible supply options—includes scheduled delivery and direct OEM drop ship to customers
• Integration and inventory—over 200 successful customer integration relationships using Arriba, SciQuest, Coupa, or direct options, with inventory reports also provided
• Traceability to support your customers—access to LIMS batch history record for every GMP oligo; Change Control Notification (CCN) service, and right to approve

Let’s build it together

From the beginning, IDT has been rooted in science of the highest quality. We were scientists serving other scientists then, and have held on to that mission for over 30 years. When you partner with us, there is no limit to what we can build together.

Learn more about GMP and OEM integrations.

Start the process by contacting us.