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Building an Assay Together

In this business, experience and expertise is everything. We are a proud B2B supplier for more than 500 diagnostic and biotechnology organizations, and have helped those organizations launch thousands of commercially available assays. Our products can be used in multiple platforms—including multiplex PCR, digital PCR, and NGS—to create molecular assays for infectious disease, cancer, inherited disease, donor-recipient compatibility, blood safety, ancestral screening, and more.

Learn how we help your team through every phase, from discovery to commercialization.

Discovery Research

Sound research is the first step in developing an effective IVD or OEM molecular assay. From product conception through your initial R&D evaluation, we’ll partner with your Product Manager and R&D Scientists to help you navigate assay design, licensing questions, and technical setbacks.

Development and Scale Up

You have finished your R&D evaluation, and now you are ready to scale up your assay. We’ll work closely with your Production Scientists to provide scalability and manufacturing flexibility. We synthesize and QC over 90,000 GMP oligonucleotides per year, and can manufacture single lots from picomole to multi gram scale.

Get the configuration you need with customization options available for product labeling, packaging, third party reagent sourcing, kitting services, and more.

Verification and Validation

As your IVD or OEM molecular assay moves into the validation phase, we’ll align with your QA and QC Specialist to ensure that your product meets all specifications and requirements. With over 35 successful audits per year, IDT is registered with the US FDA as a contract manufacturer for in-vitro diagnostic devices (IVD / ASR) & nucleic acid tests (NAT). We offer ISO 13485 and 14644 certifications, as well as US FDA registration (Registration 3004513294) and traceability to support your customers. This includes LIMS batch history record for every GMP oligo, Change Control Notification (CCN) service, and right to approve.

Commercialization

During product development and post-launch, our experienced team of B2B account managers will help your Product Manager and Procurement Specialists navigate the project from end-to-end, and assist with seamless order integration, inventory reports, and flexible supply options.

Site tour – See our B2B capabilities

Take a tour of our facilities and meet key team members within IDT who are involved in the development, support, manufacturing, documentation and commercialization of GMP and OEM products used for in vitro diagnostic (IVD) or life science research applications.

Meet our B2B support team

Meet key members of the B2B support team at IDT and learn how we can help you achieve your goals during the development, manufacturing, validation and commercialization of molecular diagnostic assays or OEM products.

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B2B Capabilities Flyer

Learn how partnering with IDT can give your team everything it needs to successfully transition from discovery to commercialization.

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Partnering with IDT

Get information on working with our dedicated B2B team, and details on forms and timelines.

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RUO or GMP oligos?

Important considerations when commercializing molecular assays for IVD applications

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Strategic Collaborations

We’ve partnered with Argonaut MS, Clear Labs, Roche, and Illumina to increase our capabilities and co-develop assays for multiplex PCR, NGS, and more.

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