Custom Assay Development Services

Custom assay development services

At IDT, we proudly partner with diagnostic and biotechnology organizations to bring innovative solutions to life. We've assisted in launching thousands of commercially available assays, and our specialists are ready to help you develop your molecular assays for infectious diseases, cancer, inherited diseases, and more.

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Expertise & experience

As a trusted B2B supplier, we partner with a diverse range of biotechnology organizations, helping them develop effective IVD or OEM molecular assays. Our versatile products support multiple platforms, including multiplex PCR, digital PCR, and NGS, empowering your molecular assays for infectious diseases, cancer, inherited diseases, donor-recipient compatibility, blood safety, ancestral screening, and more.

Support at every phase

Discovery research Innovative research is the first step in custom assay development. From concept through early R&D, we help innovators navigate assay design, licensing, and technical hurdles.
Development and scale-up Once R&D evaluation is complete, it’s time to scale. Our manufacturing capabilities offer flexible production, from picomole to multigram lots.
Customization options Get the exact configuration you need with custom product labeling, packaging, third-party reagent sourcing, kitting services, and more.
Verification and validation support We manufacture products with ISO 13485 and 14644 certifications and traceability, including LIMS batch history records, change control notifications, and approval rights.
Commercialization expertise Our account managers support commercialization teams from development to post-launch, ensuring seamless order integration, inventory reports, and flexible supply.

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Talk to an expert at IDT to ensure quality, consistency, and compliance in your research. Our services meet high standards, ensuring your projects are executed reliably.

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Custom assay solutions

Unlock the potential of your research with IDT’s custom assay development services. Our experts collaborate with you to design, develop, and optimize assays for studying infectious diseases, cancer, inherited disorders, and more. We offer flexible labeling, packaging, and reagent sourcing, ensuring your assays are perfectly suited to your requirements. Partner with us to achieve reliable, high-quality results that drive your research forward.

Research grade manufacturing	Therapeutic grade manufacturing	CGMP (ICH Q7)
Custom formulations Certificate of Analysis Commerce and/or quote ordering capabilities Specifications defined in the quote ISO 9001:2015 certified “Build and Hold” lot consistency Per lot functional testing available Custom packing Advance change notification protocols	Engineering run Custom formulations Certificate of Analysis	ISO class 8 cleanroom for post synthesis processing Analytical method development for every sequence

Research grade manufacturing

Therapeutic grade manufacturing

CGMP (ICH Q7)

Custom formulations
Certificate of Analysis
Commerce and/or quote ordering capabilities
Specifications defined in the quote
ISO 9001:2015 certified
“Build and Hold” lot consistency
Per lot functional testing available
Custom packing
Advance change notification protocols

Engineering run

Custom formulations
Certificate of Analysis

ISO class 8 cleanroom for post synthesis processing
Analytical method development for every sequence

Genomic technology is evolving faster than ever before…

And these discoveries are improving disease diagnosis and treatment with unprecedented precision.
Our organization has and will continue to evolve to meet you where your research takes you, with personalized support and services.

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