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Custom Assay Development Service


Quickly expand your menu of assays

From product concept to manufacturing and distribution
Update your product design during the project
Receive ready-to-use regulatory documentation (CE-IVD or FDA) 


For more than 15 years, Diagenode Diagnostics designs, manufactures and commercializes innovative and trusted Real-Time PCR CE-IVD kits for the detection of pathogens associated with many infections. Current focus is Mycoplasma genitalium with Macrolide Resistance detection (S-DiaMGRes™).

Diagenode Diagnostics is of course ISO 13485 certified. Based on these combined expertises, Diagenode Diagnostics also develops and manufactures custom molecular diagnostics (MDx) according to the specific requirements provided by number of leading IVD companies worldwide.

CADS Workflow


Custom Assay Development Service starts from product design to manufacturing and distribution as summarized in the flowchart below. Multiple ways are possible (see flowchart above : A, B, C, D, E…), the only right one is driven by your objective. The project is first discussed towards to a proposal structured on successive milestones, clear deliverables and options. Each project is managed under ISO 13485 by a dedicated project manager at Diagenode Diagnostics.

Because the assay development is a months project, your objective could evolve based on market trend or new internal requirements. Therefore, you can update your product design accordingly.

Moreover, each milestone is formalized by a Design Review including a go / no go decision based on deliverables. Once Verification & Validation phase is finilized, the product related information is consolidated to be ready for regulatory submission of your new assay (CE-IVD, FDA Approval, US 510k, Canada…). The distribution clearly depends on the business model that could be decided before or during the assay development project : Original Equiment Manufacturer (OEM), Legal Manufacturer, Backup Manufacturing Site, Exclusive Distributor…


Which menu gap would you like to fill in on your MDx instrument ?
Would you like to speed up your own MDx assay development ?
Would you like to boost your growth ?

What about your next assay ? When do we start discussions?


Please feel free to contact us on custom.assay@diagenodediagnostics.com for any further information.

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