Custom qPCR assay
preparation service

We review & analyze your project together. Upon request, a non-disclosure agreement is signed early in the process to safeguard your sensitive information.

We define together the specifications of the project including the technical details, instrument compatibility, quality standards and supply agreement.

Based on the defined specifications, we prepare a quotation for the test batch and for the main batch.

Customers validate our reagents in their assays prior production of a test batch, with the full support of our technical experts.

The test bacth is produced according to the specifications defined by the customers before producing the main batch.

Upon test batch validation and customer request, we produce the main batch. Your project manager keeps you posted of major steps of production, QC and shipping estimation.

Benefit from tracked shipping and receive your custom assay according to your specifications. Partial deliveries and storage of part of your batch at -20°C on demand. Re-ordering made simple: we assign a unique reference to your assay.

A custom qPCR assay preparation service provides pre-formulated assay components—such as primers, probes, and/or master mix—tailored to your specifications.

Assays can be delivered ready-to-use or partially prepared, and in the format that fits your workflow (such as tubes, plates, or 8-tube strips).

This approach improves workflow efficiency, ensures batch-to-batch consistency, reduces contamination risks (e.g. cleanrooms environments, qPCR QC release...) and simplifies paperwork.

It is particularly relevant for Lab Developed Tests (LDTs) and routine diagnostic applications, where reproducibility and traceability are essential.

Discover the full value of outsourcing your in-house assay preparation in our infographic.

Unlike a commercial qPCR kit, which comes with predefined components and limited flexibility, a custom qPCR assay preparation service is fully tailored to your needs. You retain control over assay design, target sequences, formulation, and formats (plates, strips, tubes, or bulk).

This flexibility allows laboratories to maintain their validated in-house assays while improving workflow efficiency and consistency. It also enables adaptation to new variants, changing platforms, or evolving testing requirements, which is not always possible with standard kits.

In addition, the service can support continuity of testing in situations where commercial kits are discontinued or no longer available, for example due to IVDR requirements and incoming deadlines. In such cases, laboratories can transition to a custom, controlled solution while maintaining their capacity to deliver diagnostics results in a simplified and compliant way.

Our custom qPCR assay preparation service is operated under a quality management framework aligned with key ISO 13485 requirements, ensuring a high level of control, traceability, and reliability. As an option, oligonucleotides manufactured under ISO 13485 certified process (MD 638600) can be included to complement our ISO 9001 certified service offering.

Our service covers the most critical operational pillars expected by diagnostic laboratories:

• Controlled processes through standardized procedures and cleanroom manufacturing
• Full traceability of batches, materials, and production steps
• Comprehensive and centralized documentation, including checklists, batch records and QC release reports
• Quality control (qPCR QC) performed prior to delivery
• Risk reduction, supported by automation in cleanroom and minimized manual handling

In addition, the service is fully auditable and has already been reviewed in customer audit contexts, including for class D assays.

Altogether, this provides diagnostic laboratories with a robust and reliable solution that supports their own ISO 15189 and IVDR requirements, particularly in terms of traceability, documentation, and manufacturing control.

Yes, with a custom qPCR assay preparation service, you retain full control over your assay design. Laboratories define their own primer and probe sequences, concentrations, chemistries, and reaction setup. The assay content can be adapted at any time at your initiative to cope with evolving needs (e.g. emergence of mutations or new viral strains).

Our service simply prepares the assay according to your specifications, without modifying its design unless for mutually agreed technical improvements. This ensures continuity for in-house qPCR assays while benefiting from improved manufacturing consistency, traceability, and operational efficiency.

It is an ideal solution for laboratories developing and running their own Lab Developed Tests (LDTs).

At first glance, qPCR premixing may appear more expensive than in-house assay preparation. However, when considering the total cost of ownership, premixing often proves more efficient and cost-effective. It reduces operator time, rework and validation workload, reagent loss, and the need for dedicated equipment. It also simplifies documentation and quality control processes, which are critical in regulated environments.

In a documented case study, a high-throughput diagnostic laboratory reported that their premixed qPCR assay approach was 5–10× more cost-effective than comparable commercial kits, depending on workflow and operational conditions.

Overall, premixing can generate significant savings for routine molecular testing laboratories.

Yes. Regulatory authorities generally allow the outsourcing of in-house assay preparation, provided that the laboratory using the assay remains responsible for key elements such as performance validation, compatibility with tested samples, and validation of new batches according to its own quality procedures and application requirements.

Outsourcing assay preparation can help laboratories improve process consistency, traceability, and manufacturing control, while maintaining full ownership and responsibility for the assay and its intended use.

Eurogentec manufactures and supplies key assay components such as oligonucleotides, enzymes, master mixes, and plastics. We can also source and integrate additional components not produced in-house, allowing us to deliver a complete custom qPCR assay preparation solution, tailored to your workflow and ready for routine use.

The stability of each premixed qPCR assay is determined through dedicated stability studies performed under defined storage conditions and acceptance criteria.

• Primers & probe(s) premixes are typically assigned a shelf life of 12 months, which can be extended up to 24 months as assay-specific stability data become available.
• Premixes containing Takyon master mix generally follow the same stability profile, depending on the type of assay. 

These stability periods apply upon manufacturing, when stored at -20°C and protected from light.

This approach ensures controlled expiry dating, simplified stock management, and consistent assay performance over time.