Molecular Diagnostics Development: OEM and Commercial Supply

Diagnoses with greater specificity, sensitivity, and speed, than traditional methods are now possible with molecular technologies. With our innovative technology platforms, we’ve helped our partners launch a wide range of molecular testing related to infectious diseases, animal health, reproductive health, and oncology. No matter what your application, throughput, turnaround time, or cost-per-sample needs, you can count on us to help you access the right reagents and instruments for your focus area.

Streamline your commercialization efforts with our OEM and commercial supply offerings.

Download our PCR and isothermal amplification handbook

Products and services for molecular diagnostics development

Custom raw materials

Discover our solutions and services for raw materials used in molecular diagnostics development.

Air-drying and Lyophilization solutions

Invitrogen Dry-Ready Reagents supports fast, reliable and stable assay development that requires no lyophilization.

Nucleic acid extraction

Minimize problems encountered with filter-based nucleic acid isolation methods with bead-based solutions.

Molecular diagnostic assay development: Success stories

Thermo Fisher Scientific’s dedicated OEM team supports businesses of all with their molecular diagnostic assay development needs. Our exceptional manufacturing processes, certified cleanroom facilities, integrated quality management systems, and extensive R&D experience enable us to produce the high-quality products and develop innovative workflow solutions.

Assay for cartridges

Molecular diagnostics product development: Assay for cartridges

The client, a mid-size global company, was developing a PCR-based multiplex assay for research in infectious and inherited diseases. The assay is run on an instrument platform using a disposable cartridge containing a lyophilized PCR enzyme. Taq DNA polymerase and Invitrogen SuperScript III RT from Thermo Fisher provided the performance that met their assay requirements. The Thermo Fisher OEM team partnered with the client to co-develop and manufacture a custom lyo-ready enzyme formulation that allowed our client to bring their cartridge-ready assay to market. In addition to the R&D support, the Thermo Fisher OEM team also helps customers to obtain commercialization rights and helps provide logistical support.

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Pathogen screening

Molecular diagnostic assay development for screening pathogens

The client, a mid-size global company, was developing a Taq DNA polymerase-based PCR assay to screen for hundreds of pathogens for infectious disease research. Commercially available Taq DNA polymerases often contain DNA contamination from host cells used in production of recombinant enzymes. The Thermo Fisher OEM team developed an integrative partnership with the client for this project. The team helped provide R&D support to develop low-DNA contaminant PCR and RT enzymes that met specific assay requirements, operational assistance for custom manufacturing and QC, and flexibility in the business contract terms that allowed the client to commercialize the product.

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