Enzymes for PCR and molecular diagnostics

PCR enzymes are critical raw materials within molecular diagnostic assays, but their performance must be considered as part of the complete reagent system. We help developers select off-the-shelf or custom enzymes, test and optimise their use, and address compatibility, concentration, volume and quantity requirements. Our support extends from initial R&D to larger-scale production, helping customers align technical performance with an appropriate supply route.

Taq, Hot-start and high-fidelity polymerases

Taq polymerase is a thermostable DNA polymerase used to extend primers and synthesise DNA during PCR. Hot-start Taq formats control polymerase activity before thermal activation, making them relevant where assay setup and non-specific amplification need to be carefully managed. High-fidelity polymerases are considered where amplification accuracy is a primary requirement.

LGC offers RapiDxFire™ Hot Start Taq DNA Polymerase for endpoint PCR and qPCR applications, as well as NxGen™ phi29 DNA Polymerase for processive, high-fidelity isothermal amplification of limited or degraded DNA samples.

Reverse transcriptase for RT-PCR and RT-qPCR

Reverse transcriptase converts an RNA template into cDNA for subsequent amplification. RapiDxFire™ Thermostable Reverse Transcriptase supports rapid first-strand cDNA synthesis using gene-specific primers and can be incorporated into streamlined RT-qPCR workflows. Enzyme selection should consider the RNA target, primer strategy, assay chemistry and intended amplification format.

Custom enzyme formulation

Standard catalogue formats may not always align with an established assay chemistry, intended workflow or production requirement. We help customers select an off-the-shelf or custom enzyme, optimise its use and address challenges involving compatibility, concentration, volume or quantity. Selected products also provide a route to bulk, custom or OEM project discussions.

Requirements to discuss 

• Intended molecular diagnostic application 
• Target nucleic acid 
• Amplification or processing method 
• Existing assay chemistry 
• Enzyme compatibility 
• Required concentration 
• Evaluation quantity 
• Anticipated production quantity 
• Bulk, custom or OEM configuration 

Lot-to-lot requirements and supply planning

For IVD manufacturers, an enzyme or reagent may become a critical raw material within the commercial assay. Supply discussions should therefore begin before the programme enters production. We support customers from initial R&D development to larger-scale production and supply enzymes and reagents in the concentrations and quantities required.

During an enquiry, customers can discuss expected demand, concentration, volume, quantity and the intended progression from evaluation to larger-scale supply.

Bulk and OEM supply for IVD manufacturers 

Commercial molecular diagnostic programmes often require more than a standard catalogue pack. We manufacture critical raw materials in-house and support customers as they move from initial R&D development towards larger-scale production. Selected enzyme technologies, including Ampligase™, CircLigase™, CircLigase™ II and Hybridase™, provide routes for bulk, custom or OEM enquiries.  

Commercial supply pathway

1. Define the assay application and enzyme requirement.

2. Identify an off-the-shelf or custom enzyme option.

3. Evaluate and optimise the enzyme within the assay.

4. Confirm the required concentration, volume and quantity.

5. Discuss bulk, custom or OEM project requirements.

Product quality and documentation

Product-specific documentation is available for featured enzyme technologies, including safety data sheets, manuals, user guides and product information. Selected product pages also provide specifications, usage information and details of relevant quality-control testing.

Documentation requirements should be discussed as part of the custom, bulk or OEM enquiry so that available materials can be assessed against the needs of the programme.

What to include in your enquiry

Providing clear technical and commercial requirements helps us identify a suitable starting point for your project.

• Intended application and assay format 
• Target nucleic acid and sample type 
• Amplification or enzymatic process 
• Current enzyme or reagent configuration 
• Compatibility or performance challenge 
• Required enzyme concentration 
• Evaluation volume 
• Anticipated production demand 
• Required custom, bulk or OEM format 
• Supporting documentation requirements 

Request an evaluation or discuss a custom formulation

Whether you are selecting PCR enzymes for a new molecular diagnostic assay, addressing compatibility within an existing chemistry or planning bulk enzyme supply, share your application, performance, concentration and quantity requirements with our team. We can help determine whether an existing enzyme, custom configuration or OEM project provides the most appropriate route.