The COVID-19 pandemic has elevated many of the challenges faced by clinical labs, requiring new and innovative solutions to address them. Technology development is happening faster than ever before, exposing weaknesses in diagnostic supply chains, increasing the need for innovation and thinking differently about how diagnostics should be developed, manufactured and deployed.

Many scientists know NEB as a trusted reagent provider to the life science community. What many do not know is that we also offer a portfolio of products that serve as critical components for a wide array of diagnostic products and services. Extensive molecular biology and enzymology experience provide NEB with the unique ability to help customers solve the challenges inherent in technology development and ultimately in scale-up and commercialization.


It's time to think differently

Our OEM & Customized Solutions Team has been serving customers for over 30 years. We understand the demands around technology development and product launches, and are able to apply a cross-functional team of scientists and staff to quickly optimize your reagent development. We have made significant investment in our scale-up and manufacturing capabilities, and can offer consistent and reliable supply chain with fair and flexible terms. We have also focused our efforts in project management, operations and fulfillment, positioning us to respond quickly and effectively manage your custom projects. Expansion of our quality, regulatory affairs and quality control infrastructure underscores our commitment to making the best possible products, every time.

Most importantly, we pride ourselves in being a resource to you, not just through our product offering, but through the support that we provide. As one of the few privately held molecular biology tools providers, our goal is to establish partnerships that advance our customer’s science and business objectives. 100% of our production capacity is earmarked for the customers we serve, and not for the manufacture of our own diagnostic products.

What does this all mean for you? If you are looking for reagents to incorporate into your latest technologies, laboratory developed tests (LDTs), CE/IVDs or diagnostic kits for EUA and 510K approval, and see these same challenges and need for change in the molecular diagnostic market, it’s time to think differently and consider NEB as your partner for future assay development and scale up needs.


Select a molecular diagnostic-related application to learn more:


Amplification-basedMDx_Category                     NGS-basedMDx_Category



 

Amplification-based Molecular Diagnostics

NEB has a long history in the development of reliable and convenient tools for amplification, and offers a large selection of products for PCR, qPCR, RT-qPCR and isothermal amplification. Our extensive expertise in this area has allowed us to develop optimized enzymes for a variety of applications, including incorporation into diagnostics. The table below summarizes some of the products available from NEB for diagnostic applications. Bulk and/or custom formats are available for all products, with more specific customization details included below:

Application Products Product Notes Custom Formulations Available
PCR Applications qPCR/RT-qPCR

DNA, Dye

DNA, Probe

  • Sensitive, reproducible and reliable performance
  • Compatible with automation and reaction miniaturization
  • Room temperature stable for ≥ 24 hours
  • Blue-dye-free
  • Lyo-compatible

RNA (1-step), Dye

RNA (1-step), Probe

  • Luna WarmStart RT paired with Hot Start Taq increases reaction specificity and robustness
  • Compatible with automation and reaction miniaturization
  • Room temperature stable for ≥ 24 hours
  • High conc. ideal for viral targets (NEB #M3019)
  • Includes carryover prevention (NEB #M3019)
  • Blue-dye-free
  • Lyo-compatible

RNA (2-step)

  • Novel thermostable RT
  • Single-tube format
  • 13-minute DNA synthesis protocol
  • Blue-dye-free
  • Primer-free
PCR/RT-PCR

Master Mixes

Standalone Enzyme & Buffer

 

  • ~280X fidelity of Taq
  • Consistent, fast, reliable performance
  • Compatible with automation and reaction miniaturization
  • Room temperature stable for ≥ 24 hours
  • High conc.
  • Glycerol free
  • Custom mixes
Z05 DNA Polymerase
  • RNA- and DNA- dependent DNA polymerase activities in a single enzyme
  • +/- Hot start
Hemo KlenTaq®
  • Amplification direct from blood
  • High conc.

Hot Start Taq DNA Polymerase

Hot Start Taq 2X Master Mix

  • Unique aptamer-based enzyme control supports fast protocols
  • Compatible with automation and reaction miniaturization
  • High conc.
  • Glycerol free
Isothermal Applications LAMP/RT-LAMP

WarmStart® Colorimetric LAMP 2X Master Mix (DNA & RNA)

WarmStart Colorimetric LAMP 2X Master Mix with UDG

  • Fast, clear pink-to-yellow visible detection of amplification
  • Results in approximately 30 minutes
 
SARS-CoV-2 Rapid Colorimetric LAMP Assay Kit
  • Simple, colorimetric detection of amplification of SARS-CoV-2 nucleic acid
  • Automation-compatible when coupled with absorbance plate reader
 
WarmStart LAMP Kit (DNA & RNA)
  • Master mix for LAMP and RT-LAMP workflows
  • Supports multiple detection methods, including fluorescence and turbidity
  • Automation compatible
  • Lyo-compatible
  • High conc.

Bst 2.0 WarmStart DNA Polymerase

Bst 2.0 DNA Polymerase

  • Improved reaction properties compared to wild-type Bst DNA Polymerase
  • Increased dUTP tolerance enables carryover prevention
  • Glycerol-free
  • High conc.
Bst 3.0 DNA Polymerase
  • DNA binding domain fusion supports robust performance
  • Significantly increased RT activity up to 72°C enables single enzyme RT-LAMP
  • Glycerol-free
  • High conc.
WarmStart RTx Reverse Transcriptase
  • In-silico designed RT for RT-LAMP with reversibly-bound aptamer that inhibits activity below 40°C
  • Glycerol-free
  • High conc.
Strand Displacement Nt.BstNBI
  • High purity, high quality nicking endonuclease
  • Glycerol-free
  • High conc.
Helicase-dependent Amplification Tte UvrD Helicase
  • Thermostable
  • Improves specificity of problematic fluorescent LAMP reactions
  • High conc.
IsoAmp® II Universal tHDA Kit
  • Requires only two primers
  • Produces short, discrete DNA products
 
Other Bsu DNA Polymerase, Large Fragment
  • Enables low temp. isothermal applications
  • High conc.
T4 Gene 32 Protein
  • Can increase yield and efficiency of amplification reactions
  • Glycerol-free
Deoxynucleotide (dNTP) Solution Mix
  • Highly pure
  • Custom conc.
Nuclease-free Water    

Antarctic Thermolabile UDG

  • Unique thermolabile version is completely inactivated in typical isothermal and RT-qPCR workflows
  • High conc.
Proteinase K    

Thermolabile Proteinase K

  • Unique thermolabile version is completely inactivated in typical isothermal and RT-qPCR workflows
  • High conc.

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Next Generation Sequencing-based Molecular Diagnostics

Sequencing is enabling scientists to make rapid advances in epidemiology and surveillance, basic and clinical research, and diagnostics. A fast-growing number of methods are being developed to address whole genome, as well as targeted approaches. In all cases, streamlined workflows that result in high-quality, high yield libraries are critical towards optimizing your next generation sequencing (NGS) results. The table below summarizes some of the products available from NEB for diagnostic applications. Bulk and/or custom formats are available for all products, with more specific customization details included below:

Application Products Notes
NGS-based Molecular Diagnostics DNA Sequencing DNA library preparation with enzymatic DNA fragmentation
  • Range of packaging options including 96-well plates
  • Component and kit customization
  • Kitting
  • Automation-compatible
  • Streamlined workflows
DNA library preparation for cfDNA or presheared DNA
RNA Sequencing Depletion of abundant RNAs
RNA library preparation
Virus sequencing and detection

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This content is covered by patents, trademarks and/or copyrights owned or controlled by New England Biolabs, Inc. For more information, please email us at gbd@neb.com. The use of these products may require you to obtain additional third party intellectual property rights for certain applications.

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