Supporting Molecular Diagnostics

The COVID-19 pandemic 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. Further, the acquisition of Fluorogenics™ Limited (FGL), now NEB Lyophilization Sciences™, combines FGL's expertise in lyophilization with NEB’s diverse product portfolio to offer lyophilized and lyo-compatible products and custom services optimized for diagnostic assay and platform developers.

Learn more about the benefits of using lyophilized reagents in our feature article: Enhancing Molecular Diagnostics in Regulated Markets with Lyophilized Assays.

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-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 Luna^® Universal qPCR Master Mix DNA, Probe Luna Universal Probe qPCR Master Mix	Compatible with automation and reaction miniaturization Room temperature stable for ≥ 24 hours	Blue-dye-free Lyo-compatible
		RNA (1-step), Dye Luna Universal One-Step RT-qPCR Kit RNA (1-step), Probe Luna^® Probe One-Step RT-qPCR 4X Mix with UDG Luna^® Probe One-Step RT-qPCR 4X Mix with UDG (No ROX) Luna^® Universal Probe One-Step RT-qPCR Kit Luna^® Probe One-Step RT-qPCR Kit (No ROX) Luna^® SARS-CoV-2 RT-qPCR Multiplex Assay Kit LyoPrime Luna^® Probe One-Step RT-qPCR Mix with UDG	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 Lyophilized format (NEB #L4001)	Blue-dye-free Lyo-compatible Add primers and probes (NEB #L4001)
		RNA (2-step) LunaScript^® RT SuperMix Kit	Novel thermostable RT Single-tube format 13-minute DNA synthesis protocol	Blue-dye-free
	PCR/RT-PCR	Master Mixes Q5^® Hot Start High-Fidelity 2X Master Mix Q5 High-Fidelity 2X Master Mix Standalone Enzyme & Buffer Q5 Hot Start High-Fidelity DNA Polymerase Q5 High-Fidelity DNA Polymerase	~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
		Q5 Blood Direct 2X Master Mix	Amplification direct from blood
		Hot Start Taq DNA Polymerase Hot Start Taq 2X Master Mix	Unique aptamer-based enzyme control supports fast protocols	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 Automation - compatible when coupled with absorbance plate reader
		SARS-CoV-2 Rapid Colorimetric LAMP Assay Kit	Simple, colorimetric detection of amplification of SARS-CoV-2 nucleic acid
		WarmStart LAMP Kit (DNA & RNA) WarmStart Multi-Purpose LAMP/RT-LAMP 2X Master Mix (with UDG) WarmStart Fluorescent LAMP/RT-LAMP Kit (with UDG)	Master mix for LAMP and RT-LAMP workflows Supports multiple detection methods, including fluorescence and turbidity	Lyo-compatible High conc.
		Tte UvrD Helicase	Improves specificity of LAMP reactions	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 WarmStart® Nt.BstNBI	High purity, high quality nicking endonuclease	Glycerol-free High conc.
	Helicase-dependent Amplification	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		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	NEBNext^® Ultra™ II FS DNA Library Prep Kit for Illumina^® NEBNext^® Multiplex Oligos for Illumina^® (Index Primers Set 4) NEBNext Ultra II FS DNA Module NEBNext Ultra II Q5^® Master Mix NEBNext Adaptors and Primers	Range of packaging options including 96-well plates Component and kit customization Kitting Automation-compatible Streamlined workflows
	DNA Sequencing	DNA library preparation for cfDNA or presheared DNA	NEBNext Ultra II DNA Library Prep Kit for Illumina NEBNext^® Ultra™ II DNA PCR-free Library Prep Kit for Illumina^® NEBNext Ultra II End Repair/dA-Tailing Module NEBNext Ultra II Ligation Module NEBNext Ultra II Q5 Master Mix NEBNext Adaptors and Primers
	RNA Sequencing	Depletion of abundant RNAs	NEBNext rRNA Depletion Kit v2 (Human/Mouse/Rat) NEBNext Globin & rRNA Depletion Kit (Human/Mouse/Rat) NEBNext rRNA Depletion Kit (Bacteria) NEBNext RNA Depletion Core Reagent Set for customized depletion NEBNext^® Poly(A) mRNA Magnetic Isolation Module
		RNA library preparation	NEBNext ^® Ultra II Directional RNA Library Prep Kit for Illumina NEBNext ^® Ultra II RNA First Strand Synthesis Module NEBNext ^® Ultra II Directional RNA Second Strand Synthesis Module NEBNext ^® Ultra II End Repair/dA-Tailing Module NEBNext ^® Ultra II Ligation Module NEBNext ^® Ultra II Q5 Master Mix NEBNex ^®t Adaptors and Primers NEBNext^® Immune Sequencing Kit (Human)
		Virus sequencing and detection	NEBNext^® ARCTIC SARS-CoV-2 FS Library Prep Kit (Illumina^®) NEBNext® ARTIC SARS-CoV-2 Library Prep Kit (Illumina^®) NEBNext® ARTIC SARS-CoV-2 Companion Kit (Oxford Nanopore Technologies^®) NEBNext^® ARTIC SARS-CoV-2 RT-PCR Module LunaScript RT SuperMix Kit Q5 Hot Start High-Fidelity 2X Master Mix NEBNext Ultra II End Repair/dA-Tailing Module Blunt/TA Ligase Master Mix NEBNext Quick Ligation Module NEBNext Ultra II RNA Library Prep Kit for Illumina WarmStart^® LAMP Kit (DNA & RNA)

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Products and content are covered by one or more patents, trademarks and/or copyrights owned or controlled by New England Biolabs, Inc (NEB). The use of trademark symbols does not necessarily indicate that the name is trademarked in the country where it is being read; it indicates where the content was originally developed. The use of this product may require the buyer to obtain additional third-party intellectual property rights for certain applications. For more information, please email busdev@neb.com.

Videos

LyoPrime Luna^® L4001S Vial Format Overview

In this video, learn about our LyoPrime Luna™ Probe One-Step RT-qPCR Mix with UDG, a lyophilized reagent analogous to our liquid format RT-qPCR 4X mix for sensitive detection of RNA targets.
LyoPrime Luna^® L4001S Vial Format Rehydration

This video describes the rehydration process for LyoPrime Luna™ Probe One-Step RT-qPCR Mix with UDG, a lyophilized reagent analogous to our liquid format RT-qPCR 4X mix for sensitive detection of RNA targets.
Reagents and technologies to address public health & pandemic response

This webinar explores examples of NEB-enabled assays specific to the COVID-19 pandemic. Our flexible solutions are available in a wide range of customizable formats and formulations, enabling testing platforms including qPCR, LAMP, and NGS, and can be harnessed to support diagnostic innovation at scale.
OEM & Customized Solutions Case Study: Quality & Specifications

Learn how NEB helped a startup company manufacturing a novel therapeutic with GMP-grade enzyme.