New England Biolabs is helping test developers improve accessibility with a range of development tools, including shelf-stable reagents and enzyme-based tools.

By Chris Wolski

Summary

New England Biolabs (NEB) provides essential tools and support for the development of new diagnostic tests, which are crucial for addressing emerging viral and bacterial threats, as demonstrated by the COVID-19 pandemic.

Key Takeaways

  1. Enhanced Accessibility: NEB improves access to diagnostic testing by offering enzyme-based tools and lyophilized reagents that are stable at room temperature, enabling easier and more reliable home and point-of-care testing.
  2. Focus on LAMP and RT-PCR: NEB emphasizes the development of LAMP and RT-PCR tests due to their simplicity, sensitivity, and specificity, which are critical for effective molecular diagnostics.
  3. Support for Emerging Threats: NEB aids in refining existing tests and developing new ones for emerging threats like H5N1 by ensuring compatibility with public testing resources and improving workflows for various sample types.

As the COVID pandemic demonstrated, the need for new and improved diagnostic tests are critical to meet emerging viral and bacterial threats.

Since the pandemic, New England Biolabs (NEB) has offered a range of development tools to help with the creation of new tests to improve accessibility and meet new, growing threats, such as H5N1.

In a wide-ranging interview with CLP, Greg Patton, NEB’s associate director of Applications & Product Development at New England Biolabs, and Nathan Tanner, NEB’s associate director of Research at New England Biolabs, discuss how the company helps improve access, the tools it offers developers, why the company is focusing on LAMP and RT-PCR, and how it is aiding in the fight against the emerging threat of H5N1.

Their responses have been edited for length and clarity.

CLP: There are a number of factors fueling the pivot to home testing. One of the biggest is accessibility to a growing menu of tests. How is NEB helping improve accessibility?

Greg Patton: At-home tests enable the public to inquire about their health status with a high degree of accuracy before, or in some cases, even without visiting a doctor’s office. This benefit of home testing was known before COVID, but it became dramatically more common during the pandemic and has remained appealing for targets such as the flu, strep or sexually transmitted infections. At-home tests must be reliable and use validated platforms and test chemistries to be trusted by clinicians. They should also use simple detection methods and minimal reagents to remain affordable and accessible.

New England Biolabs offers a wide variety of enzyme-based tools and workflow solutions that can be used and validated by developers interested in creating new molecular diagnostic tests1. A dedicated team of experts within New England Biolabs Lyophilization Sciences can also work with developers of point-of-care tests to design, develop and manufacture lyophilized reagents for their assays that can be shipped and stored at ambient temperatures.

CLP: You’re also helping small-scale testing, particularly, in primary care physicians’ offices. Can you outline how your room-temperature, shelf-stable reagents are helping physicians and others provide better more reliable testing?

Patton: Space is a key limitation for many points of service in healthcare, and liquid reagents used to build nucleic acid amplification tests typically require cold-chain shipping and storage. But, when liquid reagents are lyophilized, or freeze-dried, the resulting lyophilized product is dry, temperature-stable, and compact, making it easier, cheaper and more sustainable to ship and store. In addition, lyophilized tests can be provided as pre-dispensed, single-use reactions, and often allow for simple workflows that can be reliably performed by novice users. Achieving workflow simplicity, such as avoiding liquid transfers, is essential if developers aim to develop a CLIA-waived test.

Lyophilized tests can also support equity of access to molecular testing, because they can be used in regions or locations that lack the resources or infrastructure to support stringent shipping times and temperature controls.

CLP: New England Biolabs is involved in a number of testing areas—can you outline other ways you’re improving testing and increasing access?

Patton: The complexity and cost of a point-of-care test can limit its accessibility. When working with a test developer, we aim to cut down on their test’s complexity and cost by minimizing processing steps—such as sample prep and purification—and enabling direct use of samples in an assay.

CLP: The two primary areas that you’re focusing on are LAMP and RT-PCR—why?

Nathan Tanner: While we support the development of our customers’ molecular tests by offering a wide range of products depending on intended chemistry, PCR and LAMP cover a wide portion of desired applications and formats for molecular testing. This is because molecular testing of nucleic acids has a very wide utility, enabling detection of infectious diseases or identification of genetic markers in the target. PCR has been the gold standard of molecular diagnostics for decades and continues to be widely used and powerful due to its sensitivity and specificity, with newer innovations in customers’ device design reducing time and their instrument cost. LAMP and other isothermal methods extended these innovations by enabling extremely simple platforms and powering the first CLIA-waived and at-home molecular tests. That said, we aim to support the development of our customers’ molecular tests by offering a wide range of products depending on intended chemistry.

CLP: H5N1 is becoming a pathogen of concern in some corners of health care. How has New England Biolabs been involved in helping to refine the existing tests and develop new avenues? 

Tanner: The reagent chemistries we offer can be put to use for any molecular target of interest. And, indeed, numerous H5N1 publications feature labs developing assays using NEB reagents. We typically ensure compatibility with public testing resources, such as primers and probes from the CDC or other agencies.

For molecular detection of H5N1, we saw a spike in questions about compatibility with milk samples. We worked to refine milk extraction workflows with our Monarch RNA extraction products, while also showcasing compatibility of H5N1 detection with purified and direct milk samples in LAMP and PCR2. These findings were released in an application note this summer.

In addition, since the onset of the COVID pandemic, NEB has been providing tools and reagents to support the public health use of next-generation sequencing to monitor virus evolution and identify emergent strains. This has proven critical for our customers in developing new rapid tests and modifying existing tests to detect novel strains with evasion mutations, allowing real-time response. The ability to sequence viruses rapidly and efficiently is also invaluable in our customers’ therapeutics and vaccine development efforts.

Chris Wolski is chief editor of CLP.

Notes

  1. NEB products are manufactured for research use, and not for human or animal therapeutic or diagnostic use. We do not submit the products for regulatory review by any government body or other organization, and we do not validate them for clinical, therapeutic or diagnostic use.
  2. The Monarch Mag Viral DNA/RNA Extraction Kit products are for research use only. They not been validated by FDA or accepted by the National Conference on Interstate Milk Shipments, or otherwise determined by the FDA to be effective for use in the extraction of viral nucleic acids from milk. It also has not been approved by the National Animal Health Laboratory Network or otherwise validated by the USDA for use in testing of milk.