Welcome to Lateral Flow Market 2.0 — How Innovation is Driving the Expansion in Lateral Flow Technology Use

Mark Jones, Technical Director at Abingdon Health

In our latest blog, Mark Jones, COO of leading-lateral flow CDMO Abingdon Health plc outlines the emergence of Lateral Flow Market 2.0 driven part by reduced barriers to adoption of the technology following widespread adoption of LFT testing during COVID-19.

Lateral Flow Market 1.0 to 2.0….

Lateral flow tests have been around for over 30 years, with the first pregnancy tests hitting the market in the 1980s.  These simple, user-friendly tests revolutionized self-testing and paved the way for a broader range of applications.  However, by the 2010s, some might argue the industry had reached a plateau.

Then came COVID-19.

The pandemic's reliance on rapid antigen tests for COVID-19 diagnosis did more than just identify positive cases. It dramatically expanded public awareness and familiarity with lateral flow technology. People became comfortable using these tests at home, at work, and in various settings. This shift in public perception, coupled with ongoing innovation, has ushered in a new era for lateral flow technology: Lateral Flow Market 2.0.

From Maturity to Growth: The Power of Innovation

A recent PwC study underlines this point: product innovation is a top priority for 46% of medical device companies, the highest of any sector studied.  This focus on innovation is propelling the lateral flow industry back into a growth phase. Companies like Abingdon Health, a dedicated Contract Development and Manufacturing Organisation (CDMO) for lateral flow devices, are at the forefront of these exciting advancements.

Key Innovations Driving Lateral Flow Market 2.0

Lateral flow assays have come a long way since the early pregnancy tests but the advancements post-Covid are propelling the technology into new frontiers. Several key areas of innovation driving the expansion of lateral flow technology are: 

  • Particle Innovation: Traditionally, gold particles have been used as the detection label in lateral flow tests. However, new label options are emerging, offering exciting possibilities. Nanoshells, for instance, offer improved sensitivity with their bright and easily detectable signal. This paves the way for tests that can detect even lower levels of target analytes as seen with the UpFront Diagnostics stroke detection system, LVOne.
  • Design Innovation: Beyond particle innovation, advancements in assay design are also driving progress. Innovation this area are creating novel end user solution to more sophisticated and integrated assays. 52North’s Neutrocheck, a lateral flow device for the detection of neutropenic sepsis, is a wonderful example of design innovation.
  • Sample Matrix Processing: Traditionally, urine has been the primary sample matrix for at-home diagnostic tests. However, the landscape is rapidly evolving. Today, blood, faeces, and saliva are increasingly utilised as sample sources, broadening the scope of potential applications for lateral flow assays. Advancements in particle technology, assay design, and materials science have been instrumental in enabling the analysis of these complex matrices. These innovations have unlocked opportunities for developing new tests and improving sample collection methods. A prime example is the Salignostics Salistick, the world's first saliva-based pregnancy test, which demonstrates the potential of saliva as a viable sample matrix for diagnostic purposes.
  • Molecular lateral flow assays (MLFA): Combining the speed and ease-of-use of lateral flow tests with the sensitivity of molecular testing like PCR, MLFA represents a significant breakthrough and opportunity to detect analytes that would not be possible in traditional lateral flow. MLFA tests amplify target analytes up-front that are then labelled appropriately before being added to a lateral flow strip like PCRD, a Nucleic Acid Lateral Flow Immuno Assay (NALFIA). By utilising innovate amplification methods and combining with PCRD, you eliminate the need for specialised laboratory equipment, opening the doors for highly sensitive, point-of-care testing in resource-limited settings.
  • Reader technology: Advancements in reader technology are making lateral flow tests even more user-friendly and quantitative. Digital readers can analyse the intensity of the test lines, providing more objective results compared to visual interpretation. Today’s readers come in various guises from bench-top readers for use in doctors’ clinics, to portable types that can be used at-home or in-field. We are also seeing more mobile readers being developed. A big challenge for mobile readers is lighting (shadows) and hardware (mobiles) specification differences. By integrating a patented Software Development Kit (SDK) that is designed to combat these challenges by the algorithm deep learning like AppDx, mobile reader technology has the potential to change the landscape of portable quantitative testing for the betterment of all lateral flow tests.

Benefits of Innovation for Various Applications

Whilst pregnancy tests have dominated the lateral flow testing space for decades, Covid made us aware of a broader application. Coupled with the innovations described, lateral flow technology’s reach is broadening across a number of diverse fields: 

  • Clinical Diagnostics: From rapid strep tests to chlamydia detection, lateral flow tests are already well-established in clinical diagnostics. Advancements in particle innovation and MLFA promise even faster, more comprehensive, and sensitive point-of-care testing for a wider range of conditions.
  • Animal Health: Veterinarians, across both domestic and commercial, can use lateral flow tests for rapid on-site diagnosis of diseases in animals, leading to faster treatment and improved animal welfare.
  • Environmental & Food Safety Testing: The issues seen at the recent Paris Olympics within the River Seine shows us the importance of improved at-site testing and management. Lateral flow assays can detect environmental contaminants, foodborne pathogens, allergens quickly and effectively, ensuring environmental health and food safety.
  • Plant Pathogen Detection: Early detection of plant diseases using lateral flow tests like Pocket Diagnostic, is crucial for protecting crops and ensuring food security. These tests are proving valuable tools for farmers to identify plant pathogens in the field. The early detection of disease, without waiting for laboratory results, means quicker and more effective management plans can be rolled out, providing greater crop yields and consumer health improvements.

The Future of Lateral Flow Technology

With ongoing innovation, Lateral Flow Market 2.0 promises to revolutionise various industries.  The focus on accuracy, user-friendliness, portability, and affordability makes lateral flow technology ideally suited for testing in diverse settings. As research and development continue to push the boundaries of this technology, we can expect even more exciting advancements in the years to come.

Abingdon Health, at the forefront of lateral flow innovation, is committed to developing and manufacturing high-quality, reliable lateral flow tests for a wide range of applications. We are excited to see how this technology continues to evolve and contribute to improved healthcare, food safety, environmental protection, and more.

Abingdon Health’s team has over 20 years' experience in the lateral flow market and is a knowledge leader in the development, scale-up, transfer, manufacturing and regulatory approval of lateral flow products across a range of sectors. If you would like to understand more about the development, technical transfer, manufacturing and regulatory process and discuss any specific requirements don’t hesitate to contact Abingdon Health's highly experienced team.

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