Next‑Generation Lateral Flow: The Technology Convergence Shaping Rapid Diagnostics

From Strip Test to Integrated Platform
The Digital Layer
What This Means for Development and Manufacturing?
The Opportunity

In our latest blog, Chris Yates, President of Abingdon Health USA Inc, looks at how lateral flow technology is evolving beyond the simple strip test; and why the next generation of rapid diagnostics will look very different from the products that came before.

Lateral flow has spent the last fifty years proving one thing above all else: the technology works. It works at scale, it works at low cost, it works in the hands of untrained users, and it works in settings where no other diagnostic format can reach. From pregnancy testing in the 1980s to COVID-19 rapid testing in the 2020s, lateral flow has repeatedly demonstrated that in vitro diagnostic (IVD) immunoassays can deliver clinically meaningful results outside the laboratory.

The technology that defined those applications is not the technology that will define the next decade. Lateral flow is converging with complementary technologies:

• molecular amplification
• digital readers
• multiplexed detection and
• microfluidics

to create a new generation of rapid diagnostic platforms that bear little resemblance to the simple “yes/no” strip tests of the past.

The companies developing diagnostics today need to understand where this convergence is heading; because the decisions they make now about assay architecture, manufacturing, and regulatory strategy will determine whether their products compete in the market of 2030 or remain anchored in the market of 2020.

From Strip Test to Integrated Platform

The most significant shift in lateral flow is the move from standalone strip tests toward integrated diagnostic platforms where lateral flow is one component of a more sophisticated system, for example in the companion diagnostics (CDx) space.

Molecular lateral flow tests couple isothermal nucleic acid amplification with immunochromatographic readout, achieving sensitivity that rivals laboratory PCR while retaining the simplicity and speed that make lateral flow deployable at point of care. These platforms are not replacing lateral flow; they are building on its core strengths of capillary-driven fluid handling, established manufacturing processes, and user simplicity. Abingdon Health is at the forefront of this innovation working with pioneers in this field such as Stanford University spin-out StrandID to drive adoption of this innovative technology. A case study on the work with StrandID can be found here.  Furthermore, Abingdon Health’s PCRD range provides researchers with simpler approaches to testing their molecular lateral flow systems with an off-the-shelf lateral flow solution.

Multiplexed lateral flow is another frontier. Traditional tests detect a single analyte per strip. Next-generation architectures are enabling simultaneous detection of multiple biomarkers on a single device – multiplex immunoassays – supporting differential diagnosis, treatment selection, and patient stratification in a single test. For IVD companion diagnostics applications, where treatment decisions may depend on multiple biomarker results, multiplexed lateral flow creates the possibility of a single point-of-care test replacing what currently requires multiple laboratory assays. A great example is the work we have done with a global consortium led by Institut Pasteur with world leading partners including FIND, WEHI (Walter and Eliza Hall Institute of Medical Research), Armauer Hansen Research Institute, London School of Hygiene and Tropical Medicine, Pasteur Network and DiaTropix. Abingdon Health has led the development of a multiplexed 4-panel rapid serological diagnostic test to detect Plasmodium vivax hypnozoites, which will be critical for malaria disease control, especially in remote areas.

Another area of innovation is the integration of microfluidics, which is pushing lateral flow further still. By incorporating sample preparation, metering, and mixing steps into the device architecture, microfluidic lateral flow platforms can handle complex sample types, improve performance and ultimately expand the clinical settings where lateral flow can operate, and the range of analytes it can reliably detect. A great example is 52 North’s innovative sepsis test, Neutrocheck^®: a simple-to-use finger-prick blood test that simultaneously assesses neutrophil count and C-reactive protein (CRP) levels.

The Digital Layer

Alongside the physical evolution of the test strip, a digital layer is transforming how lateral flow results are captured, interpreted, and used. Dedicated readers and smartphone-based apps are replacing visual interpretation with quantitative measurement, turning a binary positive/negative result into a numerical value that supports clinical decision-making, treatment monitoring, and population-level surveillance for in vitro diagnostic test applications.

This digital integration creates new possibilities. Connected lateral flow devices can transmit results to electronic health records, enable remote monitoring of chronic conditions, and generate real-time epidemiological data. For regulatory purposes, digital readout also provides an objective, auditable result that eliminates the inter-reader variability inherent in visual interpretation, an increasingly important consideration for IVD companion diagnostics (CDx) and other applications where result accuracy has direct patient treatment and regulatory pathway consequences. Abingdon’s work with leading German biotech 4Teen4 is a case in point: we are supporting the development of a companion diagnostic test, DPP3 InvoSelect, in parallel with 4Teen4’s clinical program, aiming to identify patients most likely to benefit from this targeted therapy. Abingdon has worked with 4Teen4 to select the most appropriate reader for the user that offers a customised display that provides clear and unambiguous results.

What This Means for Development and Manufacturing?

The convergence of lateral flow with molecular, digital, and microfluidic technologies has a direct consequence for how these products are developed, manufactured, and brought through regulatory approval.  The future belongs to application-specific, technology-integrated lateral flow products that require genuine IVD development expertise, bespoke manufacturing capability, and regulatory depth – preferably with the integration of all three workstreams under full program management.

A molecular lateral flow test demands expertise in both nucleic acid amplification and immunochromatography. A multiplexed companion diagnostic assay requires understanding of biomarker biology, assay cross-reactivity, and regulatory strategy for multi-analyte in vitro diagnostic devices. A connected lateral flow platform needs a clear understanding of reader technology (e.g. hardware engineering, software development, and cybersecurity considerations) alongside traditional assay design.

This complexity changes the CDMO relationship fundamentally. Companies developing next-generation lateral flow products need development partners with broad technical capability, not just strip manufacturing capacity. It takes the ability to integrate immunoassay development with reader design, to navigate regulatory pathways for combination products, and to scale bespoke manufacturing processes that are inherently more complex than traditional lateral flow tests – these capabilities separate the CDMOs that can support the future of the technology from those that can only reproduce its past.

The Opportunity

Lateral flow is not being replaced. It is being elevated. The same core technology that made rapid testing accessible to billions of people worldwide is now being combined with complementary innovations to address clinical questions that were previously the exclusive domain of centralised laboratories. For companies developing IVD companion diagnostics, precision medicine assays, infectious disease tests, and novel biomarker platforms, this convergence represents an extraordinary opportunity; provided they choose development partners with the technical breadth and manufacturing sophistication to deliver on it.

Abingdon Health provides integrated lateral flow development, tech transfer, regulatory and commercial manufacturing services from facilities in Madison, Wisconsin, USA; Doncaster, UK; and York, UK. Our dual-site development and manufacturing capability enables companies to develop and manufacture close to their primary markets, with regulatory expertise supporting FDA 510(k), PMA, and CE-IVDR submissions. We offer full program management across development, manufacturing and regulatory workstreams with unrivaled expertise in leading complex diagnostic projects and bringing the next generation of lateral flow products to market on behalf of our customers.

Get in touch with Abingdon Health to explore how our integrated approach can accelerate your market access.