Next week, the Abingdon Health team will be at the NextGenDx Summit in Washington DC, USA, a global event connecting world-class leaders to accelerate breakthrough diagnostic innovations. Chris Yates will deliver a talk on this topic on Tuesday, 26th August at 10am in the Transforming POC Diagnostics stream, and shares his key insights with us ahead of the conference:
For decades, diagnostics ran on a simple but limiting model: draw a sample, send it away, wait. A patient with a fever in a rural clinic, a soldier in a forward operating base, or a farmer worried about a sick herd all share the same problem; the answer they need exists somewhere in a lab, hours or days out of reach. Point of care (POC) diagnostic technology developed to close that gap, bringing laboratory-grade answers to the bedside, the field, or the doctor’s office.
Over the years, the industry – including me – has talked about the decentralisation of testing and the personalisation of medicine and the role that diagnostics will play in this. We are now seeing this happen, and the next generation of these tools is being defined by three converging engineering goals:
- making tests smarter,
- making them faster, and
- making them reach further than ever before.
This shift is playing out against a backdrop of strong, sustained growth in diagnostics and MedTech more broadly. The global diagnostics market is projected to grow from $115.5bn in 2024 to $169.2bn by 2030, a 6.6% Compound Annual Growth Rate (CAGR), within a wider MedTech market already worth over $640bn today.
But the headline figure understates the real story: it is not just the market that is growing, it is the mix that is changing. Point of care diagnostics specifically is forecast to grow from $49.5bn to $106bn between 2025 and 2033 – a 10.7% CAGR – well ahead of the core market, while at-home and direct-to-consumer testing is compounding at a similar 10.9% CAGR, growing from $5.4bn to $13.8bn by 2033, alongside wearable healthcare devices growing at 10.9% CAGR too.
Testing is not simply expanding; it is decentralising, moving out of the central lab and into homes, pharmacies, and on to people’s wrists.
Several forces are driving this shift. Demographics are the most structural: the global population is set to grow toward 10.3bn by the mid-2080s, and the number of people aged 60 and over will rise from 1.0bn in 2020 to 1.4bn by 2030, a group that visits doctors more often and needs more frequent monitoring. Economics is pushing in the same direction: US family health premiums have risen 26% in five years to nearly $27,000, and the global cost of ageing is set to climb from $7tn to $15tn by 2030, making prevention and early detection a cost-containment strategy as much as a clinical one. Culture matters too; a self-directed, tech-native generation is engaging with health proactively but outside traditional clinical pathways, with the majority of Gen Z and Millennials turning to AI before they see a doctor. This pattern is repeating at pace across the Global South, where young, smartphone-connected populations are leapfrogging straight to cloud-based, point of care testing rather than waiting for fixed-lab infrastructure to be built. And AI itself is the accelerant running through all of this, growing roughly six to eight times faster than the underlying diagnostics market and becoming the connective layer that makes sense of an increasingly decentralised flow of data. Together, these forces mean the next generation of point of care diagnostics is not a niche innovation story; it is where an increasing share of the market itself is heading.
Smarter: From Strips to Systems
The first generation of POC testing – think glucose meters and pregnancy tests – relied on simple chemistry and a human eye to read a line. Smarter diagnostics now embed computation directly into the sensing process. Microfluidic “lab-on-a-chip” devices route a single drop of blood or saliva through channels engineered at the scale of a human hair, performing multiple assays simultaneously on a chip smaller than a credit card. Genalyte’s Merlin instrument is a striking example: its silicon-chip immunoassay platform achieved FDA clearance in 2024 for a TSH assay and can now run up to 26 tests from a single sample with results in around 30 minutes, delivering laboratory-grade multiplexing on a bench-top device. The basic technology is also improving, with innovation in sample preparation, labels and reagents, to create improved sensitivity and performance.
This intelligence layer matters because biology is complex, and at times messy. A single biomarker rarely tells the whole story; multiplexed sensors that read several markers at once, and that tie in additional parameters such as age, sex or location, cross-checked by an algorithm trained on thousands of prior cases, produce far more reliable calls than any single-analyte strip ever could. The Mira fertility monitor demonstrates this well: it tracks four primary sex hormones (LH, the oestrogen metabolite E3G, the progesterone metabolite PdG, and FSH), then calibrates against the user’s own baseline and age profile rather than a static textbook cut-off, building what Mira calls a personal “hormonal fingerprint.” Engineers are also building in self-calibration and quality-control checks, so a device can recognise when a sample was poorly collected or a reagent has degraded, catching errors before they become misdiagnoses. The Inito fertility monitor takes a similar approach at the strip level, with embedded QR codes and internal reference chemistry lanes built into each test strip so the device can verify and calibrate every single read.
Faster: Compressing the Clock
Speed has always been the core promise of point of care testing, but “faster” now means something more ambitious than shaving minutes off a wait. Engineering this kind of speed requires rethinking every step of the pipeline, starting with sample preparation – historically the slowest and most labour-intensive stage. Companies such as Oasis Diagnostics are redesigning this step with non-invasive systems like SuperSAL 2, PureSAL and RNAProSAL, which collect and process purified whole saliva, cell-free DNA/RNA and proteins in as little as one to five minutes, with no centrifuge or trained hand required.
Microfluidics is doing similar work further down the pipeline by folding several process steps into one device. 52North’s Neutrocheck® device, built on its patented Aster™ platform, simultaneously measures both cell-based and protein-based biomarkers from a single drop of whole blood, without a laboratory or external power source. Isothermal nucleic acid amplification techniques allow genetic material to be detected without the bulky heating and cooling cycles of traditional PCR machines; cutting infectious disease detection from hours to under twenty minutes. StrandID pushes this into a paper format, combining high-affinity multivalent DNA binding with a molecular lateral flow strip to bring laboratory-grade genetic testing precision to a simple, paper-based readout. Abingdon Health’s own PCRD technology is increasingly supporting a range of applications in this “molecular lateral flow” space – which, for me, is a particularly exciting area of POC innovation.
The interpretation step is compressing too. Unifai Technology’s AI tools cross-reference point of care readouts against external data, such as changing environmental factors and a patient’s historical metrics, turning a single result into a contextualised, rapid decision rather than a raw number. Across all of these innovations, the gap between “sample in” and “answer out” is shrinking; a gap that, in outbreak response, can be the difference between containment and spread, or in emergency medicine, between life and death.
Further: Reaching the Unreached
Perhaps the most transformative shift is geographic and infrastructural. Traditional diagnostics assume a supply chain: cold chain (e.g. refrigeration), electricity, trained lab technicians, and a facility to house it all. Billions of people live without reliable access to one or more of these. Engineering for “further” means designing diagnostics that function in their absence. This also has significant implications for self-testing, as these characteristics allow simpler, more cost-effective diagnostics into the home, increasing the ability for preventative diagnostics and allowing individuals to manage their own health proactively.
That starts with removing the cold chain itself: the Abbott CheckNow HIV rapid test kit is stored at a standard 2°C to 30°C, so freeze-dried, ambient-stable reagents replace refrigeration entirely. Connectivity is being reimagined too. One example from the Global South is in Uganda: mTrac, a government-led mobile health initiative, uses simple SMS text messages on basic mobile phones to track weekly public health data, disease outbreaks and medical stock levels from thousands of local health facilities, no broadband required, feeding into regional disease-surveillance systems that give public health officials real-time visibility into outbreaks as they emerge, not weeks after the fact.
Removing the need for a dedicated reader and for electricity allows further decentralisation still. , Abingdon’s proprietary smartphone app reader for lateral flow tests, removes the subjectivity of interpreting a line by eye, turning any smartphone camera into a calibrated reader. And Seek Labs’ Seekit molecular lateral flow device combines proprietary room-temperature chemistry with simple fluidics to deliver PCR-level diagnostic accuracy in a single-use, standalone device with no external power source at all. At a broader level, there are other shifts happening with diagnostic innovations toward on-board heating elements, paper batteries, and isothermal chemistry that removes the need for heat altogether, for example.
This reach extends POC technology across the Global South and also decentralises testing further in more developed markets such as the United States and Europe, from at-home test kits that rival hospital lab precision to telehealth-linked devices that let a rural patient’s results reach a specialist instantly. The frontier of point of care is expanding to mean any point at all: a home, a workplace, a pharmacy, a person’s wrist.
The Engineering Challenge Ahead
None of this happens without trade-offs. Smaller, cheaper and faster devices must still meet rigorous standards for sensitivity and specificity; a fast wrong answer is more dangerous than a slow right one. Regulatory pathways, manufacturing scale-up and cost remain real constraints, especially for the low-resource settings that stand to benefit most.
But the trajectory is clear. As materials science, microfluidics, molecular biology and machine learning continue to converge, point of care diagnostics are shedding their reputation as a lower-fidelity alternative to lab testing. They are becoming something new entirely: a distributed, intelligent diagnostic network that meets people where they are. Smarter, faster, further isn’t just a tagline; it’s the engineering roadmap for making accurate, timely healthcare answers a right, rather than a privilege of proximity.
What Does It Mean for Your Choice of CDMO Partner
When selecting a diagnostics CDMO partner, two key elements are essential: flexibility and integration.
Increasingly, Abingdon Health is partnering with customers that have novel, bespoke POC systems and diagnostic products. Each of these requires a unique approach, as standardised manufacturing lines and development processes are not compatible. Your CDMO must be flexible and have an open mindset to building tailored solutions that meet your specific requirements. The CDMO’s development framework must be flexible enough to support your development process, and their manufacturing setup must enable bespoke manufacturing lines or processes to be developed. We are increasingly working with customers on a range of complex POC platforms that require this approach.
Secondly, integration is key. The complexity of developing a new POC system and platform means there is a huge benefit to working with a CDMO partner that has a comprehensive service solution covering development, scale-up, manufacturing, regulatory strategy, performance evaluation and clinical trial management. Why? Because there are significant efficiencies to be made in integrating these processes and synchronising them effectively. It saves time and money and speeds up market access. One example is the use of AI and software alongside a diagnostic device: a CDMO with regulatory capabilities in both areas can integrate your regulatory approach and ensure that you, the customer, are not left co-ordinating a range of different providers across different service lines.
The Opportunity
POC diagnostics is at an exciting inflection point as we see the convergence of various technologies that allow the increased decentralisation of diagnostic technologies which are faster and smarter. For companies developing in vitro diagnostic companion diagnostics, precision medicine immunoassays, infectious disease rapid tests, and novel biomarker platforms, this convergence represents an extraordinary opportunity; provided they choose CDMO partners with the flexibility and comprehensive service offering to deliver on it.
Abingdon Health provides integrated diagnostic development, tech transfer, regulatory consulting and commercial manufacturing services from facilities in Madison, Wisconsin, USA; Doncaster, UK; and York, UK. Our multi-site development and manufacturing capability enables companies to develop and manufacture their diagnostics close to their primary markets, with regulatory expertise supporting FDA 510(k), PMA, and CE-IVDR submissions. We offer full program management across IVD and MedTech development, manufacturing and regulatory workstreams, with unrivalled expertise in leading complex diagnostic development projects end-to-end, 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.
