Looking to the future: Exploring the trends shaping next generation assay development
In this online exclusive, Dr Karen Whiting, global head of New Product Development at BBI Solutions, looks at the evolution of the diagnostics market and how new approaches can help companies’ future-proof their products.
The diagnostics market is constantly evolving and companies that want to stay ahead of the curve need to be continually exploring new approaches and innovations to ensure the future of their product.
Even a relatively traditional, well-established market like lateral flow immunoassay is not immune to the quickening pace of change and developers in these areas need to be live to innovation to continue to attract consumers and stay relevant.
As an OEM leader, which develops hundreds of immunoassays, our clients include universities, spinouts, large scale diagnostics companies and more recently pharmaceutical companies and we are seeing key shifts in approach across all our key client groups.
We work with R&D managers in the lateral flow sector to future-proof their products and create the best assay possible with the reagents available. As such, we’re attuned to shifts in the market and we’re seeing a number of emerging trends, which we predict will be key in shaping how lateral flow development is approached.
One change we’re seeing is a real push for lower limits of detection. Much lower assay sensitivity are now required, with pg/mL measurements required to detect trace biomarker amounts within the assay
This trend will have a real impact on the market and require diagnostic companies to up their game and create assays with extremely sensitive detection levels. Requirements of this level will need incredibly robust assays, capable of delivering outstanding sensitivity even at picogram levels of analyte.
In order to achieve these levels of quality, it’s key that developers are working closely with their clients at each stage of the process to create a really robust, responsive assay that is capable of dealing with the incredibly stringent requirements that industry innovation demands.
The design specification at this stage is key — it needs to consider a wide variety of aspects, such as what the assay looks like, how sensitive it is, how specific it is, and how robust it needs to be.
Processes that enable the developer to collaborate closely with the client at key stages of the assay creation process are important when operating at this level. Design control phases using a go/no go control system which ensure that each step is systematically assessed are helpful in ensuring that the process is qualified and that each stage of the assay development is carefully monitored. This ensures that the process is only advanced as it is cleared at each point.
Another key industry shift we’re seeing is a focus on quantification. It is no longer sufficient for assays to provide binary responses. There is an increasing demand for a level of quantification — providing a deeper, analytical reading of the test result. This provides our end users with more insight and information, and makes more of the data available — deepening engagement and enabling tracking and sharing of results.
We’ve seen early advances in lateral flow pregnancy test area, with a number of products available on the market that show women when conception occurred. The industry is continuing to build on this area, and we predict that this will be an area where we’ll see huge leaps over the next couple of years.
As a business committed to shaping the future of innovation in lateral flow, remaining abreast of and attuned to industry shifts and new approaches is critical. In common with many other businesses in the manufacturing sector, there is an increasing focus on sustainability, which is driving key changes across the industry. From an OEM perspective, new biodegradable products that will be able to complement and eventually replace the plastics in the test housings will be a huge priority for the industry. The development of quality, plant-based materials is just one area of innovation that promises to revolutionise the environmental impact of the diagnostics sector.
It’s an exciting time for the industry and developing an approach, which encourages best practice, and innovation throughout the supply chain will be key to ensuring we drive forward positive change and capitalise on the innovations surfacing across the sector.