With the lateral flow test market set to grow to circa 8.24 billion USD by 2022, it’s an area of the healthcare sector experiencing significant expansion, driven by factors including growing demand for point-of-care testing and home-based care.

As decentralized testing becomes a more common requirement, the growing challenge for product managers is to develop outstanding lateral flow products that will create a competitive commercial edge. This can be testing for people who might not be familiar with the technology and processes involved in immuno assay development.  

There is a significant uptake in demand around this area from new corners of the market. Lateral flow tests enable more efficient diagnosis and patient evaluation; helping to improve patient care – particularly for people with chronic cardiovascular conditions and diseases like diabetes and cancer, so they hold great potential for businesses.

Although this can seem like straightforward, simple technology, there are a number of important steps to get right in order to develop a robust, reliable test that will deliver the best results. Ideally, your OEM developer will have a number of design control phases in place that will ensure each step of the development process is carefully monitored. A go/no go design review phase that confirms each step of the process is symptomatically assessed is the ideal scenario and ensures that the procedure is only advanced as it is cleared at each point.

The first port of call for any project is the assessment of feasibility, when the antibodies, reagents and materials are selected. Before any practical work starts, it is essential that there are clear product specifications or design inputs set so the design control team knows the performance requirements of the assay in terms of sensitivity, limit of detection and specificity.

Performance parameters also need to be agreed, including what the test will look like, sample volume and read time.The assay then needs to be optimized. This is another key step along the journey and ensures that the assay is robust.

At BBI Solutions, we do this by generating data on at least three different lots of critical raw materials and ensuring equivalent performance data. As someone commissioning a lateral flow test, you should have the freedom to work hand in glove with your test manufacturer. A good supplier should act like an outsourced R&D team – meaning you don’t need to invest in developing deep levels of lateral flow capability in house.

This collaborative approach will bring a huge benefit as your OEM should have a deep well of experience which provides a solid knowledge base and removes the issues which often trip up new developers.

The increasing use of lateral flow immunoassays in diagnostic applications, means many product managers are operating outside their normal sphere of expertise. In order to develop a robust and highly performing test in as short a time frame as possible, it is worth product managers considering outsourcing the development and ultimate manufacture of the tests to an OEM partner and ensuring that they are familiar with the technology to enable them to work closely and effectively with their OEM.

Source: MDDI/Qmed