Lateral Flow Test Development

Case Study

From start-up to global business: A success story

The Challenge

European company partners with BBI to launch a world first lateral flow test

Estimated to affect 1 in 100 people, celiac (or coeliac) disease is one of the most under-diagnosed medical conditions, leaving people of all ages at risk of long-term health complications.

Traditionally an invasive procedure requiring lab analysis, a team of medical experts identified the need to lower the hurdle to diagnosis by providing lab quality results, using a rapid and cheaper solution at the point of care.

Lateral flow was identified as the platform to achieve this. A start-up, the company had application expertise, but did not have the technical experience to develop the lateral flow assay or the volume manufacturing capabilities – cue BBI Solutions.

The Solution

The company first met BBI Solutions in 2007 when it began the search for a partner with lateral flow capabilities. The decision to outsource would speed up time to market and allow the company to focus on the commercial aspects of a new product; generating demand and launch, including regulatory requirements and clinical studies.

The company considered three suppliers as part of this process. The Managing Director (MD) explained why BBI was selected as partner of choice “BBI’s development experience, combined with its FDA registered manufacturing facility and certified quality management systems, gave us the confidence we needed to move forward with this critical project”.

With a dedicated team of scientists working exclusively on the project and regular review meetings throughout, the project was a success. The MD commented:

Very few projects take the shortest path from A to B but working with BBI we were able to meet our objectives in the required timeframes

Results and Benefits

The first early screening lateral flow test to diagnose celiac disease was launched in 2010. With 200 million potential users worldwide, the company has extended its distribution network into 14 countries across Europe and has recently secured approval to sell into Australia.

While competing products have entered the market since, using the latest generation of biomarker and high quality reagents, the assay remains the most specific test in the market today.

The success of the project to a once small start-up business is evident. The human impact is also vast, the patient’s experience and diagnosis has been improved and costs reduced.

Using BBI’s experienced development team provided the company with a more efficient route to market. Outsourcing manufacture to BBI provided immediate cost and time savings and comfort that scale up would be rapid.

On the relationship with BBI today, the MD said:

In addition to its OEM services, we also use BBI’s gold – a critical reagent in our assay. Reliable and responsive, BBI is a total solution provider for lateral flow and a key partner to our business

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