From start-up to global business

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

The Challenge

080514_047Estimated 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.聽 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 鈥 cue vision-biotech.

The Solution

The company first met vision-biotech in 2007 when it began the search for a partner with lateral flow capabilities.聽 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.聽 The Managing Director (MD) explained why VBT was selected as partner of choice 鈥淰BT鈥檚 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鈥.

With a dedicated team of scientists working exclusively on the project and regular review meetings throughout, the project was a success.聽 The MD commented 鈥淰ery few projects take the shortest path from A to B but working with VBT we were able to meet our objectives in the required timeframes鈥.

Results and benefits

The first early screening lateral flow test to diagnose celiac disease was launched in 2010.聽 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.聽 The human impact is also vast, the patient鈥檚 experience and diagnosis has been improved and costs reduced.

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

On the relationship with VBT today, the MD said 鈥淚n addition to its OEM services, we also use VBT鈥檚 gold 鈥 a critical reagent in our assay.聽 Reliable and responsive, VBT is a total solution provider for lateral flow and a key partner to our business鈥.

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