Omega's deal with Japanese giant opens US possibilities

Scottish medical kit maker Omega Diagnostics has signed a deal with a subsidiary of Toyota which will help it break into the US market.

Aim-quoted Omega, based in Alva, Clackmannanshire, said yesterday it had signed a ten-year exclusive distribution agreement with Toyota Tsusho America covering the future sale and distribution of its Food Detective product in the US.

Unlike many of Omega's products, which are made for the pharmaceutical industry, Food Detective is aimed at consumers, and allows people to test themselves for food allergies. It is already sold in more than 50 countries.

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Chief executive Andrew Shepherd said the US had always been seen as a major potential market, but the need to undergo a lengthy regulatory approval process with the Food and Drug Administration (FDA) had posed a barrier.

"Having someone with the financial clout of Toyota behind us, that won't now be a concern, but it will take time," he said

Under the agreement, Toyota will fund the costs involved in obtaining relevant clinical data for a submission to the US FDA, but clearance is expected to take between one and two years.

Shepherd said it was difficult to say what effect entry into the US market would have on Omega's sales, but it was likely to be "substantial".

The Scottish firm also discussed distribution of Food Detective in Japan with Toyota. Shepherd said that a deal has been put on hold because of difficulties following the recent earthquake and tsunami, but approval by the US FDA and success in America would open the way for a launch in Japan, which has a similarly tough regulatory framework.

William Weiner, chief operating officer of Toyota Tsusho America, said: "Utilising our knowledge and experience in the diagnostic testing market in the US, along with our superior logistics and supply chain, we look forward to selling (Food Detective] through a variety of sales channels, after receiving FDA clearance."

Omega built up a working relationship with Toyota through its clinical work in Africa, where the Japanese giant is involved in aid projects.