OMEGA Diagnostics has passed a “milestone”, having gained accreditation to sell its Malaria detection products through business to business channels in the European Economic Area.

The Visitect Malaria range of three testing kits, which are manufactured at the Clackmannanshire business’ facility in Pune, India, have been granted CE Marking.

The medical diagnostic group said that it anticipated additional regulatory approvals within the next 12 months, which would enable it to participate in higher volume tender business.

Omega has also confirmed that its Pune manufacturing facility has secured its manufacturing licence until January 2021, following an annual inspection from the Indian FDA.

Andrew Shepherd, chief executive, commented: “This milestone demonstrates our continuing investment in people and infrastructure is beginning to bear fruit.

“Whilst we expect relatively modest sales during the next financial year to 31 March 2018, we anticipate generating significant demand from the subsequent financial year onwards with high quality products at affordable prices which are both crucial for commercial success.”

In its most recent accounts Omega, saw its infectious disease division grow sales by one per cent to £1.23 million. The company has invested more than £1m in its Pune site, and the CE Marking will accelerate the commercial capabilities of the facility.

In January, the group achieved accreditation from BSI and its first commercial sales of the Visitect Malaria range.