Technopath Follows Lead of IVD Manufacturers, Brings Test Consolidation to QC Processes

As reported on the IVDT Insight blog earlier this week, Technopath Manufacturing (Ballina, Ireland) has been named the Emerging Medical Technology Company of the Year at the Irish Medical Technology Industry Excellence Awards. The company received the prize during an awards banquet held in Galway, Ireland, on December 13, 2012. We spoke with Technopath CEO Malcolm Bell and asked him about the company's technology and how this award might affect the company.

A wholly owned privately held company based in Ballina, Co. Tipperary, Technopath manufactures products that monitor the quality of hospital laboratory blood tests and prevent the reporting of inaccurate results. A unique aspect of its product platform is the test consolidation it brings to IVD quality control processes.

Technopath is following the consolidation trend of the global pathology market in the western world, explains Bell. Pathology labs used to have dedicated laboratories and instruments covering many disciplines such as biochemistry, immunoassay and haematology. That has been consolidated as large-scale automated systems and single test platforms become the norm, he adds.

"The IVD industry has moved into test consolidation, whereas the associated quality control products made by our competitors have not," says Bell. Stability issues have been one of the primary reasons for the disconnect.

Malcolm Bell (left), CEO, Technopath Manufacturing, receives the Emerging Medical Technology Company of the Year award from Brian O¹Neill, Manager, Life Sciences, Enterprise Ireland.

Technopath has developed proprietary technology that removes that stumbling block and reportedly brings test consolidation to the global hospital laboratory market. Technopath received a vote of confidence in its technology recently when it signed a global product development, supply, and distribution agreement with Abbott Diagnostics, which has IVD operations in Sligo and Longford, Ireland.

"Our frozen products have a 30-month shelf life and, when thawed, deliver 10 to 14 days open-vial stability, depending on the product," says Bell. "Maintaining stability is very important. We have many proprietary steps in our procedures before we get to our finished products that enhance stability. That begins with our raw material—human plasma—which we defibrinate into serum and stabilise. We have a proprietary method of defibrinating the plasma, which greatly benefits the stability of the enzymes in the finished product. We also prestabilise many analytes before addition to the matrix, which also has a very positive effect on the end product."
Winning the emerging company of the year award has had tremendous internal impact, but it also has national and international ramifications, says Bell.

"We have had a huge 12 to 24 months in terms of getting new products to market and improving our product offering. Winning the Abbott contract brought a big sense of achievement to the team. But the award also brings greater national and international recognition. And it gives us a boost from a recruitment perspective," says Bell. That will be especially welcome as Technopath gears up for another banner year. The company currently has a staff of 78—it expects to hit the 100 mark by the end of 2013.

Norbert Sparrow