Fiomi is finalizing development of lead troponin I assay and analyzer.

Trinity Biotech is buying Fiomi Diagnostics for $9.7 million up front in cash and shares, plus potentially another $3.4 million in cash contingent on the achievement of certain regulatory filings and approvals of the latter’s lead diagnostic products.

Swedish firm Fiomi is exploiting its micropillar flow technology for the development of a panel of point-of-care cardiac markers, and associated desktop analyzer. The instrumentation and initial cassette-based troponin I assay are in late-stage development, and Fiomi expects to achieve a CE mark during the latter half of 2013. Once European approval has been granted FDA clearance will be sought.

Trinity says it plans to expand Fiomi’s existing operations in Uppsala, and will invest the extra $11 million or so it estimates will be needed to complete product development, achieve European and FDA approval, and establish full-scale production. Expanded R&D operations at Fiomi will also facilitate the development of assays for BNP, and a multiplex cardiac panel that it projects could result in a complete suite of cardiac products by the end of 2014.

The Fiomi platform also represents an ideal complement to Trinity’s own core infectious disease point-of-care business, for the potential development of highly sensitive multiplexed infectious disease assays for the pathogens responsible for Chlamydia, gonorrhoea, and influenza A/B.

Fiomi was founded in 2010 to commercialize microfluidic chip technology technology originally developed at Amic, for the POC analysis of whole blood samples, with the same performance achieved by laboratory-based tests. The Forecast technology is based on microstructured plastic chips which provide a repeatable flow of fluid in lateral flow assays, combined with an efficient fluorescence detection system.

Two days ago Trinity reported European CE Mark approval of its POC Uni-Gold™ Giardia Test, a 15-minute lateral flow immunoassay that detects Giardia lamblia antigen in fresh and preserved human stool samples. 

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