The firm received de novo marketing authorization for its combination antigen test, and the developers of subsequent tests will be able to seek 510(k) clearance.

In addition to distributing Gradientech's QuickMIC system in the US and Canada, Hardy Diagnostics will become one of the firm's largest shareholders.

Canadian life sciences firm Microbix Biosystems announced recently that it has received CE marking under the EU’s In Vitro Diagnostics Regulation for 11 of its diagnostic assay quality assessment ...

The Ireland-based firm said that the financing will support clinical trials of an HIV test and help the company to strengthen its product pipeline.

The company is targeting its RPPA-based testing to biopharma firms as well as for clinical trial work and to clinicians to help guide therapy in cancer patients.