The company has developed a blood-based test to assess whether women are carriers of the antibodies that cause maternal autoantibody related-autism.
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 ...