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 ...

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.

The firm executed contracts for 11 T2Dx instruments in the quarter and saw its sepsis test panel revenue increase 42 percent.

Last week, readers were most interested in a story about a new respiratory test launched by Roche leveraging a new PCR technology.

The firm will enter studies this month aimed at obtaining CLIA waiver for its FDA-cleared FebriDx assay to distinguish bacterial from non-bacterial infections.

Jeffrey Madison had been accused of participation in a scheme to pay kickbacks to physicians for testing referrals and billing healthcare programs for the tests.

The stool-based test is the next-generation version of Exact's existing Cologuard test for colorectal cancer screening.