The governmental funding will support the company's plans for a 1,350 participant trial that aims to further validate its protein-based cancer early detection assay.

The round, which was led by Formation Venture Engineering, will support commercialization of the company's SAAmplify-ɑSYN biomarker test as well as increased R&D.

The US Food and Drug Administration granted marketing clearances for multiple infectious disease tests and a blood culture sample preparation system, among other devices.

Tests for SphingoTec's penKid biomarker of acute kidney injury will become available to central labs through Beckman Coulter's Access instruments.

CyPath Lung is a laboratory-developed assay that uses self-collected sputum samples treated with a fluorescent compound that preferentially binds to cancer cells and cancer-related cells, San ...

The agreement's goal is to bring a blood-based test to market to stratify patients with traumatic brain injuries.

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

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.

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 ...

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

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.