CE mark

The British-based firm says that its assay detects hepatitis C via a single-use, disposable cartridge within 90 minutes of testing. 

The test, miRpredX 31-3p, is a positive theranostic test that quantifies the expression of miR-31-3p in FFPE using RT-qPCR technology. 

Based on iCubate's Amplicon-Rescued Multiplex PCR technology, the iC-GPC assay is the first of the company's portfolio's to earn CE mark.

The test is intended to detect FLT3 mutations in order to select patients for treatment with Novartis' Rydapt, and has also been approved by the US FDA.

The company's new QuantStudio 5 Dx Real-Time PCR system allows users to wield multi-modal software to detect pathogens.

The tubes enable noninvasive collection and preservation of biomarkers, such as circulating or total nucleic acids, and protein and cellular biomarkers.

T2 said that the panel will be commercially available in Europe in Q3, and added that it is in the midst of completing a pivotal trial in preparation of a submission to the FDA.

NGeneBio is moving ahead with plans to have the test cleared for diagnostic use in Korea, while envisioning a 2019 submission to the US FDA.

The test, which is currently for research use only, uses fluorescent multiplex PCR to co-amplify seven markers for analysis of the MSI-high phenotype.

The Korean molecular diagnostics startup is planning to launch the new offering in Europe, as well as China and other Southeast Asian countries.

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Thermo Fisher Scientific says it will no longer sell machines in China's Xinjiang region, according to the Wall Street Journal.

New Scientist reports that 20 percent of human and yeast proteins are uncharacterized.

The University of Zurich's Ruedi Aebersold and his colleagues analyzed a dozen HeLa cell lines to find differences in gene expression, protein levels, and more.

In Nature this week: protein-coding variants associated with body-fat distribution, and more.