CE mark

The European Commission has now approved the anti-PD-1 therapy Keytruda, and the Dako test with it, as a first-line treatment for non-small cell lung cancer.

Illumina said the registration for its analysis software is the first step toward launching a full CE-IVD VeriSeq NIPT assay in Europe.

The firm received the CE IVD mark for Amplidiag Easy, an automated system that enables nucleic acid extraction and PCR setup directly from stool samples.

The firm said that it has completed clinical trials for the Group B Strep assay for the FDA and will start trials for the C. difficile test this month. 

The Hereditary Cancer Solution combines target capture probes from Integrated DNA Technologies with specialized analytics developed by Sophia.

The test combines two previously CE marked assays that are based on the company's Nucleosomics platform for identifying and quantifying nucleosome structural features.

The combination of the new test with Biocartis' existing KRAS assay offers customers a complete solution for testing metastatic colorectal cancers as reccomended by professional guidelines.

The next-generation sequencing-based test is designed to detect bacteria and viruses in blood samples from patients with suspected infections, especially immunocompromised patients.

The assay uses loop-mediated isothermal amplification to directly detect Streptococcus agalactiae infection, a common cause of neonatal meningitis.

The real-time PCR-based test runs on the BD Max system and comes in a single tube that snaps into the BD MAX extraction cartridge.

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New results from the NASA Twins Study indicate that the immune system may rev up when in space, the Washington Post reports.

Kelvin Droegemeier, the new science advisor, spoke at the American Association for the Advancement of Science meeting, Geekwire reports.

In PNAS this week: whole-genome assembly for the white shark, paper-based microfluidic method for detecting the malaria parasite, and more.

The World Health Organization has announced the members of its gene-editing committee, according to NPR.