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FDA clearance

The US Food and Drug Administration yesterday granted emergency use authorization to Thermo Fisher Scientific's TaqPath Zika Virus Kit.

The new version of the mass spectrometry-based system adds 144 microbial species to its database and includes new tools for sample preparation.

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 firm said that the RealTime CMV test is the only commercially available cytomegalovirus that can amplify two select regions of the CMV genome.

At the WIN Symposium, a Merck executive detailed how data from a basket study led to the first pan-cancer, biomarker-informed cancer drug. 

The kit was previously approved by FDA for use on Qiagen's Rotor-Gene Q real-time PCR platform, which is one component of the automated QiaSymphony platform.

The FDA approved the real-time PCR-based test for use on the Cobas 6800 and 8800 systems to assess the response of transplant patients to treatments. 

The GenePOC GBS LB assay uses real-time PCR technology to detect GBS colonization from lim broth samples with sensitivity of 95.9 percent and specificity of 95.5 percent. 

The real-time PCR, sample-to-answer assay provides surveillance of whooping cough, a contagious respiratory disease, in clinically symptomatic patients.

The Ventana PD-L1 assay was approved as a complementary diagnostic for bladder cancer patients being considered for treatment with the immunotherapy Imfinzi. 

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The Wall Street Journal looks into FamilyTreeDNA's handling of genetic genealogy searches by law enforcement.

In a point-counterpoint in the Boston Globe, researchers discuss the potential of gene editing to prevent Lyme disease, but also the pitfalls of doing so.

MIT's Technology Review reports that researchers hope to develop a CRISPR-based pain therapy.

In Science this week: atlas of malaria parasites' gene expression across their life cycles, and more.