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The claim, enabling streamlined screening of pooled samples, follows updated industry recommendations for Zika virus screening in the US blood supply.
Roche received several clearances, including for its Cobas CT/NG assay and for modifications to previously cleared blood clotting systems.
Despite the astronomical costs, it may prove challenging to reverse course and discontinue Zika testing according to a commentary article accompanying a NEJM study.
The companies will work together to enable Foundation Medicine’s assays to be offered across Dian’s network of laboratories in China.
Lifted by a strong flu season, Cobas Liat PCR placements reached 1,500 systems in the US. Globally, year-over-year sales for the point-of-care system grew 262 percent.
Digital pathology has been relegated to research use only in many smaller labs, but an FDA approval last year, and more options targeted to them, may change that.
The company unveiled forthcoming products for high-throughput molecular testing, diagnostic lab informatics, and microbiology automation.
The FDA approved its use with tissue or plasma biopsies, giving clinicians a non-invasive option to conduct a test that provides results in a day.
Presentations largely reflected negatively on the utility of PD-L1 for stratifying response, but pivotal new data on tumor mutational burden as assessed by Foundation Medicine's genomic sequencing panel.
The firm said that its Cobas CT/NG real-time PCR assay is the first available in the US for the testing of sexually transmitted infections on its 6800 and 8800 systems.