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regulatory approval

The story has been corrected to say that certification from New York is for AssureRx's laboratory not its GeneSightRx test.
By a GenomeWeb staff reporter

By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – Rosetta Genomics today said that the New York State Department of Health has granted the firm approval to begin processing patient samples from the state for its miRview mets^2 test.

By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – Quest Diagnostics today said that its Simplexa Dengue molecular diagnostic test kit has been approved for use in Brazil for public and private health labs.

By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – China Medical Technologies today announced that its PCR-based KRAS assay has been approved in China as a companion diagnostic for an undisclosed drug targeting colorectal cancer.

By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – Gen-Probe announced on Monday that its Panther molecular testing system has received clearance from Canadian regulators for marketing there.

In a new draft guidance, FDA suggests drug and IVD companion Dx developers with dependent tests apply for review concurrently.

The firm received Japanese clearance to market the systems for in vitro diagnostic applications.

The FilmArray Respiratory Panel is a multiplex nucleic acid test designed to simultaneously detect 15 respiratory viruses.


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.

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

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.