510(k)

The test detects and distinguishes pertussis and parapertussis in nasopharyngeal swab samples. It is for use on the Quidel's Solana MDx instrument.

It is the first of three ePlex molecular multiplex panels for the diagnosis and management of bloodstream infections that can lead to sepsis.

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.

The test is designed to identify a tumor's tissue of origin by assessing 2,000 individual genes and covers 15 common tumor types.

Farsight Genome Systems is touting the rapid scalability of its analytic pipeline as it seeks to make its technology "future-proof" for clinical genomics labs.

The Xpert Xpress Flu can detect both influenza A and B virus in 20 minutes from either nasopharyngeal or nasal swabs.

The Gastrointestinal Pathogen Panel is the first of a number of planned infectious disease syndromic panels on the firm's PCR-based system. 

The firm's Group A Strep test for use on its Sofia2 analyzer also received CLIA waiver from the agency.

The new assay — the third FDA cleared respiratory test that runs on the Panther Fusion System — detects adenovirus, human metapneumovirus, and rhinovirus.

The authorization implements regulatory strategies the FDA advanced with industry stakeholders, though labs may still be more inclined to take the CLIA route, as long as it is available.

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The New York Times reports that genetic testing has uncovered unfaithful penguins at a Utah aquarium.

Cancer researcher loses funding under new Wellcome Trust anti-bullying policies, the Guardian reports.

In Science this week: International Wheat Genome Sequencing Consortium publishes the bread wheat cultivar Chinese Spring reference genome, and more.

At his FDA Law Blog, Jeffrey Gibbs discusses FDA's technical assistance for the draft Diagnostic Accuracy and Innovation Act.