510(k)

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.

The assay is part of a respiratory testing menu that includes assays for Bordetella and Flu A/B & RSV, and NxTAG and Verigene respiratory pathogen panels.

The multiplexed assay is the second available on the Panther Fusion system and the FDA is reviewing a third, the Panther Fusion AdV/hMPV/RV assay.

Pages

Researchers have sequenced the northern white rhinoceros to gauge whether it could be brought back from the edge of extinction, the New York Times reports.

Bavaria expands its forensic genetic analyses to include DNA phenotyping, raising discrimination concerns.

Tufts University researchers found a role for miRNA in transmitting stress between generations, the Economist reports.

In Science this week: gut microbiome influences liver cancer growth, spread; and more.