CE mark

The firm said that its CE-marked ePlex Blood Culture Identification fungal pathogen panel is the first of three tests that will become part of its sepsis solution.

The firm said that prior to obtaining US regulatory clearance, it's making the assay available for use as a lab-developed test by US laboratories with CLIA approvals. 

The test was recently submitted to US regulators and is expected to start contributing to Great Basin's revenues in the second half of the year.

The firm can now sell VeriSeq NIPT as a CE-IVD in Europe for trisomies 21, 18, and 13, as well as some sex chromosomal aneuploidies. 

The Liat point of care system system has launched with four assays, including three respiratory tests and a novel test for Clostridium difficile.

The firm also plans to list its cardiac troponin I assay as CE marked and plans to submit data to the FDA for clearance of its Clarity system and assay in 2018.

The test for cervical cancer screening previously received the IVD mark and US Food and Drug Administration approval on the Cobas 4800 system.

The assay can be used to identify patients suitable for treatment with ALK-targeted therapeutics such as Pfizer's Xalkori.

The firm is now launching the test in Europe, supported by results from a multicenter prospective study showing high sensitivity in detecting bladder cancer.

The company's Barocycler 2320Extreme is now available to the European biopharma market.

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The World Health Organization has announced the members of its gene-editing committee, according to NPR.

DARPA is working on developing algorithms that gauge the credibility of research findings, Wired reports.

The American Society of Breast Surgeons recommends all women diagnosed with breast cancer be offered genetic testing, the Washington Post says.

In Science this week: comparison of modern, historical rabbit exomes uncovers parallel evolution after myxoma virus exposure; and more.