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CE mark

The company has aspirations for a combined molecular/immunoassay platform, but plans to go to market with a 22-target real-time PCR-enabled syndromic panel.

The Alabama-based firm has grown its infectious disease testing menu for the BD Max system to six CE-marked tests identifying bacteria, viruses, or fungi.

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.

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The American Prospect writes that the pilot program to test the DNA of migrants could lead to more family separations.

An international commission is to develop a report on how researchers, clinicians, and regulators should evaluate the clinical applications of human germline genome editing.

The US Department of Agriculture presents a new blueprint for animal genomic research.

In Genome Research this week: repetitive element deletion linked to altered methylation and more in form of muscular dystrophy; human contamination in draft bacterial and archaeal genomes; and more.