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FDA clearance

The PCR-based test can simultaneously detect for the Zika virus, all serotypes of the dengue virus, the chikungunya virus, the West Nile virus, and a host gene. 

The iC-System is based on on iCubate's amplicon-rescued multiplex PCR technology, which detects multiple pathogens simultaneously.

The US Food and Drug Administration yesterday granted emergency use authorization to Thermo Fisher Scientific's TaqPath Zika Virus Kit.

The new version of the mass spectrometry-based system adds 144 microbial species to its database and includes new tools for sample preparation.

The control, being launched for the immunoassay-based tumor marker testing space, features HE4 and HER-2/neu, and outside the US, proGRP and SCC. 

The clearance provides clinicians in emergency departments, intensive care, and other hospital units with a tool for antibiotic stewardship.

The trial aims to validate a biomarker panel that includes Volition's colorectal cancer test in a large asymptomatic population in support of US regulatory approval.

The agency cleared the firm's test which provides a complete and simultaneous analysis of Giardia, Cryptosporidium, and Entamoeba histolytica.

NGeneBio is moving ahead with plans to have the test cleared for diagnostic use in Korea, while envisioning a 2019 submission to the US FDA.

Thermo Fisher Scientific's PCT assay for the diagnosis of sepsis was among a few tests that received 510(k) clearance last month.  

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