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FDA clearance

The company's newest products and planned updates reveal a focus on operational efficiency and increasing automation for core lab management.  

 

The Cobas vivoDx MRSA test uses new bacteriophage technology based on bioluminescence to detect bacterial colonization in nasal swabs.

In the long term, the company is developing a plan to create more tests based on its technology, which digitizes blood samples and turns them into images.

The FDA approved FoundationOne CDx as a companion diagnostic for alpelisib in combination with fulvestrant to treat certain PIK3CA-mutated breast cancers.

The companies gained FDA approval for the Liaison QuantiFeron-TB Plus Test, an automated workflow and assay for latent tuberculosis detection.

The approval of its Omics Core assay for tumor-normal mutational profiling opens the door for payor reimbursement, which is key to reaching profitability, NantHealth said.

In one of two clearances in October, DiaSorin got the nod to market its Liaison XL Zika Capture IgM II test for the detection of Zika virus IgM antibodies. 

The company's Liaison XL Zika assay previously received Emergency Use Authorization from the FDA in 2017.

Hardy Diagnostics has partnered with NG Biotech to exclusively distribute the 15-minute test in the US. It has also brought it through the US regulatory process.

Ortho said that its fully automated technology helps extend antigen phenotyping and ensures delivery of safe blood to transfusion patients.

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