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The test adds to a menu of transplant monitoring assays that includes cytomegalovirus, Epstein-Barr virus, and BK virus.
Illumina will grant Roche rights to develop and distribute IVD tests on its Dx sequencing instruments, while Roche will help expand the CDx claims for Illumina's solid tumor panel.
Luminex got the nod for a qualitative test used to simultaneously detect and identify nucleic acids from respiratory viruses and bacteria.
The approval will allow clinicians to identify NSCLC patients with ROS1 fusion genes who could benefit from treatment with Rozlytrek.
The Cobas Zika test is for use on Roche's Cobas 6800/8800 systems to screen blood donations and detects Zika virus RNA in samples of human plasma.
The company's newest products and planned updates reveal a focus on operational efficiency and increasing automation for core lab management.
The company's Accu-Check SugarView app determines blood glucose ranges without a blood glucose meter by taking photos with a smartphone camera.
The Cobas vivoDx MRSA test uses new bacteriophage technology based on bioluminescence to detect bacterial colonization in nasal swabs.
The grants were awarded through the organization's Diagnostic Accelerator, a partnership between the charity and various philanthropic partners.
The FDA approved FoundationOne CDx as a companion diagnostic for alpelisib in combination with fulvestrant to treat certain PIK3CA-mutated breast cancers.