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A recent study established high sensitivity and specificity for three CLIA waived point-of-care molecular flu tests in pediatric samples.
Foundation Medicine's liquid biopsy test will be used in the third stage of SCRUM-Japan, which focuses on advanced cancer patientsin Japan and other Asian countries.
China remains a key strategic market for Roche, and it said that it has multiple assays for 2019-nCoV coronavirus for research-use only.
Roche's overall revenues increased 9 percent, with an 11 percent increase in pharmaceuticals along with the rise in diagnostics revenues.
Since 2017, the companies have been jointly developing an in vitro assay for measurement of sTREM-1 in plasma samples of septic shock patients.
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.