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Roche Diagnostics obtained a claim expansion for its Cobas CT/NG assay, which uses real-time PCR to detect Chlamydia trachomatis and Neisseria gonorrhoeae DNA.
The Helix Laboratory Platform is the first whole-exome sequencing platform to receive do novo authorization by the agency and paves the way for others.
The firm said that the next-generation analyzer has a throughput of 1,200 tests per hour and a large test menu that includes comprehensive panels and specialty tests.
The firm said its test fits in the palm of a hand and delivers results in 30 minutes by detecting bacterial nucleic acid in throat, nasal, or nasopharyngeal swabs.
The FDA cleared a CellaVision test that provides differential counts of white blood cells, characterization of red blood cell morphology, and platelet estimations.
Fujirebio Diagnostics got the nod for a chemiluminescent enzyme immunoassay to measure levels of CA 15-3 and manage patients diagnosed with breast cancer.
The single-use, multiplex immunoassay provides results in 15 minutes and detects antibodies to HIV types 1 and 2 as well as Treponema pallidum.
The single-visit blood test is one of two FDA-cleared alternatives to the traditional tuberculin skin test, according to Oxford Immunotec.
The additions improve the system's performance and expand its antimicrobial susceptibility testing menu for bloodstream infections.
The FDA granted clearance to consumer genetic testing company Ancestry.com for the over-the-counter use of a health risk test for hereditary thrombophilia.