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 FDA granted clearance to consumer genetic testing company Ancestry.com for the over-the-counter use of a health risk test for hereditary thrombophilia.