Roche Diagnostics' revenues were driven by its centralized and point-of-care solutions as well as its tissue diagnostics business, both rising in the high-single digits.
The court ruled that Roche's claims are patent-ineligible because they are "directed to a natural phenomenon and lack any inventive concept" for a patent.
Becton Dickinson got clearance for a platform and test for the rapid identification and determination of antimicrobial susceptibility of gram-negative bacteria.
The mobile approach enables stroke patients to be assessed within the three-hour window for stroke treatment.
In some instances, Ventana said, a retrospective review and retesting of clinical cases using the affected dispensers would be necessary.
The test uses the same blood draw of a routine health exam and was designed to be unaffected biotin, a vitamin supplement that may skew some lab test results.
Qiagen's partnership and merger agreement with NeuMoDx may help it compete with high-volume molecular testing vendors such as Abbott, Hologic, and Roche.
The agency cleared a broad array of in vitro diagnostic tests, including assays for influenza, whooping cough, sexually transmitted infections, and opioids.
The companies initially expect to incorporate a CDx for Incyte's pemigatinib into Foundation Medicine's existing FDA-approved assay, FoundationOne CDx.
The university health system said that it reduced incorrectly prescribed antiviral prescriptions by almost 11 percent at the sites where it installed the Roche Cobas Liat PCR test platform.